Natural health approach is more likely to help you lose weight faster than some commercial products, suggesting that you can lose weight in less time if adhere us only their suggestions in conjunction to take prescribed pills.

To be honest, we all know that it is false statement with little corroboration said the truth in support of their exaggerated allegations. However, there are ways to lose weight weight loss pills "fad" and non-conventional regimes. This "new way" has in fact been around hundreds of years, and it is only starting to re-emerge in response to the problems of substance quick-fix solution companies.

Natural health is the best way to lose weight and feel great about yourself. We have all necessary to shed some weight at some point and time in our lives. The answer is simple and easy to reach: natural health becomes a craze not because it uses the same method as the "fad diets", but for exactly the opposite reason - it guarantees to lower your weight if you are ready to join a plan for long-term good health.

It is all about good research while ensuring that feel you well indoors, the difference of various schemes to the "mode" which help us lose weight, but which may obstruct the until our arteries. Natural health help in large research outside while helping you clean your body inside to ensure feel you 100% most of the time.

There are a million similar diets out there that you can select from, but once you have experienced natural healthy way, you will need to return to tried quick solution, commercial DCP that will feel you as soon you become progressively more healthy every day.

Bob Cotto spent much of his life as a SR. sales and Marketing Executive. Two years ago his wife of 43 years, Joanne said that she had stage 4 cancer. Since then, Bob and Joanne have devoted all their energy to help him maintain a high quality of life. To learn more about its efforts in its 4-ideal-health [http://www.4-Ideal-Health.com/] site

Our review of the diet Solution program is a program that guarantees an increase in your overall health and energy levels, coupled with an abundance of weight loss.

If you are looking for a weight loss program that can help you burn excess body fat and increase your energy on a daily basis, while improving the health of our body, the diet Solution program can be done for you.

There are many different programs, that promise a weight loss and fat burning, but there are differences in this program, compared to the rest.

We will first have a look at the brains behind the creation of this program, and then we can cover some of the basics on the program itself. With more than 10 years of experience working with clients to help them lose weight, burn fat and improve health conditions such as high cholesterol, heart disease and diabetes, specialist in nutrition and exercise Isabel De Los Rios has created this program. With a concentration of the physiology of exercise and nutrition, education of Isabel covered both of these fields in all their aspects. Inspired by the struggle of the staff for the most valuable nutrition information that she could find, Isabel has undergone its own problems with additional weight. More than 15 years of scientific research and clinical study went in the diet Solution program.

Unlike most of the mainstream of all experts various so-called nutrition programs, Isabel has a very unique approach to the problems of loss of weight and health, something that customers have tendency to really appreciated. There is so much information available on the loss of weight that it can be confusing and difficult to wade through all this. Isabel passes through it and provides the facts.

With more than 10 years as a nutrition and exercise, Isabel specialist has helped hundreds of its own private clients lose weight and get healthy with his successful healthy weight loss program. It is through this hands-on experience with real clients combined with the fact that it has learned through his education which helped solidify the formula behind his program. Irrefutable proof exists because its customers have lost weight and obtained better health.

From many other mainstream nutrition programs, principles of Isabel as displayed in his articles and methods are seen as quite radical to other schools of thought. You must orient yourself this program is waiting for you get the same old tired nutrition information that you have seen time and time again.

Many people wonder what the diet Solution program is, and according to Isabel itself, it is the guide more comprehensive and more specific nutrition and health available in the market today. The program will teach you what you know to achieve your weight loss goals teaching the principles behind the program and providing lists of stores, recipes and meal plans to make it simple. Other programs recommend silly extremes down weight. You can use this plan to make changes in lifestyle that this nutrition plan will become a way of life. As with any other program of weight loss, indicated most know that it is important to find a program that can be easily maintained throughout your daily life and activities. While other plans have very stringent ideas about eating plans, Isabel program provides a plan that is easier to follow. You can lose the weight you want and maintain weight loss that achieve you, by eating food that you like in the good combination.

Everyone who has followed this program has reported an increase in their energy level and improved their overall health. With the benefits of weight loss, people have reported improvements in their blood sugar, clearing of skin problems, the decline in their cholesterol levels, better digestion and an overall increase in their energy levels.

Most of the people who use this program highly recommends to their friends and family. You might ask why. I have tried many other programs where I achieved weight loss, but felt terrible in the process. I was simply tired of yo yo diets and programs that did not work. I am not interested to go to extremes. But I don't want to be at a healthy weight, while having a decent level of energy and maintain my overall health and well-being. You can lose weight, feel better and increase your energy while doing the diet Solution program.

Obviously, you need to do the work yourself, the weight is not just falling, but Isabel makes it really easy success. Its program includes the following:

* A plan to apply the principles, which includes detailed, instructions you can follow step by step.

* A full meal plan which will be a breeze to eat every day.

* Grocery list to help you easily select all what you need to store each week.

* Succulent recipes that will help you to remain on track with delicious choices.

You get everything you need in its manual. There are a ton of useful and important information included. You can also start the program until you have finished reading the full manual. It is not necessary to wait. Isabel has included a Quick Start section following you its program quickly and easily. In fact, using the Quick Start Guide, many people have reported losing 10-15 pounds in about 6 weeks.

You will find that the diet Solution program is not like any other diet or weight loss program. It is a comprehensive plan to help you become healthy and achieve your goals weight loss. You will perhaps be someone who has faced problems of weight your life. The diet Solution program will be down you go merry of the weight loss round and a plan to change your life and finally lose the weight. If you are faced with heart disease, diabetes or high blood pressure, the diet Solution program is an excellent choice for treating these conditions, as well.

If you're at all interested in this program, there should be efforts to look more closely at what it offers. Everything that you need plans the meal, the guarantee and premiums - are all included with the diet Solution program. Ignore the diet pills! This program is the best bang for your money on the market of weight loss.

It becomes increasingly clear that fad diets simply do not work. For those of us who are beginning to see the light and start taking responsibility for our own health weight loss plan, it's good. We are through fashion once and for all plans. We begin to get the message that we were sold a bill of goods. Not that some regimes are completely evil, but we begin to see a larger image the most promising for our total health weight loss plan.

It is more blind restrictions in what we should eat or not eat, but to understand why. When we understand why, as is the case in an arena, it gives us a more advantageous position of why we should follow in the next step, which performs the power action. Understanding empowers the action.

That said, we take a quick glance, sugar, for example. We have heard too much is bad for us, even if we crave the taste in foods we choose to eat. Eat sweet stuff can be a treat, but if we were to discover that the surplus of sugar has negative consequences for our health, our decision to slaughter them could play as a power action.

Medical journals and science reports supports the following ten to take too much sugar in the diet.

(1) Sugar suppresses the immune system - a can of soda (containing eight spoonfuls of sugar table) can compromise it by 50%!

(2) Excess sugar disrupts the mineral relationships in the body causing chromium and copper deficiency.

(3) Can cause a rapid increase of adrenaline, hyperactivity and crankiness in children.

(4) May cause an increase in bad cholesterol type. (5) Loss of elasticity and function in your body tissues.(very bad)

(6) Sugar nourishes cells cancer-connected to the development of breast and ovarian cancer.

(7) May cause reactive hyperglycemia.

(8) Can weaken the view.

(9) Can cause premature aging.

(10) Excess sugar contributes to obesity.

("Lick the sugar habit" - Nancey Appleton.) (PhD.)

In this example, you can see how excess sugar can kill you. If not, there are specific advantages to descend on the absorption of sugar into our total health weight loss plan.

If this information was useful and that you have an interest in follow-up on the loss of total weight of the health plan, please go here: http://netspin.blogspot.com/2009/07/total-weight-loss-plan.html and scroll to the bottom. There is a link to more useful information.

English born Stephen John Baker is a contributor and the source of several blogs.

He is a lover of the floor and the music of the soul. He is singer-songwriter, composer, engineer (Mr. Stevi B and Intergalactic light Machine) and is also a lover of freedom as a citizen of the great country that this world has ever known, the United States of America. Yes, I guess you could call him patriotic and proud to be. It is also a great supporter of the adage "knowledge is power" and is a believer that understanding gained knowledge is what infact, empowers action, particularly in the arena of health weight loss: [http://eatingoutdiet.com]

You ask yourself: vitamins are good for losing weight? If you have heard that there are certain vitamins that make losing weight faster and more efficient, you are quite correct. This article will discuss why take vitamins is important and refers to the types of vitamins which are the best to lose weight. If you are looking to lose weight in the coming months, these tips can make a big difference in your quest to lose weight.

Everyone knows that the vitamins and minerals is a fundamental requirement to achieve optimal health. While some vitamins are easy to obtain the diet of healthy eating based on vegetables, fruits and cereals, other vitamins are better taken as pills for convenience and efficiency. For example, eating dozens of gloves garlic believed one day is unrealistic, you can simply take a capsule to obtain the same result without indigestion and discomfort.

The question remains: vitamins are good for losing weight? Assuming that you already take a multi, calcium and magnesium and vitamin D, and any other personal vitamins for the maintenance of your health, we can proceed to answer the question of the vitamins better take to lose weight. Don't forget that if you 25 years as a fit and healthy your vitamin requirement be different if you are a man aged 60 year that eats junk food and animal products regularly.

The supplement that is gaining in popularity more to lose weight is green tea in a capsule form. It is pleasant to drink green tea, but the amount of active ingredients that aid in weight loss is not sufficient when simply take green tea in the form of a drink. Many brands now wear the capsules, so make sure you read the label to determine how many a day, you have to take green tea. Green tea capsules are usually better with a meal.

Garlic also helps to lose weight, but are much more for your health that just help get you a line of limited size. Garlic promotes cardiovascular health and is ideal for the regulation of blood pressure more it helps with weight loss. Make sure that you get a vitamin garlic to at least 200 mg of garlic by the pill. Some market brands include only 5 mg tablet. Visit your naturopath, natural health practitioner or a physician for a vitamin scheme custom designed specifically for you.

The majority of people these days are in need of assistance and support they can get when it comes to losing weight and I am sure that you are not different. There are several ways and methods to lose that weight extra nasty side, but one of the springs particularly in mind is water consumption to help lose weight. I'm sure you've heard many people say that drinking water is good for losing weight right? Well for not everyone believes that it is true, in fact that some believe in this particular theory. Let us now go into the details to see if indeed drinking water help weight loss.

Now, should not a genius to discover that the only way to ensure that you lose weight effectively must have less calories that you use every day through your daily activities. The question is what role water plays in this particular weight loss process?

Plenty to drink and water can do no harm what so ever your body unless you have a water retention problem that if you do then it is best to consult your doctor before trying to even such a diet that involves overload of water consumption. The reason that you can drink as much water without great concern is that the water, unlike most foods contain zero calories, which means that you put on weight at all but feel comprehensive at the same time. This psychological effect plays mind thinking about your body can no longer eat anything else, including any food because of the extra water in the body.

Soft drinks and most beverages, you do not have to think more when it comes to drinking water and in fact it should become part of your daily life more regularly as not only could he help weight lossbut also your overall levels of health and fitness.

What is water is that it completely cleans your body system, making it the best form of liquid you can eat. Soft drinks or any drink with too much sugar should be withdrawn or significantly reduced to the minimum consumption if you really want to lose the extra weight.

Not only are these soft drinks contain loads of sugar and calories but are also filled with artificial ingredients which is not ideal if you try to lose weight. Drink just a couple of cans of soda per day could be the reason for which you take weight through unwanted extra calories and replacing them with plain water can probably help you to stop taking the weight and you start on your way to weight reduction. He gets no simpler than this.

I understand the water is not the thing better tasting on the planet, but there is a solution to this. You may not a fan of the taste of water, but it is interesting to know that source water has a flavor that differs according to the mark. This is certainly good news for you if you're not a fan of the taste of the water so that you can persistent source water, until you find one that is in agreement with your taste buds. Another advantage of the spring, the water is that, in some cases, source water does capacity not harmful bacteria and is actually cleaner than even the water from the tap. Many people did not know much about the availability of water sources due to their constant drinking tap water simply but believe me some brands taste water in the wonderful spring to not lose hope and continue to try to find one you like the most.

Back to why drinking water is good for losing weight, always remember that water can never replace permanent food, but it should always be a part of your daily eating 2 to 3 boxes of baking soda or a drink unhealthy that you would consume every day. Another point to note is that from each day with a large glass of fresh water can help make you and your brain much more active. Start therefore replace your soft drinks for the healthier option of water today!

If the water is not consumed the majority of the day, you will start noticing symptoms such as fatigue, feeling lazy, or even painful headaches. If water actually helps the brain much better work and you can stay alert and active throughout the day.

As human beings, we all need water due to its wonderful benefits and the important role it plays in our global service corps. That said, now you know why drinking water is good for losing weight that it may be the best solution, you may receive to get rid of this unwanted extra weight from your body.

The old pants that you just would be is more adapted and you feel that you have become heavier you should be.  If you have come to decide that it is time to start you with a healthy weight loss plan.  Here are a few guides that you can follow to start with your healthy weight loss plan.

Keep a log of healthy weight loss

Keep a health lose weight log will you wonders even if it is just a simple thing to do.  Here you will write your goals and keep the simple feelings that will help keep you going through with your plan to lose weight.  Here you will write down all the encouraging progress, that you have done that you have something to remember when you need motivation.

Eat right

In pursuit of you health lose weight plan, you will need to make the necessary change in your diet and lifestyle.  You must be aware of healthier options around you and avoid the more unhealthy.  Read and learn more about the alternative of healthier eating.  For example, in your research and reading, you could be learning instead of rice and milk, more healthy are the skim milk and brown rice.  So be aware that you will be able to identify what are right for your body and a healthier new you.

Portioned meals

Learn how to control your food intake.  Yes, eating is important and necessary, but only this amount is really necessary.  Only will the rest of the additional amount you bad in the long term.  Eating is a big mistake.  Be discipline enough to say no to the delicious cuisine when you already know your body had its fill.

Move your body.

Everyone knows that it is essential to lose weight to move your body and exercise.  This will keep your body healthy and in shape!  Exercise will help you to strengthen your muscles and also to regulate the activities of your cardio vascular.  A walk outdoors every day, jog or run will be not only to put you in good shape, but also will make you feel good, better and healthier.  This is a good feeling sweat reason to exercise or work rather than just sweat because it's a hot day.  Studies show that the things every day or activities you like fidgeting, little is already a more about your healthy weight loss!

Viral videos have become very popular recently. It could be due to the human need to experience something funny, in light of all the recent bad news with weather, Japan's devastating tsunami and nuclear plant issues, along with the trouble in the Middle East. Balancing bad information with good emotions is how humans cope with a negative environment. That's why videos produced by amateurs showing double rainbow sightings, twin baby boys chattering baby-talk to one another in front of a refrigerator or pets doing silly things make us laugh. We watch, we laugh and then we send the video to as many of our friends as we can so they can laugh as well.

Seton Diabetes Education Center and the National Diabetes Education Program invite you to take the Diabetes Risk Test (available in English and Spanish) to see if you are at risk for developing diabetes.

After double rainbow video you may want to count the different colors in the food you're eating each day. A diet rich in a wide variety of colorful fruits and vegetables can make you feel good and it has been shown to improve your health.

March was National Nutrition Month and the spring and summer months are THE BEST time to make changes in your diet. Plant nurseries and Farmer's Market vendors are selling fruit and vegetable plants to place in your garden. The grocery stores are starting to stock more local produce which contributes to lower prices. The incredible depth and breadth of fruit and vegetable choices make spring and summer a wonderful time to rethink your diet and build up its nutritional strength.

Start simple. Throughout the month of April, try adding one new fruit or vegetable to your breakfast, lunch or dinner each week so that by the end of the month, you will have added five new nutrient dense foods to your diet. For added variety and balance try to pick both new fruits and new vegetables over the course of the month.

Fast and easy ways to add an extra fruit or vegetable to your meals:

Sprinkle blueberries, raspberries, strawberries, or blackberries with cinnamon on your morning oatmeal (berries are also great on top of mixed greens drizzled with balsamic vinegar and olive oil)Top scrambled egg whites with salsa then add some diced green, yellow or orange bell peppers and mango piecesAdd fresh sliced pears or peaches sprinkled with nutmeg to your morning yogurtAdd spinach and mushrooms to your omeletTry chopped beets, avocado and black beans on your dinner saladAdd sliced cucumbers (instead of pickles) and shredded carrots to your sandwichLayer sautéed roasted red peppers onto your grilled chicken or fish with some freshly squeezed lemon or lime and pepper, served with a small side of sweet potatoes.

Fruits and vegetables are colored by natural plant pigments called phytochemicals, which are which are a wide variety of plant compounds and you may know them by other names, such as; antioxidants, flavonoids, flavones, isoflavones, catechins, anthocyanidins, isothiocyanates, carotenoids, allyl sulfides and polyphenols. According to the American Cancer Society, scientists have identified thousands of phytochemicals, although only a small fraction have been studied closely. Some of the more commonly known phytochemicals include beta carotene, ascorbic acid (vitamin C), folic acid, and vitamin E. Phytochemicals are promoted for the prevention and treatment of many health conditions, including cancer, heart disease, diabetes, and high blood pressure.

Scientists are in agreement and report that a diet rich in fruits and vegetable can help:

Lower cholesterol and blood pressureReduce risk of certain types of cancerReduce the risk of birth defectsLower risk of developing cataractsImprove memory functionImprove immune functionProtect cells from damageLose weight and maintain loss

Eat fruits and vegetables from the color spectrum, including:

Red (colored by lycopene and anthocyanins) Tomatoes, beets, radishes, red potatoes, red peppers, red cabbage watermelon, guava, strawberries, raspberries, pink grapefruit cherries, red apples, red grapes, rhubarb. Orange/Yellow (colored by cartenoids like beta carotene) Apricots, cantaloupe, peaches, pineapple, mangoes, pears, yellow apples, papayas, yellow & winter squash, sweet potatoes, carrots, yellow peppers, sweet corn. Green (colored by chlorophyll, indoles, lutein, zeaxanthin) Avocado, leafy greens, spinach, artichokes, green beans, cucumbers, peas, Zucchini with skin, broccoli, Bok Choy, green peppers, kiwi, green grapes, Honeydew melon. Blue/Purple (colored by anthocyanins) Blueberries, plums, prunes, raisins, purple grapes, eggplant with skin. White (colored by anthxanthins) Bananas, cauliflower, garlic, mushrooms, onions, jicima, white potatoes.

Ingredients

1 medium to large banana
3 - 4 medium carrots*
1 red apple*
1 orange*
1 handful of fresh raw spinach
1 cup of organic blueberries
2 - 3 organic strawberries
1 teaspoon coconut oil
2 ounces yogurt of choice

Optional Ingredients

1/2 - 1 teaspoon spirulina powder
1 ounce wheat grass juice
2" x 2" section of nori (roasted seaweed sushi paper)
1 - 2 scoops of whey protein powder
1 - 2 egg whites

* You can process these fruits and vegetables through a juicer or you can add them raw to the blender. Adding directly to the blender will provide more fiber and make for a thicker juice. The optional items will alter the taste but will add more vitamins, minerals and protein to the mix.

Kimberly M. Morris MS, RD, LD, CDE

Kimberly is a Registered and Licensed Dietitian with Seton Diabetes Education Center. Seton Diabetes Education Center offers diabetes education for adults with Type 1, Type 2, Gestational and Pre-Diabetes. Sign up on GoodHealth.com for events offered by Seton Diabetes Education Center. Next upcoming free event:

Diabetes Prevention Seminar
Designed for persons with pre-diabetes or at high risk of developing diabetes.
May 4, 2011
6:00 to 7:30 pm
5555 North Lamar Blvd
Building D, Suite 125 Austin, TX 78751

Would you like to have your cake and eat it too? By adding an authentic "traditional balsamic vinegar" to any meal you get to eat healthy and decadently delicious at the same time.

Balsamic Vinegar was a well-kept secret in the Mediterranean until recent years. Unlike the typical balsamic vinegars found in America that are made from wine, true Traditional Balsamic Vinegar begins as the juice of the Trebbiano grape. In small towns in the Modena and Reggio Emilia areas of the Emilia Romagna region of Italy, families have been perfecting the production process of traditional balsamic vinegar for over 1000 years.

Ask The Expert! Olive Oil and Balsamic Vinegars
Olive Oil and Balsamic Vinegars: History, Health Benefits and Sampling
Wednesday, June 1, 2011
6:30 to 8 pm

Seton Diabetes Education Center
5555 N. Lamar
Bldg. D, Ste 125
Austin, TX 78705

Register

The grapes are typically harvested late in the season, and the juice is simmered to concentrate the juice before it is poured into vented kegs, where airborne yeast ferment the natural sugars in the grape juice to alcohol. Bacteria then convert the alcohol to acetic acid (vinegar). The complex flavors change as the product is aged for at least twelve years, though some traditional balsamic vinegars are aged for over 100 years

Balsamic vinegar retains all the minerals, antioxidants and flavor components of the grape juice. Because grapes are low sodium and low fat, the balsamic vinegar is also low in sodium and fat content, with typically only 2-4 Calories per tablespoon--carbohydrate is the calorie source. Balsamic vinegar contains calcium, iron, magnesium, phosphorus, potassium and manganese, because these minerals are present in the grapes and concentrated by the production process. Balsamic vinegar also retains the polyphenols (known for cancer fighting health benefits) and quercetin, an antioxidant that strengthens the immune system. The complex flavors of different balsamic vinegars result from the interaction of the wood containers with the juice, alcohol, flavor components of the grapes, and acetic acid over time. Families guard their balsamic vinegar production secrets closely…..cherry wood or oak wood can significantly change the taste of the final product. Aging also plays an important role in developing a desired flavor complexion--vinegars are bitter in the early years but the flavor is smoother with aging.

Balsamic vinegar adds a unique and complex flavor to salad greens when paired with a complementary oil, to marinades for meats and seafood. Balsamic vinegar can be infused during the aging process with other fruits or flavor components. These products can be reduced to further concentrate flavors for sauces.

Balsamic vinegar can be a flavor powerhouse. For persons with diabetes, the low pH helps slow the absorption of carbohydrates eaten at the same meal. One small study demonstrated that 2 Tbsp vinegar did lower the post-meal blood glucose in 10 subjects Balsamic vinegar is a healthy addition to the diet for persons with diabetes or heart disease, as well as persons trying to lose weight.

If you would like to learn more about balsamic vinegar and olive oil as part of a healthy diet, please join Seton Diabetes Education Center on June 1 to hear Jeff Conarko speak on the fine art of incorporating balsamic vinegar and olive oil into a healthy diet. Product sampling will be part of the presentation. Jeff Conarko imports balsamic vinegars and olive oils to his store here in Austin. Registration for this exciting event is open online, or call (512) 324-1891 for more information.

Ingredients

• 2 pounds pork chops
• 1/2 cup Con' Olio Manzanillo EVOO
• 1/4 cup Con' Olio Cinnamon Pear Balsamic Vinegar
• Sea salt and ground black pepper to taste

Directions

Mix balsamic, olive oil & salt and pepper in a glass bowl and pour in over chops, seal in a Ziploc and refrigerate for two hours. Grill over medium heat for five minutes a side.

Tatum Rebelle, now Tatum Maguire after her recent marriage, is a one-person exercise dynamo in Austin, Texas, and a certified pre- and postnatal fitness and nutrition expert and founder of Total Mommy Fitness. She makes fitness fun and feasible with custom designed conditioning and nutrition programs for families and especially mommies. Her clients range from women who are preparing their bodies for pregnancy to those that already have children and feel their exercise and nutrition routines have reached a plateau.

Total Mommy Fitness currently provides training at Castle Hill Fitness, located at 12th St. and Lamar Blvd, as well as in-home and outdoor training in Central Austin, Tarrytown, Westlake, Circle C, Lakeway, Oakhill and Online.Learn more about having your baby at Seton . Tatum's desire to create Total Mommy Fitness began when she worked as a trainer for popular gyms. She repeatedly observed that most of the women stopped exercising once they got pregnant. With this information in hand, Tatum decided to deepen her expertise by studying pregnancy exercise.

The latest research surprisingly disproved everything she had previously heard; not only can women stay physically active during pregnancy, but the benefits of doing so seemed endless. The excitement of this new information spurred her desire to share what she had learned with expecting mothers, to help them to continue their personal fitness throughout their pregnancy, and after.In this video, Tatum demonstrates stretching and core strengthening exercises for pre and post natal mothers.

2002 PGA Championship winner and Austin resident Rich Beem was interviewed last month on The Horn (104.9 FM) by Chip Brown and Erin Hogan on The Morning Rush show. One topic was his recent back surgery by Dr. Daniel Peterson of Austin Brain & Spine, a division of the Seton Brain & Spine Institute. Here is what they said:

Rich, you were sidelined because you underwent back surgery to repair some vertebrae and now you're playing on a medical exemption this year. Talk about your situation and how you're feeling and what's next for you.

Last year, about this time, actually, I was diagnosed with a herniated disk and had to go in and get an MRI. I found out [about the herniated disk] from my doctor, Dan Peterson, there in Austin, who's a fantastic doctor and just really, really helped me out just immensely. You know, he spent almost an hour with my wife and me. He went through the process and said, "This is what's wrong with your back and there's a bunch of different ways to attack it. If your disk is herniated as bad as it was, your best option for you to be competitive is to have surgery done."

I've heard a lot of people talking about how they've got disk problems, back problems - and the last thing they want to do is go under the knife. They're going to get injections and figure out a way [to get] through it. I'll tell you what, Dr. Peterson put me so at ease that, by the time I walked out of there, I went straight to the hospital - I signed up and it was a no-brainer.

And I'll tell you what - it was absolutely life-changing. My strength is coming back. It's almost 100 percent back. It [herniated disk] changed the way I swung the golf club. I got into some really bad habits because of the degeneration of the muscles on my right side. I just couldn't swing it [a club] the way I normally did. After the surgery, I'm able to kind of get back into swinging it like I used to - and it's making the game exciting again. It was probably one of the best things that could have happened to me - which is kind of funny to say, that I had back surgery and it was great!

Sometimes it's the thing you need to get back on track.

Temperature only tells half the story. When factored with the relative humidity, the result is called the Heat Index, which describes how hot it feels outside. We were surprised to learn that there's only a few hours during the day that aren't under a cautionary flag.
The Heat Index is the one number you should listen for in weather reports more than any other if you are going to be outside and engaging in physical exertion whether for fun, exercise or work. If the numbers reach a dangerous level mid-morning and last throughout the evening, you may want to reschedule your physical activity to the earliest possible time in the morning.
If you look over the numbers below*, you'll see how early in the day the heat index climbs past 80 degrees. In addition, once the heat arrives for the day, it tends to stick around all afternoon and into the evening, usually not dissipating until early morning.

* The shaded values reflect degrees Farenheit. The heat index data was recorded and reported by Wunderground.com on August 5, 2006.Exposure to full sunshine can increase heat index values by up to 15 °F.
Heatstroke possible with only brief activityHeat cramps, exhaustion, headaches after brief activityHeat cramps, exhaustion, headaches after prolonged activityExercise causes fatigue more rapidly.
Switching your physical activity to early morning can have additional benefits as well. Once the sun comes up on clear days, the Ultraviolet Index also rises, increasing the risk of sunburn and other ill effects of ultraviolet light. As the summer months fall within the Ozone Season, further benefits can be gained by exercising early before ozone levels reach alert status, causing respiratory irritation and inflammation in much of the population.

Daily high temperatures have started to reach to the low 80s here in Central Texas. If you've been getting a little bored with your weekly laps around Lady Bird Lake then now is the time to trade one trail for another. Clear, cool, sunny days of spring are the perfect time to head out to the local greenbelts for a hike. While hiking may be a little slower than a jog, it can definitely be used as a workout. Depending on the length of time spent on the trail, hiking can be as strenuous as a 10K or even a marathon if the terrain is challenging enough.

For a hike you may want to leave your iPod at home. You'll experience new sites, smells and sounds and if you're listening to your latest MP3 download, you'll miss out. Babbling streams, chirping birds and the rustling of the leaves in the trees are only discernible when you slow the pace down to a walk. But this isn't just a "walk in the woods," it's a workout. It's rare the hike in Austin that doesn't have some measure of climbing so you'll need to condition yourself to trekking hilly terrain.

Don't hit the trail until you are ready. The following activities will help you get started.

Make sure you can walk at least three miles on a flat surface three or four times per week to condition yourself for the most basic hike. Once accustomed to the above workout, add a backpack and carry a water bottle. Once you're accustomed to the weight and the distance, add some hills striving for the same distance and carried weight.

It's amazing to see how many people wear flip flop sandals on a hike. While this may be very appropriate for a short walk to get to a stream to swim in, you'd be better off with a good pair of hiking shoes or boots and a good pair of socks. If your feet are comfortable, there's less of a chance that you'll need to turn back too soon or twist an ankle from poor support. As with running shoes, hiking shoes and boots should go through a period of trial to break them in. To keep from getting blisters, purchase a pair of padded Orlon or wool socks.

The longer you plan to be on the trail, the more clothing you may need. For instance, during this time of year, it's not uncommon to have a 50-degree temperature difference from early morning to the late afternoon. If that's the case plan on wearing several thin layers of clothing. First, use a base layer of technical fabric that will wick the moisture away from your body. Cover this layer with an absorbant layer of cotton or similar material. you can then add a warming layer if necessary and then finish up with a wind breaker or rain protection layer. If each layer is light and not bulky, you'll be able to strip it, store and pack it without much effort. Adding a cheap, rain-proof poncho to the backpack is a good idea and will repel rain in case a quick thunderstorm appears.

The most important item that you must take with is a bottle of water. Even if the hike planned for is short and it's cool outside, you never know when you might take a wrong turn and be on the trail for hours. Plan on one water bottle for each person. If the hike will take over three hours plan for additional water.

Hiking requires energy. You'll expend anywhere from 200 to 500 calories per hour or 100 calories per mile, depending on your speed and the amount of climbing you'll be doing. Even if you ate a large breakfast before you stated, you'll find yourself getting hungry later on. It's almost a given that you won't find a convenience store on the trail so you'll need to pack in any food you'll want to eat while hiking. Avoid foods that can perish or add a lot of weight. Choose foods that are nutritious but are not bulky or weigh heavy. Nuts, dried fruits or cereal are always good choices and why they're referred to as trail mix when mixed together.

Consider taking a small first aid kit with you in your backpack. Include bandages or band aids, scissors, aspirin, tape, insect repellent and sunscreen. Limit your packed goods to under 25 pounds. Research has shown that carrying more than this weight will cause problems to the back, shoulders and knees.

The last thing you want to do is have to call the local authorities to find you. Do a little planning beforehand so you get an idea of where you'll be hiking. Note what major roads are in the area. Look at the legend and gauge how long it'll take you to hike the trail. Print or buy a map. The City of Austin provides maps online for viewing and printing.

Here are suggestions to keep you safe when you hit the trail.

Stay on the trail. If it looks like nobody has been there for months, go back to the last point where it looked like a well traveled trail.Prepare for the weather and poisonous vegetation. Note what poison ivy and poison oak look like.Make sure someone knows where you are and when you are scheduled to return.Although cell phone signal strength may be compromised, take your phone anyway.Wear appropriate shoes, socks and clothing.Avoid drinking from rivers, lakes or streams. Pack food if you'll be hiking all day.Don't push yourself too hard, and stop if you feel short of breath, dizzy, or have chest pain.

Summer brings out barbecue grills—and bacteria, which multiply in food faster in warm weather and can cause foodborne illness (also known as food poisoning). Following a few simple guidelines can prevent an unpleasant experience.

Wash your hands

Wash hands with soap and water for at least 20 seconds before and after handling food. If you're eating where there’s no source of clean water, bring water, soap, and paper towels or have disposable wipes/hand sanitizer available.

Marinate food in the refrigerator

Don’t marinate on the counter—marinate in the refrigerator. If you want to use marinade as a sauce on cooked food, save a separate portion in the refrigerator. Do not reuse marinade that contacted raw meat, poultry, or seafood on cooked food unless you bring it to a boil first.

Keep raw food separate

Keep raw meat, poultry, and seafood in a separate cooler or securely wrapped at the bottom of a cooler so their juices won’t contaminate already prepared foods or raw produce. Don't use a plate or utensils that previously held raw meat, poultry, or seafood for anything else unless you wash them first in hot, soapy water. Have a clean platter and utensils ready at grill-side for serving.

Cook food thoroughly

Use a food thermometer to make sure food is cooked thoroughly to destroy harmful bacteria. Refer to the Safe Minimum Temperatures chart for safe internal temperatures for foods. Partial precooking in the microwave oven or on the stove is a good way to reduce grilling time—just make sure the food goes immediately on the preheated grill to finish cooking.

Keep hot food hot and cold food cold

Keep hot food at 140°F or above until served. Keep cooked meats hot by setting them to the side of the grill, or wrap well and place in an insulated container.

Keep cold food at 40°F or below until served. Keep cold perishable food in a cooler until serving time. Keep coolers out of direct sun and avoid opening the lid often.

Cold foods can be placed directly on ice or in a shallow container set in a pan of ice. Drain off water as ice melts and replace ice frequently.

Don’t let hot or cold perishables sit out for longer than two hours, or one hour if the outdoor temperature is above 90°F. When reheating fully cooked meats, grill to 165°F or until steaming hot.

Transport food in the passenger compartment of the car where it’s cooler—not in the trunk.

Put these items on your list

These non-food items are indispensable for a safe barbecue.

food thermometerseveral coolers: one for beverages (which will be opened frequently), one for raw meats, poultry, and seafood, and another for cooked foods and raw produceice or frozen gel packs for coolersjug of water, soap, and paper towels for washing handsenough plates and utensils to keep raw and cooked foods separatefoil or other wrap for leftovers

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year, and some of the causes might surprise you.

Although most people know animal products must be handled carefully to prevent illness, many don’t realize that produce can also be the culprit in outbreaks of foodborne illness. In recent years, the United States has had several large outbreaks of illness caused by contaminated fruits and vegetables—including spinach, tomatoes, and lettuce.

Glenda Lewis, an expert on foodborne illness with the Food and Drug Administration, says fresh produce can become contaminated in many ways. During the growing phase, fruits and veggies may be contaminated by animals, harmful substances in the soil or water, and poor hygiene among workers. After produce is harvested, it passes through many hands, increasing the contamination risk. Contamination can even occur after the produce has been purchased, during food preparation, or through inadequate storage.

FDA says to choose produce that isn’t bruised or damaged, and make sure that pre-cut items—such as bags of lettuce or watermelon slices—are either refrigerated or on ice both in the store and at home. In addition, follow these recommendations:

Wash your hands for 20 seconds with warm water and soap before and after preparing fresh produce.Cut away any damaged or bruised areas before preparing or eating.Gently rub produce while holding under plain running water. There’s no need to use soap or a produce wash.Wash produce BEFORE you peel it, so dirt and bacteria aren’t transferred from the knife onto the fruit or vegetable.Use a clean vegetable brush to scrub firm produce, such as melons and cucumbers.Dry produce with a clean cloth or paper towel to further reduce bacteria that may be present.Throw away the outermost leaves of a head of lettuce or cabbage.

Lewis says consumers should store perishable produce in the refrigerator at 40 degrees or below.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted May 23, 2011

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Federal regulators are asking U.S. drug makers for advance warning of production shortages, saying medicine scarcities are continuing to increase at a rapid pace after reaching a record high in 2010.
Food and Drug Administration (FDA) officials are working closely with industry, health care providers, and patients to prevent and mitigate shortages of “medically necessary” medicines. Medically necessary drugs are those used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available in adequate supply.
FDA says the number of drug shortages has nearly tripled over the last six years—jumping from 61 drug products in 2005 to 178 in 2010—and that doesn’t include shortages of vaccines, immune globulin products, and other biologics, or products made from blood, tissue, or other biological source.
FDA’s Valerie Jensen, a pharmacist and expert on drug shortages, says most of the supply problems have involved “sterile injectables”—medicines given by injection or intravenously to patients in the hospital. The shortages involve cancer drugs; anesthetics used for patients having surgery; “crash cart” drugs used in emergencies; electrolytes for patients being fed intravenously; and other drug products.
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There have also been shortages of prescription medicines that many Americans take by mouth each day, including some drugs prescribed for Attention Deficit Hyperactivity Disorder (ADHD).
“FDA is doing everything within its regulatory authority to address these shortages when they occur,” Jensen says.
If a drug you’re taking is not available and you believe it might be in short supply:
Visit FDA’s Current Drug Shortages page to see if your drug has been reported as being in short supply.If your drug isn’t on the FDA’s list, send the name and dose of the drug and your contact information to FDA’s Center for Drug Evaluation and Research at drugshortages@fda.hhs.gov.If your medicine is in short supply, talk with your doctor. There may be other medicines available that can be prescribed for your illness.
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During 2010, quality and manufacturing problems were to blame for many of the shortages in the United States, says Ilisa Bernstein, deputy director of compliance in FDA’s Center for Drug Evaluation and Research.
Shortages were fueled by many different factors, including a lack of raw materials used in the manufacturing process; increased demand for some drugs; and a company’s business decision to stop making some older, less profitable drugs.
While FDA encourages companies to notify the agency about problems that could lead to shortages, Bernstein says there is currently no legal requirement for them to tell FDA. Companies that are the sole source of a medically necessary drug are legally required to inform FDA six months in advance if they plan to discontinue making that product; however, there is no legal penalty if they choose not to do so.
“FDA is urging drug makers to voluntarily notify us if they change production quantities of drugs as a matter of corporate responsibility and in the interest of public health,” Bernstein says.
When the agency gets advance warning that a shortage could occur, FDA works with other firms that make the drug and asks if they can ramp up production to fill any gap in the domestic supply of the product.
In certain situations, when manufacturers of an FDA-approved drug can't immediately resolve a shortage of a medically necessary drug, FDA sometimes identifies foreign versions of the product with the same active ingredient manufactured by reputable firms. FDA then uses enforcement discretion for the limited importation of the foreign version until the shortage of the FDA-approved drug is resolved.
Last year, FDA was able to help prevent 38 drug shortages because companies notified the agency of issues that could lead to supply disruptions.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

The Food and Drug Administration is recommending that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury.

FDA says this dose should only be used by patients who have been taking it for 12 months or longer without ill effect.

“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” says Eric Colman, M.D., deputy director of FDA’s Division of Metabolism and Endocrinology Products.

And if health care professionals find that patients now taking 40 mg of simvastatin aren’t meeting their LDL cholesterol goal, FDA is advising them to choose a different statin rather than raising the simvastatin dose to 80 mg, says Amy Egan, M.D., deputy director for safety in the FDA division.

All statins, despite their proven benefit in lowering the risk of heart attacks and strokes, carry some risk of an injury called myopathy, characterized by unexplained muscle weakness or pain. 

But the risk is greater for patients who take the 80 mg doses of simvastatin, especially in the first year of treatment. Colman says the muscle damage is often caused by interactions with other medications. And some people are genetically predisposed towards simvastatin-related myopathy, he says.

Last year, an estimated 2.1 million people were prescribed a medication containing 80 mg of simvastatin, says Egan. “It is the most potent statin available in generic form and is relatively inexpensive,” she notes.

The statin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor.

FDA has revised the drug labels for simvastatin and Vytorin to include the new restrictions for the 80 mg dose, says Egan. The labels of simvastatin, Vytorin and Simcor have all been changed to include dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body, thus increasing the risk of myopathy.

Like all statins, simvastatin is used to lower the amount of low-density lipoprotein (LDL) cholesterol—known as “bad cholesterol”—in the blood. And the 80 mg dose of simvastatin has been shown to lower LDL cholesterol by an additional 6% over the 40 mg dose.

But myopathy can be debilitating. Moreover, a rare form of myopathy, called rhabdomyolysis, can lead to kidney failure and death.

Colman says one thing FDA does not want patients to do is stop taking their statins without consulting their doctor. “The benefits of the treatment far outweigh the risks,” he says, calling occurrences of rhabdomyolysis “extremely rare.”

But Egan says you should contact your health care professional if you have:

Muscle pain, tenderness or weaknessDark or red-colored urineUnexplained fatigue

The FDA recommendation was prompted by a comprehensive review of clinical trial data and data from the agency’s Adverse Event Reporting System, one of FDA's most important tools for tracking the safety of drugs once they are on the market.

Egan explained that FDA did not want to risk the health of patients who have been successfully treated with the medication for a year or more by pulling it off the market. During the next year, the agency will monitor prescription data to determine if the labeling changes are successful in limiting the use of 80 mg simvastatin.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

unexpected and undesirable side effectsquality problems, such as a drug with an unusual odor or color, or a device with defective partsunclear or confusing instructionsfailure to deliver the expected benefit

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

OnlineRegular Mail: Use postage-paid, pre-addressed FDA form 3500Fax: 800-FDA-0178Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.

Here are some of the most recent safety alerts prompted by reports FDA has received through MedWatch.

In its continued evaluation of Tysabri (natalizumab), FDA has updated the drug label regarding the risk of progressive multifocal leukoencephalopathy (PML)—a rare but serious brain infection—in those who use Tysabri to treat multiple sclerosis and Crohn's disease.

Risk: Patients who take Tysabri may be at higher risk for PML if they have taken other drugs that suppress the immune system. The revised label addresses this new risk and summarizes the rates of PML with Tysabri use per number of intravenous infusions.

In February 2010, FDA required that the drug label and the patient Medication Guide state that the risk of developing PML increases with the number of Tysabri infusions.

FDA believes that the benefits of Tysabri continue to outweigh the potential risks.

Recommendation: Before taking Tysabri, tell your health care professional if you have previously taken a medication that suppresses the immune system, such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate.  

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Teva Pharmaceuticals has withdrawn its lansoprazole delayed-release orally disintegrating tablets from distribution. The product may also be sold under the following labels:

Sharp CorporationCardinal HealthQuality Packaging Specialist Inc.

Lansoprazole is FDA-approved to treat ulcers in the stomach and duodenum (in the small intestine), gastroesophageal reflux disease (GERD), erosive esophagitis (inflammation of the esophagus), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).

Risk: The tablets have clogged and blocked oral syringes and feeding tubes when the drug is given as a suspension through these devices. The tablets may not fully disintegrate when water is added to them or they may form clumps. These clumps can stick to the inside walls of syringes and feeding tubes. In some cases, patients have had to seek emergency medical help and their feeding tubes have had to be unclogged or replaced.

Recommendation: Do not give this product through oral syringes or feeding tubes. 

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Two lots of Topamax (topiramate) 100mg tablets in bottles of 60 have been recalled:

Lot number 0KG110, expiration date of 06-2012Lot number 0LG222, expiration date of 09-2012

Topamax, a product of the Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals Inc., is FDA-approved to treat some types of seizures in adults and children, and to prevent migraine headaches in adults.

Risk: Several consumers have reported an unusual odor, which is thought to be caused by trace amounts of a chemical compound called TBA (2,4,6 tribromoanisole). While not considered to be toxic, TBA can give off an offensive odor. A small number of patients have reported temporary problems of the stomach or intestines.

Recommendations

If you notice an unusual odor from Topamax 100mg tablets, return them to your pharmacist.Contact your health care professional if you have questions.

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FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma, or HSTCL), occurring mainly in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with the following medicines:

tumor necrosis factor (TNF) blockers, including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)Imuran (azathioprine)Purinethol (mercaptopurine)

Crohn's disease and ulcerative colitis cause inflammation of the digestive system.

Risk: HSTCL is a fast-growing cancer that is usually fatal. Most of the cases reported were in people being treated for Crohn’s disease or ulcerative colitis, but also included a person being treated for psoriasis and two people being treated for rheumatoid arthritis.

Although most reported cases of HSTCL occurred in people treated with a combination of medicines known to suppress the immune system—including TNF blockers, azathioprine, and mercaptopurine—there have been cases reported in people receiving azathioprine or mercaptopurine alone.

Recommendations

Be aware that taking TNF blockers, azathioprine, or mercaptopurine may increase the risk of HSTCL.Read the Medication Guide that comes with a prescription for TNF blockers.Do not stop taking TNF blockers, azathioprine, or mercaptopurine without talking to your health care professional.Discuss any questions or concerns about these medications with your health care professional.

For More Information

FDA Drug Safety Communication

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FDA continues to receive reports of methemoglobinemia—a rare but serious condition—associated with benzocaine products. These products may be used either as

a spray during medical procedures to numb the mucous membranes of the mouth and throata gel or liquid sold over-the-counter to relieve pain from teething, canker sores, irritation of the mouth and gums, and other conditions. Brand names include Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands.

Risk: Methemoglobinemia is a condition in which the amount of oxygen carried through the bloodstream greatly decreases. In the most severe cases, methemoglobinemia can result in death.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids. The condition occurred mainly in children age two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear from within minutes to hours of applying benzocaine and may occur after just one use or after additional uses.

Signs and symptoms of methemoglobinemia include

pale, gray, or blue colored skin, lips, and nail bedsheadachelightheadednessshortness of breathtirednessrapid heart rate

Recommendations

Call 911 immediately if you or someone you are caring for has any of the symptoms listed above after receiving benzocaine.Do not use benzocaine products on children under two years of age, except under the advice and supervision of a health care professional.Adults who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations on the product label.Store benzocaine products out of reach of children.Talk to your health care professional about using benzocaine.

For More Information

Questions and Answers on Benzocaine

Drug Safety Communication: Benzocaine Gels, Liquids

Drug Safety Communication: Benzocaine Sprays

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FDA laboratory analyses found that the Best Enhancer product, marketed as a dietary supplement, contains an active ingredient that is similar to an FDA-approved product used to treat erectile dysfunction. The active drug ingredient is not listed on the label of Best Enhancer.

Risk: The active ingredient may interact with prescription drugs containing nitrates (such as nitroglycerin) and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates.

Recommendations

If you have bought this product, stop using it and return it to the place of purchase.If you have questions, contact the product’s distributor, AVNS Inc., at 562-602-6515 or avnsinc@aol.com Monday through Friday from 9:00 a.m. to 4:00 p.m. Pacific Standard Time.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

unexpected and undesirable side effectsquality problems, such as a drug with an unusual odor or color, or a device with defective partsunclear or confusing instructionsfailure to deliver the expected benefit

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

OnlineRegular Mail: Use postage-paid, pre-addressed FDA form 3500Fax: 800-FDA-0178Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.

Here are some of the most recent safety alerts prompted by reports FDA has received through MedWatch.

Two newly published studies found that women who use birth control pills that contain the hormone drospirenone are more vulnerable to a potentially life-threatening condition.

The studies found a two to three times greater risk of venous thromboembolism events (VTE) for women who use birth control pills that contain drospirenone than for those using pills that contain the hormone levonorgestrel. Other studies have not reported an increase in risk.

Names of drospirenone-containing products include

Yaz (generics Gianvi and Loryna)Yasmin (generics Ocella, Syeda, and Zarah)BeyazSafyralDrospirenone and ethinyl estradiol

Risk: VTEs include deep vein thrombosis and pulmonary embolism. Deep vein thrombosis is a rare condition in which a blood clot forms inside a vein, usually in the lower leg or thigh. If the clot breaks loose and travels to the lungs, it can block an artery, causing a life-threatening condition called a pulmonary embolism.

FDA action: FDA is currently evaluating the conflicting results from studies and other information to assess the risks and benefits of drospirenone-containing birth control pills. The agency will continue to provide new safety information to the public as it becomes available.

Recommendations

Call your health care professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath.If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional.If you smoke and are over 35 years of age, you should not take combination oral contraceptives (those that contain two types of hormones: estrogen and progestin) because they increase the risk of serious heart and blood vessel (cardiovascular) problems, including blood clots.Report any problems you have with birth control pills to FDA’s MedWatch Program to help the agency evaluate the risk of deep vein thrombosis and pulmonary embolism with these drugs.

For More Information

Questions and Answers – Ongoing safety review of birth control pills containing drospirenone

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Parents, caregivers, and health care professionals should not feed SimplyThick to infants born before 37 weeks gestation.

SimplyThick is a thickening agent added to breast milk and infants’ formula to help premature babies swallow their food and keep it down, without spitting up. The product can be purchased from distributors and local pharmacies throughout the U.S.

Risk: SimplyThick may cause necrotizing enterocolitis (NEC), a life-threatening condition in which tissue in the intestines becomes inflamed and dies. Since FDA first learned of this problem on May 13, the agency has received reports of more than a dozen cases of NEC, including several deaths, in premature infants.

Recommendations

Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.Call your health care professional if your baby has a bloated stomach, greenish-tinged vomiting, or bloody stools—or if you have other concerns related to using SimplyThick.

Update of 6/5/11: Simply Thick LLC recalled its thickening gel products manufactured at a food processing plant owned and operated by Thermo Pac LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Ga., plant. FDA had advised the company that Thermo Pac failed to file with the agency its plans to ensure that harmful bacteria of possible public health significance are destroyed during the manufacturing process.

For More Information

Photographs of SimplyThick

Consumer Update on SimplyThick

Simply Thick LLC Press Release: Recall of Products Manufactured by Thermo Pac LLC at their Stone Mountain, Ga., Food Processing Plant

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New restrictions have been added to the prescribing and use of medicines that contain rosiglitazone. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Patients will have to enroll in a special program to receive these drugs, and health care professionals cannot prescribe them without enrolling in the program.

Risk: Rosiglitazone may increase the risk of a heart attack and other heart and blood vessel (cardiovascular) problems. Because of these risks, FDA is restricting the use of rosiglitazone medicines to

patients already being treated successfully with these medicinespatients whose blood sugar cannot be controlled with other antidiabetic medicines and are unable to take pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact)

Recommendations

Call your health care professional as soon as possible to determine if it is appropriate for you to continue taking a rosiglitazone medicine and, if it is, how to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. Your healthcare professional will need to complete and sign a patient enrollment form for you.Be aware that after Nov. 18, 2011, you will no longer be able to get your rosiglitazone medicine from a retail pharmacy. You must be enrolled in the Avandia-Rosiglitazone Medicines Access Program to receive your medicine, which will only be available by mail order through certified pharmacies.Read the medication guide you get along with your rosiglitazone medicine. It explains the risks linked to using the drug.Talk to your health care professional about the risks and benefits associated with rosiglitazone medicines.

For More Information

FDA Drug Safety Communication on Rosiglitazone-Containing Medicines

Avandia-Rosiglitazone Medicines Access Program

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One lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets has been recalled because the company, Bristol-Myers Squibb, found a tablet to be higher in potency than expected. The lot number is 9H49374A with an expiration date of September 30, 2012.

Coumadin is prescribed to treat or prevent blood clots.

Risk: Too much active ingredient can increase the risk of bleeding. Not enough active ingredient may increase the risk of clots, which could lead to heart attack or stroke.

Recommendation: Do not stop taking Coumadin until you have talked with your pharmacist to see if your tablets are from the recalled lot. If so, contact your physician for advice.

For More Information

Photo of Coumadin 5 mg Tablet

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FDA notified health care professionals that Weck Hem-o-Lok Ligating Clips should not be used to stop blood flow from the renal artery during the removal of a kidney from a living donor using minimally invasive surgery.

This V-shaped clip is made from a non-absorbable material that comes in various sizes. It is used to permanently close blood vessels or tissue structures.

Risk: The clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor.

Recommendations

If you are considering donating a kidney, talk to your health care professional about potential for surgical complicationsmethods used during living-donor surgery, and the advantages and disadvantages of each methodrisks and benefits associated with donating a kidneyIf you have donated a kidney and have any questions or concerns about your surgical procedure, contact your doctor.

For More Information

Safety Communication About Weck Hem-o-Lok Ligating Clips

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Dietary supplements distributed by two companies have been recalled because misleading packaging causes confusion in consumers who mistake them for similarly packaged antibiotics:

Pentrexyl Forte Natural, distributed by Phoenix Import & Distribution LLC, packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.Certain dietary supplements by Multi-Mex Distributor Inc. that may be labeled as antibiotic drugs, which they are not. An FDA inspection revealed the packaging resembles packages containing antibiotics readily available in Mexico and possibly familiar to Hispanic consumers. The packaging appeared to be an intentional marketing ploy. The products were distributed in Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis.

Risk: Use of these products by people who are sick could delay legitimate treatment for serious illnesses. Four children were taken to a medical center due to worsening illnesses after being given the Multi-Mex dietary supplement Amoxilina, which the parents may have believed was the antibiotic amoxicillin.

Recommendations

Do not use Pentrexyl Forte Natural or any of the recalled products from Multi-Mex Distributor. Return them to the place where you bought them for a full refund.Call 678-226-1758 if you have questions about the Multi-Mex products. Call 281-288-9838 if you have questions about the Phoenix product, Pentrexyl Forte Natural.

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Two products sold as dietary supplements contain drugs that are not declared on the label:

Slim Xtreme Herbal Slimming Capsule, sold 30 capsules per bottle, distributed by Globe All Wellness. All lots are recalled. The product was marketed for weight loss and sold nationwide through the Internet and at the company’s headquarters in Hollywood, Fla.Regenerect, by Ethos Environmental Inc., lot number 100521 (blue capsule sold individually in foil packets, expires 5/2012) and lot number 112850 (clear capsule sold individually in foil packets, expires 11/2013). Regenerect was sold in the U.S. and Puerto Rico through the Internet.

Slim Xtreme Herbal Slimming Capsule contains the controlled substance sibutramine, which was withdrawn from the U.S. market in October 2010 for safety reasons. Regenerect contains a compound (sulfoaildenafil) of an active ingredient in an FDA-approved drug used to treat erectile dysfunction.

Risk: Sibutramine (found in Slim Xtreme) is known to substantially increase blood pressure or pulse rate in some people—especially those with a history of heart disease or stroke. This product may also interact in life-threatening ways with other medications a person may be taking. Sulfoaildenafil (found in Regenerect) may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations

Do not use Slim Xtreme, or Regenerect lot numbers 100521 and 112850.If you have used either of these products and have any negative side effects, call your health care professional as soon as possible.If you have questions about Slim Xtreme or need instructions for returning the product, call 954-922-1133 Monday through Friday from 9 a.m. to 4 p.m. Eastern Standard Time.If you have questions about Regenerect or need instructions for returning the product, call 866-925-9553 Monday through Friday from 6 a.m. to 6 p.m. Pacific Time.

For More Information

Photos of Slim Extreme

Tainted Weight Loss Products

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

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Automated external defibrillators (AEDs) model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR, are recalled. AEDs are used on victims of sudden cardiac arrest who are unconscious, unresponsive, and not breathing.

Risk: The software version 2.004 or earlier may cause the device to cancel shock during the charging process, which may result in failure to resuscitate the patient.

Recommendations

Defibtech will give customers a free software upgrade. Full instructions and recommendations are being mailed to affected customers.Customers should keep their AEDs in service during the software upgrade process.

For More Information

Recall Notice on Lifeline and ReviveR AEDs

Defibtech AED Serial Number Verification

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Triad Povidone Iodine Prep Pads contained in Atwater Carey first aid kits have been recalled because the prep pads may be contaminated. The first aid kits are distributed by Wisconsin Pharmacal Company.

In March, H&P Industries recalled all Povidone Iodine Prep Pads sold in individual packets and in a box of 100 packets. The pads may be sold under the brand names of

TriadTriad PlusCardinal HealthMedical SpecialtiesVHANorth SafetyTotal Resources

Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns.

Risk: Testing showed the presence on the pads of the bacterium Elizabethkingia meningoseptica, which could lead to life-threatening infections. Treatment options are limited for infections caused by this bacterium.

Recommendations

Throw away the Povidone Iodine Prep Pads included in Atwater Carey first aid kits.Do not use Triad Povidone Iodine Prep Pads sold separately.

For More Information

Photos of Atwater Carey First Aid Kits

Photos of Povidone Iodine Prep Pads

Press Release: Important Information for Atwater Carey First Aid Kit Consumers Regarding Triad’s Povidone Iodine Prep Pads

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

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When you buy that salmon steak for grilling or that red snapper filet for baking, the Food and Drug Administration’s “Fish and Fishery Products Hazards and Controls Guidance” probably doesn’t spring to mind.

But this document—popularly known as the “Hazards Guide”—plays a key role in keeping American consumers safe from contaminated seafood.

The Hazards Guide is a roadmap for commercial fishermen and processors to follow to ensure that consumers don’t become ill from parasites, pathogens (bacteria, viruses, fungi), or natural toxins (poisonous substances produced by living organisms) in the seafood they eat.

In April 2011, FDA released the fourth edition of the Hazards Guide and posted on the FDA website an introductory video to the guide for the seafood industry.

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The Hazards Guide gives fishermen and seafood processors the latest scientific information on contaminants that can be present in their products and where they need controls to eliminate them.

For example, research conducted by FDA gave the agency new insights on what was needed to control scombrotoxin in the processing of tuna and mahi-mahi. Scombrotoxin is one of the most common causes of fish-related “food poisoning” in the U.S.

A primary component of scombrotoxin is histamine, which is formed by certain bacteria that naturally exist on the gills and inside live, saltwater fish. The histamine-forming bacteria continue to grow on dead fish, particularly if the fish are not rapidly chilled and kept chilled. The bacteria don’t harm the live fish, says Robert Samuels, a consumer safety officer in FDA’s Division of Seafood Safety. “But once a fish dies, it is vulnerable to a bacterial onslaught. When you consume certain species of fish, such as tuna and mahi-mahi, that have not been chilled properly, you could consume an overwhelming amount of histamine and your body may react violently.”

This “scombrotoxin poisoning” causes symptoms such as tingling or burning around the mouth, itchy skin, a rash or hives, a drop in blood pressure, dizziness, nausea, vomiting, diarrhea, heart palpitations, and difficulty breathing.

How the fish are handled onboard the fishing boat affects the formation of histamine, says Samuels. “Natural marine flora (like the bacteria that produce histamine) have the best opportunity to go to town on the fish before they get hit with ice on the boats or face other inhibitory or destructive treatments at a processing plant.”

FDA researchers conducted studies at sea in the warm waters of Hawaii and Granada that were conducive to the growth of histamine. “They took controlled temperature tanks on board so they could subject the fish to different environments and controls to see what conditions were conducive to or prevented histamine formation,” says Samuels. “These expeditions gave us better information related to controls at sea and the new guide reflects these controls.” 

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Fish is a big part of the American diet. Americans consumed 15.8 pounds of fish per person in 2009, according to the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service. And U.S. consumers spent an estimated $75.5 billion for seafood in 2009.

Imports made up 84 percent of the seafood eaten in the U.S. in 2009, according to the fisheries service. The new Hazards Guide reflects the large volume of imports, adding 40 more species of fish than contained in the previous guide issued 10 years ago.

“Some of the additions to the new guide are based on foreign species that are commercially harvested and processed in other countries” says Spring Randolph, a consumer safety officer in FDA’s Division of Seafood Safety.  “FDA has attempted to create a reference that is applicable to both domestic and foreign products.”

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Guidance documents represent FDA's current thinking on a topic—the agency’s interpretation of a policy or regulation (a federal law) to assist industry in following the regulation. The Hazards Guide, for example, interprets FDA’s 1997 regulation, “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products.”

A food processor can use alternative approaches to the ones provided in a guide if the approach satisfies the requirements of the applicable statutes and regulations. And a processor must show, scientifically, that the approach is adequate.

Guidance documents often give details that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.

The Hazards Guide covers such specifics as alternative temperature controls during transit, and what packaging materials are acceptable to prevent the bacteria Clostridium botulinum and its toxin from forming in fresh fish. This bacterium produces the toxin that causes botulism, a muscle-paralyzing illness that can result in death.

By giving fishermen and seafood processors FDA’s latest thinking on what hazards may occur with fish products and how to prevent them, the Hazards Guide sets the table for seafood that is truly good, not just good tasting. 

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

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Since 2006, it has been much easier for people allergic to certain foods to avoid packaged products that contain them, says Rhonda Kane, a registered dietitian and consumer safety officer at the Food and Drug Administration.

This is because a federal law requires that the labels of most packaged foods marketed in the U.S. disclose—in simple-to-understand terms—when they are made with a “major food allergen.”

Eight foods, and ingredients containing their proteins, are defined as major food allergens. These foods account for 90 percent of all food allergies:

milkeggfish, such as bass, flounder, or codcrustacean shellfish, such as crab, lobster, or shrimptree nuts, such as almonds, pecans, or walnutswheatpeanutssoybeans

The law allows manufacturers a choice in how they identify the specific “food source names,” such as “milk,” “cod,” “shrimp,” or “walnuts,” of the major food allergens on the label. They must be declared either in:

the ingredient list, such as “casein (milk)” or “nonfat dry milk,” ora separate “Contains” statement, such as “Contains milk,” placed immediately after or next to the ingredient list.

“So first look for the ‘Contains’ statement and if your allergen is listed, put the product back on the shelf,” says Kane. “If there is no ‘Contains’ statement, it’s very important to read the entire ingredient list to see if your allergen is present. If you see its name even once, it’s back to the shelf for that food too.”

There are many different ingredients that contain the same major food allergen, but sometimes the ingredients’ names do not indicate their specific food sources. For example, casein, sodium caseinate, and whey are all milk proteins. Although the same allergen can be present in multiple ingredients, its “food source name” (for example, milk) must appear in the ingredient list just once to comply with labeling requirements.

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If a “Contains” statement appears on a food label, it must include the food source names of all major food allergens used as ingredients. For example, if “whey,” “egg yolks,” and a “natural flavor” that contained peanut proteins are listed as ingredients, the “Contains” statement must identify the words “milk,” “egg,” and “peanuts.”

Some manufacturers voluntarily include a “may contain” statement on their labels when there is a chance that a food allergen could be present. A manufacturer might use the same equipment to make different products. Even after cleaning this equipment, a small amount of an allergen (such as peanuts) that was used to make one product (such as cookies) may become part of another product (such as crackers). In this case, the cracker label might state “may contain peanuts.”

Be aware that the “may contain” statement is voluntary, says Kane. “You still need to read the ingredient list to see if the product contains your allergen.”

Manufacturers can change their products’ ingredients at any time, so Kane says it’s a good idea to check the ingredient list every time you buy the product—even if you have eaten it before and didn’t have an allergic reaction.

“If you’re unsure about whether a food contains any ingredient to which you are sensitive, don’t buy the product, or check with the manufacturer first to ask what it contains,” says Kane. “We all want convenience, but it’s not worth playing Russian roulette with your life or that of someone under your care.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Did you know that FDA inspections in other countries of U.S.-bound products—including food, animal feed, drugs and devices—have doubled since 2008? And that foreign inspections of food alone have quadrupled since 2010?

Learn about FDA's global inspection program during a 30-minute webinar.

An opportunity to ask questions will follow the presentation.

When:   Tuesday, May 17, 12:30 p.m. ET

Length: 30 minutes

Where:  To join the webinar, see the instructions at www.fda.gov/AboutFDA/Transparency/Basics/ucm254903.htm. Webinar slides are posted here also.

Host:     Division of Foreign Field Investigations within FDA’s Office of Regulatory Affairs

Featured speaker: Susan Laska, deputy director of the Division of Foreign Field Investigations within FDA’s Office of Regulatory Affairs

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

May 13, 2011

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, or when prescribed inappropriately.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

identify specific, preventable harm related to medication usedevelop methods (interventions or strategies) to reduce harmidentify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

In its regulatory role, FDA has always tried to prevent medication errors, says Weiss. “A lot of what we do at FDA to reduce medication errors is because we have the authority from Congress to regulate drugs, drug labeling, and drug manufacturing standards.”

But the Safe Use Initiative is different, says Weiss, because it involves collaborations with other parts of the health care industry and professions—besides drug manufacturers and distributors—to reduce harm in ways that do not require regulation. Potential collaborators include

physicians, nurses, and other health care professionals and their professional societiesstate and federal agenciespharmacies, hospitals, and other health care facilitieshealth insurerspatients, caregivers, consumers, and groups representing their interests

FDA continues to add opportunities for collaboration to its growing list of projects that could reduce preventable harm from medicines. Two such opportunities are

to support and assist in the removal of abbreviations on prescription container labelsto support efforts to educate patients about the misuse and abuse of prescription drugs

Although FDA regulates prescription drug labeling—the printed material that accompanies such drugs—individual states regulate the label that the pharmacist attaches to the pill bottle. FDA is working with pharmacies, medical standards organizations, and others to set standards for this bottle label, such as spelling out the full name of a prescription drug instead of using an abbreviation that consumers may not understand.

For example, the prescription form of acetaminophen is often abbreviated “APAP” on the label of the bottle the consumer is given at the pharmacy. If consumers don’t know that “APAP” and “acetaminophen” are the same and are already taking an over-the-counter acetaminophen product (such as Tylenol or another brand), they could be taking too much acetaminophen and accidentally overdose. Too much acetaminophen can cause liver damage.

The Safe Use Initiative team is also working to make consumers aware of the importance of checking drug labels in general because many have the same ingredient—like acetaminophen, which can be found in more than 600 medications.

Another Safe Use Initiative project addresses the taking of prescription drugs when not needed. “About 55 percent of people who misuse or abuse prescription drugs get them from friends and family,” says Dale Slavin, Ph.D., associate director of the Safe Use Initiative.

“We need to create opportunities for discussion between the patient and the doctor,” Slavin says. “We, through collaborative efforts, want to provide tools that the doctor can use to have frank conversations with patients, and tools that the patient can use to understand the benefits, risks, and limitations of their treatment.”

This is especially important for opioid drugs, says Slavin, “where the abuse potential is there, the dependence potential is there, and the potential for others to steal or misuse their drugs is there.”

FDA invites comments and suggestions on drug safety issues and how to prevent harm at cdersafeuseinitia@fda.hhs.gov.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted June 29, 2011

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As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”

The U.S. has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in 2008, and spinach in 2006—but a new law has set in motion sweeping improvements to the safety of our food supply.

President Obama signed the FDA Food Safety Modernization Act into law on Jan. 4, 2011, but the year before, the Food and Drug Administration was already gearing up for important work that was mandated by the act: the Produce Safety Regulation.

This regulation will establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables. “This will be a monumental shift in food safety,” says James R. Gorny, Ph.D., FDA’s senior advisor for produce safety.

Since 1998, produce growers have had available the “Good Agricultural Practices” issued by FDA and the U.S. Department of Agriculture (USDA). But this guidance is not an enforceable regulation like the Produce Safety Regulation will be, says Gorny.

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"This will be a monumental shift in food safety."

As part of the regulatory process, FDA publishes a “proposed rule” and then invites comments to the proposed rule “docket” (public record) online or by mail.  Anyone can comment on a proposed rule, and the agency considers all comments submitted to the docket before drawing up the final rule, or regulation. FDA also intends to hold public meetings about the proposed Produce Safety rule after it is published, to provide additional opportunities for the public to comment. The agency expects to publish a proposed Produce Safety rule by spring 2012.

Due to the diversity of produce farms throughout the country—ranging from a few acres to thousands of acres, and growing from a few crops to dozens of vegetable varieties—FDA decided to reach out to growers before drafting the proposed rule.

In 2010, technical experts, scientists, and other staff from FDA and USDA went on the road to meet with growers as well as produce industry groups, public policy groups, state agricultural departments, and public health departments in 13 states. They toured farms—both big and small—and talked to the owners. Some of the farm tours were attended by FDA leadership, including FDA Commissioner Margaret A. Hamburg, M.D., and Deputy Commissioner for Foods Michael R. Taylor, J.D. At the invitation of FDA, USDA Deputy Under Secretary for Marketing and Regulatory Programs Ann Wright joined several of the tours as did a number of state commissioners of agriculture. 

“Before we put pen to paper, we wanted to find out what growers are doing now and the food safety challenges they face,” says Gorny.

“It was a very refreshing change in the process that was welcomed by the growers and that allowed them to be a part of the process,” says Bob Jones, Jr., co-owner and production manager of the Chef’s Garden, a 300-acre farm in Huron, Ohio.

“The Ohio growers, in general, have a great appreciation and understanding of the necessity of good food safety,” says Jones, who also serves on the board of several agricultural associations in the state. “We have a social responsibility to consumers who purchase and consume the food we grow.”

Several themes emerged from the visits, says Gorny. Many growers commented that produce safety standards should

be appropriate and flexiblebe science-based and risk-basedbe practical—not overly burdensomeapply to both imported produce and domestic producebe accompanied by a strong education and outreach program

The agency is working to create a regulation that will be flexible and appropriate for both large-farm operators and smaller farmers—including sustainable, organic, and Amish farmers FDA met when touring the country.

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“One of the themes we heard over and over is ‘educate before you regulate,’” says Gorny.

FDA doesn’t make produce safer, he adds. “We make the rules that must be followed to keep produce safe. So we need to assist growers with knowledge and training to comply with those rules.”

FDA is exploring partnerships with state agricultural departments and extension services, produce industry groups, and coalitions such as the Produce Safety Alliance—a collaboration between Cornell University, USDA, and FDA—to reach out to growers and provide them with training regarding on-farm produce safety.

Jones says everybody who handles food—growers, packers, transporters, processors, grocers, and consumers—has an important part to play in food safety. “You can educate growers on all they can do in the field—for instance, with water quality and worker hygiene—to lower the likelihood of microbial contamination,” he says. But it won’t be effective unless all the other food handlers practice food safety, too.

The bottom line, says Gorny, is that FDA wants American consumers to be able to buy healthful fruits and vegetables with the utmost confidence in their safety.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

July 11, 2011