Filed under: FDA
The Food and Drug Administration (FDA) sent warning letters to manufacturers and distributors of dietary supplements containing 1,3-dimethylamylamine (DMAA) due to lack of safety evidence provided before marketing. The FDA states that information about the safety of DMAA as a dietary supplement ingredient has not been identified. For more information, see the FDA News Release and HPRC’s latest on Dietary Supplement Products Containing DMAA.
Many adverse events associated with dietary supplement use go unreported. HPRC has developed one page information resources on how to report adverse events. Warfighters and their families can follow the directions for reporting adverse events to MedWatch (FDA) and Natural Medicines Watch. In addition to these sites, Health care providers can follow step by step directions for reporting via AHLTA.
Apple juice containing arsenic has been a topic in the news recently. The Food and Drug Administration (FDA) has put together questions and answers to assist the public in sorting through the information. The FDA’s conclusion is that apple juice is safe to drink. More information is available in FDA: Apple Juice Safe To Drink.
According to an Associated Press article from August 2, 2011, the Food and Drug Administration (FDA) has warned the manufacturer of the melatonin-laced brownies known as "Lazy Cakes" that the government considers them unsafe and could seize them from store shelves. The brownies were originally sold under the name Lazy Cakes, but the manufacturer of the product has changed the product name to Lazy Larry.
The FDA said that melatonin has not been found to be safe for use in conventional foods. “On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin,” said the letter, sent last Thursday by the agency’s acting director for the Office of Compliance. Melatonin is not approved for use in any food, the FDA said.
HBB, LCC, the Memphis-based company that makes Lazy Cakes/Lazy Larry, was given 15 days to respond to the FDA with details on specific steps it would take to correct its violation of the ban against melatonin use in food.
It should be noted that the HPRC has been covering Lazy Cakes since they first became available.
Agromod Produce, Inc., is recalling all papayas distributed nationwide and to Canada due to potential contamination with Salmonella Agona. For more information, read the Food and Drug Administration Press Release.
Cytosport, Inc. was cited for having false or misleading label and website claims in violation of several points of federal law for several products, including “Chocolate Muscle Milk Protein Nutrition Shake,” “Vanilla Crème Muscle Milk Light Nutritional Shake,” and “Chocolate Peanut Caramel Muscle Milk.” The company is in violation of the Federal Food, Drug, and Cosmetic Act and is required to take specific actions to correct the violations. More information is provided in the FDA Warning Letter.
New York dietary supplement manufacturer Howard Sousa, of Artery Health Institute LLC and DeSousa LLC, has agreed to remove drug claims on his company’s website. Sousa’s Advanced EDTA Oral Chelation capsules were promoted on the website as drugs since the marketing language made disease treatment claims. More information is provided in the FDA News Release.
Warfighters are deployed to all kinds of environments, including hot and dry conditions where sun exposure is a concern. Choosing a "broad-spectrum" product that protects against sunburn, skin cancer, and premature skin aging is important, but product labeling can be confusing. Now, however, the Food and Drug Administration (FDA) is taking steps to regulate the labeling of sunscreen products in order to help consumers choose a product that will protect them from sun damage to the skin.
The new measures include a regulation, effective one year from now, that requires sunscreens to undergo a standard test if they want to be labeled as a “broad spectrum” product. Those that pass the test will be allowed to use “broad spectrum” on their packaging, which indicates a product that provides protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). UVB rays are primarily responsible for sunburn, but both UVA and UVB rays are harmful and can cause sunburn, skin cancer, and premature skin aging.
Other provisions in the FDA regulation include:
- A warning about the risk of skin cancer and early skin aging on the labels of sunscreen products that are not broad spectrum.
- The amount of time the consumer can expect protection from a product with water resistance claims must be stated on the front label. The FDA, based on standard testing, will allow either a 40-minute or 80-minute timeframe on labels.
- Products will no longer be allowed make a claim of “waterproof” or “sweatproof” or use the term “sunblock,” nor can they make the claim of immediate or instant protection or protection for more than two hours without reapplication.
Additional measures regarding the labeling of sunscreen products have been proposed. To learn more, view the FDA’s full article.
The USDA announced on June 2, 2011, that its classic food guide Pyramid is being replaced with the easy-to-understand and interactive MyPlate. Using a “familiar mealtime visual,” MyPlate is intended to remind Americans about balancing meals with the five food groups: fruits, vegetables, grains, protein, and dairy. Based on the 2010 Dietary Guidelines, notable changes to the new guide are the inclusion of more fruits and vegetables, less grains, and the re-categorization of oils as providing “essential nutrients” but not appearing on the plate.
The result is a simple visual graphic of a balanced meal that families can use as a tool to make sure the portions of the major food groups are covered in meals. The simplicity of the graphic helps ALL family members, especially children, become more engaged in what and how much they should be eating. An interactive plate on the MyPlate website allows users to click on each section of the plate, which then displays a page for the selected food group with description, key message, and a list with pictures of single-serving sizes of some common foods in that group. These changes allow families to easily identify what a healthy, balanced meal looks like. Also featured is an Interactive Tools section that enables users to develop personalized plans and learn about specific healthy food choices. When all family members know the basics of healthy eating, mealtime can truly be a shared event.
MyPlate can also encourage family discussions about healthy foods, which can help develop good eating habits by all members of a family. For example, you can find out if there are any particular foods that family members like or dislike, and then find and offer alternatives in the specific food group of a disliked item. This will help eliminate the likelihood that someone will skip the essential healthy components of a meal. Get everyone excited and involved during mealtime! Fun meals shared as a family can promote healthy eating habits for children that they can carry into adulthood and can reinforce family bonding.
Keep in mind that MyPlate isn’t designed as strict rule to be followed—it’s perfectly fine to have dairy products directly on the plate instead of in a cup. Desserts, which are currently placed in the “Empty Calories” section, are okay when consumed in moderation in appropriate portions. You may still have to seek out other sources for how to prepare foods in healthy ways and to determine for the nutrition content of many food items. The information on MyPlate should be used as a tool to build a foundation of knowledge about food choices and help set healthy eating goals for your family. Families should take this change as an opportunity to get the entire family involved in healthy eating.
Probiotic products were seized by U.S. Marshals after the Food and Drug Administration (FDA) complained that the products were marketed as drugs. The company who sells the probiotic products claims that the products will prevent or treat disease, which is in violation of the Federal Food, Drug, and Cosmetic Act. More information is provided in the FDA News Release.