Filed under: FDA
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.
Virtue Calves was cited for selling veal calves that contain illegal drug residues, which is in violation of the Federal Food, Drug, and Cosmetic Act. The company is now required to keep careful records of which animals have been medicated so that illegal drug residues do not enter the food supply. 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.
Food and color additives exist in many of the foods that we eat. They are used to improve safety and freshness, maintain the nutritional value of foods, and improve texture and appearance. The Food and Drug Administration (FDA) has put together a helpful brochure reviewing how additives are approved for foods, types of food ingredients, and a description of food and color additives.
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.
We’re bombarded with ads for health products when we read magazines, turn on the TV, and go to a store. Products claim to cure an illness, improve our looks, or just help with overall health, but how do we know how to spot a health fraud? The Food and Drug Administration (FDA) defines a health fraud as: “Articles (drugs, devices, foods, or cosmetics for human or animal use) of unproven effectiveness that are promoted to improve health, well being or appearance.” Read their fact sheet for more information.
The Food and Drug Administration (FDA) is warning consumers to stop using dietary supplement products that claim to be antimicrobial (antibiotic, antifungal, or antiviral) drugs. These products are falsely promoted to treat upper respiratory infections, sinusitis, pneumonia, bronchitis, and colds, and they look like antimicrobial products sold in Mexico. More information, including product names, is provided in the FDA Press Release.
The Food and Drug Administration (FDA) has issued a press release to consumers warning them about a counterfeit product being represented as the dietary supplement "ExtenZe.” The counterfeit product has hidden ingredients, including tadalafil or a combination of tadalafil and sildenafil, which are active ingredients of FDA-approved drugs, making these products unapproved drugs. Taking these products with prescription medications containing nitrates could lower blood pressure to dangerous levels. More information, including the lot numbers on the counterfeit packages, is provided in the FDA Press Release.