Filed under: Dietary supplements
Food Safety News is reporting that Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods. A recent HPRC Performance News post notes that there have been questions raised on commercially available products such as Lazy Cakes and Lulla Pies that are marketed as "relaxation" brownies - which contain high doses of the sleep aid melatonin.
These products are being sold as dietary supplements to help people relax and fall asleep, rather than foods containing additives. Senator Durbin contends that these foods are being sold as dietary supplements but are really foods containing a dietary ingredient additive, which would require FDA approval. He has asked U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to see if she has the authority "to oversee the safety of foods containing dietary supplement additives."
The vast array of dietary supplement products come in the form of tablets, capsules, powders, drinks, and energy bars. You can learn about dietary supplement labels, effectiveness, quality standards, safety and risks, and other important information about these products from the National Institute of Health’s Office of Dietary Supplements publication “Dietary Supplements: What You Need to Know.”
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.
Lazy Cakes, Kush Cakes, and Lulla Pies are the names of melatonin-laced snacks that have been in the news lately as an antidote to the trend of energy/caffeinated powered beverages and products. But there is no research available on whether they are safe, or whether they actually work.
The New York Times reported on the sale of these products and others that are being sold online and in convenience stores and smoke shops. Some claim melatonin has a relaxing effect and can be used to alleviate jet lag or simply help induce sleep. But the Food and Drug Administration hasn't approved melatonin as a food additive or confirmed its safety when used as a sleep aid.
The HPRC began encountering stories of melatonin-laced brownie products back in March 2011, and we posted a Healthy Tip then that focused on the emergence of Lazy Cakes.
The Federal Trade Commission (FTC) is seeking to bar deceptive claims made by websites posing as reputable news sites to entice consumers to buy acai berry weight-loss products. The FTC says these companies are not “news-gathering organizations” and their claims that acai berry supplements can cause rapid weight loss are unsupported. For more information, read the FTC release: “FTC Seeks to Halt 10 Operators of Fake News Sites from Making Claims About Acai Berry Weight Loss Products.”
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to several companies selling unproven products claiming to treat, cure, and prevent sexually transmitted diseases (STDs). These products—such as Medavir, Herpaflor, Viruxo, C-Cure, and Never an Outbreak—violate federal law because the FDA has not evaluated them for safety and effectiveness. Some are marketed as dietary supplements, but the FDA considers them drugs since they are offered for the treatment of disease. More information is provided in the FDA Press Release.
Vitamin B12 is one of the eight B vitamins and is water-soluble. Our bodies do not store vitamin B12 so we must consume it daily. It is an important nutrient that helps make DNA, the genetic material in cells, and is essential for normal functioning of the brain and nervous system. Good food choices for vitamin B12 are beef liver, clams, fish, meat, poultry, eggs, and other dairy products. Read the Office of Dietary Supplement’s Vitamin B12 Fact Sheet for additional information.
We know about colas, coffee, tea, and chocolate, but caffeine can also be found in some over-the-counter drugs and herbal dietary supplement products. Energy drinks contain caffeine, and some also contain guarana, a plant with high amounts of caffeine. Yerba mate, green tea extract, and kola nuts are also sources of caffeine, and can be found in weight-loss and performance-enhancing dietary supplements. Be sure to read labels for hidden sources of caffeine.
The U.S. Food and Drug Administration (FDA) has information for consumers regarding dietary supplements: Questions and answers, regulations, and safety alerts. Click here for their website.