Filed under: Dietary supplements
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 marketing and selling of dietary supplement products has become a 20-billion-plus industry. Consumers are bombarded with ads, and some people turn to them as “healthier” choices to prescription and over-the-counter medications. Consumers should seek products that have been properly manufactured and should be aware of potential interactions with medications. For other important tips, read the article “Prepared Patient: Vitamins & Supplements, Before You Dive In”.
Tainted dietary supplements most often occur among products typically marketed for weight loss, sexual enhancement, and bodybuilding. They can have deceptive labeling as well as undeclared, harmful ingredients. The question is: How can consumers protect themselves from these products?
The Food and Drug Administration (FDA) has recently taken some steps to help consumers look out for potentially harmful dietary supplement products. Consumers and healthcare professionals can receive notifications from the FDA by subscribing to the RSS feed. The Commissioner of Food and Drugs also sent a letter to the dietary supplement industry reminding them of their responsibility to prevent the sale of tainted products in the United States. The FDA has also made it easier to report to the FDA about tainted products.
Some of these tainted dietary supplement products contain active ingredients of FDA-approved drugs or other compounds that are not classified as dietary ingredients. These products can have serious side effects, including death. The FDA has identified roughly 300 tainted products that are not legal dietary supplements and are warning consumers about the serious side effects of these products. Consumers should be cautious of:
- Product ads that claim to “melt your fat away,” or claim that “diet and exercise [are] not required,” or products that use the words “guaranteed,” “scientific breakthrough,” or “totally safe.”
- Products that use numerous testimonials about “results seen” from using the product.
- Any product that is labeled or marketed in a foreign language. Consumers should not buy or consume these products.
- Products that are marketed as herbal alternatives to FDA-approved drugs.
- Products marketed and sold on the Internet.
There have been some recent voluntary recalls due to FDA investigations of dietary supplement products. Some of these have included weight-loss products that contained the prescription drug ingredient sibutramine. Sexual enhancement products have also been recalled for containing the undeclared drug ingredients sulfosildenafil and tadalafil. Other products marketed as supplements have been identified as containing various prescription drug ingredients.
It is important that consumers be aware that, under the Dietary Supplement Health and Education Act of 1994, companies do not need FDA approval prior to marketing such products. Thus, generally speaking, the FDA does not approve dietary supplements.
Consumers need to be savvy when they make product purchases, and when in doubt, check with a healthcare professional or registered dietitian to determine if you need a dietary supplement product and to help determine what could be a tainted product. If it looks too good to be true, chances are it is. For more information, read the “FDA’s Beware of Fraudulent ‘Dietary Supplements’.”
CNN.com is reporting on a new government study which reports more than half of American adults take at least one dietary supplement. But despite their popularity, many experts remain skeptical of their effects.The study, sponsored by the Centers for Disease Control and Prevention's National Center for Health Statistics, found that more than 40 percent of Americans used supplements from 1988 to 1994, but by 2006 more than half were doing so. Multivitamins were found to be the most commonly used supplement.
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.