Filed under: FDA
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.
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.
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’.”
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.
The Food and Drug Administration (FDA) has found nearly 300 fraudulent products–promoted mainly for weight loss, sexual enhancement, and bodybuilding–that contain hidden or deceptively labeled ingredients.
Red 40, Yellow 5, Yellow 6, and other dyes are artificial colorings allowed in foods in the U.S., yet there is a long-standing debate over whether food dyes contribute to hyperactivity in children. The Food and Drug Administration’s (FDA) Food Advisory Committee met the last week of March and determined that there is not enough evidence to support the link between food dyes and hyperactivity in children. For now, there will be no warning labels on food products containing dyes.
The Food and Drug Administration (FDA) has issued a warning about a vitamin solution, Soladek; samples that were tested contained dangerously high levels of vitamins A and D. The FDA has advised consumers currently using this product to stop immediately.
For more information, read the FDA warning.
Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain Sibutramine an undeclared drug ingredient. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Click below to access the recall alert.
The FDA held a press conference on 12/15/2010 announcing that it was sending a letter to all dietary supplement trade associations, as well as posting a message to consumers, about the growing problem related to the sale of various misbranded drug products masquerading as "dietary supplements."
In a report from the September 2010 issue of Consumer Reports®, the twelve most dangerous dietary supplements posing health risks have been identified. According to the report, these are dietary supplements which are taken by millions of Americans and have been found to cause serious health problems, including cardiovascular, liver, and kidney problems.