Posted in Drug & Medical Devices, Health & Wellness on March 28, 2014

The FDA has issued a warning that some over-the-counter weight loss pills, being sold as dietary supplements, are actually dangerous, unapproved and misbranded drugs. 

Pure Edge Nutrition recently announced that it is recalling several of its products, after it was discovered the supplements contained undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein. Sibutramine, a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons. Phenolphthalein is used medicinally as a laxative and not approved for marketing in the United States.

Products containing sibutramine and phenolphthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.

These products may also interact in life threatening ways with other medications a consumer may be taking.

Click here to read the complete recall.

Different Regulations for Dietary Supplements

Although dietary supplement manufacturers must register their facilities with FDA, the dietary supplements themselves are not subject to premarket testing or FDA approval. Additionally, manufacturers are not required to provide the FDA with any evidence that a supplement is safe or even effective.

According to agency’s website, this is because the FDA regulates dietary supplements under a different set of regulations than conventional drug products:

• Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of federal regulations.
• The FDA is only responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. 

Misbranded – A dietary supplement is misbranded if its labeling is false or contains misleading information regarding nutrition and health claims, ingredients and quantities.

Adulterated – According to the Dietary Supplement Health Education Act (DSHEA) of 1994, adulteration of a dietary supplement occurs when it does any of the following:

• Presents a significant or unreasonable risk of illness or injury when used in accordance with the suggested labeling or, if unlabeled, under ordinary conditions of use
• Is a new entity and lacks adequate evidence or information to ensure its safety of use
• Has been declared an imminent hazard by the Secretary of the Department of Health and Human Services
• Contains a dietary ingredient that is present in sufficient quantity to render the product poisonous or deleterious to human health 

Before taking any dietary supplements, including diet pills, herbs, vitamins or minerals, you should speak to a qualified health care provider. He or she can help best determine the benefits and risks.

Source: “Bella Vi, Super Fat Burner contain dangerous drugs: Tainted dietary supplements” by Brie Zeitner, The Plain Dealer, March 27, 2014.