FDA Warns of Weight Loss Pills and Dietary Supplements with Undeclared Drugs

The FDA has issued an alert to notify consumers not to purchase over 25 different weight loss pills, some of which are marketed as dietary supplements. These products, which are being sold in retail stores and through the internet, contain undeclared, active pharmaceutical ingredients which could pose serious health risks.

The weight loss products highlighted in the FDA warning include:

2 Day Diet, 3x Slimming Power, Fatloss Slimming, 5x Imelda Perfect Slimming, Lida DaiDaihua, 3 Day Diet Japan Lingzhi, 7 Diet Day/Night Formula, 999 Fitness Essence, 24 Hours Diet, GMP, Imelda Perfect Slim, Miaozi Slim Capsules, Perfect Slim 5x, Perfect Slim, ProSlim Plus, Phyto Shape, 7 Day Herbal Slim, Slim 3 in 1, Slim Express 360, Slimtech, Superslim, TripleSlim, Somotrin, 8 Factor Diet, Royal Slimming Formula, Zhen de Shou, Extrim Plus and Venom Hyperdrive 3.0.

The FDA has indicated that the weight loss pills pose serious health risks, with the potential to cause increased blood pressure, seizures, tachycardia, palpitations, heart attacks or strokes. The products may contain pharmaceutical ingredients which are controlled substances or not approved for marketing in the United States.

Some of the products contain sibutramine, which is the active pharmaceutical ingredient in the anti-obesity drug Meridia, a medication that is only available by prescription. Receiving this product in an over-the-counter product may increase the risk of side effects like tachycardia, increased blood pressure, seizures and palpitations.

Rimonabant, which is approved in Europe but not in the United States, has also been found to be present in some of the listed weight loss pills and dietary supplements. Over the last two years, this active pharmaceutical ingredient has been linked with an increased risk of depression and suicidal thoughts. It has been associated with 720 reported adverse reactions and at least 5 deaths in Europe.

The pharmaceutical ingredient phenolphthalein has also been found in some of these products, which is a solution used in chemical experiments and a suspected cancer causing agent.

Consumers have been advised to immediately stop using these dietary supplements and weight loss pills, and to contact their doctors regarding possible side effects and future treatments for obesity.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences.”

Dietary supplements are not usually regulated by the FDA, but if a product contains active ingredients it does require FDA approval. Many of these products indicate that they only contain “herbal” ingredients, but actually have pharmaceutical ingredients which may be potentially harmful and are not listed on the product labels or in advertisements, making them illegal in the United States.

The FDA has indicated that they are inspecting companies marketing the illegal products and seeking recalls. The agency may take additional steps against companies that do not cooperate in recalls, such as issuing warning letters or initiating seizures and filing criminal charges.