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FDA Recalls Dietary Supplements Due to Dangerous Undeclared Ingredient

Co-authored by Jacob Exline of The Collins Law Firm, P.C.

On August 24, the U.S. Food and Drug Administration (FDA) reported a recall of 13 different dietary supplements produced by Novacare, LLC due to an undeclared ingredient, salicylic acid, which is harmful to consumers if swallowed. The FDA performed a sample analysis, found the salicyclic acid, and subsequently marked the products as unapproved new drugs. The Novacare products are used to aid in weight loss and are taken orally in capsule form. While the products have not yet been reported to have caused any injuries, they should be immediately returned to the Utah-based company.

Salicylic acid is a drug used to treat skin problems such as pimples. However, if swallowed, it is toxic and harmful to consumers. Salicylic acid can cause nausea, vomiting, gastrointestinal irritation, loss of hearing, and sweating as well as severe reactions of blurred vision, mental confusion, cerebral edema and cardiorespiratory arrest (which could be life-threatening). The FDA states that those who are allergic, elderly, have a history of stomach problems, or consume three or more alcoholic drinks a day have a higher risk of toxicity.

Unfortunately, this is not the first time Novacare has had issues with its dietary supplements. In 2010, the company recalled multiple supplements after a different undeclared ingredient, sulfoaildenafil, was discovered after analysis by the FDA. Sulfoaildenafil, a drug for erectile dysfunction, can lead to dangerously low levels of blood pressure if combined with other prescription drugs.

In March of this year, attorney generals from multiple states began an investigation into Novacare's business practices. They are looking closely at how it markets its products, including labeling and the declaration of active ingredients.

If you have purchased any of Novacare dietary supplements, you can return the product directly to Novacare. If you have consumed the product and are experiencing any problems, seek medical attention immediately. The FDA and Novacare are encouraging the return and cease of consumption of all dietary supplements until the undeclared ingredient can be removed. For more information, please visit the Novacare Recall and the FDA Recalls, Market Withdrawals, & Safety Alerts website.

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