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From Health Law Daily, November 18, 2015

Feds crack down on dietary supplements for dangerous ingredients, false promises

By Mary Damitio, J.D.

The Department of Justice (DOJ) and its federal partners brought criminal and civil cases against over 100 makers and marketers of dietary supplements that allegedly contained hidden active ingredients or that made unsupported health or disease treatment claims. The DOJ announced the nationwide sweep, which includes cases filed in federal courts in 18 states and is part of a year-long federal effort to focus on the dietary supplement market, which has become an area of growing concern for health officials.

Federal partnership. The DOJ partnered with the FDA, the Federal Trade Commission (FTC), the U.S. Postal Inspection Service (USPIS), the IRS, the Department of Defense (DoD) and the U.S. Anti-Doping Agency (USADA) to raise awareness of the risks of unlawful dietary supplements and to assist service members who are targeted by athletic performance supplements.

Best sellers. The DOJ brought criminal charges in 14 cases as part of its nationwide sweep. In one such case, criminal charges were brought against USPlabs LLC and several of its corporate officers for the production of its “widely popular” workout and weight loss supplements that are sold as Jack3d® and OxyElite Pro™. The products have brought in hundreds of millions of dollars for the company. USPlabs LLC and its operators were indicted on a variety of charges including the unlawful sale of dietary supplements, obstruction of an FDA proceeding, and conspiracy to commit money laundering. Federal agents reportedly seized numerous assets in connection with the case, including investment accounts, real estate, and a number of luxury and sports cars.

False labeling. According to the indictment, USPlabs conspired to import ingredients from China by using false certificates of analysis and false labeling. USPlabs allegedly told some of its retailers and wholesalers that natural plant extracts were included in its Jack3d and OxyElite Pro products, when the products actually contained a synthetic stimulant that was manufactured in a Chinese chemical factory. USPlabs also allegedly sold some of its products without determining whether they were safe and when it knew of studies that linked their products to liver toxicity.

Continued sales. USPlabs and its principals informed the FDA that it would stop distributing OxyElite Pro in 2013 after it had been found to be connected with multiple liver injuries. However, the company allegedly continued to sell as much of the products as quickly as possible at dietary supplement stores across the country.

Disease cures. The DOJ also filed five civil cases seeking injunctive relief against entities and individuals who allegedly sold supplements as cures for diseases. One such case was brought against Clifford Woods LLC d/b/a Vibrant Life and Clifford Woods for allegedly selling supplements as cures for Alzheimer’s disease and cancer. Another civil case was brought against an individual doing business as Viruxo for allegedly selling a dietary supplement as a treatment for herpes.

Unsubstantiated claims. Twenty-five civil actions were also brought by the FTC against dietary supplement makers for unsubstantiated claims about their products, including claims that the products alleviated opiate withdrawal symptoms and caused dramatic weight loss. In 11 of the cases, courts have ordered dietary supplement makers to change their business practices.

Educational efforts. The Uniformed Services University of the Health Sciences’ Consortium for Health and Military Performance, through its Human Performance Resource Center (HPRC), teamed up with the USADA to develop educational materials to the provide service members with information to protect them from purchasing risky dietary supplements. The partnership launched an online interactive educational module about dietary supplements and two mobile applications that are available through Google Play and the Apple App stores. The educational materials are intended to augment information that is currently available on the USADA’s website and the HPRC’s Operation Supplement Safety (OPSS) website.

Infographic. The FTC created an infographic to assist consumers in understanding the range of dietary supplement products and the risk of taking such supplements. The FTC has also published blogs with more information about dietary supplements.

Warning. Over the past year, the FDA has found over 100 products that were marketed for sexual enhancement, weight loss, and body building, and which contained hidden active ingredients. As a result, the FDA has issued a continued warning to consumers about the risks of some over-the-counter products that are falsely marketed as dietary supplements that can contain harmful, hidden active ingredients.

Companies: USPlabs LLC; Clifford Woods LLC d/b/a Vibrant Life and Clifford Woods; Viruxo

MainStory: TopStory DrugNews FDCActNews AdvertisingNews SupplementNews LabelingNews MisbrandingNews

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