U.S. Agencies Make Sweeping Actions Against Supplement Companies

Washington, D.C.—Several federal agencies, including the U.S. Department of Justice, the Department of Defense, the U.S. Food and Drug Administration, the Federal Trade Commission and the U.S. Anti-Doping Agency held a joint press conference on Nov. 17 to announce sweeping actions against several dietary supplement manufacturers “to stem the tide of unlawful dietary supplements being sold to consumers nationwide,” stated Benjamin Mizer, principal deputy assistant attorney general for the civil division.

The announcement is the end of a year-long effort involving more than 100 supplement makers in civil and criminal cases.

Mizer opened by stating that consumers are turning to supplements to “lose weight, get an edge in athletic performance, or improve their overall well-being” and are ingesting products without knowing if they can do what they claim to do. “Consumers may be choosing supplements over other proven therapies under the mistaken belief that these products can help,” he stated.

First, Mizer announced the 11-count indictment of USPlabs, maker of several popular workout and weight-loss supplements such as Jack3d and OxyElite Pro. The indictment included four USP executives, S.K. Laboratories Inc. operators and one USPlabs consultant for “criminal conspiracy to sell toxic substances.” Four defendants have already been arrested.

Mizer said USPlabs did not complete sufficient safety testing (including selling a product USPlabs suspected caused liver damage) and stated that the supplement was natural even though the firm knew that it was 100% synthetic. Moreover, USPlabs “falsified paperwork to stay off the radar of regulatory agencies,” said Mizer, and misrepresented products to retailers and consumers. “The deception put lives at risk,” he stated said. The company continued to sell the product after FDA gave them warnings.

Added Mizer, “The allegations against USPlabs and its operators should serve as a wake-up call to the supplement industry. The unmistakable message is that the department of justice and its federal partners will be vigilant when it comes to the health and safety of the American public. Fighting illegal activity in the dietary supplement industry is a high priority of our consumer protection agenda.”

Howard Sklamberg, J.D.,‚Ä®deputy commissioner for global regulatory operations and policy, added, “The criminal charges against USP Labs should serve as notice to industry that if your products are found to be severely harming health, the FDA will exercise its full authority under the law to bring you to justice and to protect consumers.”

Gary Barksdale, acting deputy chief inspector of the U.S. Postal Inspection Service, announced that several warrants were served last week “as part of the nationwide sweep on dietary supplements.” On Nov. 17, additional warrants were served in Massachusetts and California. Civil cases brought by the Department of Justice, and investigated by the U.S. Postal Inspection Service, involved Vibrant Life, Viruxo, Optimum Health, Bethel Nutritional Consulting and Regeneca Worldwide. “Despite legitimate medical breakthroughs, scammers continue to peddle worthless pills, oils, and ointments, promising miracles and defrauding the public…The U.S. Postal Service helps to halt scammers from selling their wares to unsuspecting citizens.”

Meanwhile, Riley Dolan, acting deputy director for the FTC’s bureau of consumer protection, said that his agency was announcing “three new actions, one complaint and two settlements, 20 warning letters to go along with 11 other cases the ftc has announced in the last year.” He stated that the agency just filed a claim against Sunrise Nutraceuticals “for its marketing of a concoction of vitamins, minerals and herbs purported to alleviate the terrible physical and mental symptoms of opiate withdrawal. Sunrise said the product allowed addicts to get and stay clean on the first try, but as alleged in the FTC complaint, they did not have the science to back up that claim.”

Additional civil actions were brought against Health Nutrition Products and NPB Advertising by the FTC.

Dolan added that the FTC is also “seeking monetary relief” from several companies involved in weight loss scams.

Unfortunately, some of the language used at times to describe these actions was inclusive of the entire supplements industry when the products in question were not legal supplements at all.

Said Loren Israelsen, president of the United Natural Products Alliance, "However, one unfortunate message was the frequent use of the term ‘dangerous dietary supplements,’ when the law does not recognize the suspect products as dietary supplements but rather unapproved drugs, which FDA has noted on many occasions and which would have been useful to repeat today.

Mizer conceded that not every dietary supplement is problematic. “We are not here to criticize the entire supplement marketplace. Not every supplement contains an undisclosed ingredient. Not every label lies about what’s in the bottle. Not every claim about a dietary supplement is unsupported.”

Mizer said that consumers can do their own due diligence by speaking with their health-care providers and consulting FTC’s and FDA’s websites for more information.

In response Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association, stated, "We have long called on the government to prosecute illegal activity to the full extent of the law, and today’s action demonstrates the government’s vast power to regulate this industry. We welcome the coordination and collaboration of the other agencies involved, and offer to work with them and others to continue educating the public about the benefits of proper dietary supplement usage.”

Steve Mister, CEO of the Council for Responsible Nutrition, also felt the announcement is good news. He said: "These actions both help consumers navigate the market to avoid products that may do them harm, and also level the playing field for responsible companies who do things right. We pledge our support to help the government on this important initiative.”

In reaction to the news, GNC announced it would no longer sell products made by USPlabs or any of the indicted companies. As reported by Trib Live, "GNC said it had no reason to believe any USPlabs products sold by GNC were a health or safety threat but stopped selling them in the best interest of customers, pending further review."

Published in WholeFoods Magazine, January 2016, online 11/17/15 (updated 11/23/15, 12/1/15)