Principal Deputy Assistant Attorney General Ben Mizer took the podium Tuesday to announce a multi-faceted approach to “stem the tide of unlawful dietary supplements” in the U.S.—one that’s motivated by a spate of lawsuits and severe illness resulting from the substances.
According to the National Institutes of Health the “majority of adults” take a dietary supplement either every day or occasionally. Since the Federal Drug Administration does not approve the substances, the $40 billion industry remains unregulated, which leaves room for companies to hide a cocktail of ingredients within their product.
A study from April of this year published in the Drug Testing and Analysis journal found the presence of synthetic speed that’s never been tested in humans in 11 different supplements. A 2014 study published in the Journal of the American Medical Association found “two thirds of supplements previously recalled by the FDA were still tainted with prescription drugs.”
Beyond unethical, the hidden ingredients can prove widely dangerous.
A paper published this October in The New England Journal of Medicine found an estimated 23,000 emergency room visits each year to be related to dietary supplements. Twenty-eight percent involved young adults between the ages of 20-34, must of whom suffered cardiovascular problems.
Tuesday’s announcement marks the biggest effort to clean up the supplement industry thus far.
The “sweep of actions” to be taken in the following months includes plans from the Federal Trade Commission, the FDA, the U.S. Postal Services, the Department of Defense, and the Anti-Doping Agency.
On the legal front, Mizer said the attorney general’s office intends to pursue civil and criminal cases against the makers of these products for knowingly selling dangerous drugs. He announced a new case against the maker of a workout/weight loss supplement, USP Labs. Sold under names like Jack3d and OxyElitePro, the best-selling supplement is made with chemicals from China that Mizer said the company knew were dangerous and used anyway.
After falsifying documents and doctoring the packaging, USP Labs began selling the supplements to the American public, some of whom ended up needing liver transplants to survive. When the FDA instructed the company to discontinue sales, it refused. “The allegations against USP Labs at should serve as a wake-up call to the supplement industry,” said Mizer.
Last month, Oregon’s Attorney General Ellen Rosenblum filed a lawsuit against GNC, one of the largest supplement-makers in the nation, claiming that it “knowingly sold products spiked with two synthetic drugs.” One of the two ingredients, picamilon, is a Russian drug used to treat migraines and brain damage. GNC responded to say that it was committed to providing customers with the “highest quality supplements” using the “purest ingredients.”
Howard Sklamberg, the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, spoke next, calling dietary supplements one of the “most challenging” areas for his organization to regulate. He said the FDA plans to take “vigorous action” against false claims and to crack down on false labeling that hides pharmaceutical ingredients.
Next up was Gary R. Barksdale, Acting Deputy Chief Inspector of the U.S. Postal Service, who said his team began issuing search warrants nationwide on Friday. Reilly Dolan, Acting Deputy Director for the FTC’s Bureau of Consumer Protection, said his organization plans to attack “deceptive and unfair” marketing practices in the industry.
Dolan said that while some supplements that make up the $40 billion industry do work, others are “nothing more than 21st century snake oil.” To combat the marketing tactics, his team is announcing two settlements, twenty warning letters, and 11 other cases. He condemned “disreputable companies” for preying on health issues of average Americans, from obesity to drug addiction, and convincing them that their supplements could fix their problems.
Dr. David J. Smith, Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, said the DOD and the Military Health System are in “full compliance” with the DOJ. He called the issue of supplements a “top threat” in the U.S. Military, noting that 70 percent of active duty service members take some form of supplement. Smith commended the group for taking on the issue, and said his goal was to “keep our service men fit to serve.”
The last to speak was Amy Eichner, The U.S. Anti-Doping Agency’s Special Advisor on Drugs and Supplements—who said that her demographic is one of the supplement industry’s key markets. “Elite athletes, all athletes, including recreational level, youth athletes, masters athletes, even the kids on playing fields in your neighborhoods are very heavily targeted by dietary supplement companies…” said Eichner. “The actions announced today are a real win for clean athletes.”
Eichner announced a new USADA education and awareness app called Supplement 411, aimed at helping athletes make informed decisions about which supplements they choose to try.
Mizer ended his speech making an important distinction between unlawful dietary supplements and lawful ones. “We are not here to criticize the entire supplement marketplace,” he said. “Not every label lies about what’s in the bottle. Not every claim about a dietary supplement is unsupported.” Still, he said, that “critical steps” must be taken to ensure that “justice is served.”