In addition, at the same time the Federal Trade Commission announced an action against a company marketing a dietary supplement that alleges to treat consumers going through opiate withdrawal and FDA announced a series of five civil actions against dietary supplement marketers. The sweep includes federal court cases in 18 states, according to the agency.
Hiding illegal ingredients
The USPLabs indictment alleged the company falsified documents in an effort to camouflage the sale of products containing illegal and unsafe ingredients. The indictment named USPLabs, executives Jacobo Geissler, Jonathan Doyle, Matthew Herbert and Kenneth Miles and also cited contract manufacturing partner S.K. Laboratories and its executives Sitesh Patel and Cyril Willison (aka Eric White). The indictment relates to the products Jack3d, OxyElite Pro and OxyElite Pro New Formula.
“The defendants falsified claims when the products crossed the border. They falsified labeling and marketing materials relating to these products. All of these people, from regulators to retailers to consumers, trusted the defendants were telling the truth about their products. They were not,” said Deputy Assistant Attorney General Benjamin C. Mizer at the news conference.
The indictment alleges that S.K. Labs and USPLabs colluded to hide ingredients of questionable provenance by falsifying Certificates of Analysis. “China can just doctor us a CofA stating it’s an extract,” the indictment quotes Patel as saying in an e-mail.
“USPLabs embarked on a unmistakable course of conduct where, starting at least with DMAA, they imported numerous shipments of substances intended for human consumption using false and fraudulent CofAs,” the indictment says.
DMAA was wholly synthetic, the indictment alleges, but was passed off as an extract of geranium. The company also allegedly imported other chemicals from China under false labels to test them for possible use in supplements. Among these was aegeline, a synthetic version of an Indian botanical extract derived from a tree. USPLabs allegedly instructed its Chinese suppliers to call the chemical “green coffee.”
Liver toxicity
The indictment also alleges that USPLabs used an ingredient the company strongly suspected could cause liver damage. The ingredient was a Chinese herb called Cynanchum auriculatum, believed by USPLabs to have weight loss potential. The company opted for a powdered form of the root of the plant as opposed to an extract, and believed that this would prevent any liver problems, but had done no testing to verify this, the indictment said.
“The defendants allegedly recognized the product could potentially cause liver toxicity but they went ahead and sold it based on this belief,” Mizer said.
Participating in the announcement was a who’s who in tainted and overhyped product enforcement. Among the partners in conference were the United Postal Service’s Inspection Service, FDA, FTC’s Bureau of Consumer Protection and the Department of Defense. Also participating was the United States Anti Doping Agency, an NGO targeting the use of illegal substances in sports. The Postal Service representative announced several search warrants that had been served in the last few days on dietary supplement companies and the FTC highlighted a number of ongoing enforcement actions on non-compliant claims language.
Enforcement welcomed
The announcement of the USPLabs indictment was met with enthusiasm by industry stakeholders, who have long beaten the drum for ramped up enforcement of industry bad actors.
“We are quite pleased, thrilled even,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “We wrote to new Attorney General Loretta Lynch when she took office back in the spring and urged her to use the might of her office to prosecute more companies putting illegal products on the market.”
“Where there are violations of Federal law, we support Federal regulators being strong,” said Dan Fabricant, executive director and president of the Natural Products Association. Fabricant said he had to be circumspect in what he had to say about the USPLabs indictment, as it is a case he participated in during his recent stint at the Food and Drug Administration.
“None of this comes as a great shock. It’s probably a very good signal to companies marketing weight loss products specifically that they really want to take a good review of their marketing materials,” said attorney Marc Ullman, Of Counsel with the firm Rivkin Radler LLP.
“The use of a dietary supplement to treat opiate withdrawal is outrageous. The mainstream industry should welcome these cases,” he said.
More reaction to follow on NutraIngredients-USA