In October, Life Sciences Decoded described the increased state and federal scrutiny against the dietary supplement industry, including a lawsuit that the Oregon Attorney General filed against GNC. This scrutiny and enforcement continues to unfold with news that the U.S. Justice Department has indicted 117 companies and individuals for selling tainted, mislabeled or misleading products, as reported in the New York Times on Nov. 17, 2015. This latest round of enforcement represents inter-agency action in conjunction with the FDA, FTC and the U.S. Anti-Doping Agency and the joint agency crack down on the sale of illegal, misbranded or tainted dietary supplements.
The impact of these DOJ actions to the dietary supplement industry is yet to be fully realized. However, it is clear that the supplement industry will continue to be the target of increased enforcement actions and government scrutiny.
For one company, Dallas-based USPlabs, makers of popular workout and bodybuilding products, and six of its executives, the government investigation led to the indictment of the company and its CEO. According to the DOJ, USPlabs advertised its product as containing natural plant extracts, even though it actually contained a synthetic amphetamine-like chemical called DMAA, or dimethylamylamine. DMAA was the subject of a 2013 FDA statement warning of the effects of DMAA and a finding that there is no evidence of DMAA occurring naturally in plants. The FDA sent warning letters to 11 companies, including USPlabs, advising that DMAA-containing products are illegal and should be taken off the market, despite USPlabs’ attempt to show that DMAA was safe and effective for its intended use. The FDA also specifically stated that “consumers should not buy or use any dietary supplement products containing DMAA.” After that warning, USPlabs agreed to destroy more than $8 million worth of inventory of products containing DMAA, including Jack3d and OxyElite, both subjects of the current Justice Department action.
As of the publishing of this article, Jack3d was still available for purchase from leading retailers, including GNC.
Federal dietary supplement compliance
Not all of the companies named in the indictments allegedly had tainted products like USPlabs’ Jack3d. Sunrise Nutraceuticals, maker of Elimidrol, marketed its product as “guaranteed to work” in reducing the symptoms of opiate withdrawal, which are unsubstantiated claims according to the Justice Department, the FTC and the FDA. This marks a continued trend in 2015 wherein government agencies, including the FDA, are placing heightened scrutiny upon the dietary supplements industry. In addition to the GNC lawsuit in Oregon, in April, 14 Attorneys General authored a letter to the Congressional Committee on Commerce, Science, & Transportation, Subcommittee on Consumer Protection, Product Safety, Insurance, & Data Security calling for increased standards and review of the oversight of the nutritional supplement industry. The letter stated:
The multibillion dollar herbal supplements industry is built on the promise that its products will improve the health and well-being of those who use them. Yet, a current state investigation has raised serious concerns about the marketing and safety of the herbal supplements regularly consumed by millions of Americans. . . Recently, the New York State Office of the Attorney General examined popular herbal supplements sold by four major retailers. Many of the products tested were contaminated with allergens, plant species left off the label, or other potentially dangerous substances, or so thoroughly “processed” that the genetic material of the original “natural” plant source was unrecognizable or not present at all. As a result, several members of Congress, including leadership from these subcommittees, called on the FDA to investigate the findings.
This increased attention comes as a direct result of certain members of the supplement industry:
- Promoting products for uses for which there is no adequate scientific evidence to support those claims;
- Using products that have been banned by the FDA;
- Using unapproved dietary ingredients and mislabeling of those products.
These recent government actions and continued investigations into the dietary supplement industry and its practices should warn the industry to review its practices and, where appropriate, clean up its regulatory compliance practices. This scrutiny of the industry will only increase going forward in light of the FDA’s focus on food safety and, of course, supplements fall within the regulatory definition of food. Industry members should take the opportunity to heed the federal government’s implied warning found in these recent actions and ensure that:
- All labeling complies with FDA requirements in 21 C.F.R.§ 101
- All manufacturing, processing and holding complies with current Good Manufacturing Practices under 21 C.F.R. § 111; and that
- New requirements created under 21 C.F.R. § 117 (including new HARPC safety plans) are in the process of being applied in each processing, manufacturing or holding facility.
At Thompson Coburn, we have a team of attorneys with experience filing and advising new dietary ingredient notifications with the FDA, as well as GRAS petitions, on behalf of food and dietary supplement manufacturers for both human and animal products. If you have any questions about the issues in this article, or any others, please contact us.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.