By Erik Goldman
A coordinated set of enforcement actions by the Food & Drug Administration, the Federal Trade Commission, the Department of Justice, the Department of Defense, the postal service and several other federal agencies has the dietary supplement industry playing defense....and also applauding.
Earlier this month, the Department of Justice announced its pursuance of civil and criminal cases against more than 100 supplement makers, charging them with illegal spiking of supplements with pharmaceuticals, inclusion of ingredients that are inappropriate for use in supplements, or making false, unsubstantiated or misleading marketing claims.
The largest case with the highest profile was the set of criminal charges brought against a Texas company called USPlabs, maker of workout and weightloss thermogenic "supplements" that actually contain fluoxetine as well as synthetic stimulants. The company's most popular product called OxyElite Pro, has been the subject of multiple previous enforcement actions, including a 2013 order from the FDA to stop distribution of the product following multiple reports of liver failure in OxyElite users.
In this month's action, USPlabs executives have been brought up on criminal charges.
The current federal sweep includes five civil court cases alleging fraud, misleading advertising, failure to comply with good manufacturing procedures, unlawful sale of illegal ingredients, and promotion of supplements as cures for diseases including cancer and arthritis. The FTC has also brought dozens of civil actions alleging false and misleading advertising. Regulators have been particularly focused on supplements marketed for muscle-building and athletic performance enhancement, sexual enhancement products, those containing poure powdered caffeine, those containing the substances BMPEA and DMBA which are considered illegal by federal agencies.
(For links to further info on various indictments, see list below).
Loren Israelsen, executive director of the United Natural Products Association (UNPA) says that his organization applauds the coordinated effort to eliminate bad players from the rapidly growing industry.
Loren Israelsen, Executive Director, United Natural Products Alliance"We were gratified to see the breadth of agencies represented. UNPA and responsible industry have long urged regulators to take decisive action against noncompliant products," said Israelsen in a statement issued by UNPA.
"We encourage regulators to continue to assure consumers of wide access to safe, beneficial and well-researched dietary supplements. For our part, we will continue to work closely with all regulators on the types of cases they described today to support and encourage a supplement industry that operates within the law and continues to be deserving of widespread consumer trust."
Israelsen and other supplement industry leaders say this month's regulatory assault goes a long way to counter the oft-heard canard that the supplement industry is unregulated. “The clear message for industry, Congress, the media and consumers is that there is broad authority held by various agencies to regulate dietary supplements.
The federal actions follow a year of state-level clampdowns heralded by the New York Attorney General's attempt to take down major supplement retailers like GNC and Vitamin Shoppe on allegations they were selling fraudulent herbal products. Though AG Schniederman's efforts were largely rebuffed, they did set precedent for a number of AG actions in other states, as well as a tide of class-action lawsuits.
While he says he welcomes stronger enforcement efforts aimed at eliminating truly fraudulent and dangerous products, Israelsen said he is also concerned that some regulators may be less concerned with public protection and more concerned with election year politics.
There is a fine line between policy that protects the public and encourages the highest standards in product manufacture, and one that's designed to thwart what is currently a thriving industry. Israelsen sees rough seas ahead for supplement companies, particularly those playing in the big box retail or online sectors.
For the most part, regulators are not targeting healthcare professionals who dispense supplements. Compared with major retailers, dispensing clinicians are very low profile, and they tend to be dispensing practitioner-grade products that are typically made to pharma standards and are much less likely to contain undeclared, ilicit or dangerous ingredients.
Further, Israelsen surmises that neither the Attorneys General nor the federal regulators want to get tangled up in matters of clinical judgment or physician-patient relationship issues.
For more information on recent regulatory actions:
Download Bethel Nutritional complaint (1.9 MB)
Download optimum complaint - filed (552.09 KB)
Download vibrant life complaint - filed (79.41 KB)
Download Viruxo filed complaint (676.94 KB)
Download Vivaceuticals Inc Complaint (112.27 KB)
Download Supplement Sweep Chart to release_2015-11-12_updated (29.19 KB)