In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. Every two weeks, we send out an email that gives a brief synopsis of enforcement actions in the dietary supplement space (we never share our subscription list, and you can opt out at any time at the bottom of each email). Staying apprised of enforcement trends in the industry, from FDA warning letters to FTC false advertising allegations, can help you to stay above the fray and off of the regulatory radar. Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
Here are the recent enforcement actions taken against purportedly non-compliant dietary supplement companies, and the claims made against them:
Department of Justice (“DOJ”) Activity
On September 16, a DOJ official wrote a letter to two U.S. Senators alleging that illegal activity within the supplement industry “has become a massive, and wide-ranging, consumer protection problem.” Assistant Attorney General for Legislative Affairs Peter Kadzik added “Reports of illnesses, even deaths, are all too common. Put simply, we can all do more to make certain that consumers who purchase dietary supplements know that the products are safe and that the products will deliver on their advertised promises.” These statements were in response to letters written by Senators Martin Heinrich (D-New Mexico) and Orrin Hatch (R-Utah) to U.S. Attorney General Loretta Lynch regarding the need for more regulation of the industry. Kadzik ended by saying “We are committed to taking steps to root out and, as appropriate, address unlawful activity in the dietary supplement industry.”
Food Safety Prison Sentence: 28 Years
The 61-year-old former owner of the disgraced Peanut Corp. of America (PCA) was sentenced to 28 years in prison for charges relating to a 2009 outbreak strain of Salmonella Typhimurium that sickened 714 persons in 46 states and left nine dead. The case shows the potential severe consequences of adulterating food-and dietary supplements are classified as food-under the Federal Food, Drug & Cosmetic Act (FD&C). “It’s important for supplement marketers to realize that violations of the FD&C, of which the Dietary Supplement Health and Education Act is a part, need to be taken seriously,” said Rick Collins, a partner with the New York-based law firm Collins, McDonald & Gann, P.C., in an emailed statement to Natural Products INSIDER. “The perception that FD&C violations are only limited to one or at most three years of prison exposure is mistaken. Cases involving adulterated products, including dietary supplements, can include charges of mail fraud, wire fraud, money laundering and conspiracy, all of which ratchet up the exposure. Parnell’s sentence shows the hammer the Government wields, if it wants to, in an adulterated product case.”
New York Attorney General (“NYAG”) Action
On September 10, the NYAG issued thirteen cease-and-desist letters to dietary supplement marketers who used devil’s claw in their products. The NYAG claims that the devil’s claw supplements do not contain “devil’s claw,” which is the common name for the botanical Harpagophytum procumbens (“procumbens”), but instead contain Harpagophytum zeyheri (“zeyheri”). The NYAG claims that procumbens and zeyheri are different and that the latter is of cheaper quality. He found the discrepancy by relying on the same DNA barcode testing techniques deployed in his previous attack on dietary supplements that some experts say is inappropriate for testing finished herbal supplements. Many experts in the field believe procumbens and zeyheri are equally effective, and that the NYAG’s action amounts to a battle over semantics.
U.S. Senate Action
U.S. Senator Richard Blumenthal (D- Connecticut) and U.S. Senator Dick Durbin (D-Illinois) are attempting to reintroduce the Dietary Supplement Labeling Act. If passed, the Act would require additional information on labels and “expand the registration requirements for a dietary supplement manufacturing or processing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured or processed; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.” Blumenthal adds as a soundbite: “The dietary supplement market is a dangerous Wild West of inadequate regulation. . . . Without more transparency regarding the dangers of these products-and more scrutiny over the often outrageous health benefit claims-consumers simply have no way to know what they are taking.”
CMG in the News
Collins, McDonald & Gann, P.C. attorney Robert Danko published an informative piece in Natural Products Insider that can help you understand your supplement firm’s cGMP obligations, and hopefully guide you in becoming compliant. See http://www.naturalproductsinsider.com/articles/2015/09/cgmp-s-and-the-testing-requirements.aspx
If you have a dietary supplement company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.