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. We regularly 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:
DoJ/FDA/FTC
On November 17, the Department of Justice, together with FDA and FTC, reported pursuing criminal and civil cases against over 100 dietary supplement makers and marketers. The enforcement actions, including several cases that DoJ announced that day, were part of a year-long sweep of the supplement market. DoJ’s headline case is an 11-count indictment against USPlabs LLC, one of its manufacturers (S.K. Laboratories Inc.), and their executives. According to DoJ, USPlabs “engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.” Further, DoJ alleges that USPlabs lied about using natural plant extracts in its Jack3d and OxyElite Pro products. According to the indictment, the products actually contained a synthetic stimulant, DMAA. The indictment alleges that S.K. Laboratories’ executive (who was also indicted), discussing the purportedly natural substance in an email exchange, wrote “lol stuff is completely 100% synthethic [sic].” Federal agents seized investment accounts, real estate, and cars belonging to the defendants. The indictment contains allegations only, and the defendants are presumed innocent.
In conjunction with the USPlabs case, FDA and DoJ announced several civil cases against supplement companies that allegedly marketed their products as treatments for various diseases, including Alzheimer’s disease, cancer, herpes, and arthritis. The complaints allege that these practices “defrauded consumers through the sale of unapproved new and misbranded drugs.”
Not to be left out, FTC (with DoJ) announced a number of civil actions against supplement marketers over allegedly unsubstantiated advertising claims. For example, FTC alleges that one company made false or unsubstantiated claims that its product “alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction.”
DoJ Press Release:
http://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases
USPlabs Indictment: http://www.justice.gov/usao-ndtx/file/793786/download
FDA Guidance
On November 19, FDA issued its final “Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.” The guidance recommends that firms use phrases like “Not bioengineered,” “Not genetically engineered,” and “Not genetically modified through the use of modern biotechnology” rather than “not genetically modified” or claims using the acronym “GMO.” However, FDA writes that it “does not intend to take enforcement action against a label using the acronym ‘GMO’ in a statement indicating that the product (or an ingredient) was not produced through the use of modern biotechnology, as long as the food is, in fact, not derived from a genetically engineered plant and the food’s labeling is not otherwise false or misleading.” Further, FDA recommends that marketers not claim that products are “free” of ingredients derived through the use of biotechnology. Instead, it recommends that “manufacturers consider the use of other types of statements to indicate that a plant-derived food has not been produced using bioengineering.”
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm
SARMs in the Spotlight
For quite some time, companies selling a variety of Selective Androgen Receptor Modulators (known as SARMs) as dietary supplements have flown under the radar. SARMs likely do not fit the definition of “dietary ingredients” that may be legally sold in “dietary supplements” (see partner Rick Collins’ July, 2015 column in Muscular Development for a detailed explanation of why that is). However, “supplement” marketers had been using the ingredients in dietary supplement products with little attention from FDA or the media. That changed when Holly Holm knocked out Ronda Rousey at UFC 193. One of Holm’s sponsors apparently at one time sold products containing SARMs, which are on WADA’s list of banned substances. This discovery has led to ample media attention, bringing SARMs into the spotlight for the first time. If the pattern where media targets an ingredient, then FDA acts against that ingredient holds (think DMAA, DMBA, BMPEA), then SARMs could be the next class of ingredients that FDA pursues in enforcement actions.
The New Normal
Within the last two months, DoJ, FDA, FTC, the Oregon Attorney General’s Office, and class action attorneys have pursued dietary supplement companies over failing to follow GMPs, making disease claims or unsubstantiated claims, and using allegedly unsafe or non-compliant ingredients (and lying about it), among other reasons. The dietary supplement industry is being targeted from every angle. Regulators are not going away-according to DoJ’s press release, it is “focus[ing] enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide.” If you have a supplement company and you have not had your labels, ingredients, and marketing reviewed for legal compliance, or if you are not buttoned-up from a GMP perspective, you are risking that your company’s name will be in the next DoJ enforcement announcement. The time for complacency and hoping that chancy practices go unnoticed is over.
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.