Dietary supplement makers face ‘misbranding’ minefield, need FDA guidance

Regulation of the dietary supplement industry leaves much to be desired. While there are numerous statutes and regulations that govern industry practices, the lack of detailed FDA guidance outlining threshold levels of impurities or other byproducts leaves dietary supplement manufacturers and distributors open to potential liability for misbranding.

There is seemingly no logical basis for the lack of guidance. The highly regulated pharmaceutical industry has FDA-set threshold levels for impurities. Other food products, such as eggs, also have detailed regulations outlining the quantity of filth or other impurities allowed to be present before human consumption.

We see similar guidance outlining threshold levels of impurities in other consumer products. For example, the Environmental Protection Agency has set legal limits on over 90 contaminants in drinking water. Yet FDA continues to sit back and allow dietary supplement manufacturers to operate in the gray before seeking punitive action when it feels like a member of the industry has crossed an arbitrary line.

By way of analogy, imagine there is a known minefield. For pharmaceutical companies, FDA provides them with a map identifying the vast majority of the mines, and, in effect, offers them a clear path to successfully navigate the field. Mistakes may be made when a company does not follow the road map, or perhaps an accident occurs, but for the most part, everyone can make it to the other side.

For dietary supplement companies, FDA only provides a map outlining the boundaries of the field but identifies no mines, and (to make it more fun) then tells the industry to wear a blindfold while they work their way through to the other side.

Misbranding definition

Under 21 U.S.C. § 331, introducing an adulterated or misbranded food into interstate commerce is prohibited. A dietary supplement is “adulterated” if it contains an ingredient that “presents a significant or unreasonable risk of illness or injury” when used as directed or “[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health.” (See 21 U.S.C. § 342.)

Because adulteration requires a potential injury, it is almost impossible for FDA to argue that a miniscule amount of an impurity renders the supplement adulterated as it would be unlikely to have any physiological effect on the consumer and therefore cannot injure him or her. Unfortunately, that limiting factor does not clip the heels of FDA. The agency still has misbranding to fall back on.

“Misbranding” is a term that encompasses many different types of conduct and does not have the same limitations as “adulteration.” A dietary supplement may be misbranded if the label is false or misleading; if the product is sold under the wrong name; if the label does not possess the requisite information, including ingredients; or if it is in a format that does not allow the consumer to identify key components easily. (See 21 U.S.C. § 343).

This broad definition of misbranding can lead to illogical practical applications. Namely, FDA may find a dietary supplement to be misbranded if its label does not list impurities because there is no guidance regarding threshold levels that would otherwise negate potential liability.

The question then becomes, how do dietary supplement companies respond? There are seemingly only two choices, neither of which is palatable:

- Dietary supplement companies undergo a massive transformation, and rather than act in conformance with cGMPs (current good manufacturing practices), become the equivalent to manufacturers of semiconductors making their products in clean rooms and preventing any level of unwanted impurities or contaminants from rendering their products misbranded.

- Or, prior to releasing any product into the stream of commerce, run a series of endless tests that identify every “ingredient” in the product, regardless of quantity, and creating a label listing every substance identified.

Either choice is cost-prohibitive and defies common sense.

Still, dietary supplement companies should not be held to the same standard as a pharmaceutical company, and FDA cannot prosecute every case where a dietary supplement label is misbranded because the ingredient list does not include a substance that is in parts per million (“ppm”) or parts per billion (“ppb”).

Yet with an expansive and oppressive reading of applicable statutes, FDA can potentially bring criminal misbranding charges against dietary supplement companies for products containing any amount of an illegal substance or impurity.

FDA enforcement

Of all the potential impurities or contaminants that could possibly exist in dietary supplements, illegal anabolic steroids have been a favorite topic of FDA. And rightfully so since keeping illegal drugs out of dietary supplements should be a focus for every member in the industry.

Enforcement activity involving steroids has often been brought under the theory of adulteration, not misbranding. That makes sense. When a steroid is in a dietary supplement, it renders that product potentially injurious to the consumer’s health, at least when the steroid is at a level that can have a physiological effect.

However, FDA would be unable to bring adulteration charges if the amount of steroid present in the product is of such a small quantity that consumption of the product—according to the label—would not expose the consumer to illness, injury or otherwise negatively impact their health.

Typically, FDA prosecutions have been limited to cases where a dietary supplement was either largely or entirely comprised of anabolic steroids or anabolic steroid ingredients, not those products containing trace or ineffective amounts of a potential manufacturing byproducts. (See e.g., United States v. Mesika, et al., No. 1:16-CR-00224-MHC-CMS (N.D. Ga.); United States v. Anabolic Science Labs LLC and Robert Eric DuBois, No. 2:16-CR-20035-JTF (W.D. Tenn.); United States v. Bodybuilding.com LLC, No. 1:12-CR-00115-BLW (D. Idaho)).

However, under a theory of misbranding, FDA need not show a potential for injury. This opens the door for charges related to minimal amounts of an illegal anabolic steroid.

The above demonstrates FDA needs to issue guidance on permissible threshold levels of impurities in dietary supplements, which would enable dietary supplement companies to avoid claims of misbranding. In contrast to the above potential for arbitrary enforcement actions in the dietary supplement space, FDA has set clear guidance on when impurities are allowed in pharmaceutical products.

In the second part of our series, we will juxtapose the ways in which FDA has set forth specific parameters for pharmaceutical companies to avoid misbranding claims with the recent decision in Sandoz Inc. v. Becerra and FDA’s newest guidance on major food allergens. The Sandoz decision and FDA guidance indicate FDA has the ability to provide dietary supplement companies with the roadmap to navigate the minefield yet chooses not to provide that guidance.

Zachary S. Taylor is an associate at Epstein Becker & Green in the health care and life sciences practice who assists dietary supplement companies and health care entities in criminal government investigations, civil litigation, and regulatory proceedings. He also helps clients navigate state and federal regulatory issues.

Lauren Petrin is an associate at Epstein Becker & Green in the health care and life sciences practice who assists pharmaceutical, biologic and medical device companies on FDA regulatory compliance issues, including those relating to human subject protections and the conduct of clinical trials, interactions with the FDA, advertising, promotion and labeling, and internal corporate investigations. Lauren also advises FDA-regulated entities in corporate transactions and licensing matters.

Jack Wenik is a member of Epstein Becker Green in Health Care and Life Sciences and Litigation practices who focuses on guiding dietary supplement companies and health care providers to reduce the risks of litigation by the government. He has advised clients dealing with cases from fines to corporate integrity agreements, and Medicare/Medicaid exclusion. Wenik is a regular speaker and commentator to the media on dietary supplement and drug topics.