From Trump to the FTC: 2017 Dietary Supplement Regulatory Issues to Watch

CLICK ON IMAGES TO VIEW SLIDESHOWNutritional Outlook: What impacts, positive or negative, could the dietary supplements industry face under a Donald Trump administration in 2017?Michael McGuffin
President
American Herbal Products Association (AHPA)

President Trump’s campaign rhetoric strongly suggests his preference for small federal government, which could mean less pressure on businesses and industries. This may present opportunities to enact improvements to the existing dietary supplement regulatory framework in 2017 and beyond. The dietary supplement industry’s self-regulatory initiatives may also take on even greater importance if president Trump weakens federal regulations. President Trump’s anti-regulatory and anti-establishment posturing suggests the administration will work to bring change. Because it remains to be seen exactly what changes the administration will work to enact, it will be important for the industry to stay actively engaged to identify and take advantage of opportunities and address challenges created by any changes.


Larisa Pavlick
Vice President, Global Regulatory & Compliance
United Natural Products Alliance (UNPA)

It’s assumed that a Republican administration will take a more business-friendly approach to regulation. We do know that the Trump transition team has stated that it wants the FDA to promote greater innovation. We are all looking to the new administration for style clues as cabinet members and their federal departments establish priorities and policies.


John E. Villafranco
Partner
Kelley Drye & Warren LLP

The most significant impact of the Trump administration will likely be at the FTC. President Trump will appoint new Commissioners, including a new Chairperson. The Chair will then appoint a new director of the Bureau of Consumer Protection (BCP), which has jurisdiction over supplement advertising and labeling.

At the beginning of the last administration, President Obama appointed Chairman Leibowitz, who then appointed David Vladeck as Director of the BCP. That appointment set the direction of FTC enforcement against supplements for the next eight years. And it was a long and hard eight years.

The FTC consistently sought to impose heightened, drug-style clinical trial standards on a variety of health-benefit claims, including claims for dietary supplements. Some companies fought back and litigated against the FTC in court. The FTC won some cases, particularly where disease claims were at issue. For instance, the FTC won the merits portion of FTC v. POM Wonderful where claims to treat or prevent serious diseases, including heart disease and prostate cancer, were at issue. The FTC also won where a company had claimed that its product was a “clinically proven natural solution to diabetes.”

The FTC, however, consistently lost where it sought to impose heightened standards on non-disease structure/function claims and defendants offered credible expert testimony in defending themselves. First, the FTC lost at the 11th Circuit in FTC v. Garden of Life, where cognitive-function claims for a children’s omega product were at issue. Next, the FTC lost Basic Research v. FTC where weight-loss claims were at issue. Finally, the FTC lost FTC v. Bayer, where it had challenged claims that a probiotic would improve digestive health. The courts in each of these cases found that the FTC had sought to enforce a substantiation standard that moved beyond its own guidance on the “competent and reliable scientific evidence” standard. The courts wouldn’t allow that. To be sure, the FTC won a couple cases on non-disease claims, but those cases involved claims like “reverses gray hair,” and the defendants offered no science or expert testimony.

It’s hard to imagine that the new administration would have the same appetite as the outgoing administration to enforce stringent clinical trial standards in cases where companies have offered credible science and qualified experts in support of their claims. We expect the new administration to be more interested in encouraging those types of companies-and fostering innovation and business growth.


CLICK ON IMAGES TO VIEW SLIDESHOWPhotograph by Michael Vadon/Wikimedia Commons/CC-BY-SA-4.0.