|Please find below the latest edition of our monthly newsletter specifically for our clients marketing dietary supplements. We hope this helps you stay out in front of regulatory challenges.
When Substantiating Traditional Use Claims, Consider Modern Standards
BY KRISTI WOLFF
In the wake of ExpoWest, the rise of Ayurveda has become increasingly apparent. For those who may be unfamiliar, Ayurveda is an ancient Indian system of medicine that combines a variety of lifestyle practices, the use of plants and herbs as medicinal treatment, in addition to diet and exercise. While well-known and accepted in India, Ayurveda is relatively new to the U.S. market but growing quickly. As the market has grown, advertising claims that certain ingredients or products have ties to Ayurvedic medicine have also proliferated.
The FTC’s guidance, Dietary Supplements: An Advertising Guide for Industry, speaks to “traditional use” claims, suggesting that marketers should look closely at consumer perception of the claims and the degree of supporting evidence that the claims likely convey. In addition, it is important to avoid implications that such products have been evaluated for efficacy if that is not the case. The Guidance notes that “[a]s consumer awareness of and experience with ‘traditional use’ supplements evolve, the extent and type of qualification necessary is also likely to change.”
The FTC has not been very active in enforcement relative to “traditional use” claims historically. However, given recent FTC enforcement trends toward looking closely at product and claim substantiation, we anticipate that the agency takes a conservative view of whether a claim based in traditional use could be properly substantiated. Companies marketing in this space will want to be sure to consider the full body of available substantiation to determine whether the “competent and reliable” scientific evidence standard can be met.
||Prescriptive Requirements for Advertising Substantiation: A Prescription for First Amendment Trouble
BY JOHN VILLAFRANCO
As we have discussed before, the FTC launched an effort in 2010 to amend the standard language in its orders governing health-related advertising. Rather than simply requiring “competent and reliable scientific evidence” for future health benefit claims, most orders since 2010 have included rigid requirements that a company possess a certain type and amount of clinical trials. New provisions, for instance, require “human clinical testing that is randomized, double-blind, and placebo-controlled.” Apart from the language in new orders, the FTC has also shifted gears to argue that, even under the basic legal requirement for “competent and reliable scientific evidence,” many health benefit claims require controlled clinical studies.
The FTC’s push for clinical trial support for non-drug products has prompted litigation. The FTC has prevailed in some cases in requiring clinical trials. See FTC v. POM Wonderful, 777 F.3d 478 (2015); FTC v. Wellness Support Network, Inc., 2014 WL 644749, No. 10-cv-04879 (N.D. Cal. Feb. 19, 2014). In other cases, it has not. See Basic Research LLC v. FTC, No. 2:09-cv-0779 (D. Utah Nov. 25, 2014); FTC v. Garden of Life, 845 F. Supp. 2d 1328 (S.D. Fla. 2012), aff'd in part and vacated in part, 516 F. App'x. 852 (11th Cir. 2013); United States v. Bayer Corp., No. 2:07-cv-00001-JLL-JAD (D.N.J. Sept. 24, 2015). In the most recent victory for industry, Bayer successfully argued that a clinical trial requirement advanced by the FTC and its scientific expert impermissibly sought to require “drug-level clinical trials” for a probiotic dietary supplement. Bayer had promoted its product with allowed structure/function claims, rather than unapproved disease treatment or prevention claims.
What’s perhaps ironic – and helpful for industry – is that even where prescription drug promotion is concerned, regulators are facing increasing difficulty in defending rigid standards. Generally, prescription drugs require FDA approval and can be promoted only for their approved uses. The FDA has long taken the position that “off-label” promotion – which is promoting unapproved uses to doctors – is prohibited, end of story, regardless of the underlying substantiation or use of clarifying disclosures. However, decisions in Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 7, 2015), and United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), have cast grave doubt on that prohibition where off-label promotion consists solely of truthful and non-misleading statements. The courts have found that a rigid prohibition against all off-label promotion, regardless of truthfulness, conflicts with First Amendment protections. The courts have found that some lesser evidence than perfectly executed clinical studies can be used to support properly qualified off-label claims.
In arguing against clinical trial requirements advanced by the FTC, companies have often pointed to First Amendment cases, like Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), to support the proposition that regulators cannot prohibit commercial speech as long as it is based on credible evidence. The drug cases discussed above provide additional support for this idea. The body of law, together, suggests that, regardless of the product at issue – whether it be a dietary supplement, food, health app, or even in some situations, a prescription drug – unreasonably high and inflexible standards often fail to withstand First Amendment scrutiny.
Marketing Bans, Avalanche Clauses, and Forfeiture
BY JOHN VILLAFRANCO
A recent FTC settlement with two individuals and over 40 companies that they operated highlights the FTC’s typical tactics in cases where it believes defendants are responsible for egregious violations. The FTC alleged that the defendants promoted green coffee supplements with “gut check” claims, debited consumers’ bank accounts without authorization, enrolled consumers in negative option programs without authorization, and violated the Telemarketing Sales Rule. Stipulated orders permanently ban the individuals and companies from selling either negative option programs or dietary supplements. The orders also require the defendants to forfeit approximately $9.2 million in cash and assets, including a Ferrari, numerous bank accounts, and several college savings accounts. An “avalanche clause” provides that another roughly $96 million will become due if it is found that the defendants misrepresented their financial status in the course of negotiations.
In many other cases, the FTC has grouped together high dollar settlements, avalanche clauses, marketing bans, and splashy announcements about the forfeiture or sale of luxury cars, vacation homes, art, and jewelry. Unfortunately, as in the most recent case, many of the past cases have involved dietary supplement sellers, and these cases can influence regulators’ perception of the industry as a whole. In facing any inquiry from the FTC, the first order of business for many credible companies in the industry is to show that they are not a fly-by-night operations bilking the masses.
||FDA Targets Products Containing Methylsynephrine
On March 31, 2016, FDA issued warning letters to seven companies over products containing methylsynephrine, which is also known as oxilofrine and p-hydroxyephedrine. The letters allege that methylsynephrine fails to meet the statutory definition of a dietary ingredient. Section 321(ff)(1) defines a dietary ingredient as
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).
The letters did not discuss FDA’s perspective on the safety of the ingredient. FDA officials have reported that the agency has received 47 adverse event reports associated with dietary supplements containing methylsynephrine.
In recent years, FDA has issued warning letters over other substances that the agency believes fail to meet standards for safety or dietary ingredient status. Those substances include Acacia rigidula, BMPEA, DMAA, DMBA, Picamilon, and pure powdered caffeine.