What makes up “competent and reliable scientific evidence?” That’s a question that has vexed many a practitioner and client. A federal district court judge in New Jersey recently weighed in on that topic (opinion here) and it wasn’t good news for the FTC. In FTC v. Lane Labs-USA, Inc., et al., the FTC asked that the U.S. District Court for New Jersey fine Lane Labs, a supplier of dietary supplements, $24 million as a result of the lab’s alleged violation of a nine year old consent order in which it agreed to only make representations about the effects of its dietary supplement products that could be supported by competent reliable scientific evidence. In its complaint the FTC alleged order violations relating to two Lane Labs’ products — AdvaCAL, a calcium supplement, and Fertil Male, a product derived from a Peruvian plant known as “Maca” that allegedly increases male fertility.
The Defendant relied upon several clinical studies and the testimony of a scientific expert for each of its products. The FTC’s experts criticisms of the study were familiar ones to those who practice in this area. They included the fact that the studies were underpowered, used rats instead of humans, that the products had inert ingredients not found in the products tested, and that the studies tested one proposition (increase in bone density) from which the claim (reduced risk of fractures) had to be inferred. Defendant’s experts rebutted each of these criticisms.
The Court found that the FTC had not met its burden of proof and that the Defendant had taken reasonable steps to comply with the Order:
- The court found that while all four experts were credible and knowledgeable, the Defendant’s experts were more reasonable. In particular, the court was critical of the overly exacting standard of one of the FTC’s experts in evaluating the reliability of clinical studies.
- Neither of the FTC’s experts found that Lane Labs’ supplements were not effective or constituted a health risk to the public, but instead that the studies relied upon by Lane Labs had “questionable aspects,” including using rats versus humans to study effects and having a smaller number of participants. As the court pointed out, however, Lane Labs’ experts were able to successfully explain why those aspects didn’t corrupt the overall value of studies, thereby swaying the court in their favor.
- The court agreed with Lane Labs’ experts’ more inclusive view of the kinds of research that substantiate claims, including research that is tangentially related, if not directly on point, to a claim.
- The court would not find a violation of the Order where there was simply a difference of opinion among credible experts
- Lane Labs “did what they were supposed to do” in seeking expert advice before relying upon scientific articles and peer reviewed studies attesting to the purported effects of AdvaCAL and Fertil Male. To ask the company to do more would be unreasonable, said the court.
If the Court’s decision is upheld in the face of a likely appeal, it may present a clearer and potentially less exacting path to substantiating dietary supplement and other claims. In particular, so long as a company relies upon legitimate studies that a credible expert says are good, a few flaws here and there or the contrary views of an FTC expert may not be enough to sink the product claims.
