The battle to protect the dietary supplement industry takes many fronts, and companies have discovered it can help to have a friend when you end up in court. A “friend of the court,” that is.
The dietary supplement industry has seen a dramatic (and unwelcome) increase in litigation over the past few years, both from private plaintiffs in the form of class-action litigation and challenges from regulators, involving everything from advertising and label claims to the legitimacy of ingredients and accuracy of label statements for contents.
The Council for Responsible Nutrition’s (CRN) Legal Committee has filed amicus curiae briefs in an increasing number of these cases. “Amicus curiae” literally means “friend of the court.” The opportunity to file these briefs allows organizations or individuals who are not actually a party in the lawsuit to instruct a court about the potential impact the decision will have for the broader community, or to raise legal issues that might not otherwise come to the attention of the judge from the parties themselves. A successful amicus brief can even change the outcome of the decision by offering the court the context for how its ruling may serve as precedent or shape future legal cases in ways it had not intended.
CRN historically filed amicus briefs in notable cases pitting Pom Wonderful and Bayer against the FTC. With the uptick in litigation this past year, CRN has taken a more prominent role to defend the First Amendment and ensure the protections of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Here are some examples:
Last fall, the prescription drug firm Amarin initiated a case before the U.S. International Trade Commission (ITC), alleging esterified EPA (eicosapentaenoic acid) fish oil is a drug and the importation of the ingredient for use as a dietary supplement is illegal. The claims were made even though these products have been in the U.S. market for 30 years.
The claims are somewhat attenuated because Amarin bootstrapped the alleged violations of international trade laws (necessary for ITC to have jurisdiction) to supposed violations of the Lanham Act (unfair trade practices), which in turn were bootstrapped to alleged violations of the Federal Food, Drug & Cosmetic Act (FD&C).
In two separate amicus briefs filed with ITC, CRN argued FDA—not ITC—was the proper agency to adjudicate these allegations as the sole arbiter of the FD&C. And ITC agreed, refusing to open the investigation and dismissing the suit.
But the story continues, as Amarin challenged ITC’s decision in the U.S. Court of Appeals for the Federal Circuit. CRN filed a third amicus brief, urging the appellate court to uphold ITC’s determination that Amarin’s claims were not properly before it. CRN argued that allowing other agencies to usurp FDA’s exclusive authority to interpret the FD&C would undercut its singular ability to interpret and properly enforce DSHEA.
Class-action litigation has also attracted attention. In Korolshteyn v. Costco and Sonner v. Nature’s Way, both in the U.S. Court of Appeals for the Ninth Circuit, CRN came to the aid of several supplement marketers whose marketing claims for ginkgo were challenged as false and misleading. While amicus briefs are reserved for appeals, in this case, CRN moved to address issues at the district court.
CRN’s brief addressed the appropriate legal standard for private litigants in false advertising cases. It argued that while a government regulator may be able to premise its false advertising allegation merely on a lack of substantiation by the advertiser, by contrast, a private litigant must identify facts that would prove the claims are false. In other words, the law requires that private plaintiffs offer facts that could prove falsity of the claims; merely arguing that the advertiser’s substantiation is weak or equivocal is not enough.
CRN’s involvement in another case, FTC v. Quincy Bioscience, illustrated why amicus briefs are so important. While the defendant in that case had to focus its arguments on defending the specific advertising claims being challenged by FTC, CRN’s brief was able to address larger issues affecting the entire supplement industry. CRN’s brief exposed FTC’s effort to impose drug-level standards of substantiation on the popular supplement Prevagen.
The advertiser had, in fact, conducted a randomized clinical trial on the product, but not to FTC’s satisfaction under its novel legal standard. The amicus brief argued how FTC’s higher standard was erroneous and defies DSHEA, agency guidance and decades of agency practice.
Lastly, CRN has filed amicus briefs in two separate matters involving the state attorneys general of Oregon and Washington. Both cases involve state attorneys general arguing that the advertising for 5-Hour Energy products was deceptive under their state consumer protection laws without alleging any reliance by consumers on the claims or that there was any damage as a result of the alleged claims. Moreover, the Attorney General should be required to demonstrate the alleged false or misleading statements are material to consumers’ purchasing decisions.
In the Oregon case, the CRN brief argued the state could not allege the advertiser acted willfully (a requirement to find a violation of the state’s unfair trade practice statute) where the court acknowledges there is conflicting scientific evidence, some of which supports the advertiser’s claims. The Washington Attorney general sought to impose a rigid standard of substantiation, holding advertisers to the requirement that any advertising claims must be supported by a “clearly established” fact. CRN objected to such a high burden and insisted that a charge for false advertising must be based on more than a dispute about the methodology employed in the scientific study that serves as the substantiation.
While most of these cases are still awaiting a decision, they demonstrated that the robust defense of the supplement industry features a new tool: amicus briefs.
Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.