Katie Bond is a partner, and Samuel A. Butler is counsel, in the Washington, DC office of Lathrop GPM. Originally published as a Lathrop GPM Client Alert. Reprinted with permission.

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After a long year of chasing big tech and headlines, the FTC needed a break. And what better way to soothe the soul than a nice stretch of the law. Seemingly out of nowhere, the agency just issued a new guidance document on health-related advertising. Here’s what to know about it.

Years ago, in 1998, “follow[ing] a year of outreach” with “industry groups, consumer organizations and government offices,” the FTC announced a guidance document, Dietary Supplements: An Advertising Guide for Industry.  On December 21, 2022, without any such outreach, the FTC announced a new version, Health Products Compliance Guidance.

Companies should be aware of the new guidance, particularly given the aggressive nature of the current FTC. But the new guidance still must be read in the proper context of actual, binding law. Many of the stances announced in the new guidance simply fail to align with the law.

Most notably, the 1998 guidance properly advised that “a guiding principle” for the level of substantiation required for health-related claims will be “what experts in the relevant area of study would generally consider to be adequate.” As such, the agency would “consider all forms of competent and reliable scientific research” even if “[a]s a general rule, well-controlled human clinical studies are the most reliable form of evidence.”

The new guidance still acknowledges “randomized, controlled human clinical trials (RCTs) are the most reliable form of evidence.” However, it now purports to require that level of evidence as a default for any health-related claim. It states that “as a general matter, substantiation for health-related benefits will require evidence in the form of human clinical testing” that is both “randomized” and “controlled.”

This rigid stance isn’t new, although it’s never been supported by prevailing case law. Despite the 1998 guidance, the FTC, for years, attempted to advance the same rigid approach in litigation – without much success at all. Judge Easterbrook probably explained the situation best:

Nothing in the Federal Trade Commission Act, the foundation of this litigation, requires placebo-controlled, double-blind studies. The Act forbids false and misleading statements, and a statement that is plausible but has not been tested in the most reliable way cannot be condemned out of hand. The burden is on the Commission to prove that the statements are false. . . . Think about the seller of an adhesive bandage treated with a disinfectant such as iodine. The seller does not need to conduct tests before asserting that this product reduces the risk of infection from cuts. The bandage keeps foreign materials out of the cuts and kills some bacteria. It may be debatable how much the risk of infection falls, but the direction of the effect would be known, and the claim could not be condemned as false. Placebo-controlled, double-blind testing is not a legal requirement for consumer products.

Other courts have also followed that approach, which perfectly aligns with other longstanding law. Since the 1970s, the courts have recognized that the Pfizer factors apply in determining the level of substantiation for any sort of advertising. Thus, courts must consider (1) the type the claim – e.g., claiming to support good health versus to treat disease; (2) the type of product – e.g., a food or dietary supplement versus a prescription drug; (3) the potential benefits if the claim is truthful, (4) the possible health, economic, or other consequences if the claim is false; and of course, (5) the level of substantiation experts in the relevant field deem adequate.

Only by denying such case law can the FTC default to requiring a randomized, controlled study – the most expensive and highest level of medical research available – for any given health benefit claim. Sure, require that type of evidence for a cancer drug, but not so much for orange juice or a zinc supplement claiming, “supports the immune system.” Courts get that. Fortunately, the new FTC guidance correctly acknowledges it “doesn’t have the force or effect of law.”