Crafting legally compliant dietary supplement claims is nearly its own art form and to succeed a fundamental understanding of what a supplement may legally claim is essential. The divide between an allowed “structure/function" claim and a prohibited disease treatment claim is often thin and gray, and particular attention must be paid to not only the language of the express claim but also any implied claims the language creates. This is especially so with inflammation-related claims, as a small detail may open the door to significant regulatory scrutiny. As discussed below, it may be possible to make some structure/function claims relating to inflammation as long as there is a clear understanding of the regulatory backdrop and the lines to toe.
The most important consideration is that a dietary supplement may only claim to impact the structure or function of the body (commonly called “structure/function" claims). They cannot make so called “drug" or “disease" claims—claims that they diagnose, treat, cure or prevent any disease—as doing so causes them to be a drug. An appropriate structure/function claim may describe the role of a nutrient or ingredient intended to affect the structure or function of the human body. Additionally, it may also characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function. A claim that mentions a specific disease or class of diseases would likely not qualify as a structure/function claim. Further, special considerations arise when a structure/function claim may imply something to consumers. Even if an express claim is in proper structure/function form, the claim may nonetheless be impermissible if it implies that the dietary supplement is intended to diagnose, treat, cure or prevent a disease.
Inflammation itself is not necessarily a “disease," and rather is more of a bodily reaction to stimuli. Far from being a disease, if we had no inflammation, we would not survive. This makes it fair game for structure/function claims, right? Wrong! In fact, FDA has consistently taken the opposite stance on inflammation-related claims. FDA’s commentary in its final rule on structure/function claims stated its position that inflammation is not the appropriate subject for a claim. Specifically, the preamble in the final rule states that claims such as “improved joint mobility and reduces joint inflammation and pain" and “anti-inflammatory effect on the gastrointestinal tract," are disease claims. Arguably, inflammation in these contexts is not a disease. But FDA’s point in classifying these claims as disease claims lies in the implication of referring to “inflammation."
Essentially, FDA’s position is that making an inflammation claim almost always inherently implies disease treatment because inflammation is associated with so many different diseases and conditions. Since FDA believes references to inflammation generally result in an implied disease claim, and disease claims are prohibited on supplements, the de facto FDA position is that dietary supplements generally cannot make inflammation-related claims. That position has been made clear in numerous warning letters issued over the years for supplement products making express and implied inflammation claims.
Nevertheless, it may be possible to make inflammation-related claims in limited contexts. The key is to limit the scope of the claim so that it cannot possibly be said to imply disease treatment. The language of the claim is critical and one misstep can render it a disease claim. Marketers may tend to focus on a claim’s verb, but that can lead to missing disease implications in the overall context of the claim. For example, “supports healthy inflammation response" would likely be an impermissible disease claim; however, “supports healthy inflammation response to intense exercise" may be a permissible structure/function claim because “to intense exercise" qualifies the claim and narrows it to a non-disease state. It is necessary to step back when drafting inflammation-related claims and examine the claim in its entire context in order to ensure there are no implied disease claims hiding.
Additionally, it is important to note changing a verb to something less “aggressive" does not necessarily transform an inflammation claim from an impermissible disease claim to a permissible structure/function claim.
For example, consider these two statements: “prevents everyday foot inflammation" and “helps provide comfort for everyday foot inflammation?" Replacing “prevents" with “helps" will not change the fact that the claim likely implied that it is treating and/or preventing arthritis.
While an inflammation-related structure/function claim may be properly made, the contexts that don’t run afoul of FDA regulations are quite limited. Utmost care should be used when choosing the language of claim and always ensure that it is sufficiently qualified to be referring to a non-disease state (and of course to match the scientific support for the claim!)
Learn more about toing the line when making inflammation claims during the Addressing Inflammation Naturally … Legally workshop on Friday, Sept. 29 at 8:30 a.m. at SupplySide West in Las Vegas. The Workshop is underwritten by NEC.
Ashish Talati is a partner with the law firm Amin Talati. He leads the firm’s FDA practice, counseling clients on matters of regulatory compliance. Talati also advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal agencies, and in court.
Amit Sharma is an associate with Amin Talati.