Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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Page 134 of 160

126 INSIDER September/October 2017 SupplySide West 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 infl ammation-related claims, as a small detail may open the door to signifi cant regulatory scrutiny. 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 specifi c 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. Infl ammation 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 infl ammation, 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 infl ammation-related claims. FDA's commentary in its fi nal rule on structure/function claims stated its position that infl ammation is not the appropriate subject for a claim. Specifi cally, the preamble in the fi nal rule states that claims such as "improved joint mobility and reduces joint infl ammation and pain" and "anti-infl ammatory effect on the gastrointestinal tract" are disease claims. Arguably, infl ammation 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 "infl ammation." Essentially, FDA's position is that making an infl ammation claim almost always inherently implies disease treatment because infl ammation is associated with different diseases and conditions. Since FDA believes references to infl ammation 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 infl ammation-related claims. Nevertheless, it may be possible to make infl ammation-related claims in limited contexts. The key is to limit the scope of the claim, so that it cannot be said to imply disease treatment. 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 infl ammation response" would likely be an impermissible disease claim; however, "supports healthy infl ammation response to intense exercise" may be a permissible structure/function claim because "to intense exercise" qualifi es the claim and narrows it to a non- disease state. It is necessary to step back when drafting infl ammation-related claims and examine the claim in its entire context in order to ensure no implied disease claims are hiding. Additionally, it is important to note changing a verb to something less "aggressive" does not necessarily transform an infl ammation claim from an impermissible disease claim to a permissible structure/function claim. For example, consider these two statements: "prevents everyday foot infl ammation" and "helps provide comfort for everyday foot infl ammation?" Replacing "prevents" with "helps" will not change the fact that the claim likely implied that it is treating and/or preventing arthritis. While an infl ammation-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 claims, and brands should ensure that claims are suffi ciently qualifi ed to be referring to a non-disease state (and of course to match the scientifi c support for the claim). Ashish Talati is a partner with the law fi rm Amin Talati & Upadhye ( He leads the fi rm's FDA practice, counseling clients on matters of regulatory compliance. Talati also advocates on their behalf before FDA, FTC, Customs, USDA, DEA and other federal agencies, and in court. Amit Sharma is an associate with Amin Talati & Upadhye. Inflammation Claims—Worth the Heat? by Ashish Talati and Amit Sharma Learn more about toing the line when making infl ammation claims during the "Addressing Infl ammation Naturally … Legally" Workshop, underwritten by National Enzyme Co., on Friday, Sept. 29 at 8:30 a.m. at SupplySide West in Las Vegas. Scan Here Addressing Infl ammation at SupplySide West

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