Nutritional Outlook

Nutritional Outlook, June 2018

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■ NUTRITIONAL OUTLOOK 10 JUNE 2018 FROM THE EDITOR In May, FDA turned its enforcement eye to nutricosmetic dietary supplements that make "sun protection" claims. FDA Commissioner Scott Gottlieb, MD, announced on May 18 that FDA sent warning letters to four makers of ingestible supplements the agency said made claims beyond what's legal for dietary supplements—claims that would cause the products to be considered drugs. T ese beauty-from-within supplements boasted ef- fects ranging from the ability to "protect you from both UVA and UVB rays" to the ability to "[treat] skin disorders such as psoriasis, eczema, polymorphic light eruption, and sunburn." Read more about these claims on page 12. FDA permits sun protection claims for topical sun- screen products, which the agency regulates as over-the- counter drugs. FDA maintains a prescribed list of ap- proved topical sunscreen ingredients the agency deems safe and ef ective based on scientif c evidence. While FDA regulates topical sunscreens as OTC drugs, the agency regulates nutricosmetics as dietary supplements. (T e agency does not recognize "nutri- cosmetics" as an of cial product category unto itself.) To be a legal dietary supplement, then, nutricosmetics must restrict themselves to the ingredients and health claims permitted for supplements. T ese ingestible beauty products can still make structure-function claims of, for instance, maintaining skin moisture or suppleness—provided, of course, f rms have the proper evidence to substantiate those claims. Once a company starts making "prevention" claims, such as those related to "photoprotection," "protecting" skin from "sun dam- age," or providing a "defense" against UV rays linked to skin cancer, however—all claims used by the companies FDA sent warning letters to—a f rm begins to stray into illegal drug territory. "Skin-health claims on ingestible products that are consistent with the rules that apply to dietary supplements are still allowed," says Kristi Wolf , a partner in the advertising and food and drug law prac- tice at law f rm Kelley Drye & Warren LLP (Washing- ton, DC). But in regard to the f rms FDA sent warning letters to, "T ese letters signal that where a product's claims cross over into prevention of a disease or condi- tion, FDA considers these products to be drugs and they would be required to comply with applicable drug rules." "FDA's position on the claims at issue is not surpris- ing," says Wolf continues. "Sunscreens are regulated as OTC drugs because the intended use is to prevent sun- burn and skin damage. Based on the claims, the intended use of the products discussed in the warning letters was also to prevent sunburn and skin damage, but the ingre- dients at issue were not recognized as safe and ef ective for sun protection purposes. T us, it is FDA's position that these products were being marketed as unapproved new drugs." Should supplement makers assume that no nutricos- metic products will ever be able to make sun protection claims, based on FDA's stance on these particular prod- ucts? T at's not quite the way to think about the issue, Wolf says. "T ese letters do not signal that FDA would never be open to an ingestible product, provided that it had the appropriate evidentiary support; rather, they signal that these products and ingredients are not recog- nized to have that support," she says. Not only that, says Megan Olsen, assistant general counsel for the Council for Responsible Nutrition (CRN; Washington, DC), "FDA guidance cautions about draw- ing bright-line rules between permissible and impermis- sible dietary supplement claims." A more prudent approach would be to look within. If you're a supplement maker engaged in or interested in the nutricosmetic space, the best practice when deciding which claims to make would be to follow directions as usual: review the soundness of the evidence substantiating your claims, and keep in mind that "FDA will look at the intended use of the product based on the marketing claims to determine what category the product falls into—e.g., cos- metic, dietary supplement, or drug," says Wolf . If your product is intended to be a dietary supple- ment, claims of diagnosing, curing, mitigating, treating, or preventing a disease are f rmly of the table. Nutricos- metic f rms can use FDA's warning letters as a caution to, if warranted, go back and take a hard look at their own products and claims. Just don't rely on FDA's actions against other companies to determine whether or not your company is in the clear. "Determining the level of scientif c evidence necessary to support a claim is fact specif c, and companies should not simply rely on blan- ket rules regarding whether a certain type of evidence can support a claim," says Olsen. Jennifer Grebow Editor-in-Chief Shining a Light on Sun Protection Health Claims

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