On May 22, the FDA Commissioner Scott Gottlieb, MD, released a statement about the FDA’s new actions to keep consumers safe from harmful effects of sun exposure, and to ensure safety and true benefit of sunscreens. As part of this, the FDA sent warning letters to companies “illegally marketing pills and capsules labeled as dietary supplements that make unproven drug claims about protecting consumers from the harms that come from sun exposure without meeting the FDA’s standards for safety and effectiveness.”
In other words, ingredients—and resulting branded products—are not allowed to make “sunscreen/sunblock/sun protection/UV protection” claims. Some brand marketers may be worried that anti-wrinkle or other skin support claims may be next.
But not to worry, said Annie Vo, PhD, R&D specialist, Vinh Hoan Corporation (Vietnam), partner of Gencor (Irvine, CA), as there are distinctions. UV rays are proven to accelerate skin aging and cause skin cancers. “There is no data, by correlation or by clinical trial, showing the prevention of skin cancer development by supplements. Furthermore, sunscreens act by absorbing or reflecting the UV rays. Supplements do not have these properties.
Vo added that marketing and advertising supplements as an “internal sunscreen” is misleading consumers and therefore, she believes this action by the FDA is appropriate. Rates of skin cancer remain high in many Western countries where nutrition is sufficient and supplements are widely available, “so the idea that supplements can protect against skin cancer needs to be scrutinized,” she asserted.
Samantha Ford, business development director, AIDP, California, agreed. “It is expected that sunscreen-related claims would be scrutinized the same way as any other disease-related claim. The beauty from within aspects of skin health—wrinkles, fine lines, skin hydration, firmness, elasticity—are cosmetic, not disease,” she defined. “With the appropriate substantiation, I don’t anticipate any regulatory challenges when it comes to product claims in this arena.”
