FDA sends warning letters to 'sunscreen supplement' makers for overstating benefits

By Adi Menayang contact

- Last updated on GMT

Getty Imahes / Wavebreakmedia
Getty Imahes / Wavebreakmedia

Related tags: Astaxanthin, Carotenoid, Lycopene, Warning letter

Many ingredient suppliers have invested in research exploring how ingesting carotenoids may protect skin from UV damage, but as warning letters from the FDA sent out last week show, sun protection is not a claim dietary supplements can make.

In time before Memorial Day Weekend, when many Americans gather with friends and family in picnics outdoors or relax on a boat and soak up some sun, FDA commissioner Scott Gottlieb sent out a statement to the public​ reminding them of how to stay safe under the sun.

Dietary supplements got a mention, but not a good one.

“We’ve found products purporting to provide protection from the sun that aren’t delivering the advertised benefits. Instead they’re misleading consumers, and putting people at risk,”​ Gottlieb said in the statement last week.

“Today we 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.”

Carotenoids, lycopene, lutein and zeaxanthin

The companies that received warning letters were GliSODin Skin Nutrients (the Advanaced Skin Brightening Formula product), Napa Valley Bioscience (Sunsafe Rx), Pharmacy Direct (Solaricare), and Sunergized LLC (Sunergetic).

Only two of the products—Sunsafe Rx and Advanced Brightening Formula—are still up online. Based on information of the products’ ingredients, both contain the carotenoid lycopene and citrus bioflavonoids. Sunsafe Rx also contains lutein, zeaxanthin, and astaxanthin.

Many of these ingredients have studies that have explored potential UV ray-protection benefits, such as studies on astaxanthin published in 2017 (one on mice​ and another on humans​), a 2010 human study on lycopene​, and a 2016 study on both lycopene and lutein​.

But to the FDA, sun damage is a disease, and claiming to prevent sun damage is a disease claim, which only drugs can do. The claims that got these supplements in trouble include:

  • "BROAD SPECTRUM PROTECTION Protects you from UVA and UVB rays…"
  • "RELIEF FOR PHOTOSENSITIVITIES Can help prevent or treat…solar keratosis…”
  • “Every second you spend in the sun damages your skin. But Sunsafe Rx is always working: it protects your whole body ….”
  • “The secret to Sunsafe Rx is Antioxidine. … can defend your skin and eyes from sun damage.”
  • “The Advanced Skin Brightening Formula contains ingredients that reduce oxidative stress (one of the harmful effects of UV light)..."

Is there room for ingestible protection?

Gottlieb’s letter emphasized that ‘legitimate sunscreens’​ are over-the-counter drugs that come in lotion, cream, stick, and spray form. Ingestibles weren’t included, but should they?

That was the question posed by Dr. Mark JS Miller, principal at Kaiviti Consulting​, which has clients in the dietary supplement industry.

He argued that the public could benefit from knowledge and access to these types of supplements.

“There is a vast array of evidence that ingestibles–dietary components or supplements—can modify oxidative stress in a variety of organs and tissues. The source of this oxidative stress can include mitochondria, various enzymes and UV radiation,”​ Dr. Miller told NutraIngredients-USA.

“While these events have similarities with common topical approaches to sun protection, traditionally they have not been classified in the same manner as the acute topical interventions. Could they? Should they?”

“We currently use these approaches for the health of another organ exposed to the same radiation—the eye–and so it is reasonable to pose a legitimate question—why not skin?”

Another tool in the sun protection arsenal

Dr. Miller emphasized that he thinks it would be ‘inappropriate’ ​to recommend ingestibles instead of topicals with known SPF values. “We need more data,” ​he said.

“But I think ingestibles form an excellent complementary approach and can enhance the effects of topicals. Additionally, they can suffice in situations where the use of topicals may be restricted e.g. the recent ruling in Hawaii to protect the reefs from sunscreen chemicals.

“The public needs UV protection, so why limit it to topicals? Use all the tools in the toolkit.”

When Sunsafe Rx first launched in 2012, founder and president of parent company Napa Valley Bioscience, David Murphey, told us​ that the supplement was meant to be used in combination with sunscreen.

No one is suggesting you should go out all day in hot sun without covering up or necessarily using sunscreen​,” he said.

“Supplements are about giving you an extra layer of protection, but also for times when you would probably not think about using sunscreen or covering up—when you are going to and from work, driving and so on—what I’d call incidental sunlight exposure.”​​

But perhaps supplements should stay away from using phrases like ‘UV ray protection’ and emphasize on pack that a supplement should go hand-in-hand with topical SPF.

Yasuko Kuroda, executive vice president of astaxanthin manufacturer AstaReal USA​, told us that a more beauty-from-within message is one that supplement makers can make, such as “astaxanthin…is a powerful carotenoid antioxidant that helps the skin fight off harmful free radicals that can cause visual effects of aging.”

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