In May, Scott Gottlieb, MD, commissioner of the US Food and Drug Administration, sent out a communication to consumers and industry about dietary supplement marketers who were making sunscreen-like sun protection claims on their products. This is an illegal disease treatment claim, Gottlieb maintained.
“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.
“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.”
Warning letters sent out
The companies that received warning letters were GliSODin Skin Nutrients (the Advanced 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.
But Israeli company Algatech, which supplies astaxanthin from its tube algae culture facility in the south of the country, says that does not mean that astaxanthin has no benefits when it comes to oxidative stress in the skin caused by UV exposure.
The company said despite Gottlieb’s concerns, it has data from a study conducted by Japanese company Fuji, one of its customers, that demonstrates the benefits of the carotenoid in ameliorating the skin damage associated with long term UV exposure.
“Natural astaxanthin is a highly potent active ingredient and in the clinical study conducted with Algatech's product, it was shown that supplementation with natural astaxanthin can prevent damage to the skin caused by exposure to UV light,” Algatech said in a statement released to NutraIngredients-USA.
Claims focused on specific mode of action
The key, the company said, is to keep the two modes of action separate. Sunscreen prevents UV rays from reaching the skin’s deeper tissues. Continued exposure over time raises the risk of skin cancer, which is why dermatologists push sunscreen use so assiduously.
But what about those rays that do reach the skin? Over a lifetime, the skin absorbs UV radiation from walking the dog, 40 minutes of mowing the lawn, or other casual exposures where consumers are unlikely to be carefully gooping up with sunscreen beforehand. This is where carotenoids in the skin can help, the company says.
“Sunscreen topical products absorb UV radiation and reduce the amount of radiation affecting the skin. They act similar to clothing, as long as they are effective. Astaxanthin does not prevent the radiation from hitting the skin, however, it does increase the cells' defense against the damage and the related free radicals formation that can be caused by sun radiation,” the company said.
The research the company has done in several models, including in hairless mice and in humans, shows the carotenoid can lessen the damage that UV rays cause in the deeper skin tissues. Such damage contributes to premature skin aging symptoms such as dryness, sagging and wrinkles.
“Astaxanthin creates another important layer of protection that support the skin health over time. Astaxanthin is not a replacement for avoiding the solar radiation. Nevertheless, we all know that no sunscreen can provide 100% protection and we must use additional measures to protect ourselves such as wearing a hut and sunglasses,” the company maintains.
Big future market
Having a place at the nutricosmetic table will be an important market benefit for astaxanthin, Algatech said. The company said some estimates show the global nutricosmetics market is estimated to reach $12.6 billion by 2024, growing at a CAGR of 12.6% from 2017 to 2024.
“A daily intake of natural astaxanthin can enhance our skin protection, as was shown in several studies,” Algatech added.
“The Protective Role of Astaxanthin for UV-Induced Skin Deterioration in Healthy People—A Randomized, Double-Blind, Placebo-Controlled Trial”
10(7), 817; https://doi.org/10.3390/nu10070817
Authors: Ito M, Seki S, Ueda F
Additional Algatech statement:
Algatech emphasizes that FDA guidelines about claims should be always respected. Studies show that astaxanthin may support skin health, and should be used as another layer of protection in summer days. Astaxanthin is not a replacement of sun screen, and other necessary measures to protect the sun, like hat and long clothes. Algatech is located in a desert, at one of the most sunny places on earth and we are fully aware of the importance of using all possible ways to maximize the skin health protection.