"There’s no pill or capsule that can replace your sunscreen."
And with that straightforward comment, part of a written statement from Commissioner Scott Gottlieb, the Food and Drug Administration is warning consumers not to purchase alleged sun-protection supplements from four companies because they do not work.
In addition, the public needs to be warned that taking these products misleads consumers and delivers a "false sense of security," which puts "people at risk."
At the same time, the FDA has put these "unscrupulous" manufacturers on notice Tuesday, sending "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."
The products are:
- Advanced Skin Brightening Formula – made by GliSODin Skin Nutrients, of Toronto, Ontario
- Sunsafe Rx – made by Napa Valley Bioscience, of Santa Monica, CA
- Solaricare – made by Pharmacy Direct, Inc., of Dover, DE
- Sunergetic – made by Sunergized LLC, of Woodbury, NY
These companies are selling ingestible supplements that claim to protect users from the harmful effects of the sun. This, of course, is a flat-out lie. Other falsehoods on their labeling and packaging include protection from sunburn, as well as protection from premature skin aging that's caused by sun exposure.
The FDA says that if an effective, ingestible product was legally on the market, it would be considered a drug and would require FDA approval. But the agency has never approved such a product.
The above companies receiving warning letters were, according to Gottlieb's statement, "instructed to correct all violations associated with their products and were advised to review product websites and product labeling to ensure that the claims they are making don’t violate federal law."
Here are the warning letters sent by the FDA's Office of Compliance, dated May 18, to GliSODin Skin Nutrients; Napa Valley Bioscience; Pharmacy Direct, Inc; and Sunergized LLC.
Skin cancer is the most common cancer in the United States, afflicting an estimated one in five Americans in their lifetime.
Protect yourself the proper way, by using approved, high-SPF sunscreen, wearing sun-blocking clothing and by avoiding direct sun exposure between the hours of 10am and 2pm, the hottest part of the day.
And whatever you do, stay away from these useless and potentially harmful products.
