New FDA Sunscreen Guidance Calls For Better Ways To Confirm SPF Ratings

Following a recent study that suggested many sunscreens do not provide the sun protection factor (SPF) levels described on their labels, federal health officials have introduced a draft guidance that would require manufacturers to undergo advanced testing of over-the-counter sunscreen to guarantee UV ray protection. 

The FDA announced issued a press release on May 22, announcing a new draft guidance in the Federal Register, which addresses the need for additional testing on topical over-the-counter (OTC) sunscreen products, and whether the active ingredients are generally recognized as safe and effective for their intended use.

The guidance, titled “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations”, instructs the industry to conduct in vivo absorption trials for topical active ingredients that are under consideration for inclusion in the OTC monograph.

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The goal of the guidance is to recommend certain studies be conducted to support the inclusion of an active ingredient in an OTC drug monograph. By laying out how manufacturers can evaluate the absorption characteristics of topically applied active ingredients, the FDA hope to encourage more product innovation.

Recently, the FDA has warned about products like Advanced Skin Brightening Formula, Sunsafe RX, Salaricare, and Sunergetic, which are considered dietary supplements, with labels claiming to prevent sunburn and offer UV protection similarly to topical lotions. The FDA sent warning letters to the manufacturers of each of the products this week instructing them to correct all violations and update the product labeling.

Sunscreens come in several forms including lotions, sprays and sticks and each is labeled with an SPF level that tells the consumer the strength of the product against UV rays.

Currently, the FDA requires sunscreen manufacturers to test the validity of their SPF claims before marketing the SPF level on labels. However, verification of lab testing is not required by the FDA, nor does the agency require any pre-market testing. The FDA only requires that, upon request, manufacturers provide copies of validity testing.

However, recent studies have raised questions about the effectiveness of sunscreen, finding that some consumers using topical OTC sunscreens could be at more risk of UV ray exposure than they expect. Research released earlier this week by the consumer watchdog group, Consumer Reports, found 24 of 73 popular OTC sunscreens tested in a study had less than half the SPF claimed on the bottle.

A specific concern identified in the study was whether OTC sunscreens lived up to their water-resistant and very water resistant labels. The study found that Water resistant and very water resistant indicate the SPF levels are maintained for 40 minutes (water resistant) or 80 minutes (very water resistant) before they begin to run.

Excessive ultraviolet (UV) rays can be extremely harmful to the skin of those exposed causing a wide variety of adverse health effects including infections from rupturing blisters, precancerous skin lesions, skin cancer, eye damage, and aging of the skin among many others.

According to the American Academy of Dermatology (AAD), more than 8,500 people are diagnosed with skin cancer every day and on average, one American dies from the deadly skin cancer disease melanoma every hour. The American Cancer Society estimates that the number of Americans developing skin cancer has doubled over the last thirty years.

Experts have attributed a much of the significant rise in skin cancer diagnosis to indoor tanning. In a study published in the medical journal JAMA Dermatology in 2017, researchers found that indoor tanning before the age of 30 is linked to a six-fold increased risk of developing skin cancer.


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