Taking Action Against Skin Cancer and Misleading Labels

The FDA is taking new steps to ensure products being marketed to protect consumers from the sun’s harmful effects deliver on their promises. FDA Commissioner Scott Gottlieb, MD, announced several new initiatives this week, while also promoting the National Council on Skin Care Prevention’s annual Don’t Fry Day.

Exposure to natural and artificial ultraviolet (UV) light has a direct impact on a person’s risk of developing skin cancer— the most common form of cancer in the United States.¹ It is estimated that 1 individual dies from skin cancer every hour in the United States,² and 1 of 5 Americans are estimated to be at risk of developing skin cancer in their lifetime.¹ Skin cancer rates are increasing in the United States, and it is estimated that there will be more than 73,870 new cases of malignant melanoma this year, as well as more than 2 million new cases of basel cell, and squamous cell skin cancers.² Most cases of melanoma, the deadliest form of skin cancer, can be attributed to UV exposure.

The effects of exposure to UV radiation from the sun or indoor tanning beds are cumulative, adding up over a lifetime.¹ Advancing better UV protection has been a key goal of efforts by the healthcare community, and government agencies in recent years, Gottlieb said in a statement.¹

As part of these efforts, the National Council on Skin Cancer Prevention has designated the Friday before Memorial Day as Don’t Fry Day. Supported by the FDA, the effort encourages sun safety awareness as the United States enters into the summer season.²

“The upcoming Don’t Fry Day is a good reminder that we need to reduce the risks from harmful UV radiation. Given the recognized public health benefits of sunscreen use, the FDA is committed to finding ways to help bring a wider assortment of safe, and effective sunscreen products to the public,” said Gottlieb, in a statement.

One step taken by the FDA is to better ensure that products marketed to offer protection from the sun’s harmful effects deliver on their promises.¹ “Many of us make efforts to wear protective clothing and seek shade. But for times when we must, or want to be outside enjoying the weather, consumers should know that the products they’re using to protect themselves are effective at guarding them from harmful UV radiation and safe to use on themselves and their families. Unfortunately, this isn’t always the case,” said Gottlieb, in a statement.

According to the comissioner, the FDA recently sent warning letters to companies illegally marketing pills and capsules labeled as dietary supplements that make unproven claims about protecting consumers from the harms that come from sun exposure without meeting the FDA’s standards for safety and effectiveness.¹ These products, including Advanced Skin Brightening Formula, Sunsafe Rx, Solaricare, and Sunergetic, claim to help prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer. Their manufacturers were instructed to correct all violations associated with their products, and they were advised to review product websites, and product labeling to ensure that the claims they are making don’t violate federal law.¹

Legitimate sunscreens are made in a wide range of sun protection factor (SPF) values, and are OTC drugs that come in many forms. These include lotions, creams, sticks, and sprays.¹ All of these formulations are applied topically to the skin. All sunscreens are tested to measure the amount of UV radiation exposure it takes to cause sunburn when using a sunscreen, compared to how much UV exposure it takes to cause a sunburn when not using a sunscreen.¹

Over the years, the FDA has updated labeling requirements placed on sunscreens marketed without approved applications to reflect the latest science on UV exposure. In the interest of increased sun protection, the FDA is now also encouraging the industry to conduct research on additional sunscreen active ingredients that will help answer critical questions about their safety, and has issued guidance describing its enforcement approach with respect to OTC sunscreen products marketed without approved applications during the period before a final OTC sunscreen monograph becomes effective. In the interim, unless the failure to pursue regulatory action poses a potential health hazard to the consumer, the FDA does not intend to object to the marketing without an approved application of OTC sunscreen products that have all of the characteristics outlined in the guidance.¹

For consumers, the American Cancer Society (ACS) offers its guidance about sunscreen products. It recommends choosing a sunscreen with “broad spectrum” protection, which protects against UVA and UVB rays, both of which can contribute to skin cancer. (Many products protect only against UVB rays.) The ACS also recommends using a sunscreen with SPF 30 or higher to filter out at least 97% of UVB rays.

Furthermore, the cancer advocacy organization warns consumers that “water resistant” does not mean a product is “waterproof.” For best results with a “water resistant” sunscreen, it recommends reapplying at least every 2 hours, and more often if swimming, sweating or drying off with a towel, which usually rubs off the product.

Individuals with lighter-toned skin are more susceptible to UV radiation damage, although people of all races and ethnicities can be at risk for skin cancer.² Individuals with a family history of skin cancer, a large number of moles or freckles, or a history of severe sunburns early in life are at a higher risk of skin cancer.²

In addition to utilizing effective sunscreen, the ACS offers recommendations for minimizing risk of skin cancer:³

• Cover Up: Wear clothing and a wide-brimmed hat, as well as sunglasses that block at least 99% of UV light, when out in the sunlight.
• Seek Shade: Limit exposure to direct sun, especially between 10 am and 4 pm, when UV rays are strongest.
• Avoid Tanning Beds and Sunlamps: Both can cause serious long-term skin damage.

Warning signs of skin cancer may be spotted early.⁴ According to the ACS, finding signs early, when they are small and have not spread, makes it easier to treat skin cancer. According to the ACS, some of the most common signs of melanoma include:³

• Asymmetry: One part of a mole or birthmark doesn’t match the other
• Border: Edges are irregular, ragged, notched or blurred
• Color: The color is not the same all over a birthmark or mole with shades of brown or black, and sometimes with patches of pink, red, white or blue
• Diameter: A spot is larger than ¼ inch across, about the size of a pencil eraser
• Evolving: The mole is changing in size, shape or color

According to Gottlieb, the FDA is continuing to evaluate scientific issues related to sunscreens. The agency also expects to address sunscreen dosage forms, and the effectiveness of SPF values.

References

• U.S. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens [news release]. Silver Spring, MD: FDA website; May 22, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608499.htm. Accessed May 23, 2018.
• National Council on Skin Care Prevention. Don't fry day. NCSCP website. https://www.skincancerprevention.org/programs/dont-fry-day. Published May 23, 2018. Accessed May 23, 2018.
• American Cancer Society. Choose the right sunscreen. https://www.cancer.org/latest-news/choose-the-right-sunscreen.html. Accessed May 23, 2018.
• American Cancer Society. Have a sun-safe summer. https://www.cancer.org/latest-news/stay-sun-safe-this-summer.html. Accessed May 23, 2018.