The US House of Representatives recently passed legislation to require that the federal Food and Drug Administration (FDA) speed approval of new types of sunscreen. The agency hasn't added a new active sunscreen ingredient to its approved list in 15 years, and eight ingredient applications have been pending before the FDA, some for as long as a decade. Many of these products are available in other countries and have been for years.
The so-called Sunscreen Innovation Act would impose deadlines on the FDA to ensure it approves existing and future sunscreen ingredient applications faster. A companion bill is also pending before the Senate Committee on Health, Education, Labor and Pensions.
It's About Time
"It's about time," says Mona Mofid, MD, a dermatologist in San Diego, Calif. and the medical director of the American Melanoma Foundation. "The Europeans have had several sunscreen ingredients that we haven't had. No one ever died from sunscreen that I'm aware of, but one person dies every hour in this country from skin cancer," she adds.
"As skin cancer cases reach epidemic proportions, physicians need a diverse set of tools to keep patients safe," agrees Michelle Henry, a Mohs surgeon and dermatologist at Sadick Dermatology in New York City. "I understand why the FDA is hesitant to allow new products, as there are real concerns such as potential allergenicity; however, our current sunscreens are not enough. There are newer ingredients that provide better UVA coverage allowing for true broad spectrum protection--the ideal sunscreen."
Ban the Tan Movement Grows
The FDA also been slow to call attention to the dangers of indoor tanning, Mofid adds. "Until recently tanning booths in the US were Class I medical devices (the same as bandages) whereas in England, they are labeled carcinogenic on the same level as asbestos," she says.
The FDA recently issued a final order reclassifying tanning beds and tanning booths from low-risk to moderate-risk devices. The order also requires that the products carry a visible black-box warning that explicitly states that the sunlamp products should not be used on people younger than 18. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.
The US Department of Health and Human Services and the federal Centers for Disease Control and Prevention also highlighted the increasing concerns about the use of indoor tanning devices this summer with a new call to action, recommending:
- Continued research on indoor tanning trends and behaviors
- More messaging alerting consumers on the dangers of indoor tanning
- Increased enforcement of existing regulations on indoor tanning
So far 11 states in the US have banned minors under 18 from indoor tanning, including California, Delaware, Hawaii, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas, Vermont and Washington.
A tan is a tan is a tan, say leading dermatologists. "Whether you get your tan at the beach or at a tanning salon, the harmful effects are the same," sums up Jill Waibel, MD, Miami Dermatologist. "A tan is a burn and is an indication of skin damage. Cumulative damage caused by UV radiation can lead to premature skin aging, wrinkles, pigmentary disorders, and deadly skin cancer."
- Additional reporting by Denise Mann
Wendy Lewis is President of Wendy Lewis & Co Ltd Global Aesthetics Consultancy, author of 11 books and Founder/Editor in Chief of http://www.beautyinthebag.com
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