Jun 13, 2019
In this special takeover episode, guest host Dr. Candrice Heath talks to Dr. Vincent DeLeo about the new sunscreen regulations issued by the US Food and Drug Administration (FDA), beginning at 7:54. Despite heightened concerns about the safety of sunscreen ingredients brought on by these new regulations, the FDA still recommends sunscreen use as an important component of sun protection. “They’re not saying that any of these [ingredients] are necessarily dangerous by any means,” Dr. DeLeo explains, “simply that they need more data.” Dr. DeLeo breaks down the complicated sunscreen regulatory process and provides tips for alleviating patient fears about sunscreen use. He also addresses recent concerns in the media about systemic absorption of sunscreen ingredients.
We also bring you the latest in dermatology news and research:
1. AAD issues position statement addressing sexual, gender minority health, featuring an interview with Klint Peebles, MD, co-author of the position statement and co-chair of the AAD's LGBTQ/SGM Expert Resource Group. Dr. Peebles is on twitter @DrKlintPeebles.
2. Tick-borne disease has become a national issue.
Things you will learn in this episode:
- Sunscreens are regulated by the FDA as over-the-counter drugs.
- The first proposed rule for sunscreens was issued by the FDA in 1978 with 21 approved chemical agents that were generally recognized as safe and effective (GRASE).
- A number of preliminary rules have been issued over the last few decades, but a final monograph has never been provided.
- The 2011 sunscreen final rule included 16 ingredients that were considered GRASE and outlined labeling and testing methods for sunscreens.
- In the 1970s, consumers typically only used sunscreens 3 to 4 days per year during beach vacations. Today, health care professionals recommend more frequent use of sunscreens with higher sun protection factors, which has led the industry to use sunscreen ingredients at higher concentrations.
- An important component of the new sunscreen regulations is the requirement of maximal usage trials (MUsTs) to evaluate absorption of sunscreen ingredients into the skin and systemic circulation.
- Of the 16 approved sunscreen ingredients, only zinc oxide and titanium dioxide are recognized as GRASE per the FDA’s new guidelines. The remaining ingredients are not necessarily considered dangerous but will have to undergo industry testing so the FDA can determine their safety and efficacy.
- “My guess is that [the final monograph] is going to take years,” Dr. DeLeo speculates. “It will without question cost the industry money to do these tests, so my guess is that when this all shakes out, we will have fewer sunscreens on the market, and those sunscreens almost surely will be more expensive.”
- In 2014, Congress passed the Sunscreen Innovation Act to encourage the FDA to create a process to fast track the approval process for sunscreen ingredients used in Europe and other countries.
- Due to media coverage of the new sunscreen regulations and the complicated nature of the approval process, many patients may limit their use of sunscreens. Dermatologists should be prepared to dispel patient fears and give advice on which products are safe to use.
- The FDA’s recent findings on systemic absorption of sunscreen ingredients were intended to provide risk assessment guidelines for future industry testing, but more data are needed before any true risk can be established.
Hosts: Elizabeth Mechcatie; Terry Rudd; Candrice R. Heath, MD (Lewis Katz School of Medicine, Temple University Hospital, Philadelphia)
Guest: Vincent A. DeLeo, MD (Keck School of Medicine of the University of Southern California, Los Angeles)
Show notes by Alicia Sonners, Melissa Sears, and Elizabeth Mechcatie.
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