Sunscreen is a lotion, spray, gel or other topical product that absorbs or reflects some of the sun's ultraviolet radiation on the skin exposed to sunlight and thus helps protect against sunburn. Depending on the mode of action, sunscreens can be classified into physical sunscreens or chemical sunscreens. Medical organizations such as the American Cancer Society recommend the use of sunscreen because it aids in the prevention of squamous cell carcinomas. Many sunscreens do not block UVA radiation, which does not cause sunburn but can increase the rate of melanoma and photodermatitis, so people using sunscreens may be exposed to high UVA levels without realizing it. The use of broad-spectrum sunscreens can address this concern. Diligent use of sunscreen can also slow or temporarily prevent the development of wrinkles and sagging skin.
Provisions of the bill
This summary is based largely on the summary provided by the Congressional Research Service, a public domain source. The Sunscreen Innovation Act would amend the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter sunscreens. The bill would require the United States Secretary of Health and Human Services to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in the United States are appropriately labeled. The bill would make sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act. The bill would establish a framework for the review and approval by the Food and Drug Administration of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information. The bill would direct the Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens. The bill would require the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factorgreater than 50.
This summary is based largely on the summary provided by the Congressional Budget Office, as ordered reported by the House Committee on Energy and Commerce on July 15, 2014. This is a public domain source. H.R. 4250 would modify the review process that allows the marketing of certain new ingredients in non-prescription sunscreen based on a determination by the Food and Drug Administration that they are generally recognized as safe and effective. The Congressional Budget Office estimates that implementing H.R. 4250 would cost $28 million over the 2015–2019 period, assuming appropriation of the necessary amounts. H.R. 4250 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. H.R. 4250 contains no intergovernmental mandates as defined in the Unfunded Mandates Reform Act. The bill would impose private-sector mandates, as defined in UMRA, because it would allow FDA to require that marketing applications for certain sunscreen products be submitted in a new standardized format. CBO estimates that the direct cost of complying with those requirements would not exceed the annual threshold established by UMRA for private-sector mandates.
Debate and discussion
The Melanoma Research Alliance supported the bill. In a video produced by the group, a melanoma survivor said that "when I heard that there were actually ingredients that the FDA is basically holding hostage, it infuriates me, it's crazy." The Centers for Disease Control and Prevention reported that in 2010 over 60,000 Americans were diagnosed with melanoma. The most common form of cancer in the United States is skin cancer. In 2009, chemical company and sunscreen manufacturer Ashland Inc. "significantly expanded its existing sunscreen production facilities in Columbus, Ohio, after the FDA announced it expected to make decisions on the pending ingredient applications before the end of the year." Five years later, the FDA had still not made a decision and Ashland was unable to sell this type of sunscreen in the United States.
