Comments of the National Center for Health Research on the FDA Draft Guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data”
Docket No. FDA-2015-D-4021
We appreciate the opportunity to comment on the draft guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data.” We strongly support the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. Americans are using sunscreens more frequently and for more years than ever before.
In 2012, there were almost one million people living with melanoma in the United States, and incidence rates have been increasing by 1.4% per year over the past 10 years. Despite warnings to avoid sun exposure, adults and children are spending a great deal of time in the sun, making safe and effective sunscreens essential to prevent skin cancer. At the same time, Americans are using sunscreens more frequently and on a more long-term basis than ever before. Our safety and efficacy standards must reflect that Americans of all ages rely on these products to protect them from skin cancer.
We need conclusive evidence that sunscreen products are safe and effective for long-term use, particularly for infants, children, and pregnant women. Major public health authorities, including the FDA, National Cancer Institute, and the International Agency for Research on Cancer, have concluded that the available data do not support the assertion that sunscreens alone reduce the rate of skin cancer.[2,3,4] The safety and effectiveness testing requirements proposed in the draft guidance will provide the level of evidence that we need to be able to trust our sunscreen products to protect us and not harm us.
Infants and Children
Infants and children are more vulnerable to unsafe chemicals, because they use sunscreen more often and are more susceptible to the risks of chemicals in sunscreen. Since infants and children have such a large surface area relative to their body weight, they are also at risk of absorbing a much higher dose of any chemicals present in sunscreen. And since their bodies are still developing, they are also more susceptible to hormone disruptors that are present in sunscreen.
Very little data are available on the safety of these products in infants and children. For these reasons, we strongly urge the FDA to stipulate that clinical studies must provide demographic subgroup analyses of these and other susceptible populations before the products are allowed to be marketed for widespread use.
Sunscreens are Not Cosmetics
Sunscreens are not “just cosmetics” and should not be regulated as such. Research indicates that chemicals used in sunscreens require thorough study. Sunscreen chemicals may lose their effectiveness when exposed to light, or may cause cancer rather than prevent it. For example, studies of several active ingredients currently on the market have raised concerns about photostability—how long the protections last under real-world conditions. It is important that manufacturers provide clear scientific evidence proving the product remains active when exposed to sunlight for a reasonable length of time. A sunscreen is of no benefit if its active ingredient is degraded. Testing for photostability should be required as part of the pre-market testing of sunscreen active ingredients. Consumers need to know how long products are effective so that they can reduce skin cancer risk.
There is also evidence that certain active ingredients demonstrate potentially carcinogenic activity when exposed to UV light, such as generating free radicals that damage DNA and cause harmful mutations. Testing for carcinogenic activity should be done under conditions that reflect real-world use as closely as possible, e.g., during UV light exposure. Such carefully designed testing is needed to ensure that safety data is reliable and meaningful. Without such information, products intended to help prevent cancer may do just the opposite.
Several sunscreen ingredients currently on the market have endocrine-disrupting or carcinogenic activity.[7,8] For example, oxybenzone is a widely used sunscreen ingredient and, with up to 10% absorption through the skin, it is found in the blood of nearly every American as well as in breast milk.[9,10,11] Research has shown it acts like an estrogen in the body, is associated with endometriosis in women, and alters sperm production in animals. This ingredient should be banned from sunscreen and FDA must not let this mistake be repeated by allowing new sunscreen ingredients to be marketed without sufficient safety testing.
Carcinogens in Sunscreen?
We strongly support the FDA’s proposal to require that active ingredients be tested for carcinogenicity and developmental and reproductive toxicity prior to marketing. These studies must be carefully designed to mimic the conditions of real-life sun exposure, including temperature and humidity. Studies also suggest that absorption into the blood stream continues to occur from the deeper skin layers even after the sunscreen is washed off so measurement should occur up to 24 hours after the sunscreen is first applied. We also urge the FDA to define an amount of sunscreen to be applied for absorption studies that is reflective of typical use. For example, the declared SPF on current sunscreen labels is based on the use of a sunscreen layer of 2 mg/cm2 but studies show that most people apply only a quarter of that amount (0.5 mg/cm2). Additionally, the National Institute of Environmental Health Sciences has concluded that endocrine-disrupting agents often have greater risks at low doses so dose-response testing is not appropriate for these studies. Without well-designed studies, children and other vulnerable groups could be harmed by hormone-altering ingredients.
Finally, we strongly agree with the proposal to require testing of the active sunscreen ingredient with each vehicle (e.g. cream, spray, etc.) in which it will be delivered. Different product formulations that are more water- or lipid-soluble may change the properties or absorption of active ingredients in ways that could affect safety or efficacy of the final product. For example, alcohol-based formulations appear to increase sunscreen absorption and some sunscreen chemicals may enhance the skin absorption of other sunscreens when applied in combination.
In conclusion, the safety and effectiveness testing requirements for new sunscreen chemicals proposed in the draft guidance will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm. We understand the desire for innovative new sunscreen products but this must not come at the expense of safety or effectiveness. We urge you to finalize this draft guidance without delay.
- SEER Stat Fact Sheets: Melanoma of the Skin. National Cancer Institute. http://seer.cancer.gov/statfacts/html/melan.html. Accessed March 15, 2016.
- FDA (Food and Drug Administration). Sunscreen Drug Products for Over-the-Counter Human Use, 76 Fed. Reg. 35,672 (June 17, 2011).
- IARC (International Agency for Research on Cancer). IARC Summary Recommendations for Public Health Action, 2001. Available at: http://www.who.int/uv/resources/recommendations/en/IARCSum.pdf. Accessed 03/16/2016.
- National Cancer Institute: PDQ Skin Cancer Prevention. Bethesda, MD: National Cancer Institute. Date last modified 02/05/2016. Available at: http://www.cancer.gov/types/skin/hp/skin-prevention-pdq. Accessed 03/16/2016.
- Gonzalez, H et al. Photostability of commercial sunscreens upon sun exposure and irradiation by ultraviolet lamps. BMC Dermatology. 2007; 7:1.
- Hsiao IL, Huang YJ. Effects of serum on cytotoxicity of nano- and micro-sized ZnO particles. J Nanopart Res. 2013;15:1829.
- Schlumpf M et al. In vitro and in vivo estrogenicity of UV screens. Environ Health Perspect. 2001 Mar;109(3):239-44.
- IARC Monograph on Titanium Dioxide. 2006.
- Janjua NR, Mogensen B, Andersson, AM, Petersen JH, Henriksen M, Skakkebaek NE, Wulf HC. Systemic absorption of the sunscreens benzophenone-3, octyl-methoxycinnamate, and 3-(4-methyl-benzylidene) camphor after whole-body topical application and reproductive hormone levels in humans. Journal of Investigative Dermatology. 2004.123(1): 57-61.
- Janjua NR, Kongshoj B, Andersson AM, Wulf HC. Sunscreens in human plasma and urine after repeated whole-body topical application. J Eur Acad Dermatol Venereol. 2008. 22(4): 456-61.
- Sarveiya V, Risk S, Benson HAE. Liquid chromatographic assay for common sunscreen agents: application to in vivo assessment of skin penetration and systemic absorption in human volunteers. Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences. 2004. 803(2): 225-231.
- Krause M, Klit A, Blomberg JM, et al. Sunscreens: are they beneficial for health? An overview of endocrine disrupting properties of UV-filters. International Journal of Andrology. 2012. 35: 424–436.
- Klimová Z, Hojerová J, Beránková M. Skin absorption and human exposure estimation of three widely discussed UV filters in sunscreens–In vitro study mimicking real-life consumer habits. Food Chem Toxicol. 2015;83:237-50.
- Schug TT, Janesick A, Blumberg B, Heindel JJ. Endocrine disrupting chemicals and disease susceptibility. Journal of Steroid Biochemistry & Molecular Biology. 2011.127: 204– 215.
- Benson HA. Assessment and clinical implications of absorption of sunscreens across skin. Am J Clin Dermatol. 2000;1(4):217-24.