FDA issues final rulemaking on testing and labeling of sunscreen products

Jun 15 2011

The U.S. Food and Drug Administration (FDA) today issued its final rulemaking addressing the way in which the agency will require sunscreen products to be tested and labeled.  The agency also published three other documents, including a Draft Enforcement Guidance for Industry document, further explaining the final rule, a Proposed Rule on sunscreens with SPFs greater than 50, and an Advance Notice of Proposed Rulemaking (ANPR) recognizing and requesting information about alternative dosage forms of sunscreen products such as sprays, powders, wipes, and shampoos. These documents may be found at:  www.fda.gov/sunscreen.

For more than 30 years, consumers have benefited from the use of sunscreen products to protect themselves from the harmful effects of the sun, including sun burn, premature skin aging, and certain types of skin cancer.  The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory bodies throughout the world, and there is an extensive body of credible scientific research that demonstrates the safety and efficacy of sunscreens.

"FDA's recognition today of the important role sunscreens play in protecting the public not only from sunburn but also from skin cancer and premature aging due to the sun is a very significant victory for public health.  The role of UV rays in causing skin damage and the role of sunscreens in protecting against this sun damage are widely acknowledged within the medical and scientific communities, and we're very pleased the agency has taken this critical step.

"Sun exposure is cumulative and the greater the exposure, the higher the risk to all skin types of developing signs of premature skin and/or certain types of skin cancer.  Skin cancer is the most common of all cancers in humans, and skin cancer rates in all races are rising in the U.S.  This ruling will help further educate consumers about the importance of using sunscreens as part of an overall sun protection regimen that includes avoiding the sun during peak hours and wearing protective clothing.

"We are also pleased that FDA reaffirmed there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide.  The agency confirmed that it evaluated available scientific literature, tested sunscreen nanoscale ingredients and concluded they do not penetrate the skin.

"We urge the agency to keep this rulemaking current and evolving to accommodate new scientific research that becomes available and enable companies to continue to innovate by producing products with higher SPFs, new effective ingredients, new dosage forms and even additional public health benefits.

"In its Proposed Rule, FDA acknowledged that SPFs higher than 50 have been substantiated by independent clinical testing labs, and the results are validated and repeatable.  We look forward to working further with the agency on this issue.  Individual companies may also provide their own additional data supporting SPFs higher than 50.

"We are evaluating FDA's specified implementation period, but we are concerned about manufacturers' ability to make the required testing and labeling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labeling.  It is unusual for FDA to require such a short implementation period for a rule making of this scope.  Manufacturers typically require at least two years to design and implement broad-scale, product-wide labeling changes.  

"The industry and the FDA share a mutual goal of ensuring that consumers are protecting themselves against the sun and are aware of the benefits sunscreen products provide. The labeling clarity the Final Rule provides will help achieve this goal."