CHPA: Sunscreen Efficacy Ceiling Is More Harmful Than SPF Claim Limit
This article was originally published in The Tan Sheet
|
FDA should not impose an efficacy ceiling on sunscreen formulations even if it caps sun protection factor label claims at 50 or 50+, industry stakeholders argue. An efficacy limit that would prohibit the sale of products formulated with a tested SPF above 50 is unnecessary, unjustified and would hinder innovation, the Consumer Healthcare Products Association and the Personal Care Products Council say in joint comments filed Sept. 15. The comments respond to FDA’s proposed rule on revised effectiveness determination of sunscreen drug products for OTC use (Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - Pink Sheet, 20 Jun, 2011.). In the proposed rule, FDA requested feedback on potentially banning products with tested SPFs above 50 from the monograph because the higher concentrations of active ingredients could be considered excessive and potentially unsafe. This is separate from the agency’s proposal in the same Federal Register notice to cap SPF labeling at 50 but to allow stronger formulations to be sold as 50+. If an efficacy ceiling were in place an SPF 85 product could not be marketed, even as 50+. “FDA’s general approach to combination drugs prohibits the inclusion of additional active ingredients if they do not provide additional benefit,” the agency explained in the proposed rule. “More specifically,” it added, “if having an SPF above 50 does not confer additional clinical benefit in a sunscreen the risk benefit-assessment for these sunscreens may no longer be favorable.” CHPA and the council argue such a ceiling is unnecessary because “‘a self-imposed’ ceiling already exists by virtue of the monograph’s permissible levels of active ingredients” that can be in a final formulation, they write. Further, they note, “FDA currently has no safety concerns with the approved monograph active ingredients and monograph levels and combinations” considered generally recognizable as safe and effective. FDA has not finalized the sunscreen monograph in part because it is still reviewing the safety of some active ingredients, the agency notes. However, a top FDA official said when the proposed rule was released that the ingredients currently on the market are safe (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - Pink Sheet, 20 Jun, 2011.). The trade groups note other countries with an SPF claims cap do not have formulation efficacy ceilings. Ceiling Could Block Advancements Rather than benefit public health, ceilings could cause harm by discouraging research into “new and better sunscreens,” the American Society for Dermatologic Surgery says in comments filed Sept. 15. CHPA and the council agree. “Improvements in formulation skills and technology, together with the availability of improved sun filter ingredients, has resulted in a steady increase in the SPF number that can realistically be delivered by a sunscreen product,” they say. “Had a ceiling been introduced concurrently with industry’s ability to formulate to an SPF 15, the technological advancements made in the last 20 to 30 years in science in UV filters, photoprotection and related health care improvements are unlikely to have been achieved.” A ceiling also would deprive consumers of several potential clinical benefits of higher SPFs. Since 2007, medical journals have shown sunscreens with SPFs higher than 60 can prevent actinic keratoses and invasive squamous cell carcinoma in organ transplant recipients, reduce lesions in patients with polymorphic light eruption and cutaneous lupus erythematosus and minimize erythema and wheal development in patients with solar urticaria, according to comments filed Aug. 31 by the American Academy of Dermatology. The academy adds that it supports further increases to the allowable SPF “as substantiated by clinical efficacy data and corroborated by accurate SPF testing.” FDA Should Harmonize SPF Cap With EU Without an efficacy ceiling, CHPA and the council would not object to the proposed label cap of SPF 50 as long as firms can petition for an exception to label with a higher SPF, as proposed by FDA. However, the groups recommended FDA harmonize the cap with the European Commission’s recommendation of SPF 60 or greater. Harmonization would enhance public health protection, improve government efficiencies and streamline industry efforts as international commerce continues to increase, they say. |