2015 In Review: Legislative Letdowns Weigh On Industry And NGOs Alike
This article was originally published in The Rose Sheet
The US Sunscreen Innovation Act's implementation, which has frustrated TEA sponsors, Congress and public-health advocates, was a hot topic for "Rose Sheet" readers in 2015, as well as a lawsuit in the EU that could greatly dilute the European ban on cosmetic animal testing, much to animal-welfare groups' dismay.
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The Environmental Working Group renews its call for a cap on SPF values at 50+, asking FDA to investigate whether anti-inflammatory ingredients added to sunscreen formulations are boosting SPFs without providing meaningful protection against UV damage. The NGO also recommends changes to the agency’s SPF testing requirements to improve the accuracy of labeled SPF claims.
The EU's ban on animal-tested cosmetics and ingredients could be narrowly limited to tests performed to meet the European Cosmetics Regulation's data requirements – exempting testing undertaken to comply with third-country regulations or other EU laws – if the European Court of Justice sides with industry next year. Stakeholders expect the court's advocate general to render an opinion on the matter in March 2016.
Time and extent applicants seeking GRASE status for UV filters should provide FDA with the kind of clinical safety data used to support approval of chronic-use cutaneous drug products, and nonclinical testing should focus on potential long-term adverse effects, according to newly released draft guidance required from the agency under the Sunscreen Innovation Act. FDA is particularly interested in receiving comments about final formulation safety testing it anticipates requiring under specified monograph conditions.