On 22 November2016, the US Food and Drug Administration (FDA) published its final guidance on safety and effectiveness data for OTC sunscreen ingredients. Eagerly awaited by the industry, seeking to be able to use in the US UV-filters already on the European market for years, the document does not yet fully satisfy it.
The Guidelines issued by the FDA details the safety data needed to establish that an OTC sunscreen active ingredient is generally recognized as safe and effective (GRASE).
In its introduction, FDA states that this guidance addresses the current thinking of the Food and Drug Administration’s about the safety and effectiveness data needed to determine whether a OTC sunscreen active ingredient, or combination of active ingredients, evaluated under the Sunscreen Innovation Act (SIA), is generally recognized as GRASE and not misbranded when used under specified conditions. It aims to help sponsors identify and obtain the safety and effectiveness data needed to show that a sunscreen active ingredient is GRASE.
According to the Agency, the recommendations in this guidance are designed to ensure that FDA’s GRASE determinations for OTC sunscreen active ingredients under the SIA are consistent, up to date, and appropriately reflect current scientific knowledge and patterns of non-prescription sunscreen use by consumers.
It also addresses FDA’s current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.
Good point but not enough for the industry: in a communiqué published on 22 November 2016, the Personal Care Products Council says it is “disappointed to see …
