The Sunscreen Innovation Act: COSMED on what you need to know

By Catherine Apolinario, Cosmed Regulatory Affairs Manager

27-Jan-2017 - Last updated on 27-Jan-2017 at 13:39 GMT

With the Susncreen Innovation Act coming into force in the US, we take a look at it from the European market’s perspective. Here’s what you need to know.

COSMED, the professional association of the cosmetic industry in France, is a leading authority on regulation and has supplied the following guest article on the topic.

Here, the association, which sits in the European Commission for the development of cosmetic regulation, as well as in national and international standardization bodies, gives an overview of the act and the issues around it.

What is the Susncreen Innovation Act, and why has it happened?

The majority of sunscreens available in the United States are marketed under the over-the-counter (OTC) Monograph System. The U.S. Food and Drug Administration (FDA) reviews the active ingredients in these products to determine whether the ingredients are generally recognized as safe and effective (GRASE) for OTC sunscreen use.

In sunscreen monograph, only 16 UV filters can be used in sunscreen product (compared with 29 in Europe). Moreover, the monograph does not include nano forms. The last OTC sunscreen was approved by FDA in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting decisions 14 years later.

Given the increased number of skin cancer and the lack of technical novelties, authorities decided to change approval process.

Sunscreen Innovation Act implementation

The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.

The intent of the Act was to ensure Americans gain access to the latest safe, effective and innovative sunscreen products. The SIA also sets deadlines for reviewing the ingredients and taking certain other actions.

Since the SIA was passed, FDA has met all the deadlines for implementing this complex legislation by issuing final guidances and rulemaking required to date.

FDA reviews the previous sunscreen application to identify necessary data but has yet to receive the additional data requested.

Final guidance documents issuance

In November 2016, as required by the SIA, FDA released 4 final guidance documents:

Withdrawal of a 586A Request or Pending Request: this guidance provides recommendations for the process of withdrawing a “586A” request, submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the SIA, and withdrawing a pending request, as defined by the SIA.
Section 586C(c) Advisory Committee Process: This guidance explains the process by which FDA intends to carry out the convening of advisory committees to provide recommendations on requests submitted under the SIA and the number of requests to be considered per meeting.
Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions: this guidance addresses FDA's current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as GRASE.
Over-the-Counter Sunscreens: Safety and Effectiveness Data: This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the SIA is generally recognized as GRASE and not misbranded when used under specified conditions.

Safety and Effectiveness Data

Published in November 2016, these guidelines, the most important ones for manufacturers, details the data needed from sunscreen manufacturers or other interested parties before FDA can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens.

FDA highlights the importance of human absorption data and real exposure to UV filter. For this reason, industry shall provide data from a Maximal Usage Trial (MUsT) in order to determine blood absorption and its level. This test is already used by FDA for all topically applied drugs, and especially for drugs that are used routinely.

FDA also asks manufacturer to test sunscreen active ingredient in several formulations to evaluate safety and effectiveness of finished product. To achieve this aim, manufacturer have to determine margin of security (MoS).

Promising prospect for European Manufacturers?

In Europe, sunscreen products are considered as cosmetic product and formulator can choose between 29 UV filters without restriction on combination. As a result, it can be difficult to export sunscreen product from Europe to the United States.

Cosmetic associations and NGOs say that the approach outlined in the guidances falls short and did not take the industry’s comments into account.

They regret also that it is not reflective of the current ingredient safety assessment framework, recognized and used by the majority of health authorities worldwide. In effect, all the tests listed by the FDA are not required by other countries and there is no agreement upon protocol.

Theresa M. Michele, Director of the Division of Nonprescription Drug Products of FDA, hopes that "together we can help bring a wider assortment of safe and effective sunscreen products to the American public”.

Actually, the SIA promises a more effective and transparent FDA review. It will therefore be necessary to see in practice the effectiveness and the outcomes of this new procedure.

COSMED boasts 725 SMEs members. Its contributions and regulatory and scientific views are internationally recognized. Cosmed provided a regulatory monitoring to institutions and enterprises.