S. 2491: Supporting Accessible, Flexible, and Effective Sunscreen Standards

This bill, titled the Supporting Accessible, Flexible, and Effective Sunscreen Standards Act, proposes modifications to the regulatory framework under the Federal Food, Drug, and Cosmetic Act. Its primary focus is on improving the review process for nonprescription drugs that are applied to the skin, specifically sunscreens and similar topical products. Here are the key components of the bill:

Review Process Enhancements

The bill mandates that the Secretary of Health and Human Services (HHS) will make changes to how the safety and efficacy of active ingredients in topical products, such as sunscreens, are evaluated. These changes will include:

• Allowing the incorporation of real-world evidence, which refers to data collected outside of traditional clinical trials, in the assessment of these products.
• Ensuring that the evaluation considers whether the benefits of the active ingredients outweigh their risks.

Non-Animal Testing Methods

Another significant aspect of the bill is a commitment to exploring non-animal testing alternatives for determining the safety and effectiveness of topical drugs. Specifically:

• The Secretary will review existing non-animal testing methods and establish guidance on how to use these alternatives in the safety evaluations.
• Within one year of the bill's enactment, new draft guidance regarding the use of these non-animal testing methods must be issued.

Sunscreen Administrative Order

The bill provides that any final administrative ruling regarding nonprescription sunscreen active ingredients must:

• Take into account historical safety data of sunscreens previously accepted for sale in the U.S.
• Recognize the role of broad-spectrum sunscreens (SPF 15 or higher) in skin cancer prevention.
• Apply the new evidence and testing standards for sunscreen ingredients established by this bill.

Reporting and Transparency Requirements

The legislation requires the Secretary of HHS to create a reporting system that includes:

• Annual reports over five years detailing the implementation of the new evidence and testing standards.
• Updates about the number of sunscreen active ingredient requests reviewed and the progress of incorporating non-animal testing alternatives.

These reports must be submitted to specified committees in the House of Representatives and the Senate and published on the FDA's website within seven days of submission.

Clarifications

The bill clarifies that none of the changes proposed should alter the existing standards for determining whether a drug is generally recognized as safe and effective.

Relevant Companies

• PG - Procter & Gamble: As a major manufacturer of sunscreens and skin care products, changes in regulatory standards could affect product approval timelines and formulations.
• AVP - Avon Products: As a cosmetics and skincare company that offers sunscreens, Avon may need to adapt its products to comply with new testing standards.
• NEWR - Newell Brands: This company produces a variety of consumer goods, including sunscreens. Regulatory changes could impact their product lines.