Washington, D.C.—In two recent public filings, the Natural Products Association (NPA) encouraged the U.S. Food and Drug Administration (FDA) to adopt standards that would result in the availability of more natural ingredients in sunscreen for consumers.
In addition to the new standards, the NPA has also called on FDA to clarify what it considers to be active ingredients in sun protection products and also to amend the approval process to allow more applications for new products.
In a news release, NPA’s senior vice president of scientific and regulatory affairs, Corey Hilmas, M.D., Ph.D, stated, “changing the process by which new sunscreen products are approved will greatly serve the American consumer, giving them access to more effective natural products and support the important goal of reducing skin cancer in the United States.”
The public filings come on the heels of FDA announcing the availability of two draft guidance for industry entitled “Nonprescription Sunscreen Drug Products—Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act” and “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.”
According to a notice issued by FDA, the draft guidance for the Nonprescription Sunscreen Drug Products will address “FDA’s current thinking on how we will determine whether a sponsor’s submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products.”
Before FDA implements the SIA, NPA wants FDA to modify the draft with these specific items:
- Specify the timeframe for which sponsors are allowed to submit additional information after an initial refusal of the 586A request.
- List both the technical specifications required and technical specifications that should be omitted from the Common Technical Document (CTD) to be considered a complete GRASE submission.
- Clarify whether combination active ingredients are required to submit multiple GRASE submissions and how this would affect the submission of safety and toxicity data.
The draft guidance for the Advisory Committee Process will address the “requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph.”
NPA also encourages FDA to modify the current draft of the Advisory Committee Process by:
- Reconsider the frequency that the Nonprescription Drugs Advisory Committee (NDAC) meets in regards to the 586A request as well as the number of pending 586A request reviewed by the committee.
- Allow for an NDAC request to be made only when a request is no longer pending.
Published on WholeFoods Magazine Online 2/5/2016