FDA Issues Sunscreen Guidance

On November 22, The US Food and Drug Administration (FDA) published “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data – Guidance for Industry,” as required by the Sunscreen Innovation Act (Public Law 113 – 195).

But industry experts were less than pleased with the guidance. 

“From my initial reading of the draft guidance, the FDA is moving full-throttle with treating sunscreens as drugs and is expecting the full complement of drug tests that any pharmaceutical drug requires,” observed Nadim A. Shaath PhD, president, Alpha Research & Development Ltd.  “This includes Human dermal safety studies (human irritation and sensitization studies and human photosafety studies)  and Human absorption studies (MuST) and they added pediatric considerations.  On the non-clinical safety testing, they require both dermal and systemic carcinogenicity studies, developmental and reproductive toxicity studies and toxicokinetics. The FDA has added post marketing safety data requiring that manufacturers provide a myriad of information on adverse drug experiences and reported side effects.”

According to an FDA blog published yesterday and authored by Theresa M. Michele, M.D.,, director of the Division of Nonprescription Drug Products, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research, the “guidance recommends that industry provide data from a Maximal Usage Trial or MUsT, to help determine if the ingredient is absorbed into the blood and at what level. This type of study is designed to capture the effect of maximal use on absorption into the blood. It is the same standard used by FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.”
 
The full final FDA guidance document can be accessed here.

The Public Access to SunScreens (PASS) Coalition issued the following statement in response to the FDA’s final guidance:

“The PASS Coalition’s mission is to work collaboratively with FDA, Congress and stakeholders to ensure Americans have access to the latest sunscreen technology.  We are pleased the FDA met the statutory deadline under the bipartisan Sunscreen Innovation Act to publish a final guidance on sunscreen ingredient testing. We support the changes from the earlier draft – especially changes to the formulations and the body surface area to be tested. However, we were disappointed that the agency’s approach remains inconsistent with the recommendations made by independent scientific reviewers that were published in peer-reviewed literature. We look forward to continuing to work with FDA and the new Administration to ensure that safe ingredients get to market as quickly as possible.”
 
The bipartisan Sunscreen Innovation Act was signed into law by President Obama on Nov. 26, 2014.

The law streamlined the approval process for new sunscreen ingredients to ensure that these ingredients receive a transparent review within a predictable timeframe. The intent of the Act was to ensure Americans gain access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays. 

Although treatments for melanoma are improving rapidly, the survival rates are still low. According to PASS, taking steps to prevent melanoma are key, and part of those steps is using the most technologically advanced sunscreen products available. People around the world are doing that, but they aren’t in the US.
 
PASS re-asserted that the last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting final decisions 14 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 20 years.
  
FDA stated, “The vast majority of sunscreens available in the United States are marketed under a regulatory framework called the OTC Monograph System. 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. The Sunscreen Innovation Act (SIA) of 2014 established an alternative process for the review of safety and effectiveness of additional active ingredients for use in sunscreens, and set deadlines for reviewing the ingredients and taking certain other actions. But SIA did not eliminate the need for a GRASE determination for new sunscreen active ingredients before reaching the market without an approved marketing application, and it did not relax the scientific standards for these products. Further, FDA’s review deadlines are only triggered after the data have been submitted to the agency.”
 
The FDA post further stated, “Since the SIA was passed, FDA has met all of the deadlines for implementing this complex legislation. That includes inviting public comment on our actions, holding requested meetings with industry, issuing draft and final guidances, issuing proposed and final rulemaking required to date, and issuing a report to Congress on our progress.”
 
“When the SIA was enacted, eight sunscreen active ingredients were already under evaluation. The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive GRASE determination on those within the SIA-required time frame, but has yet to receive the additional data we requested. Today, as required by the SIA, we released a final guidance documentthat details the Agency’s current thinking on the specific information we believe we need from sunscreen manufacturers or other interested parties before we can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens. This guidance will also help clarify FDA’s outstanding requests for additional safety and effectiveness data on the eight active ingredients, including the importance of human absorption data.”
 
In closing, Michele penned, “We hope the final guidance encourages industry to provide the FDA with the data we need, so that together we can help bring a wider assortment of safe and effective sunscreen products to the American public.”

FDA may meet with some resistance from industry. According to Shaath, a more serious proposal that the FDA has floated in this guideline is the testing of the final formulations.

“They are requesting that manufacturers perform invitro permeation testing before marketing each new formulation. This new requirement will have a major impact in our industry if implemented,” he insisted. “Unfortunately, the Sunscreen Innovation Act of 2014 has only given the FDA an excuse for setting more requirements and impediments for manufacturers to introduce new ingredients and formulations for sunscreens.”