The US Food and Drug Administration has announced the availability of a guidance for industry entitled “Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data.”
|FDA Issues New Guidelines on Sunscreen Safety & Efficacy
Safety & Effectiveness Guidelines
This guidance addressed 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 Sunscreen Innovation Act (SIA)
is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addressed FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.
While a majority of the safety and effectiveness guidelines for sun screen focused on Ingredient safety data, final formulation testing will almost certainly continue to be part of most final sunscreen orders. And the closing section of the FDA’s new recommendations covers this aspect of sun care approval.
That section explained that:
“FDA’s current thinking is that final formulation safety testing of nonprescription sunscreens would not generally call for an in vivo study. Instead, FDA expects that the conditions of marketing specified for sunscreen active ingredients in final sunscreen orders would require manufacturers to perform in vitro permeation testing before marketing each new formulation.”
Clinical Safety Testing
The guidelines cover clinical safety testing (comprised of human dermal safety studies, human absorption studies and maximal usage trials, as well as pediatric considerations); nonclinical safety testing (which covers both dermal and systemic carcinogenicity studies; developmental and reproductive toxicity studies; and toxicokinetics); and post marketing safety data.
As the FDA notes in the new guidelines and in today’s Federal Register that “this guidance does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
Most notably, in regard to effectiveness, according to the new guidelines:
“When applying these regulations to each potential sunscreen active ingredient, FDA requests that sponsors provide evidence from at least two adequate and well controlled SPF studies showing that the active ingredient effectively prevents sunburn, because sunburn prevention is the minimum indication for an OTC sunscreen product.”
“Two adequate and well controlled SPF studies of the active ingredient at a lower concentration than the maximum requested should be conducted according to established standards. These SPF studies should demonstrate that the selected concentration provides an SPF value of 2 or higher.”
Broad spectrum claims and labeling should be dealt with in the final sunscreen order.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of huma/n and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.