FDA Calls For More Information On Sunscreen Additives In New Guidelines

Federal regulators have issued final guidance on the safety of additives used in sunscreens, calling for manufacturers to provide proof of their safety and effectiveness. 

The FDA’s final guidance for sunscreen is an extension of the Sunscreen Innovation Act of 2014 (SIA) which set deadlines for the agency to review active and added ingredients in sunscreens to determine if the products are generally recognized as safe and effective (for over-the-counter use.

The act also established an alternative process for reviewing the safety of active ingredients. The prior approval process allowed the majority of sunscreens to be marketed under the OTC Monograph System, where the FDA reviewed active ingredients to determine if they were safe and effective for consumer use.

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The final guidance for sunscreens was issued on Tuesday, as a part of the legislation and focuses on data manufacturers will be required to provide to show that their products, and the ingredients in this products, are safe for consumers to use.

The legislation required manufacturers to focus on chemical and human studies needed to get approval to include a new ingredient in the product. The companies will need to provide data from “maximal usage trials,” to determine if an ingredient is absorbed into the blood.

New York Senator Charles E. Schumer recently called on federal regulators to launch and investigation into sunscreen manufacturers‘ marketing practices to determine if the SPF levels they market and advertise are true SPF protection levels for consumers.

In addition, the FDA indicates that it is vitally important to complete human studies to determine whether sunscreen may result in chronic systemic exposure to the ingredients and to what extent use of sunscreen may cause any ill side effects.

A study published in April indicated sunscreen exposure may contribute to the decline of sperm fertility. The study suggested UV filters mimic the effect of progesterone, affecting male fertility. Another study from 2014, indicated benzophenone, one of the active ingredients of sunscreen, decreases a man’s fertility by 30 percent.


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