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.

Did You Know?

Change Healthcare Data Breach Impacts Millions of Customers

A massive Change Healthcare data breach exposed the names, social security numbers, medical and personal information of potentially 100 million Americans, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

BioZorb Lawsuit Indicates Recalled Tissue Marker Migrated After It Failed To Absorb, Resulting in Severe Pain and Surgical Removal
BioZorb Lawsuit Indicates Recalled Tissue Marker Migrated After It Failed To Absorb, Resulting in Severe Pain and Surgical Removal (Posted yesterday)

Days after the FDA announced a BioZorb recall, an Arkansas woman has filed a lawsuit, indicating that her BioZorb tissue marker migrated out of position, causing pain and disfigurement, instead of harmlessly absorbing into the body as advertised.

Judge Outlines Suboxone Tooth Decay Lawsuit Census Requirements
Judge Outlines Suboxone Tooth Decay Lawsuit Census Requirements (Posted 2 days ago)

To help the parties identify Suboxone lawsuits that can be used as representative samples in early bellwether trials, the federal judge presiding over the litigation has directed the parties to conduct a census of all tooth decay claims.