On November 13, 2014, the U.S. House of Representatives passed the Sunscreen Innovation Act (SIA), a bill which requires the U.S. Food and Drug Administration (FDA) to review the safety and effectiveness of new over-the-counter (OTC) sunscreen active ingredients in less than a year’s time upon request. The SIA was passed on to the House by the U.S. Senate, which passed the bill in September 2014. It is now up to the U.S. president to either veto the bill or sign it into law.
The SIA was brought to the table in March 2014 by U.S. Senator Jack Reed (D-RI) and U.S. Representative Ed Whitfield (R-KY) because of frustration within the sunscreen industry regarding FDA’s slow reviewing pace. FDA regulates sunscreen ingredients as drugs. New drugs are usually required to submit new or abbreviated new drug applications, which require extensive scientific information. FDA offers a Time-and-Extent (TEA) review process as an alternative to the drug application process for products that are new to the United States, but can prove to have been marketed safely and successfully in other countries. The problem is that FDA has not approved even one sunscreen under the TEA process, despite the fact that at least four sunscreen ingredients were submitted more than six years ago.
If the SIA is signed into law by the U.S. president, FDA will be required to review sunscreen ingredients within 11 months of being submitted. As for those ingredients currently awaiting FDA review under TEA, FDA will be required to review those within 8 months of the SIA coming into effect. FDA would obtain information about a new sunscreen ingredient from its sponsor and the public. After its review, FDA would decide whether or not the ingredient is safe for use in the United States. Ingredients that are deemed to be safe and effective would be usable in OTC sunscreen products.
Along with the new sunscreen ingredient approval process, the SIA would require FDA to generate testing and labeling requirements for sunscreen sprays. FDA treats sprays differently than other forms of sunscreen because of the nature of application. FDA is concerned about whether or not sunscreen sprays adequately cover and protect the body and the possible effects of inhalation.
In a 2011 guidance document, FDA stated that sprays could be included in the OTC sunscreen monograph as long as the manufacturer included a warning to keep the product away from the user’s face and included the instructions for use specified by FDA in the guidance. However, FDA mentioned that it intended to propose that sprays not be included in the monograph if the agency did not receive sufficient information about the safety and effectiveness of sprays, which it requested in an Advanced Notice of Proposed Rulemaking in June 2011. If FDA has not received substantial data by the time the agency is required to generate requirements for sprays, FDA may decide that sprays are not generally recognized as safe and effective (GRASE). If this happens, manufacturers of sunscreen sprays would no longer be able to market their products without FDA approval. They would be required to go through the extensive drug application process in order to prove their spray was safe and effective.
The SIA would also require FDA to revisit whether sunscreen may be labeled with an SPF greater than 50. In 2011, FDA stated in a consumer update that there was not “adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.” So, the agency proposed that sunscreens with an SPF above 50 should be labeled “SPF 50+” rather than a specific number. The proposed rule, however, was never finalized, so FDA currently uses enforcement discretion for sunscreen products labeled with SPFs above 50.
Drug products are subject to various FDA regulations, even after approval. Drug establishments must register with FDA, list their products, and follow strict labeling requirements. Registrar Corp assists drug establishments to comply with these U.S. FDA regulations. For more information about FDA regulations for drug companies or what Registrar Corp can do to help, contact +1-757-224-0177 or speak with a Registrar Corp Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/LiveHelp