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FDA’s First Action under the Sunscreen Innovation Act

On November 26, 2014, U.S. President Barack Obama signed the Sunscreen Innovation Act (SIA) into law.  Proposed in March 2014, the SIA requires FDA to review new sunscreen ingredients within 11 months of being submitted and to finalize testing and labeling requirements for sunscreen sprays.

On January 7, 2015, FDA announced the availability of six sunscreen feedback letters under the SIA.  According to the announcement, the letters contain FDA’s “tentative determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in OTC sunscreen drug products.”  The feedback letters had been previously issued between February 21, 2014 and November 13, 2014, but when SIA was enacted, existing sunscreen feedback letters became proposed sunscreen orders.

Proposed sunscreen orders can be placed into three categories:

  1. GRASE and not misbranded if marketed in accordance with such order
  2. Not GRASE and is misbranded
  3. Not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional data are necessary to allow FDA to determine otherwise

All six of the feedback letters announced by FDA were classified under category C, therefore the sponsors of the submitted ingredients will need to provide additional information to FDA to determine whether or not the ingredients are safe for use in sunscreen.

Registrar Corp assists drug companies with U.S. FDA regulations.  If you have any questions about FDA’s regulations for sunscreen products, contact Registrar Corp at +1-757-224-0177 or speak with a Registrar Corp Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.

*Update: On February 24, 2015, FDA took initial action on the last two pending ingredients (ecamsule and enzacamen).  As with the previous six, FDA determined that the data are insufficient to classify the active ingredients as GRASE.





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