Wednesday, May 12, 2021

FDA Publishes Notice of Intent for Environmental Impact Statement for Certain Sunscreen Drug Products - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Publishes Notice of Intent for Environmental Impact Statement for Certain Sunscreen Drug Products

Today, the U.S. Food and Drug Administration published a "Notice of Intent (NOI) to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use." The National Environmental Policy Act requires federal agencies to consider the potential environmental consequences of certain actions. 

The purpose of an Environmental Impact Statement (EIS) is to provide information concerning any significant environmental impacts associated with a major federal action. The EIS announced today will evaluate any significant environmental impacts for oxybenzone and octinoxate in sunscreen products.  FDA is conducting an EIS because questions have been raised about the potential harmful impacts from sunscreens containing oxybenzone or octinoxate on the environment. 

The NOI briefly describes the proposed preparation of the EIS and notes that by publishing this NOI, FDA is beginning the "scoping process" to help identify the environmental issues to be considered in the EIS, eliminate those that are not significant, and address alternatives to the proposed action.  

The public, including federal and state agencies, tribal governments, and other stakeholders may comment on the scope of this EIS. To submit a public comment, please visit the NOI. For more information and updates about the progress of the EIS, please visit FDA's EIS webpage.


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