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Here are the Major Changes FDA is Proposing to Make to the Sunscreen Rule!

On February 26 2019, the United States Food and Drug Administration (FDA) proposed a rule that would alter the regulations associated with the manufacturing and selling of sunscreen, as well as other sun-care related products. Since the closing of the comment period on May 28th, 2019, FDA has received over one thousand comments from industry players voicing their concern over various aspects of the proposed measures.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

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By |2021-10-28T15:33:57-04:00September 10, 2019|International Law, International Trade, International Travel, U.S. Food and Drug Administration (FDA)|3 Comments
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Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements

This Friday, May 25, 2012 is officially designated as Don't Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn't want you to fry either. On June 18, 2012 the FDA's new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013. Read on to learn of the major changes you should see as a result of the new requirements.

By |2021-11-10T14:49:43-05:00May 23, 2012|U.S. Food and Drug Administration (FDA)|Comments Off on Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements
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