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Archive for the ‘Cosmetics’ category

On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. The final rule requires specific labeling statements based on the results of these tests. As of December 17, 2013, all […]

The U.S. Food and Drug Administration (FDA)’s deadline for most sunscreen manufacturers to comply with new labeling rules is only 10 days away. In June 2011, FDA issued a final rule for the labeling of sunscreens being marketed without an approved application (i.e., being marketed under the OTC monograph). The final rule drastically changed the […]

An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released […]

On June 14, 2011, FDA issued new rules for labeling and testing of sunscreen products. In addition to the new rules, FDA issued an additional proposed rule and a call for data concerning future rulemaking. These new rules present dramatic changes to past labeling requirements, and a departure even from what FDA proposed in 2007. To help industry make sense of the new rules, Registrar Corp has published the following “Top 10” highlight list of changes mandated for manufacturers of sunscreen products.

Failure to report cosmetic products sold in California which contain certain harmful ingredients is a criminal offense. The list of these harmful ingredients was recently updated.

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