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CTFA comments on plano lenses

This article was originally published in The Rose Sheet

Executive Summary

Proper classification of a product under the FD&C Act "depends upon the intended use of the product and not upon the composition or safety of the product," the Cosmetic, Toiletry and Fragrance Association maintains in recent comments to FDA. Comments respond to an April 4 Federal Register notice and accompanying import detention guidance released by FDA clarifying its position that non-corrective contact lenses should be regulated as cosmetics rather than medical devices. While CTFA notes it "takes no position specifically" on the guidance, it maintains a product is accurately classified as a cosmetic when there is no intent that the product is used "to prevent or treat disease or to affect the structure or function of the human body"...



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