delete PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Regulation establishes GRASE status, formulation limits, and mandatory labeling for over-the-counter skin protectants including lip balms, astringents, and combination products
Federal micromanagement of low-risk topical products imposes substantial compliance costs on manufacturers, particularly small businesses, while providing no meaningful safety benefit. Trivial products like moisturizers and lip balm pose minimal risk and are better regulated through market mechanisms, tort law, and voluntary standards. The rule creates barriers to entry, stifles innovation, and represents an unconstitutional overreach into personal care decisions that should be left to consumers and producers.