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News and Press: Policy News

Personal Care Products Safety Act Introduced

Wednesday, April 29, 2015   (0 Comments)
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A Personal Care Products Safety Act (S. 2014) bill was recently introduced in Congress that would significantly expand FDA's authority over cosmetic products sold in the United States. The bill spells out various regulations including registration of facilities, registration of products, mandatory recall authority, adverse and serious adverse event reporting, good manufacturing practices, and user fees. The provisions are not that dissimilar from the existing FDC Act applicable to nonprescription drugs.

The bill proposes to have FDA investigate at least five different cosmetic ingredients for safety each year. Beginning in year 1 those safety studies would analyze propylparaben (a common cosmetic preservative); methylene glycol (a formaldehyde-releasing chemical previously used in some hair-straightening treatments); diazolidinyl urea (a preservative used in various cosmetics including shampoo and conditioner), Quaternium-15 (a preservative used in shaving cream, skin creams, etc.), and lead acetate (used in hair dye). 

Implementation and review costs would be covered by registration fees linked to the gross annual sales from cosmetics of the registered companies with fees ranging from $250 (gross sales from $500,000 to $2.5 million) to $1.1 million (gross sales of $5 billion (i.e., $5,000,000,000) or more).

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