FDA Warning Letter Depicts Personal-Care Regulation's Present, Possible Future
This article was originally published in The Rose Sheet
Cosmetic firms already are being closely watched by FDA for overreaching product claims, but if formal good manufacturing practices are established for the sector down the road under regulatory reform legislation, companies could be targeted increasingly with warning letters like that issued to Beauty & Health International for quality-control violations at its Garden Grove, California facility.
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ICMAD's recent regulatory workshop offered perspective from FDA's Linda Katz and industry experts on the inspection process for cosmetics facilities under current law. It's clear that FDA inspections can be an ordeal, but that would pale in comparison to challenges that could arise under the proposed Personal Care Products Safety Act.
The firm's violative label claims include Aloe Vera Gel "cures everything" and its branding mistakes include failing to list all ingredients for its Aloe Capsules and Original Whole Leaf Aloe Vera Capsules.
Hexamethylene diisocyanate polymers and keratin/keratin-derived ingredients are safe as currently used in the cosmetics sector, provided that good manufacturing practices are being employed, the Cosmetic Ingredient Review Expert Panel suggests. The group issued four final assessments, advanced a slew of tentative reports and finalized its 2017 review priorities at its June 6-7 meeting in Washington.