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Safety – The road to compliance.jpg

Safety: The road to compliance

The distinctions between cosmetics and other classes of goods are quite plain under FDA regulations. Cosmetic manufacturers are requested to register their manufacturing operations, but are not required to follow GMPs (good manufacturing practices). That doesn’t mean anything goes, though, as cosmetic ingredients have to be adequately substantiated for safety prior to marketing.

Cosmetics—topically applied solutions to battle the challenges of aging—are less regulated than beauty-from-within dietary supplements. Even though cosmetics include products that bleach hair and skin, are sometimes absorbed through the skin, or are ingested in the case of lipsticks and lip balms, no regulatory agency reviews ingredients before they can be used.

This does not mean that brands can put anything in cosmetics; it simply means that there is notification process required as with dietary supplements. Brands should consider regulations that require each ingredient used in any finished cosmetic product to be adequately substantiated for safety prior to marketing. As with other regulations, the manufacturer holds the safety responsibility and should be able to provide it on demand.

The nongovernmental organization Cosmetic Ingredient Review (CIR) Expert Panel reviews ingredients and makes determinations of their safety. An endorsement from the group carries significant weight with FDA as substantiation of safety of the ingredients.

Including new ingredients in personal care products comes with regulatory responsibilities. Creating an internal dossier of safety is good for business and consumer trust.

To read this article in its entirety, check out the Healthy aging: Outward vitality – digital magazine.

Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity, where he is COO. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN).

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