Tattoo Ink Manufacturers Warned About Microbial Contamination After Recalls
FDA sends warning letters to two Florida tattoo ink firms linked to a safety alert and recall in May and a New Jersey tattoo ink company for contamination in products that require the firms to quickly correct deficiencies that are a ‘significant’ health and regulatory concern.
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According to its May 16 notice, the agency intends to award the contract to NSF International. An FDA spokesperson said NSF already undertook related work for the agency in 2018 and has rendered similar services for the US Environmental Protection Agency.
Under current cosmetics regulations FDA does not have the authority to order product recalls, as it does in the dietary supplement space, for example. Voluntary cosmetic recalls have been typically light in recent months, most often citing microbiological issues.
FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands
OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.