Mandatory Recall Guidance Positions FDA For ‘Robust’ Use Of Authority
This article was originally published in The Rose Sheet
Final guidance on mandatory recall authority under FSMA specifies how FDA allows firms opportunities for voluntary recalls and evidence it may consider when deciding whether to mandate a recall. But a consumer advocacy group critical of FDA says the guidance adds nothing for protecting public health.
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Consumer health marketers’ immediate internal communication and outreach to consumers often provides evidence to plaintiffs’ lawyers, says attorney Victoria Calhoon. Plaintiffs' lawyers “smell blood in the water” once a recall is made public but companies can defend against litigation.
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 for the first time exercises its mandatory recall authority over food and supplement products to order Triangle Pharmanaturals, which opened for business in Las Vegas in April 2017, to recall all of the kratom-containing products it has distributed and to cease distributing additional products.The agency also notes in the announcement that it continues to scrutinize kratom's safety unrelated to contamination.