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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Separate criticisms show opposite sides of the coin of public perception constantly flipping for businesses large and small making and marketing supplements available in US.
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.