Recalls With Potential For Serious Health Risks Will Identify Points Of Sale
This article was originally published in The Rose Sheet
Executive Summary
"Certain supply chain information is confidential between the supplier and retailer" and makes it difficult for FDA to release lists of retailers offering recalled supplements and foods, says Commissioner Scott Gottlieb. But a draft guidance says for some Class I cases, which pose reasonable probability of serious adverse health consequences or death, additional information about retailers selling potentially harmful product may be key to protecting consumers.
You may also be interested in...
US FDA's Expectations And Firms’ Responsibilities Clarified In Voluntary Recalls Final Guidance
Final guidance describes in greater detail than draft published in 2019 the agency’s expectations for marketers and other businesses’ responses when they need to recall FDA-regulated products.
'Mock' Recalls Suggested, But US FDA Isn't Joking About Recalling Products
FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms. Instead, on top of November guidance on mandatory recall authority and February guidance on recall public notifications, FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.
FDA Debuts List For Rapidly Announcing Noncompliant Ingredients In Supplements
FDA announces addition of Dietary Supplement Ingredient Advisory List page to its website to identify ingredients it has preliminary determined should be used in dietary supplements. It also publishes warning letters submitted recently to firms marketing supplements containing two ingredients agency has concluded should not be used: eight were warned about using an ingredient identified as "DMHA" and three about using phenibut.