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 But a draft guidance says for some Class I cases, which pose reasonable probability of serious adverse health consequences or death, additional information about retailers selling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.
Addresses for retailers offering dietary supplements and other food products recalled due to "a reasonable probability" using the product "will cause serious adverse health consequences or death" could be published by FDA, the agency says.
Announcing a draft guidance on "Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls," Commissioner Scott Gottlieb said FDA "has not traditionally released lists of specific retailers where recalled foods may have been purchased" because "certain supply chain information is confidential between the supplier and retailer" and in most cases information that recalling firms publish is sufficient to help consumers.
However, in some cases "additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption," Gottlieb stated on Sept. 26.
Under FDA's policy explained in the guidance, it will publicize retail consignee lists, including internet addresses, for food and supplement recalls when a product likely to be available for consumption is not easily identified as being subject to a recall from its retail packaging.
The draft guidance states that recalls that trigger publication of retail locations offering the products will be Class I cases, which pose reasonable probability of serious adverse health consequences or death.
Conventional food products, particularly raw vegetables, meat and poultry are more likely than supplements and other nutritional products to become contaminated and prompt Class I recalls that are announced with retail consignee addresses. However, recalls of dietary supplements, particularly herbal products, occasionally are linked to contaminants and are deemed Class I recalls by FDA, such as the recalls of kratom supplements found contaminated by salmonella that have been reported across the US in 2018. (Also see "Salmonella In Kratom, Like Use Of The Herb, Exceeds FDA Expectations" - HBW Insight, 2 Jul, 2018.)
Additionally, recalls of products marketed as supplements but spiked with drug ingredients, including some that are not approved for use in the US, could be announced with addresses of locations selling the products because they could have reasonable probabilities of serious adverse health consequences or death. (Also see " Injunction Ends Spiked Supplement Marketers' Attempt To Deceive FDA" - HBW Insight, 31 Aug, 2018.) (See recent health, beauty and wellness product recalls classified by FDA in a table linked below.)
The commissioner noted examples of foods sold directly to consumers with no universal product code (UPC) or bar code, such as deli cheese, nuts, and fresh fruits and vegetables sold individually, or rawhide chews or pet treats sold in bulk.
Health, Beauty And Wellness Product Recalls
The document written by FDA's Office of Regulatory Affairs and its centers for Food Safety and Applied Nutrition and for Veterinary Medicine said the agency intends to collect and compile retail consignee lists and have the information ready as a source for addresses it would need publish to inform consumers about certain Class I recalls.
Gathering the information after a recall has started would be ineffective for informing consumers. "Identifying retail consignees can be a time-consuming process that often involves obtaining information from multiple entities throughout a supply chain, including the recalling firm and intermediate distributors," stated ORA and the FDA centers.
Gottlieb also noted that FDA in in January published a draft guidance on situations where the agency and firms would publicize public warnings to help carry out recalls. Both draft guidances are steps in an initiative the commissioner launched to improve FDA's recall processes.