Products consisting of or containing only pure or highly concentrated caffeine have been linked to deaths and are deemed by FDA to represent a significant public health threat. FDA considers some of such dietary supplements to be adulterated under section 402(f)(1)(A) of the Food, Drug, and Cosmetic Act.
FDA, Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018).
Tuesday, April 17, 2018
Tuesday, April 03, 2018
First FDA Mandatory Food Recall Order
On April 3, 2018, FDA issued its first mandatory recall order for a food product. The order was issued to Triangle Pharmanaturals LLC for all its all food products containing powdered kratom. The order came after several products were found to contain Salmonella, and the company refused the agency’s request for a voluntary recall.
The Food Safety Modernization Act gave FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. These requests by FDA are titled, “Notification of Opportunity to Initiate a Voluntary Recall,” but are sometimes called the “last chance letter,” because the letter provides the company with a last opportunity to issue a recall before FDA enforcement action.
The Food Safety Modernization Act gave FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. These requests by FDA are titled, “Notification of Opportunity to Initiate a Voluntary Recall,” but are sometimes called the “last chance letter,” because the letter provides the company with a last opportunity to issue a recall before FDA enforcement action.
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