The FDA set a precedent of issuing a mandatory recall under the Food Safety Act authority. The FDA applied, in part, a statutory authority for foods to a drug substance.
Perhaps, the scope of the FDA's mandatory recall for food finds a back door for ordering drugs off of the market. Was the product really a dietary supplement, as claimed by the distributor or did the FDA deem the dietary supplement as a drug?
This raises issues of a product falling under a food classification and a drug metabolic action. There are lessons emerging from this for drug marketers, re-labelers, and manufacturers. How does this precedent change your view of recall management now that foods, drugs, and devices all face the possibility of a mandatory recall in one way or the other?
The FDA's action here is a two-for-one hit and in the interest of public health, which seems to be a fortuitous move in protecting the public health. It draws attention to the agency's mandatory recall authority under the Food Safety Act and illustrates how dietary supplements can veil the fact that they can be dangerous. Public policy seems to be as much a part of the considerations in this case as are the dangers of Salmonella poisoning.