– OPINION –
Editor’s note: The FDA has issued a similar warning for Answers brand pet food. The manufacturer, Lystn LLC, has not issued a recall despite testing and warnings from the Food and Drug Administration.
The U.S. Food and Drug Administration is warning pet owners that FDA samples of five raw cat and dog foods from Darwin’s Natural Pet Products, made by Arrow Reliance Inc., have tested positive for Salmonella and a sixth FDA sample tested positive for Salmonella and Listeria monocytogenes (L. mono).
The affected products are sold in frozen 2-pound packages and consist of select lots of Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs. These product lots should not be fed to pets.
Darwin’s Natural Selections pet food is generally sold online through a subscription service.
The FDA has ordered Arrow Reliance Inc. recommended recall of all six batches of products. To date, the company has not recalled the affected products and may continue to distribute them. Therefore, the FDA advises consumers to continue checking Darwin’s Natural Selection Antibiotic & Grain-Free products for the affected lot numbers before feeding them to pets.
What authority does the FDA have to mandate a recall?
The FDA’s mandatory food recall authority went into effect when the FSMA went into effect on January 4, 2011. Section 423 of the FD&C Act, as added by Section 206 of the FSMA, gives the FDA the authority to order a responsible party to recall a food item. when the FDA determines that there is a reasonable probability that the food item (other than infant formula) is adulterated under Section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. § 343(w)] and that use of or exposure to such article will cause serious adverse health effects or death to humans or animals (SAHCODHA).
Before FDA can exercise its mandatory recall authority under Section 423 of the FD&C Act, FDA must determine that there is a reasonable probability that the food item (other than infant formula) has been adulterated under Section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. The FDA must also determine that there is a reasonable probability that use of or exposure to such food will cause SAHCODHA.
Once FDA has determined that the criteria for a mandatory recall have been met, FDA must first provide the responsible party (as defined in section 417(a)(1) of the FD&C Act) the opportunity to voluntarily cease distribution and to recall. the food item. FDA will notify the responsible party in writing of this option via expedited delivery method. If the responsible party refuses or does not voluntarily cease distribution and recall the food item within the time and manner prescribed by FDA, FDA may, if directed, direct the responsible party to cease distribution of the food item, order the responsible party to notify certain other persons to stop distributing the food product, and to provide the responsible party with an opportunity to request an informal hearing, to be held no later than two days after the issuance of the notice order will take place.
After these steps are completed, the FDA may order a recall under Section 423(d) of the FD&C Act if it determines that withdrawal of the item is necessary. Only the FDA Commissioner has the authority to order a recall under Section 423(d). If necessary, recall orders under Section 423(d) shall be revoked by the Commissioner.
In accordance with Section 423(g) of the FD&C Act, FDA will ensure that a press release is issued regarding the recall, as well as warnings and public notices, as appropriate, to notify affected consumers and retailers. The publication will include, at a minimum, the name of the food item being recalled, a description of the risks associated with the food, and, to the extent practicable, information about similar food items not affected by the recall.
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