Will the FDA use its Recall Authority to Mandate a Pet Food Recall due to Salmonella and Listeria?

• The U.S. Food and Drug Administration is cautioning pet owners that FDA samples of five Darwin’s Natural Pet Products raw cat and dog food made by Arrow Reliance, Inc. tested positive for Salmonella and a sixth FDA sample tested positive for Salmonella and Listeria monocytogenes (L. mono). 
• Affected products are sold in frozen 2-pound packages  and consist of certain 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 foods are generally sold online through a subscription service. 
• The FDA recommended that Arrow Reliance, Inc. recall all six lots of product. To date, the firm has not recalled the affected products and could continue to distribute them. Therefore, FDA advises consumers to keep checking Darwin’s Natural Selection Antibiotic & Grain-Free products for the affected lot numbers prior to feeding to pets.

What Authority does the FDA have to mandate a recall?

The FDA’s mandatory food recall authority went into effect when FSMA was enacted on January 4, 2011. Section 423 of the FD&C Act, as added by section 206 of FSMA, gives the FDA the authority to order a responsible party to recall an article of food where the FDA determines that there is a reasonable probability that the article of food (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 the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Before the FDA can use its mandatory recall authority under section 423 of the FD&C Act, the FDA must make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. The FDA must also make a determination that there is a reasonable probability that the use of or exposure to such food will cause SAHCODHA.

Once the FDA has determined that the criteria for a mandatory recall have been met, the FDA must first provide the responsible party (as defined in section 417(a)(1) of the FD&C Act) with an opportunity to voluntarily cease distribution and recall the article of food. The FDA will notify the responsible party of this opportunity in writing using an expeditious method of delivery. If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than 2 days after the issuance of the order.

After these steps are completed, the FDA may order a recall under section 423(d) of the FD&C Act if it is determined that the removal of the article from commerce 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 vacated by the Commissioner.

In accordance with section 423(g) of the FD&C Act, the FDA will ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, to provide notification to affected consumers and retailers. The publication will include, at a minimum, the name of the article of food subject to recall, a description of the risks associated with the food, and to the extent practical, information about similar articles of food that are not affected by the recall.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.