Publisher’s Platform: FDA, why not use your mandatory recall authority to protect pets and humans?

– NOTICE –

In less than a year, Darwin’s natural products have proven to be contaminated by Listeria, Salmonella (three times) and E. Coli O157: H7. This year, Dawin’s pet food has been epidemiologically and genetically linked to kidney failure in a young UTAH child.

However, although Darwin refused voluntary reminders in both cases, the question must be asked, why did the FDA not use its compulsory recall authority?

First reminders and epidemic.

September 20, 2024, The Food and Drug Administration of the United States warned the owners of pets that the FDA samples of five Darwin natural pet products are food and dog food manufactured by Arrow Reliance, Inc. tested positive forSalmonellaAnd a sixth sample of the FDA was tested positive for Salmonella and Listeria Monocytogenes (L. Mono).

FDA Advisory: Do not feed certain lots of Darwin natural selections due to Salmonella and Listeria Monocytogenes

• Darwin natural selections of antibiotic chicken recipe without cat cereals
  • Lot no: 10832 MFG. Date: July 25, 2024
• Darwin natural selections of antibiotic chicken recipe without cat cereals
  • Lot no: 10856 MFG. Date: August 04, 2024
• Darwin natural selections of antibiotic chicken recipe without cat cereals
  • Lot no: 10890 MFG. Date: August 13, 2024
• Darwin natural selections recipe for antibiotic chicken and cereal for dogs
  • Lot no: 10828 MFG. Date: July 24, 2024
• Darwin natural selections recipe for antibiotic chicken and cereal for dogs
  • Lot no: 10844 MFG. Date: July 30, 2024
• Darwin natural selections recipe for antibiotic chicken and cereal for dogs
  • Lot no: 10887 MFG. Date: August 12, 2024

The FDA recommended Arrow Reliance, Inc. recall the six lots of products. To date, the company has not recalled the affected products and could continue to distribute them.

July 29, 2025, The FDA is informed of pet owners that a sample of natural products from Darwin Natural Pet Beef Dog Food by Arrow Reliance Inc. has been tested positive for Escherichia coli (E. coli) O157: H7 which is associated with a human disease. In addition, a sample of Darwin chicken dog food and a sample of Darwin duck dog food were tested positive for Salmonella Infantis and Hadar, respectively. The closed product of the three affected terrains, which were obtained from the freezing freezer of the sick human, were tested by a third -party laboratory in May and June 2025.

FDA Advisory: do not feed some prizes of Darwin natural pets due to E. coli O157: H7 and Salmonella

• Darwin’s Natural Pet Products, All-Natural Biologics and Cereals, Beef recipe for dogs
  • Lot 10662, date of the MFG: May 30, 2024
• Darwin’s Natural Pet Products, All-Natural Biologics and Cereals, Chicken Recipe for Dogs
  • Lot 10683, date of MFG: 05 June 2024
• Darwin’s Natural Pet Products, natural selections Duck for dogs
  • Lot 10638, date of the MFG: May 22, 2024

The FDA recommended to Arrow Reliance, Inc. Recall the prizes of the product that tested positive for E. coli O157: H7 and Salmonella. To date, the company has not recalled the affected products. These products, manufactured in May or June 2024, were sold frozen, have no expiration date on the label and could still be in consumer freezers.

What authority does FDA have to demand a reminder?

The compulsory FDA compulsory food reminder authority has entered into force when the FSMA was promulgated on January 4, 2011. Article 423 of the FD & C ACT, as added by article 206 of the FSMA, gives the FDA the authority to order a responsible part to recall a food article where the FDA determines that there is a reasonable probability that the FD (other than the infantile formula) is the adult [21 U.S.C. § 342] or poorly extended under article 403 (W) of the FD & C law [21 U.S.C. § 343(w)] And that the use or exposure to such an article will lead to serious unfavorable consequences for health or death to humans or animals (Sahcodha).

Before the FDA could use its compulsory recall authority under article 423 of the FD & C Act, the FDA must determine that there is a reasonable probability that the article of food (other than the preparation of infants) be falsified under article 402 of the FD & C law or badly marked under article 403 (W) of the FD & C law. The FDA must also decide that there is a reasonable probability that use or exposure to these foods causes Sahcodha.

Once the FDA has determined that the criteria of a compulsory reminder have been met, the FDA must first provide the responsible party (as defined in article 417 (a) (1) (1) of the FD&C law) the possibility of ceasing voluntarily distribution and recall of the food article. The FDA will inform the responsible part of this opportunity in writing using a fast delivery method. If the responsible party refuses or does not cease voluntarily of the distribution and to recall the article of food within the time and the manner prescribed by the FDA, if it is prescribed, the FDA may order the responsible party to stop distributing the article of food, to order the responsible party for requesting an informal hearing for not having been held later than 2 days after the responsible party.

Once these steps are completed, the FDA can order a reminder under article 423 (d) of the FD & C law if it is determined that the deletion of the article of the trade is necessary. Only the commissioner of the FDA has the power to order a reminder under article 423 (D). If necessary, the recall orders under article 423 (d) are canceled by the commissioner.

In accordance with article 423 (g) of the FD & C ACT, the FDA will ensure that a press release is published concerning the recall, as well as alerts and public opinions, if necessary, to provide notification to assigned consumers and retailers. The publication will include, at least, the name of the food article subject to a reminder, a description of the risks associated with food and insofar as practical information on similar food items is not affected by the recall.

Do I miss something here?

BTW – Thanks to Efoodalert for a historic account:

https://efoodalerlet.com/2023/08/17/darwins-drags-feet-on-food-recall-request-again/embed/#?secret=2y4abog3in#?secret=gwjfbcas0z

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