What to do if you think you have a recalled product
A pet food company’s federal lawsuit accuses the FDA of refusing to establish formal standards, instead using money to bully state departments of agriculture into enforcing outdated “nonbinding” policies.
That, the maker of Answers pet food claims, deprives consumers of more pet food choices by its effect on raw pet food makers.
Answers manufacturer Lystn, a Pennsylvania-based company, brought the suit July 5 in Colorado federal court against the Food and Drug Administration, the U.S. Department of Health and Human Services, the Colorado Department of Agriculture, Colorado Agriculture Commissioner Kate Greenberg and two other individuals in the Colorado agency.
What Lystn wants is an admission that it was denied due process rights in the FDA’s actions, FDA claims about adulterated food from Lystn eliminated from federal and state records, and financial damages.
An FDA spokesman responded in an email to the Miami Herald: “It is the agency’s policy not to comment on pending litigation. Because your question/comment appears to be related to issues in a pending lawsuit, we are unable to provide a response at this time.”
Similarly, the Colorado Department of Agriculture emailed, when asked about the lawsuit, “This inquiry pertains to an open investigation, and it is the policy of the Colorado Department of Agriculture not to comment on pending or ongoing litigation.”
The FDA issued an alert in January about A+ Answers Straight Beef Formula for Dogs, claiming it was adulterated because it tested positive for salmonella; that Lystin had recalled the food in Nebraska after the positive test but resisted a national recall; and that federal law requires all pet food to be free of pathogens, including salmonella.
Lystn’s suit says four independent tests showed no salmonella; that it hadn’t recalled the food (Lystn said in January it stopped further distribution, which is different from a recall); and there’s no such federal law, just a nonbinding policy the FDA pushes states to enforce as law.
“The FDA uses a Compliance Policy Guide that contains nonbinding recommendations of a ‘zero tolerance’ of salmonella for enforcement,” Lystn posted to its website in January. “In contrast to human consumed products inspected by the USDA, (in which) a certain percentage of Salmonella is allowed...”
The suit contends that instead of creating rules by which to govern, as Congress ordered in 2007, the FDA still uses “nonbinding guidance policies,” one of which is zero tolerance for any salmonella in any pet food product. And, the suit claims, the FDA sidesteps its limitations by making the states do its bidding.
The federal agency “compels state regulatory agencies to enforce in exchange for a piece of roughly $11.1 million in FDA funding,” the suit says.
Colorado’s Department of Agriculture says it found salmonella and listeria in a sample of Answers pet food pulled off a retail shelf, a finding Lystn disputes as far as the amount and type of salmonella and listeria. But what Lystn really has a problem with, the lawsuit says, is Colorado adopting the FDA’s zero tolerance standard and doing so in what Lystn claims is violation of Colorado state law.
In 2018 and 2019, a run of FDA pet food recalls for salmonella and listeria found in the food disproportionately hit smaller companies that produce raw pet food. State agencies often did the testing. The suit says these recalls are evidence of the FDA wielding power without weight of law or legitimate policy.
“The FDA compels manufacturers to issue voluntary recalls or face unspecified punitive action,” the suit says. “The FDA is happier living in regulatory limbo...when its Compliance Policy Guide is treated by most of the industry as the law of the land. (Lystn) is, frankly, an outlier. With extremely rare exception, everybody else ‘voluntarily’ recalls after the FDA tells them to.”