Almost eight years after gaining statutory power to mandate food recalls, the FDA is officially publishing information to help industry understand when the agency will use its authority.
In a guidance document scheduled for publication in the Federal Register today, the Food and Drug Administration uses a question-answer format to explain how, when and why the government will force companies to recall food for people and animals.
Congress gave the mandatory recall authority to the FDA as part of the Food Safety Modernization Act, which was signed into law in January 2011. A number of provisions in the Act had delayed activation dates, but the FDA gained the power to force food and feed recalls as soon as the legislation was signed into law by President Barack Obama.
Since 2011, the FDA has used its mandatory recall power three times. In 2013 the agency forced the recall of Salmonella-tainted pet treats produced by Kasel Associates Industries; in 2014 it required the recall of OxyElite Pro Dietary Supplements; and in April this year it mandated the recall of all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC after several products were found to contain Salmonella.
Scott Gottlieb, FDA commissioner, issued a statement Nov. 5 indicating the agency will not be shy about flexing its recall muscles.
“Fortunately, most companies collaborate with the FDA to rapidly initiate voluntary recalls of hazardous food products. On average, a recall occurs within four calendar days of the problem being discovered,” Gottlieb said.
“However, we’ve seen cases where companies don’t voluntarily agree to issue a recall of food products that are violative, even if the food products are reasonably likely to cause serious illnesses or death. … Most of our regulated industry partners share our commitment. But when they don’t, Americans should know that the FDA won’t hesitate to take steps to protect their health.”
The main variable in the mandatory recall equation is whether a food or feed will cause SAHCODHA — that’s the FDA’s shorthand for “serious adverse health consequences or death to humans or animals.” According to the new guidance document, circumstances and/or evidence that can trigger the agency’s recall authority include:
- Significant food safety observations made during establishment inspections;
- Results from sample analyses, which may include those for raw materials or finished food products, and certain sample swabs from the food facility manufacturing environment;
- Epidemiological data such as foodborne outbreak data directly related to the food product that suggest disease or injuries have already occurred from the consumption of/exposure to the product;
- Vulnerability of the population that normally consumes or is exposed to the food product, taking into account high-risk groups such as infants, toddlers, the elderly, pregnant women, medically-compromised individuals, certain pets, and young livestock;
- Nature of the food product, for example ready-to-eat food, raw, cooked;
- Reportable Food Registry data;
- Consumer and trade complaints; and
- Whether the responsible party has failed to initiate a voluntary recall.
The FDA will give food and feed businesses the opportunity to initiate voluntary recalls before ordering mandatory recalls, according to the guidance document. The document lists several examples of situations when the FDA would consider using its mandatory recall authority. Previous situations that could have triggered FDA to issue mandatory Class 1 recalls include:
- Peanut butter, alfalfa sprouts, and deli products found to be contaminated with Salmonella;
- Under-processed canned chili that contained Clostridium botulinum toxin;
- Smoked salmon and pumpkin seeds found to be contaminated with Listeria monocytogenes;
- Products containing undeclared allergens such as milk, peanuts or eggs;
- Baby food that posed a choking hazard;
- Horse feed contaminated with elevated levels of monensin;
- Pet foods contaminated with elevated levels of melamine and cyanuric acid, or contaminated with Salmonella or Listeria monocytogenes; and
- Sheep feed containing elevated levels of copper.
If the agency issues a mandatory recall, it will publicize the recall with alerts and public notices, as appropriate, to provide notification to affected consumers and retailers. The alerts and notices 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,” according to the guidance document.
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