Full Mandatory Recall Authority Used Only Once. Don’t Be the Second!

Earlier this week, FDA issued an Advisory against feeding dogs a branded pet food due to Salmonella and Listeria monocytogenes (Lm). The advisory stated that FDA had recommended the company recall the products, but “To date, the firm has not initiated an adequate recall of the affected products.”

Had the company not then conducted  a voluntary recall, FDA could have used the authority it was given by FSMA to order a mandatory recall. As it was, the public FDA advisory not only inked a blackmark against the company’s brand for not initially recalling the product, it also increased its susceptibility to repercussions if the pet food caused illness or death among animals or humans between the time of the recommendation and the eventual recall.

So, what is the process? When and why would FDA issue an advisory or mandate a recall?

In this case, it began with consumer complaints. FDA received three complaints of illness in dogs that ate the products, so the agency collected and tested unopened retail samples and found two of the products to test positive for Salmonella, a third tested positive for Lm, and a fourth for Salmonella and Lm. Pretty strong evidence for a recall / issuance of an advisory when the recall is not initiated!

Because the firm did follow up with a recall, FDA considered it to be company initiated and posted the company’s announcement on its site. The standard recall procedure then ensued. While some damage was already done by the FDA public advisory, it could have been much worse. If the company did not recall the product, for which FDA determined there was a reasonable probability that the adulterated or misbranded food would cause serious adverse health consequences or death, the agency could:

1. Order them to cease distribution of the food and to give notice to others to cease distribution; then
2. Give the company an opportunity to request an informal hearing on the mandated recall, which would have to be held within 2 days after the issuance of the order; then
3. 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.

It is important to note that only the FDA Commissioner has the authority to order or vacate a recall.

Before ordering (or vacating) a recall, FDA will evaluate the evidence and circumstances, considering such things as:

• Any significant food safety observations made during establishment inspections.
• Results from sample analyses (e.g., from raw materials, finished food, and/or facility manufacturing environment).
• Epidemiological data (e.g., food borne outbreak data that suggest disease or injuries have occurred from the consumption of/exposure to the product).
• Vulnerability of the population that normally consumes or is exposed to the food product (e.g., infants, toddlers, elderly, pregnant women, medically compromised individuals, certain pets, young livestock).
• Nature of the food product (e.g., ready-to-eat food, raw, cooked).
• Reportable Food Registry data.
• Consumer and trade complaints.

While FDA prefers to work with companies on voluntary recalls, it has invoked its mandated recall authority, but has had to take it all the way to issuing a mandatory recall order only once: A dietary supplement company refused to voluntarily recall product that was found to be contaminated with multiple strains of Salmonella.

The process FDA followed was:

• The first step after determining the contamination was the FDA issuance of a “Notification of Opportunity to Initiate a Voluntary Recall,” a formal request advising the company that, if it did not conduct a voluntary recall, FDA could order that distribution be ceased within 24 hours.
• The company did not comply with the request.
• The following day, the FDA ordered the company to cease distribution of the products. The company was also given an opportunity to request an informal hearing, which would have to be held within 2 days after the issuance of the order.
• The company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing.
• FDA issued the mandatory recall order.

In the announcement, FDA stated that its mandatory recall action was based on the imminent health risk posed by the Salmonella contamination, “and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions.”

FDA also noted that its first approach is to encourage voluntary compliance, “but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”

If that sounds rather alarming, it should. FSMA gave FDA a grave new authority, and the agency is serious about its enforcement. The reason it has only been fully used once is because the others came to their senses and “voluntarily” recalled the product before the mandate needed to be issued.

If you have any questions or need assistance with recalls, recall prevention, or any FDA advisories or enforcement letters, give TAG a call. We can help you protect your brand.

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