FDA’s Recall Powers

Products that contain a major food allergen (such as milk, egg, fish, shellfish, tree nuts, wheat, peanuts, or soybeans) are considered misbranded if the product label does not disclose allergen, either through a “Contains” statement or in the ingredient list. Some of the evidence FDA may consider in making determinations of adulteration or misbranding include observations made during inspections; results from sample analyses; epidemiological data; Reportable Food Registry data; and consumer and trade complaints.

FSMA allows FDA to collect user fees from companies that do not comply with a food recall order. These fees include the time spent by FDA in conducting food recall activities, including obtaining technical assistance, follow-up effectiveness checks, and public notifications. The agency can also assess civil monetary penalties. When finalized, the guidance document will reflect the agency’s “current thinking” on this topic, FDA said.

Prior Mandatory Recalls

The FDA has exercised its mandatory recall authority twice since FSMA was enacted in 2011. In 2013, the agency ordered a mandatory recall of Salmonella-tainted pet treats manufactured by Kasel Associated Industries Inc., Denver, Colo. Kasel had initially voluntarily recalled some but not all its affected products. After receiving the mandatory notice, it subsequently completed the recall.

Also in 2013, FDA ordered the recall of OxyElite Pro dietary supplements manufactured by USPLabs LLC, Dallas, Texas, that had been linked to dozens of cases of acute non-viral hepatitis. At least 47 people were hospitalized, three received liver transplants, and one death was reported. The FDA warning letter said the products were adulterated because they contained aegeline, a new dietary ingredient for which USPLabs had not provided safety evidence, as required. After receiving the mandatory recall notice, the company voluntary recalled the products.

This was not the company’s first run-in with FDA. A short time earlier USPLabs had destroyed different lots of OxyElite Pro after FDA issued an administrative detention order because of the presence of a stimulant in those products, DMAA (dimethylamylamine), which can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders, and death. The agency said it had received more than 100 reports of illness, including six deaths, among people who used the products. It was after this that USPLabs substituted aegeline for DMAA.

“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Daniel Fabricant, PhD, director of FDA’s Division of Dietary Supplement Programs, at the time. “Losses to the company [estimated at $22 million retail] should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”

Preparing for a Recall

“It is a well-founded truism in the food industry that it is not a matter of if you will have a recall but when,” says Michael A. Walsh, a partner with the Strasburger & Price lawfirm in Dallas. The FDA is taking its expanded powers under FSMA seriously “and will impose significant costs on those who refuse to obey its edicts,” he says. “It is also a well-founded truism that lack of planning distinguishes a problem from a crisis. More than ever, having a recall response team and procedures in place before you need them should be the first order of business,” Walsh wrote in an online blog posting.

Preparedness is essential in order to respond adequately to any recall-related issue agrees David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods. “A recall can happen in a variety of ways, including from a customer complaint, a call from a supplier who says there is a problem in what was shipped, or a call from the FDA,” Dr. Acheson says. “It may not be your fault. Bad things happen to good companies because biological systems are not predictable.”