FDA’s New Enforcement Powers

The FDA has used its enhanced records access authority several times. During its April 2013 investigation of an E. coli O121 outbreak associated with frozen pizza producer Rich Products Corp., Buffalo, N.Y., the FDA obtained records from a different facility that had milled raw wheat and other flour ingredients. The agency also used the expanded authority in October 2013 while investigating a dietary supplement from USP Labs LLC, Dallas, Texas, associated with reports of liver toxicity. “The records access was quite broad in that case as well,” Wagner said.

Since 2007, FDA has invoked its records access authorities (under the BT Act and FSMA) 26 times in cases when firms refused to turn over records. Wagner noted that FDA may not need to invoke this authority as much in the future because FSMA Section 103, the Hazard Analysis and Risk-Based Preventive Controls, requires food processors and manufacturers to make their records available “promptly” to FDA upon request.

Suspension of Registration

A more powerful enforcement tool is the suspension of facility registration. FSMA Section 102 allows FDA to suspend the registration of a facility when the agency determines that food manufactured, processed, packed, received, or held has a “reasonable probability” of causing SAHCODHA. Unlike the enhanced records access, a suspension order requires the personal approval of the FDA commissioner. One reason is the provision’s implications: A suspension order applies to all operations and facilities associated with a company’s registration, not just the one that may be linked to SAHCOHDA. “It has the effect of an injunction,” Wagner said, because it prohibits a company from introducing any food into commerce, including items produced before or after the suspension order was received.

FDA has exercised this authority twice. In November 2013, it suspended the registration of Sunland Inc., Portales, N.M., following an outbreak of Salmonella in peanut butter that sickened at least 35 people in 19 states. In March 2014, FDA used this authority against Roos Foods Inc., Kenton, Del., a producer of Latin-themed cheese and other dairy products, after an outbreak of listeriosis linked to its soft cheeses products from which one person died and seven others were hospitalized.

“It’s typically not one thing that goes wrong that leads to a problem of this magnitude; it’s a multiple factors that contribute to a problem of this size,” says David Acheson, MD, CEO, The Acheson Group and a former FDA associate commissioner for foods. In the case of Sunland, the FDA had reviewed the facility’s internal testing records and found multiple positive Salmonella results throughout the plant and in finished product during the previous three years, along with other “serious violations” of current Good Manufacturing Practices. Even though Roos Foods had voluntarily recalled its products, FDA invoked the suspension after inspectors found unsanitary conditions in the facility, including rainwater leaking from the roof onto cheese processing equipment, bags of salt, packaging materials, and pooling on food contact surfaces.

“It’s difficult to argue that FDA shouldn’t exercise the option for immediate action when food-contact surfaces are being subjected to a ‘rain storm’ of potential contamination,” Dr. Acheson argues in a recent posting.

Mandatory Recall

FSMA Section 206 for the first time gives FDA mandatory recall authority of food products. The threshold is a reasonable probability that food is adulterated or mis-

branded and evidence that its use or exposure will cause SAHCODHA. A recall order also requires the FDA commissioner’s approval. According to Wagner, a mandatory recall comes at the end of a process. The first step is a verbal request to undertake a voluntary recall. If the firm declines, the next step is a 423(a) letter, formally known as Notification of Opportunity to Initiate a Voluntary Recall. “If the firm refuses to do anything after that point, that’s where you will get an order to cease distribution and notify customers or conduct a mandatory recall,” Wagner said.