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.