The U.S. Food and Drug Administration (FDA) recently issued its final guidance on the definition and labeling of medical foods, entitled "Frequently Asked Questions About Medical Foods:...10 June 2016
FDA Suspends Sunland's Registration; First Use of New Suspension Authority
On November 26, the Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a producer of nuts, and nut and seed spreads. Notably, this is the first time FDA has used its registration suspension authority, which was established by Section 102(b) of the FDA Food Safety Modernization Act (FSMA). Significantly, this action effectively shuts down the facility, because a facility is prohibited from introducing food into commerce, or importing or exporting food when its registration is suspended. FDA’s use of its suspension authority illustrates the current environment of increased enforcement and FDA’s willingness to use the new tools provided by FSMA. This suspension also provides insight into the likely content of FDA's future registration-suspension regulations.
FDA explained that Sunland’s registration was suspended because “peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations.” In a letter FDA Commissioner Margaret Hamburg sent to the company, the agency outlines the alleged violations committed by Sunland and explains the basis for the agency’s suspension action. Specifically, FDA determined that Sunland met the legal standard for suspension, as set forth in Section 415(b) of the Federal Food, Drug and Cosmetic Act, based on the company’s testing records and testing by FDA that showed multiple positive Salmonella results from both environmental testing throughout the facility and in finished products, as well as unsanitary conditions in the facility (e.g., presence of Salmonella, Current Good Manufacturing Practice (CGMP) violations that could lead to cross-contamination).
FDA has not yet issued regulations implementing the registration suspension provision of FSMA. In the absence of regulations, FDA is following the suspension protocol set forth in the statute and the agency’s pre-existing regulations in 21 C.F.R. Part 16, regarding Regulatory Hearings. FDA’s letter to Sunland is notable because it provides some insight as to the likely content of the future regulations, as it specifies some requirements and standards that are not set forth in the statute.
In particular, if no written request for an informal hearing regarding the facility’s suspension is submitted within three business days of the issuance of FDA’s Suspension Order, Sunland will be deemed to have waived its right to request a hearing. FDA’s letter also specifies that a hearing will only be granted if Sunland’s request includes evidence showing that there is a “genuine and substantial issue of fact that warrants a hearing.” Note that if no hearing is held contesting the Suspension Order, the company instead may apply for reinstatement based on corrective actions.