The Sunland, Inc. suspension case illustrates FDA's heightened commitment to enforcement under the Obama administration. It also offers several key lessons concerning an FDA investigation into a facility or its manufacturing practices that all industries regulated by FDA—not just food companies—should understand.
On November 26, 2012, the U.S. Food and Drug Administration (FDA) announced the suspension of the registration of Sunland, Inc., a producer of nuts, and nut and seed spreads, pursuant to the FDA's authority under Section 102 of the Food Safety Modernization Act (FSMA) of 2011. The suspension was FDA's first use of its registration suspension authority under Section 102 of the FSMA, and the consequences are steep. Sunland, Inc. is prohibited from introducing its products into interstate or intrastate commerce, and the suspension order states that no other person can introduce any food made at the Sunland facility into commerce in the United States or offer to import or export any food that came from the Sunland facility in Portales, New Mexico.
Under Section 102 of the FSMA, FDA has the authority to suspend the registration of a food facility if the FDA "determines that food manufactured, processed, packed, received, or held by a facility . . . has a reasonable probability of causing serious adverse health consequences or death to humans or animals." If FDA reaches that determination, the agency then can suspend any facility that "(A) created, caused, or was otherwise responsible for such reasonable probability; or (B)(i) that knew of, or had reason to know of, such reasonable probability; and (ii) packed, received, or held such food." Once a suspension order is issued, FDA must offer the suspended facility an opportunity for an informal hearing to challenge the suspension order. To secure an informal hearing, the suspended facility must submit a written request that provides facts showing that a "genuine and substantial issue of fact" exists as to the grounds for the suspension, thus warranting a hearing.
With Sunland, FDA demanded the request for an informal hearing to be submitted within one business day of Sunland, Inc.'s receipt of the suspension order. This dramatically short time line for submitting a hearing request derives from the statutory language of the FSMA, which requires that, unless FDA and the suspended registrant agree otherwise, the informal hearing must occur within two business days of the suspension order.
After an informal hearing has been held, the FDA may require the facility to submit a corrective action plan or vacate its suspension order. In the interim, any violations of the suspension order can lead to violations of the Federal Food, Drug, and Cosmetic Act and can subject a violating facility to an injunction or other penalties, including potential imprisonment and heavy fines.
FDA's investigation into Sunland, Inc. began in September 2012 when the Centers for Disease Control and Prevention (CDC) received at least 35 reports of Salmonella Bredeney outbreaks in 19 states. FDA and CDC coordinated an investigation and linked the outbreaks to peanut butter made by Sunland. Trader Joe's, a distributor of the peanut butter, voluntarily recalled the product from its shelves. Sunland voluntary recalled almond butter, peanut butter, and other nut and seed products shortly thereafter. In total, Sunland recalled 240 different products.
FDA continued to investigate Sunland after the recalls, and its investigation revealed the presence of Salmonella in raw peanuts and other environmental samples from Sunland's peanut-processing facility. The suspension order also charged Sunland with violations of the Current Good Manufacturing Practices (CGMP) regulations governing food facilities, including that the foods were prepared, packed or held under insanitary conditions. Sunland attempted to rebut the agency's allegations of CGMP violations with a written response to FDA’s Inspection Report (Form 483), but FDA found that response inadequate because, according to the FDA, it omitted "significant details" about the planned physical repairs and corrective actions.
The Sunland, Inc. suspension case illustrates FDA's heightened commitment to enforcement under the Obama administration. It also offers several key lessons concerning an FDA investigation into a facility or its manufacturing practices that all industries regulated by FDA—not just food companies— should understand.
- A facility facing an FDA probe into its manufacturing practices should start investigating facts concerning alleged practices at the earliest-possible moment it learns of alleged violations. An early investigation is vital to preparing a comprehensive and thorough reply to the Form 483 issued after a formal FDA inspection, and should include detailed reviews of any documents or product samples obtained by FDA during the inspection. As illustrated by the Sunland action, any corrective action plan offered in response to an inspection should be designed with care, to be both comprehensive and attainable.
- Although FDA can invoke its FSMA suspension power only under the somewhat narrow circumstances where a food has a "reasonable probability of causing serious adverse health consequences or death," any food company that has conducted a Class I recall should anticipate that, in the worst-case scenario, the agency will invoke its FSMA suspension authority. Accordingly, any such firm should be ready to prepare a written request for an informal hearing within a short time frame after the issuance of a suspension order, as occurred with Sunland.
- It may be worthwhile to consult outside FDA regulatory counsel as soon as the FDA initiates any formal contact with a regulated company to help direct negotiations and interactions with the FDA and to the protect the confidentiality of internal investigations and expert consultants' reports. In addition, if an FDA probe involves allegations of adverse health consequences, the target also may want to consult with experienced products liability counsel to help mitigate the potential impact of private litigation alleging injury, illness or even death.
- Finally, FDA's invocation of its FSMA suspension authority suggests that additional suspensions may be on the horizon. With the potential for criminal and monetary penalties, now is the time for food facilities—including dietary supplement makers—to assess their compliance with CGMPs and other laws and regulations affecting the manufacture and processing of food products.
For Further Information
If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Michael A. Swit, Elinor L. Hart, any member of the Pharmaceutical, Medical Device, Pharmacy & Food industry group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.