Does your food company need to register with the U.S. Food and Drug Administration (FDA)? “Yes” is the answer to that basic, but critical question for each company, domestic and foreign, that manufactures, processes, packs or stores human or animal food for consumption in the United States (See Table 1 below for exceptions.) The failure to properly register a food facility is a prohibited act under the Food, Drug and Cosmetic Act (FD&C Act). The federal government can subject a noncomplying company to an enforcement action that seeks to prevent the company from continuing to operate and, if appropriate, prosecute responsible persons. Of course, even a slight supply delay as a result of registration issues could have a catastrophic impact on a company’s supply obligations and relationships. Therefore, it is important that companies take the time, and if need be obtain assistance, to properly register.
Food company registration is not a new concept. Registration allows FDA to respond quickly and efficiently to food-safety related issues and incidents. But prior to the passage of the Food Safety Modernization Act (FSMA) in 2011, owners, operators or agents in charge of domestic and foreign food facilities had to register, but only once, pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Now, FSMA requires food facilities to renew their registration every even-numbered year. That biennial registration is ongoing and open only from October 1, 2014, to December 31, 2014. The failure to timely renew will result in expiration of a company’s registration.
In addition to directing food companies to register more frequently, FSMA also requires food companies as part of the registration process to:
• Provide FDA with the contact information, including email address, for the person FDA is to contact at the facility regarding registration and other issues
• Identify the general categories of food products manufactured, processed, packed or held at the facility
• Submit information regarding other applicable food categories as FDA may direct
• Assure that FDA will be permitted to inspect its facilities as the FD&C Act provides.
Although the registration renewal is relatively easy to accomplish, food companies should take advantage of the biennial registration process to take stock of and alter as necessary their registration information, obligations and strategies, including:
• Is the registration information accurate? Companies are required to update registration information within 60 calendar days of a change in that information. Nevertheless, if a company has been tardy with updates, now is the time to make sure the information is accurate.
• Has the person designated by the company to be FDA’s contact changed or that person’s contact information changed? And, is the designated person the appropriate person for that task? An unexpected knock on the company’s door by FDA may spell a crisis situation, such as a recall. Is the designated person knowledgeable about the company’s recall plan, a member of its recall team and readily accessible? A food company should consider whether the person it identifies on its registration will be the same person who will interact with FDA and other government agencies during the pendency of a food safety-related crisis.
• Does the company have an effective protocol for communications with FDA and other governing agencies? (It should as part of its recall and crisis management plan.)
• Have any of the types of foods that are manufactured, processed, packed or held at the facility changed?
• Must the company also register its facilities with or obtain operating licenses from state and local governing agencies?
The biennial registration process also presents a good opportunity for companies to assess how the information they provide may impact government oversight of their operations. For example, will information provided about foods manufactured, processed, packed or held at the facility affect FDA’s risk assessment of the facility? The risk profile that FDA creates for a facility is likely to impact the frequency with which FDA inspects a facility. In turn, is the company ready for an FDA inspection, including ready access to the documents and materials needed to show that its registration is accurate and its operations comply with FSMA? And, regardless of impact on the risk profile, a company’s description of the food products it manufactures, processes, packs or holds could serve as the catalyst for an inspection where that type of food product either is currently experiencing or is generally susceptible to food safety-related issues. In other words, it is important to make sure that the information provided as part of the renewal process is accurate, as inaccurate information conceivably could give rise to an inspection that, in actuality, is not warranted.
The regulations by which food companies must operate are complex and vast, and FSMA demands more exacting standards in an effort to prevent adulterated products from reaching the marketplace in the first place. Proper planning and careful oversight of regulatory obligations, even those as basic as food company registration renewal, are critical to a food company’s success.
John T. Shapiro is partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).