On April 4, 2014, FDA issued a final rule expanding its access to records in an emergency under authority provided by the Food Safety Modernization Act (FSMA). This final rule adopted, without any change, an interim final rule issued by FDA in February 2012. Under this newly established authority, FDA may inspect and copy records in emergency situations.
Under the final rule, FDA’s emergency access to records is expanded to include records involving a foodincluding supplementsFDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences to humans or animals. FDA may inspect and copy records from manufacturers, processors, packers, distributors, warehouses, importers or any other entity involved in handling of the suspect food. FDA may inspect and copy manufacturing records, information on receipt of raw materials, distribution records, customer lists, testing records, and complaint and adverse event records.
In order to invoke its emergency record access authority, FDA must follow established procedures, which include issuance of an FDA form 482c to a company. Before the FDA form 482c request is made, several internal procedures must be adhered to. The relevant FDA district must first obtain concurrence from the Office of Enforcement who coordinates with FDA’s Office of Emergency Operations. The Office of Emergency Operations then notifies the relevant FDA center, such as FDA’s Center for Food Safety and Nutrition (CFSAN). The appropriate FDA center then makes the determination of whether there is a reasonable belief that the food product in question presents a serious adverse health risk, thus warranting a request for emergency access to records. The Office of Chief Counsel (OCC) is also consulted on the scope of the records. When all organizations within FDA are in concurrence regarding whether the situation warrants an emergency request and the scope of the request, the relevant District moves forward with issuance of the FDA form 482c.
While FDA asserts that records will remain confidential, it is important to note the tangential implications of providing FDA access to such records. The ability for FDA to access a wide range of records during an emergency situation may heighten scrutiny on all parties involved with a specific food product whether it be a contract manufacturer, a raw material supplier or a retail distributor. FDA may also request records from any of the parties involved in the supply chain irrespective of whether the possible risk is associated with only one company.
The million dollar question then becomes, “Can a company refuse access to records?" According to the final rule, companies may not refuse access to or copying of records that are covered under the expanded authority. In fact, refusal to permit access to or copying of records requested is a prohibited act under section 301(e) of the Federal Food, Drug & Cosmetic Act (FD&C). If a company were to refuse access, FDA may initiate civil or criminal action. Depending on the situation, FDA may also suspend a food facility’s registration thereby preventing the importation and exportation of food products; administratively detain or seize food products; issue a mandatory recall under another newly established FSMA authority; or proceed to obtain a court injunction against the company. Clearly, the repercussions of denying access are stringent and are meant to be a deterrent from non-compliance.
The next question is then, “Can a company refuse access to certain records?" Under the final rule, FDA may not access financial data, pricing data, personnel data, research data, sales data (other than shipment data regarding sales), recipes (the formula, including ingredients, quantities and instructions necessary to manufacture a food product; note that a list of ingredients without quantities or instructions does not constitute a recipe and is accessible by FDA), and records from farms, restaurants or those related to food under exclusive jurisdiction of USDA. Thus, if posed with a situation where FDA requests information that is beyond the scope of tracking and identifying a possible risk related to a food product, it may be prudent to respectfully assert that such records are not covered under FDA’s Emergency Records Access rule.
With FDA’s heightened records access authority in play, it is important for companies to review their record-keeping practices to ensure full compliance with dietary supplement GMPs (good manufacturing practices) and other relevant record-keeping regulations. All records that are required to be maintained under the GMP regulations should be developed with the understanding that FDA may indeed, at some point, ask for access to these records, whether through a routine facility inspection or pursuant to its emergency records access authority under FSMA.
FSMA continues to have a substantial impact on the dietary supplement industry with the broadening of investigative authority and the increasing enforcement activities that transcend previous regulatory framework outlined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). As such, companies should become familiar with the various initiatives under FSMA and their respective implementation dates as they apply to their dietary supplement business.
Abhishek Gurnani is a partner at Amin Talati (amintalati.com). Gurnani provides regulatory, transactional and litigation services to food, drug, dietary supplement, medical device and cosmetic companies.