After years of wrangling over how to respond to a series of high-profile foodborne illness outbreaks and other potential food security threats, Congress finally passed the FDA Food Safety Modernization Act (the Act), significantly enhancing U.S. Food and Drug Administration (FDA) authority over food safety and imposing additional requirements on food manufacturers. President Obama signed the Act into law on January 4, 2011. Most of the additional requirements will also apply to manufacturers, packers, and importers of dietary supplements and their components, which are included in the statutory definition of food. Summarized below are some of the more significant provisions that will be of interest to the dietary supplement industry.
New Dietary Ingredients: Within six months, FDA must issue guidance explaining what constitutes a "new dietary ingredient" in a dietary supplement, when notification to FDA of a new dietary ingredient is required, what evidence is needed to support safety, and methods for establishing the identity of a new dietary ingredient. Industry has long awaited guidance on this murky area of existing law. In addition, FDA will be required to notify the Drug Enforcement Agency (DEA) if it believes that a new dietary ingredient may be an anabolic steroid or analogue.
Mandatory Recall Authority: The Act immediately provides FDA with the authority to order a recall if a company refuses to voluntarily recall a food for which "there is a reasonable probability" that it is adulterated or contains an undeclared food allergen if consumption will cause "serious adverse health consequences or death." This is essentially the same standard as used to define a Class I recall under FDA regulations. FDA must establish an "incident command operation or a similar operation" within 24 hours of any mandatory or voluntary Class I recall and must publish an image of any food subject to a mandatory recall on its website. Within 90 days of enactment, FDA must establish a user-friendly search engine on its website for consumers to find information about mandatory food recalls.
Improving the Reportable Food Registry: Under existing law, a food manufacturer or packer must notify FDA of any "reportable food," i.e. one "for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death." Under the Act, FDA may require submission of consumer-friendly information about the reportable food, including a description, affected lot codes, and contact information. FDA will be required to post this information on its website as a one-page summary. Grocery store chains with 15 or more stores that sold the food will be required to post the summary in their stores within 24 hours and keep it posted for 14 days.
Registration of Food Facilities, Suspension: Under current law, food manufacturers must register with FDA one time and provide updates with respect to certain changes in registration information. The Act now requires re-registration every two years. An abbreviated renewal process will be available for registrants with no changes to report. More significantly, FDA now has the authority to suspend the registration of a facility if it determines that the food packed or held there "has a reasonable probability of causing serious adverse health consequences or death." An informal hearing process is provided for facilities facing a suspension.
Administrative Detention of Food: The Act significantly broadens FDA's existing authority to administratively detain food by changing the standard from "credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death" to "reason to believe that such article is adulterated or misbranded." This change is effective 180 days after enactment, and FDA must issue an interim final rule implementing the change within 120 days after enactment. This significantly lower standard for administrative detention makes it much more likely to be used in the future than it has been to date.
Inspection of Records: FDA's existing authority to inspect manufacturing and distribution records when it "has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death" is expanded immediately to now include any "other article of food" that FDA "reasonably believes is likely to be affected in similar manner." Such other articles might include, for example, dietary supplements or ingredients produced on the same manufacturing line as those reasonably believed to present a health threat. Notably for the dietary supplement industry, FDA had already (controversially) asserted authority to inspect certain records relating to good manufacturing practices (GMPs) for dietary supplements during routine inspections in its Final Rule implementing dietary supplement GMPs.
Protection Against Intentional Adulteration: Within 18 months, FDA is required to promulgate regulations to protect food in bulk or batch form from intentional adulteration where FDA identifies clear vulnerabilities and finds a high risk of serious adverse health consequences or death. FDA must conduct vulnerability assessments, weigh risks and costs, and determine appropriate science-based strategies for protection.
Enhancing Tracking and Tracing of Food and Recordkeeping: FDA must conduct pilot projects to explore methods to improve the tracking and tracing of food within nine months of enactment. FDA must then establish a system to track and trace food based on the results of the pilot projects. Within two years of enactment, FDA must issue a proposed regulation requiring additional recordkeeping requirements for tracing of high-risk foods. Assessment of risk will include a consideration of the history of outbreaks attributed to the food type, the likelihood of contamination, and steps taken in the manufacturing process to reduce the likelihood of contamination. The new regulations cannot require: (1) the use of specific technologies, (2) duplicate records, (3) that a facility change business systems, (4) a full pedigree of the food, or (5) product tracing to the case level. It remains to be seen what, if any, dietary supplements or components may be found to be high-risk.
Targeting of Inspection Resources for Domestic Facilities: FDA must evaluate the risk profiles of facilities based on type of food, history of regulatory violations and recalls, rigor of the facilities' hazard analysis and risk-based preventive controls, whether food is imported and certified, and other criteria that FDA finds to be appropriate. Domestic facilities found to be high risk must be inspected at least once in the five years following enactment, and then at least once every three years. Domestic facilities that are not found to be high risk must be inspected at least once in the seven years following enactment, and then at least once every five years. FDA may rely on inspections conducted by other federal, state, or local agencies in meeting the required inspection frequency.
Laboratory Accreditation for Analysis of Foods: Within two years of enactment, FDA must provide for the recognition of accreditation bodies to accredit food-testing laboratories and establish a public registry. Within 30 months of enactment, only laboratories accredited by a recognized accreditation body may be used for food testing in support of admission of imported food, as required by regulation to address a food safety problem, or as otherwise deemed appropriate by FDA. In such cases, test results must be reported directly to FDA.
Employee Protection: Food facility employees reporting violations of FDA requirements will receive whistleblower protection against retaliation.
Hazard Analysis and Risk-Based Preventive Controls: Under regulations that FDA must promulgate within 18 months after enactment, most food facilities will be required to conduct a hazard analysis and implement risk-based preventive controls. This provision is not applicable, however, to manufacturers of finished dietary supplements that are already subject to FDA's GMP regulations for dietary supplements. Presumably, this reflects Congress's judgment that FDA's comprehensive and highly prescriptive GMP regulations for dietary supplements obviate the need to apply this provision. Importantly, however, this provision will apply to manufacturers of components of dietary supplements, who are not subject to the dietary supplement GMP regulations.
Authority to Collect and Use Fees: FDA will have authority to collect fees for (1) re-inspection of facilities found in non-compliance, (2) recall expenses incurred by FDA if a facility refuses to conduct a mandatory recall, (3) costs associated with a voluntary qualified importer program (see below), (4) re-inspection of imported food, and (5) export certificates for food.
Provisions Affecting ImportersAnd Foreign Facilities
The following provisions will be of interest to those importing food into the U.S. or operating foreign facilities, including finished dietary supplements, bulk dietary supplement dosage forms for repackaging, bulk dietary ingredients, or other components of dietary supplements.
Port Shopping: FDA is directed to work with the Department of Homeland Security to prevent "port shopping," the practice of attempting to import food at a different port of entry when it has been refused admission at another port.
Prior Notice and Food Rejected by Other Countries: Existing requirements for prior notice of imported food are amended to require a prior notice to list any country that refused entry of the food.
Foreign Supplier Verification Program: Effective two years after enactment, importers will be required to verify that their imported food complies with U.S. requirements, is not adulterated, and does not contain an undeclared allergen. Within one year of enactment, FDA must issue guidance on the development of foreign supplier verification programs.
Voluntary Qualified Importer Program: Within one year of enactment, FDA must establish a voluntary program under which importers may obtain expedited review and importation of food. Eligibility will be based on several factors, including the nature of the food, risk of intentional adulteration, compliance history of the foreign supplier, the exporting country's ability to ensure compliance with U.S. standards, and the practices of the importer, including recordkeeping, testing, inspections and audits of facilities, traceability of food, temperature controls, and sourcing.
Authority To Require Import Certifications for Food: FDA may require third party certifications for specific types or sources of imported food, based on risks associated with the food or its source, including a finding that food safety systems in the country of origin are inadequate.
Accreditation of Third-Party Auditors: Within two years of enactment, FDA is required to implement a system for recognizing accrediting bodies to accredit auditors, who will be authorized to certify that foreign facilities meet FDA requirements.
Targeting of Inspection Resources for Foreign Facilities and Imported Food: FDA must evaluate the risk profiles of facilities based on type of food, history of regulatory violations andrecalls, rigor of the facilities' hazard analysis and risk-basedpreventive controls, whether food is imported and certified,and other criteria that FDA finds to be appropriate. FDA must inspect at least 600 foreign facilities in the year followingenactment and then double that number each year over the next five years. Inspection of imported food will be based on riskprofile, considering the type of food, its origin, history ofthe importer, rigor of the importer's foreign supplier verifica-tion, whether the importer participates in the Voluntary Qualified Importer Program, and whether the food is imported andcertified.
Impact of Refusal of Inspection: Food may not be imported from foreign facilities that refuse or delay by more than 24 hours an FDA request for inspection.
In light of these sweeping changes to the regulatory landscape for dietary supplements and other food manufacturers, packers, and importers, affected companies should closely analyze the impact of the new legislation to their business and make any needed changes to their policies and procedures.
John G. Moore is an attorney in the Washington, D.C. office of Hunton & Williams LLP (www.hunton.com) in the firm's Food and Drug Practice. He can be reached at firstname.lastname@example.org.