FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements

The US Food and Drug Administration (FDA) has released a new guidance document intended to clarify elements of a 2002 law passed in the hopes of better allowing the agency to deal with bioterrorism concerns.

Background

The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPR) of 2002 was passed months after a series of terror attacks hit the US in 2001. While airborne attacks on the World Trade Center buildings and the Pentagon are almost universally remembered from that time period, less-remembered were a series of letters containing spores of anthrax which were sent to high-profile targets through the US postal system.

The latter prompted US officials to reconsider the safety of food and medicinal products, and in particular the susceptibility of their respective supply chains to bioterrorism.

Focus has written about the act and its effects before. In August 2012, FDA released a final rule requiring medical device establishments to register with FDA through an electronic process. That requirement was originally established under the PHSBPR. Another 2012 report by the Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) faulted FDA's tracking of dietary supplement manufacturers under the same law, saying many companies would not be able to be located in the case of an emergency. For example, 28% of companies surveyed by OIG indicated that they maintained facilities that were not registered with FDA.

In both cases-and in the cases of other types of medical products-the PHSBPR is intended to allow FDA to quickly ascertain which products are adulterated, which company is producing the products, and the physical location where the products were produced. Such information facilitates both recalls and more effective investigations, especially in an increasingly global environment in which supply chains can span multiple countries.

Important Sections of the PHSBPR

The law has since been amended, notably by the FDA Food Safety Modernization Act (FSMA) of 2011, which amended Section 414 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which allows FDA to access records relating to food products believed to be adulterated.

The section reads:

If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

A later paragraph also permits FDA to establish regulations governing recordkeeping requirements for the transport, manufacture, processing, distribution, receipt, holding or import of food products, including dietary supplements.

Updated Guidance

FDA's latest guidance document, What You Need To Know About Establishment, Maintenance, and Availability of Records--Small Entity Compliance Guide, is set up in a question and answer format, and intended to help small businesses comply with the PHSBPR and FSMA.

For example, the guidance clarifies that FDA's authority under Section 414(a) of the FD&C Act applies to both foreign and domestic companies so long as FDA believes that a food product is adulterated or presents a threat to human or animal health. If such circumstances exist, FDA may then access and copy any records it needs to investigate that threat.

The guidance also notes that FDA's authority is most likely to be used in situations of foodborne outbreaks, product recalls, adverse event reports, consumer complaints or epidemiological evidence linking the food product to illness or death.

During the course of its investigation, FDA may require that companies grant it access to:

• manufacturing records
• raw materials (ingredients and packaging) receipt records
• product distribution records
• product inventory records
• test records
• recall records
• reportable food records
• customer distribution lists
• complaint and adverse event records

There are some exceptions to FDA's record-seeking activities, such as financial data, pricing data, personnel data, research data, sales data and information about the specific "recipe"-i.e. the specific quantities needed to manufacture a food-used at a facility.

Failure to allow FDA to access authorized records can result in injunctions, seizures, mandatory recalls, registration suspensions and administrative detentions, FDA said.

The guidance is in final form and available on FDA's website.

Federal Register Notice