Todd Harrison & Todd Halpern09.01.02
Implementing The Bioterrorism Act
How nutraceuticals companies canbetter prepare themselves for the new law.
By Todd Harrison & Todd Halpern
On June 12, 2002, President Bush signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Act”). The purpose of the Act is to improve the ability of the U.S. government to respond to acts, or threatened acts, of bioterrorism. This sweeping law will impose significant new responsibilities upon FDA and the industries it regulates. The provisions of the Act that apply to food likewise apply to dietary supplements. More specifically, while the Act amends the FD&C Act as amended by the Dietary Supplement Health and Education Act, the definition of dietary supplement remains unchanged. In this regard, dietary supplements are regulated as food under the FD&C Act except for certain limited exceptions that are not applicable in this instance. See FD&C Act §§ 201(f), 201(g), and 201 (ff) (“[e]xcept for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of [the FD&C Act].”Accordingly, when the term “food” is used herein, it includes dietary supplements.
Many of the provisions of the Act require FDA to issue final regulations within 18 months of June 12, 2002. Other provisions become effective within 90 days of June 12, 2002. Moreover, even if FDA fails to issue new regulations, in many instances, the Act's provisions are self implementing (i.e., the requirements of the law must be followed even if FDA does not issue final regulations implementing the law).
The key provisions of the Act that affect the food and dietary supplement industry are summarized as follows:
• Development of Food Safety and Security Strategy
The Act directs the President’s Council on Food Safety, in consultation with federal government agencies, the food industry and scientific organizations, to develop a crisis communications and education strategy with respect to bioterrorist threats. The strategy must address, among other things, threat assessments, technologies and procedures for securing food processing and manufacturing facilities and modes of transportation, response and notification procedures, and risk communications to the public.
• Inspections/Maintenance: Production of Records Upon a “Reasonable Belief” that Food is Adulterated and Poses a Threat of Serious Adverse Health Consequences or Death to Humans or Animals
The Act requires FDA to issue regulations regarding the establishment and maintenance of records by food companies within 18 months of June 12, 2002. The purpose of the regulations is to permit FDA to more readily identify the immediate previous source and subsequent source of the food. The Act further permits FDA to examine and copy records related to food items if it has a reasonable belief that the food is adulterated in a manner that poses a serious health threat. However, FDA does not have the authority to require maintenance of records regarding a particular transaction or activity in which the business in not a party. Rather, the records need only identify the party who received the food and the party to which the food was delivered.
• Detention – Credible Evidence or Information Indicating Food Presents Threat of Serious Adverse Health Consequences or Death to Humans or Animals
The Act also requires FDA to step up their inspection of imported food at the port of entry and permits the Agency to detain any food that it believes, based on “credible evidence or information,” presents a serious health threat.
• Debarment of Malfeasant Importers
The Act provides that FDA may debar any person who has been convicted of a felony related to the importation of food into the U.S. or has engaged in a pattern of importing food that presents a threat to the health of humans or animals.
This provision will also require a company to ensure that its supplier has not been debarred. Otherwise, FDA could detain the product at port.
• Registration of Food Facilities
The Act requires FDA to issue a regulation requiring the registration of all domestic and foreign companies that manufacture, process, pack or otherwise hold food on a one time basis (i.e., there is no annual registration required). While annual registration is not required, FDA must be notified in a timely manner of any subsequent changes to the registration (e.g., change of address, name change, addition of a new facility).
When registering, companies will need to provide FDA with the following information: the company's name; all trade names the company uses and the address of each food facility.
While the Act gives FDA until December 12, 2003 to issue these regulations, the registration requirement is self-implementing. Thus, regardless of whether there are final rules in place, companies are required to register with FDA by December 2003. As with the debarment provision, companies will need to ensure that any foreign supplier that it is doing business with is also registered with FDA. Otherwise, if the product is being offered for import by unregistered company or entity, the product will be detained at port.
• Notice of Imported Food Shipments:
The Act requires that companies provide FDA with prior notice of articles of food to be imported or offered for import into the U.S.. FDA has until December 12, 2003 to issue final regulations implementing this requirement. However, as with the facility registration requirement, companies are required to start notifying FDA of the importation whether or not the Agency has issued final regulations. In such an event, the Act requires the importer to provide no less than 8 hours notice and no more than 5 days notice of the intent to import the food.
• Marking Articles Refused Admission Into the U.S.
This provision permits FDA to require that the owner or consignee of a food articles that has been detained to mark the article with a clear and conspicuous statement: “UNITED STATES: REFUSED ENTRY.” Once so labeled, the statement cannot be removed.
• Port Shopping: The Act also prohibits port shopping. Under this provision, once the article has been offered for import and refused entry, the product will be deemed adulterated unless the owner or consignee demonstrates that the article is in compliance with the FD&C Act. The purpose of this provision is to prohibit port shopping (i.e., attempting to import via a different port entry than the port that refused its admission into the U.S.).NW