FDA should grandfather any food ingredient or product already in the chain of distribution when it implements provisions in the Public Health Security & Bioterrorism Preparedness & Response Act, according to CHPA.

The step is necessary because some dietary supplements and product ingredients might be in storage for years when the provisions take effect, the Consumer Healthcare Products Association notes in Sept. 4 comments to the agency.

"Receipt of some of these ingredients will predate passage of the act. Records such as country of origin and previous ownership simply may not exist," the association points out.

CHPA was one of several groups to submit comments regarding the sections of the act that deal with registration of food facilities, administrative detention, establishment and maintenance of records and prior notice of imported food shipments.

The act requires the Center for Food Safety & Applied Nutrition to issue final regulations on the four sections of the bill by Dec. 12, 2003 (¹ Also see "Bioterrorism Efforts At Forefront Of CFSAN Activities; GMPs Remain Priority" - Pink Sheet, 22 July, 2002., p. 16). Four separate working groups within CFSAN are charged with developing the regulations. Comments on CFSAN's drafting of the regs were due Aug. 30.

Addressing the registration of facilities, CHPA notes that under the bill, companies will be required to provide FDA with "timely" updates about information such as a change in a facility's name, ownership, or address, as well as changes to the trade names and general food categories of foods processed, packaged or held at the facility.

The trade group maintains that immediately notifying FDA "each time a new food trade name is started at a facility or discontinued at a facility" would be impractical, and instead suggests the agency "make annual or biannual electronic message requests...or direct mail/fax requests" to obtain such information.

The Center for Science in the Public Interest disagrees, urging that FDA require frequent, detailed updates from registered facilities. In Aug. 20 comments, CSPI recommends that FDA go beyond "the minimal information required for registration...[to] also request optional information about the nature of the facility's operation."

This information should include "each different product manufactured, processed, packed or held by the facility, the average quantities of such product[s]... and each name and label under which the products are marketed," as well as "whether the facility operates on a seasonal basis...and whether the products made... change depending on the season," CSPI maintains.

Unlike CHPA's annual/biannual notification suggestion, CSPI recommends FDA require notification "within 30 calendar days of the changes," and 15 days if a company goes out of business.

With regard to the database FDA is required to establish containing every registered facility, CSPI proposes that it include data about "registration or recordkeeping violations, as well as warning and other letters, enforcement actions and detentions of product by that particular company."

Clarification is needed concerning what steps a company should take if it discovers it has been dealing with unregistered facilities, CHPA adds.

"If a firm learns that a food product has been stored...at a facility that has not been registered with FDA, what happens to that food product?" CHPA asks.

"Can the firm help get the unregistered facility registered and then continue using the product?...Does FDA have to give a formal concurrence before the food can be used? Must the food be destroyed?" CHPA continues. It notes such events will likely occur often and states "FDA needs to have a process to register the facility so that food is not needlessly destroyed."

Comments from industry addressed types of businesses and facilities that should be exempt from the bill's requirements.

CHPA maintains that R&D facilities should be exempt the act's provisions along with "buildings that only ship food products directly to consumers," which should be classified as exempt "retail food establishments" rather than "nonexempt warehouse[s]."

Drug manufacturers, which already are required to register with the agency, should be exempt from registering separately if they also manufacture dietary supplements, CHPA adds.

In separate comments, the Council for Responsible Nutrition, National Nutritional Foods Association and American Herbal Products Association each agree that "multi-level marketing" distributors be categorized as exempt retail establishments as well.

NNFA also requests that health food stores where food products are prepared for consumers be exempted from the act's registration and record maintenance requirements. Such an exemption would significantly help GNC stores, many of which are opening "smoothie" bars.

The term "facility," used to define what establishments must register with FDA, needs to be interpreted with flexibility, CRN adds.

For instance, multiple buildings on a single campus or adjacent buildings with different addresses owned by a single company should be considered as a single facility. "These are judgements perhaps best made by the corporation, provided the registration meets the need to adequately identify each location," CRN says.

Turning to the administrative detention section of the bill, CHPA urges that FDA "spell out how disputes... will be handled expeditiously in order to help prevent spoilage of detained food and dietary supplements."

The regulations should also address how detained material will be stored "to prevent the needless deterioration of product," the association states. It points out that "many botanicals are particularly sensitive to moisture and humidity, and some ingredients like vitamin C are susceptible to light."

With regard to the collection and maintenance of data, trade association comments recommended that, where possible, existing systems should be used.

"Using or linking to existing systems will substantially lessen the economic impact of the act for FDA and industry, encourage cross agency coordination and increase the likelihood of high compliance from the onset," CHPA states.

The American Herbal Products Association's Aug. 30 comments note the act authorizes "and encourage[s] the use of electronic methods" to ensure compliance. Electronic systems "will be essential to minimizing any burden that might be involved in the registration process," AHPA says.

The bioterrorism bill was signed into law by President Bush June 12 (² 'The Tan Sheet' June 17, 2002, In Brief). Other sections of the act address the stockpiling of potassium iodide and increasing the frequency of FDA plant inspections.

CFSAN Bioterrorism Regs Should Include Grandfather Clause – CHPA

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