DIETARY SUPPLEMENTS TO BE INCLUDED IN FDA HAZARD ANALYSIS

DIETARY SUPPLEMENTS TO BE INCLUDED IN FDA HAZARD ANALYSIS quality control proposal for all foods, which the agency expects to publish later this fall, FDA's Robert Lake reported at the Council for Responsible Nutrition's annual meeting on Sept. 23. Lake, who is senior associate director of the office of policy, planning and strategic initiatives in FDA's Center for Food Safety and Applied Nutrition, noted that FDA hopes to publish an advanced notice of proposed rulemaking that would extend hazard analysis critical control point (HACCP) inspections to all foods, including dietary supplements, when the agency publishes a proposed rule adopting HACCP inspections for seafoods. The seafood proposal is expected "very shortly," Lake said. Lake explained that the ANPR "is directed at everyone who's in the food business and the purpose of it is to elicit public comment" on a "set of ideas and a laundry list of questions" that must be answered before a broad HACCP proposal for foods can be issued. Questions to be resolved, Lake said, relate "not only to the applicability of HACCP and what it might mean to different segments of the [food] industry, but [also to] whether there are segments of the industry that should be exempt" from a HACCP program. Lake emphasized that, in contrast to the HACCP proposal for seafood, "we are at a very early stage in our thinking" on a HACCP program for other food products. The CFSAN official added that, during the comment period for the ANPR, "we will provide an opportunity for meetings with consumer and industry and public health professional groups who wish to dialogue with us" about a potential HACCP program. Lake said that adoption of the HACCP program will assure each manufacturer that "the products he manufactures are safe, that what's in the package is what's represented on the label," and that the products do not contain pathogens or other material that "might be hazardous to consumers." The plan would essentially identify "what the potential hazards are in [the company's] manufacturing operation" and "put in place a system" to "avoid the hazard," Lake stated. Also under a HACCP system, FDA would have "access to those [manufacturing] records that relate to safety" during inspections, Lake said. With such mechanisms in place, he continued, "we would be in a far better position to project that this safe state of affairs would continue." The FDAer underscored that food manufacturers "under the law have a basic responsibility for safety" of their products. Lake told the CRN audience that consideration of a HACCP system for all foods emerged from an internal agency debate "about what regulatory approach [and] what change in the regulatory system can we employ that would . . . actually improve the quality control of manufacturing to assure" the safety of foods. Attorney Stephen McNamara (Washington, D.C. firm of Hyman, Phelps & McNamara) questioned "whether FDA [has] the right to [inspect] manufacturing records for food companies." Lake responded that, based on FDA's "present interpretation," the agency does "have the regulatory authority to not go after all records" during inspections "but at least those records that relate to the safety of the product." He added that FDA plans to explain its thinking on its right to collect safety records in the upcoming seafood HACCP proposal.