The National Nutritional Foods Association (NNFA) has welcomed the Food and Drug Administration (FDA) confirmation last week to exclude health food stores from mandatory registration under the food safety provisions contained in the bioterrorism preparedness law (Public Health Security and Bioterrorism Preparedness and Response Act of 2002).
The bill, signed into law by President Bush on June 12, 2002, requires all facilities engaged in "manufacturing, processing, packing, or holding of food for consumption" to be registered with the FDA. Despite bill language that stated "retail food establishments" would be exempt from the registration provision, the FDA was initially unsure whether health food stores would qualify as such.
"Based on statements made by lawmakers during the passage of the bill, as well as the actual wording in relevant passages, NNFA has been adamant that health food stores were never intended to register," said David Seckman, NNFA's executive director and CEO. "We've supported and sought confirmation of this position for the past several months, so it's gratifying that the proposed rule published today comes to the same conclusion."
FDA's proposed rule will, however, require facilities that sell both directly to consumers and to distributors and wholesalers (such as warehouse clubs) to register. These do not meet the definition of a retail facility because they do not sell food directly to consumers only.
Under the Bioterrorism Act, food manufacturers, including manufacturers of dietary supplements, must register by 12 December 2003 even if the FDA has not issued final regulations. Determining a retail establishment and whether the registration requirement applies, will be on a facility-by-facility basis, said the NNFA, referring to a public meeting held last week.
NNFA will provide a detailed analysis of the proposed requirements in the February edition of NNFA Today.