FDA Rules Propose Pre-Market Notification on Biotech, Not ConsultationFDA Rules Propose Pre-Market Notification on Biotech, Not Consultation

FDA Rules Propose Pre-Market Notification, Not Consultation

WASHINGTON--Alongside the Food and Drug Administration's (FDA)draft guidance for voluntary labeling, another draft guidance and proposed rulewas issued that if finalized, would require food developers to notify FDA atleast 120 days in advance of the intent to market a food or animal feeddeveloped through biotechnology and provide research showing the product is assafe as its conventional counterpart."These initiatives will further assure that all food products developedusing the tools of modern biotechnology are known to the Food and DrugAdministration, so that FDA can continue to examine these products before theyreach market," said Jane E. Henney, M.D., FDA commissioner.However, opponents of biotech foods continue to have questions about theprocess of the proposal and draft guidance. "While we're pleased to seethat FDA has responded favorably to much of the National Nutritional FoodsAssociation's [NNFA] petition on genetically modified foods, it is not clearthat the proposal will provide the transparency sought by NNFA," said DavidSeckman, NNFA executive director and chief executive officer. According to NNFA,even though FDA will make letters received from notifiers available to thepublic, companies may opt to file notices confidentially.In addition, some anti-biotech groups feel that this proposal does notrequire mandatory consultation between manufacturers and FDA as previouslypromised. FDA's proposal also includes a recommendation that "prospectivenotifiers participate in a presubmission consultation program." CraigWinters, executive director of the Campaign to Label Genetically EngineeredFoods, suggested that this wording means that while notification is mandatoryaccording to the proposal, consultation is only recommended. Winters also saidthat the proposal still does not address the issues at hand. "The FDAshould be requiring pre-market safety testing, not just notices orconsultations." Written comments on the draft guidance will be takenthrough March 28 at Dockets Management Branch (HFA-305), Food and DrugAdministration 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. For moreinformation, visit www.fda.gov/bbs/topics/NEWS/2001/NEW00747.html.