FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T97-15                           Judith Foulke     (202) 205-4144
April 17, 1997                   Broadcast Media:  (301) 827-3434
                                 Consumer Hotline: (800) 532-4440
 
        FDA PROPOSES SIMPLIFIED GRAS NOTIFICATION SYSTEM
     FDA has proposed a replacement for the current system by
which manufacturers may get affirmation from FDA that a food
substance is generally recognized as safe (GRAS).  The
streamlining would allow FDA resources to be redirected, among
other priorities, to food additive questions that involve public
health issues.
     Food ingredients whose use is generally recognized as safe
by qualified experts are not required by law to receive FDA
approval before marketing.  Under current procedures, a
manufacturer may determine that use of a food substance is GRAS
without formally petitioning to FDA.  However, if a manufacturer
wants FDA affirmation of its determination, the company must
submit a petition and go through a rule-making process.
     Today, the agency has proposed to establish a notification
procedure that would replace that lengthy rule-making process.
Manufacturers may still make a self-determined GRAS declaration,
claiming exemption from the premarket approval requirement for
food additives.  However, instead of petitioning FDA for
affirmation, they would simply notify FDA of their GRAS
determination and provide evidence that supports their decision.
After evaluating the notification, FDA would respond to the
manufacturer within 90 days.
     The manufacturers' notification would serve as a basis for
informing FDA without the need for rule-making.  Under the
proposal, any GRAS affirmation petition that is pending, when a
rule establishing a GRAS notification procedure is finalized,
would be converted into a notification or dropped from review.
     The proposal allows for notification to be revisited if new
information indicates a reason for concern.
     Because the proposed notification procedure is considerably
simpler than the current affirmation process, manufacturers would
have greater incentive to inform FDA of their GRAS
determinations.  Therefore, FDA would gain increased awareness of
ingredients in the nation's food supply and the cumulative
dietary exposure to GRAS substances.
     The simplified notification procedure would also redirect
FDA resources from the resource-intensive GRAS affirmation
process to questions that may have a greater impact on public
health protection.  Resources could also be directed to the
preparation of documents that would provide the industry with
guidance on complex food ingredient safety issues, such as those
posed by novel proteins, carbohydrates, fats and oils, or other
substances used in food.
     This proposal reflects FDA's commitment to achieving the
goals for the Reinventing Food Regulations part of the
President's National Performance Review.
     FDA will accept comments on the proposed regulation for 90
days following its publication in the Federal Register.  Written
comments may be submitted to FDA Dockets Management Branch,
(HFA-305), 12420 Parklawn Drive, Rockville, MD. 20857-0001
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