Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies (1999) / Chapter Skim
Currently Skimming:
Workshop Summary
Workshop Summary
Pages 1-12
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
A recent FDA proposed rule (see section on "Extramural Reviews" in Appendix A) , if finalized, would eliminate the FDA GRAS affirmation process and establish a FDA GRAS notification procedure in its place.
|
From page 2... ...
for ensuring the safety of new food ingredients. Manufacturers of controversial new food ingredients have sought FDA approval, and the agency has experienced a rise in the number of applications seeking approval for novel food technologies, such as bioengineered foods, macronutrient substitutes, or genetically produced or modified foods or ingredients, placing additional burdens on an agency already constrained by resource limitations.
|
From page 3... ...
Following the enactment of the 1958 Food Additives Amendment, FDA affirmed that a number of food ingredients met the GRAS standard. After questions were raised about the safety of some GRAS ingredients, the agency initiated a review of these ingredients in 1972.
|
From page 4... ...
As a result, several food ingredients have remained in interim food additive status for many years. LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS Evaluation of the legal framework of the ingredient approval process Pennants a comprehensive understanding of the events and legal history from which current foci laws emerged.
|
From page 5... ...
Change or Enforce Deadlines for Petition Reviews As mentioned, statutory deadlines for reviewing food additive petitions are rarely, if ever, met by the agency. FDA representatives informed workshop participants that the statutory clock is reset when the agency requests additional information for the review of a petition, but such timekeeping does not explain the gross delay in petition approval.
|
From page 6... ...
FDA has, in some cases, deferred completely to qualified outside review boards to conduct food ingredient reviews. As mentioned earlier, from 1972 to 1982 FDA commissioned FASEB to re-evaluate over 450 GRAS substances following concerns raised about the GRAS ingredient cyclamate.
|
From page 7... ...
Prioritize Reviews Currently FDA reviews food additive petitions in the order in which they are received. In light of the serious resource constraints on CFSAN, prioritizing reviews based on benefit could allow some petitions to move through the review process faster.
|
From page 8... ...
This discussion of the scientific and regulatory aspects of food ingredient review included key lessons learned about food safety, science and compliance infrastructure, ways in which the process has improved over recent years, and, finally, suggestions for change. Several speakers observed that scientific advances have led to more detailed studies, more data, and increased complexity in the development of information to support food additive petitions.
|
From page 9... ...
. The revised document is intended to provide updated guidance to petitioners regarding suggestions for toxicological safety data to assess direct food and color additives and GRAS ingredients.
|
From page 10... ...
Although these efforts offer initial steps in improving the food additive review process, participants recognized that long-term solutions may require statutory change. International Efforts While the food industry is interested in protecting the approval of new direct food additives, it is equally concerned with protecting the use of existing approvals in the global marketplace.
|
From page 11... ...
Consumer Perspective The length of the direct food additive review process is not a serious consumer concern. The imposition of user fees may also be largely inconsequential, but consumer representatives prefer user fees to an alternative that would make petitioners more directly responsible for funding the review.
|
From page 12... ...
Accredited outside experts residing in academia, professional scientific associations, and public interest groups may need to be involved in the evaluation process, but barriers, such as the Federal Advisory Committee Act, the confidential nature of the data submitted, and concerns about potential conflict of interest, limit the involvement of outside experts. However, because the resources of FDA have remained almost level in constant dollars in recent years and the overwhelming competing pressures on the federal budget suggest that the future will be no brighter, the FDA will need to continue to rely on outside experts to resolve complex issues.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.