The FDA strongly encourages companies to inform the agency of GRAS
conclusions through the notification procedure finalized with the rule.
approval for PinnoThin[R], food companies are able to capitalize on the contributions of this satiety ingredient in a weight management product.
Application Process for GRAS
Notification and Novel Food Applications
If a substance is properly deemed GRAS
under its intended conditions of use, it may be legally added to food without FDA's review or concurrence.
In 1990, FDA confirmed the GRAS
status of Simplesse[R], a fat replacement made from milk or egg white protein, for use in frozen desserts.
Once NutraSweet submits a GRAS
petition, FDA's review process should take about 12 to 18 months, Norris says, which would coincide with NutraSweet's marketing goal.
Most supplement manufacturers and their suppliers have not taken advantage of the GRAS
self-determination process, often because of the added cost to product development and their level of understanding of the process.
Associates provides a team of highly skilled toxicologists and regulatory scientists delivering the expertise that the law requires in order to make GRAS
Obviously, manufacturers benefited from the GRAS
concept because the expense of animal testing and the preparation of petitions for the thousands of ingredients already in use would not be required.
Some critics might feel the GRAS
concept leaves too much discretion in the hands of the food industry.
To obtain GRAS
status is not as straightforward as Congress might have made it sound.
Lignisul MSM[TM] has received generally recognized as safe (GRAS
) status under the FDA requirements for GRAS
self-affirmation, according to its supplier, Carolwood MSM, Greenville, PA.