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Generally Recognized As Safe and Effective (GRAS/GRAE)

Our toxicology team is comprised of some of the most worldwide recognized experts in the field of toxicology, backed up by over 30 years experience in FDA safety requirements and regulation. Those, in partnership with our legal-regulatory department, have successfully submitted hundreds of GRAS/E applications over the last decades in compliance sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA. However if the substance is “generally recognized as safe” (GRAS), among qualified experts, then premarket approval is not required.

Our staff has successfully written the dossiers necessary to support GRAS status and our colleagues, whom we call upon for the GRAS review, are recognized by the scientific and regulatory communities as experts in their fields. At present we are working with some of the market leaders in the natural beverages and dietary supplements markets to provide GRAS/E certification for their new products. Additionally, for our dietary supplement clients we have successfully filed and obtained new dietary ingredient approvals.

If you are interested in our FDA/GRAS/GRAE services, please do not hesitate to contact us at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it . We will be glad to discuss your case.

 




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