Ingenious Ingredients (Ing2) has announced it has achieved self-affirmed GRAS (generally recognized as safe) status for its Enfinity-branded paraxanthine ingredient for use in food and beverages.
Texas-based Kaneka has announced that it has completed the self-affirmation Generally Recognized as Safe (GRAS) process for its Floradapt Brain (Lactobacillus plantarum DR7) probiotic.
Italy’s Bionap Bioactive Natural Products has announced it has self-affirmed the GRAS (Generally Recognized as Safe) status of its CogniGrape standardized grape extract for use as a source of dietary polyphenols and/or as an antioxidant for use in food...
A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make...
A letter from a member of Congress to FDA calls into question the inconsistencies between the NDI process and how GRAS submissions are evaluated and the lack of communication between the staffs working on these issues.
Spanish firm Interquim SA, part of the pharmaceutical company Ferrer, announced that the FDA has no objections to the company’s Generally Recognized as Safe (GRAS) claim for its standardized orange extract.
Hailed by experts as ‘needed’ and ‘significant’, the US Food and Drug Administration has issued draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS).
Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...
The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.
New FDA rules clarifying the process by which ingredients are deemed generally recognized as safe (GRAS) have been welcomed by some stakeholders, but harshly criticized by others, who say any system allowing firms to self-determine the safety of their...
The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by much.
FDA is considering adding pre- and post-market enforcement “enhancements” to the final rule for the process of determining food substances are GRAS – or generally recognized as safe, according to a top agency official.
Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue the system is actually working pretty well.
An increase in GRAS (generally recognized as safe) determinations for an ingredient, and particularly self-affirmed GRAS, suggests that industry is looking at the alternatives to NDI notifications, but what are the consequences?
TSI Health Sciences, the Montana-based producer of supplement grade glucosamine and chondroitin, has announced self-affirmed GRAS (Generally Recognized As Safe) status for its joint health product Pureflex for use in conventional foods and beverages.
Californian-based herbal ingredients supplier, BI Nutraceuticals, says a third-party GRAS review of its ingredients suite will offer added value to its growing number of food and beverage clients.
