Gras

News in brief

Bionap self-affirms GRAS status for standardized grape extract

07-Sep-2021

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...

As a result of GRAS process FDA has no idea of what's on market, say paper's authors

08-Apr-2021 By Hank Schultz

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...

Inconsistencies between NDI, GRAS raised in letter to FDA

06-Jan-2020 By Hank Schultz

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.

News in brief

Kaneka gets GRAS status on baby probiotic

18-Dec-2019 By Hank Schultz

Kaneka has announced self affirmed GRAS status on its Baby Colic probiotic dietary supplement meant to ease babies through gut discomfort episodes.

Comet Bio achieves milestone with self-affirmed GRAS status for prebiotic fiber

07-Nov-2019 By Danielle Masterson

The prebiotic Arabinoxylan Plant Fiber Extract trademarked as Arrabina, is officially considered safe.

FDA has no objections to GRAS status of Spanish firm’s hesperidin

11-Mar-2019 By Adi Menayang

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.

‘Needed’: FDA issues draft guidance for best practices for GRAS panels

20-Nov-2017 By Stephen Daniells

Hailed by experts as ‘needed’ and ‘significant’, the US Food and Drug Administration has issued draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS).

Kohjin announces special status from Kosher certifier

18-May-2017 By Hank Schultz

Kohjin Life Sciences has added to the long list of certifications for its Opitac Glutathione with a special status from a Kosher certifier.

Bodybuilding.com urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

23-Nov-2016 By Hank Schultz

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...

Self-affirmed GRAS omitted from new NDI draft guidance

18-Aug-2016 By Stephen Daniells

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.

Senator slams FDA final rule on GRAS: ‘a self-graded take home exam that industry doesn’t even have to hand in’

15-Aug-2016 By Elaine Watson

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...

GRAS route will still be popular with hard line taken in NDI draft on synthetic botanicals

12-Aug-2016 By Hank Schultz

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’s list of food priorities include finalizing rules for GRAS & gluten-free labeling for fermented foods

21-Apr-2015 By Elizabeth Crawford

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. 

AHA GRAS attack reaction: Why self-affirmed GRAS is not ‘GRAS lite’

21-Feb-2012 By Elaine Watson

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.

‘Uptick’ in GRAS interest suggests industry looking for NDI alternative

16-Jan-2012 By Stephen Daniells

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?