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"GRAS" but not listed on the GRAS lists?

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I frequently wish to use ingredients that are not listed anywhere in CFR 21 (and yes, I know all the query tricks to find weirdly labeled entries). I've always assumed that not finding an ingredient in a GRAS list constitutes a dead end, but I recently noticed this on a ttb.gov page:


Can the use of a substance be GRAS even if it is not listed by FDA? Yes…The use of a substance is GRAS because of widespread knowledge among the community of qualified experts, not because of a listing or other administrative activity.”

Does anyone here have experience using this loophole? 

If so, how did you make the case to the TTB formulation agent that your ingredient was safe?

Does anyone here have any other insight about using non-GRAS-list ingredients?

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Never handled it personally but this was covered in my classes:

Generally Regarded As Safe means exactly what it says. The GRAS list maintained by the FDA is basically as a FAQ and fast-track for commonly used ingredients. To make a case that a non-listed ingredient should be considered as GRAS, find evidence and make the information easy to digest and fact check. Note that GRAS is also application-dependent. A plant that has traditionally been used for color may be GRAS as a color agent, but not as a major ingredient. You will need to find historical examples of your ingredient being used in similar contexts and explain why any differences don't matter.

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This is a complicated question.  Here is how I understand it.   Because the FDA was drowning in requests for GRAS determinations, it took refuge in a policy that allows a food manufacturer to self-certify that an ingredient is GRAS.  However, to do so, the food manufacturer must possess evidence that would have convinced the FDA to issue a GRAS certification if the FDA had examined the evidence itself.   Under those circumstances, it seems to me that self-certification is not something that most of the people engaged in craft businesses can pull off.  The FDA struggled with the rules for more than 10 years, then issued guidelines.  TTB reported on this in its newsletter.  Here is what TTB said:





August 19, 2016


Each producer and importer of alcohol beverages is responsible for ensuring that the ingredients in its products comply with the laws and regulations that FDA administers, including rules regarding criteria for concluding that a substance is “generally recognized as safe” (GRAS). Industry members are reminded that TTB's approval of a COLA or formula does not imply or otherwise constitute a determination that the product complies with the Federal Food, Drug, and Cosmetic Act.

Source: FDA Constituent Update dated August 12, 2016

In a step to strengthen its oversight of food ingredients, the U.S. Food and Drug Administration today issued a final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives.

The rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted.” The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts. The final rule also formalizes the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

The FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with today’s rule. While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts.

The GRAS final rule is the most recent step we are taking to strengthen the FDA’s oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods and Veterinary Medicine Program’s Strategic Plan, the FDA will develop and implement innovative regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.


Now, TTB requires that you submit a formula when you add harmless coloring, flavoring, or blending materials to a spirits product that comes under TTB's labeling jurisdiction. However, in all instances, the FDA is the arbiter of what is and is not safe.  TTB bows to the FDA's determinations.

The question, then, is what TTB would do it you asserted, in a formula, that you cannot give a GRAS number because you have self-certified, to the FDA, the safety or "kukiboja" root (my invention) as a flavoring ingredient in your specialty item.  I suspect it would not be well received.  The burden is going to fall on you to show the sense of the community of experts applies in the case of spirits, and not just kukiboja jelly or chewing gum.    

Thomas Merton wrote in his journal, "Isn't life absurd enough already without our adding to it our own fantastic frustrations and stupidities?"  I have a feeling attempts to use kukoboja extract might be piling frustrations onto the absurdities.  

I will add that the possibility that said extract could destroy kidney function is not an absurdity to be ignored.  The requirement for proof that it is safe should not be decomposed along with the rest of the administrative state.  I prefer to live free of concerns that food producers are poisoning me, even if it means that the food producer is not free to add any damned thing it wants.   Tweedle-dee and Tweedle-dum; freedom to and freedom from.  Sometimes it is necessary for government to put a thumb on the scale to balance to and from on a reasonable way




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I had to do this with a winery ingredient.  I went to the FDA and spoke to a scientist (this took a week to find one who 1.) would call me back 2.) knew what I was talking about) and showed them the GRAS from the manufacturer.  They agreed that the ingredient could be used in beverage alcohol, wine.  I then went to the TTB formulations via email with the FDA contact info, GRAS from the manufacturer, and quotes from my conversation and noted the FDA on copy agreed that this item could be used. 

No idea how this ended as I was laid off soon after...but there is my story.

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