TTB - What are we in for?

[Amazondrink]

We have submitted a formula for a vermouth type drink that contains an ingredient that isn't GRAS. It's got decades of use in Brazil, but hasn't been used in alcoholic beverages here in the U.S..

If the TTB rejects our formula, what will we need to do in order to gain approval? Is it the same process as having something approved by the FDA--i.e. submitting or conducting studies that show that it's safe, to the extent that satisfies the FDA?

Thank you.

 

[dhdunbar]

There may be someone on this forum who has the expertise to discuss FDA GRAS policy, but don't rely on what anyone says unless they cite both credentials for making the comments and sources by which you can verify them.   I know that FDA provides for self-certification, but that it requires that anyone who self-certifies that an ingredient is GRAS must conduct the same research, etc, that the FDA would conduct if it were asked to grant approval, something for which it says it ho longer has the time. 

At least I THINK I know that.  

FDA explains the basic rules as follows (see https://www.fda.gov/food/ingredientspackaginglabeling/gras/)

"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under 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, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

• Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
• Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.

You can find a discussion of the notification procedures at https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.htm.

These are simple Google searches.  I've done them in five minutes.  I'm not qualified to comment on them further.  

 

 

 

[Amazondrink]

Thank you very much for the reply. I guess I'm confused by how the TTB and FDA intersect on this and whether or not the standards for ingredient approval are different for alcohol vs non-alcoholic beverages. 

[dhdunbar]

I can answer this question.  TTB and FDA both have jurisdiction over the labeling of alcoholic beverages. That is why you must register a DSP with TTB AND with the FDA.

TTB has the primary responsibility for enforcing both the TTB and FDA requirements,  but, in doing so,  TTB defers to the FDA on matters of food safety, including ingredients.  Someone on the forum once accused me of being good at cut and paste Google searches.  I didn't respond directly, but I will say here that sometimes doing anything more than pointing someone in the direction of persons who can give them authoritative answers is the only responsible answer one can give.  I think that is the case here.

Here is how TTB puts it (see: https://www.ttb.gov/ssd/bal_product_safety.shtml):

The Food and Drug Administration (FDA) is responsible for determining which ingredients are prohibited from use in food and/or beverage products. Under a Memorandum of Agreement (MOA) with the FDA, the TTB Beverage Alcohol Laboratory (BAL) analyzes alcohol beverage products for limited and prohibited compounds. The laboratory enforces these restrictions for alcohol beverages as per FDA guidance. For more information, please see the regulations at 21 CFR part 189, Substances Prohibited from Use in Human Food.

You can find the full agreement at https://www.ttb.gov/main_pages/memo-understanding.shtml.  This is the 1987 vestrion.  There was also a 1974 version which you can find on TTB's website.

Here, in  more detail than you may want, is how TTB describes how to determine what you can add to beverage alcohhol )See: https://www.ttb.gov/formulation/determine-ingredients-beverage.shtml).  Note the final comment, "For any questions regarding how GRAS determinations are made or the particular GRAS status of an ingredient, please contact the FDA's Center for Food Safety and Applied Nutrition.  If TTB directs you to the FDA for answers, then that is where you should go.  Don't rely on what people like me say.  

How to determine If and How Ingredients May be Used in Your Beverage

Here is some information to help you determine if and how certain substances may be used as ingredients in your alcohol beverage products.  Note that this is offered as guidance only; please refer to the complete text of 21 Code of Federal Regulations as the final authority.

Learn more about:

• Substances that are Generally Recognized as Safe
• Food/color additives and limitations on their use
• Substances prohibited from use in human food

Substances that are Generally Recognized as Safe (GRAS)

You may use any substance that is “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration (FDA) in making your beverage. 

Criteria for Determining if a Substance is GRAS

Per the FDA, "Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

• Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
• Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers."

FDA Lists of GRAS Substances

The FDA has several lists of substances that can be used in food based on the GRAS provision.  Per the FDA, “Importantly, these lists are not all-inclusive. Because the use of a GRAS substance is not subject to premarket review and approval by FDA, it is impracticable to list all substances that are used in food on the basis of the GRAS provision.

• 21 CFR Part 182 contains the remnants of a list, which FDA established in its regulations shortly after passage of the 1958 Food Additives Amendment. The list is organized according to the intended use of these substances. As part of the agency's comprehensive review of GRAS substances in the 1970s, FDA affirmed that the use of some of the ingredients on this original GRAS list is GRAS, and moved the affirmed uses of the substance to 21 CFR Part 184.
• 21 CFR Part 184 contains a list of substances that FDA affirmed as GRAS as direct food ingredients for general or specific uses. This list derives from the agency's 1970s comprehensive review of GRAS substances and from petitions that FDA received to affirm the GRAS status of particular uses of some food ingredients.
• 21 CFR Part 186 contains a list of substances that FDA affirmed as GRAS for certain indirect food uses.
• FDA's Internet site also contains a list of substances that have been the subject of a notice to FDA - i.e., when a firm has notified FDA about its view that a particular use of a substance is GRAS. You can access this summary of GRAS notices, along with FDA's response, from the GRAS Notification Program 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.”

To learn more about GRAS, see FDA’s:

• Generally Recognized as Safe: Overview and Resources
• Frequently Asked Questions about GRAS

Contacting FDA

For any questions regarding how GRAS determinations are made or the particular GRAS status of an ingredient, please contact the FDA's Center for Food Safety and Applied Nutrition.

 

 

 

[Amazondrink]

Wow. Thank you so much for the very thoughtful and complete reply.