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Formulas & LabelingNews

A Quick Primer on GRAS Ingredients and Additives

By April 28, 2018October 28th, 2021No Comments

I’ve been receiving a lot of questions about GRAS numbers for ingredients in formulas lately, so I wanted to put together a quick guide to at least orient your attempts. The FDA folks have reviewed this and added feedback, so you can be confident in the information.

How are food additives and ingredients regulated?
As general background, the Federal Food, Drug, and Cosmetic Act (FD&C Act) is the primary food and drug law of the U.S. According to the FD&C Act, any substance that is added to food must be one of the following:

  1. an approved food additive
  2. an approved color additive
  3. Generally Recognized as Safe (GRAS) as determined by qualified experts for the intended conditions of use
  4. prior sanctioned for that use by FDA or the U.S. Department of Agriculture (USDA)
  5. fall into another category exempt under Section 201(s) of the FD&C Act

FDA provides a short overview on their website.

What is GRAS?
Generally Recognized as Safe, or GRAS, is a designation by the FDA for a specific use of a specific ingredient. Things are not just GRAS or not; they are GRAS for a specific use. So, for example, something might be GRAS for use in baking, but not in alcohol. All of this, if you’re a regulation nerd, is in the Code of Federal Regulations Title 21, or you can see the GRAS FAQs.

How does a food additive get approved?
The use of a food additive must be approved prior to its use. Additives already approved can be found in Title 21 of the Code of Federal Regulations. The use of a new additive requires regulation for approval, and can be gained through the Food Additive Petition Process.

How does something get designated GRAS?
Substances added to food can be concluded to be GRAS if there is general consensus that it is safe in that particular use by experts. There’s a rather in-depth process of gathering data on the safety of an ingredient, explained here. Companies can notify the FDA that they have concluded a substance is GRAS through the GRAS Notification Program.

What about coloring?
This gets a little weird. Additives that are used primarily for coloring, or additives that provide coloring, cannot be GRAS for use as a color. Color additives require their own listing, which requires similar types of safety data as food additive approval. This isn’t for every use of every ingredient, necessarily, but it can come up, particularly with herbs. Also, things like gold are considered color additives, so they are not approved as an additive.

You can buy batteries on Amazon, too, but you can’t put them in mead. That’s a bit of a strong example, but the basic point is that Amazon and the Internet are international markets, and that really doesn’t have much to do with whether a specific ingredient is allowed to be used in a specific way in the United States.

Here’s some food grade gold leaf on Amazon:

Gold Leaf

And I just told you that gold isn’t an approved additive in the US.

Likewise, lots of herbal things sold as “teas” are not actually ok for adding. Butterfly Pea Flower, which is famous for its blue color, for example, cannot be considered GRAS for its use as a color, full stop. You could obtain approval for its use by the Color Additive Petition Process, but, until it is approved, it cannot be lawfully used to impart color to food marketed in the United States.

What about home mead making?
The FDA has nothing to say about stuff not for commercial sale. They’re telling you that gold is not an approved ingredient; if you want to put it in your mead at home… that’s on you. But for that matter, you can also make braggots at home, or, if you’re nuts, add outright poisonous ingredients like the random mushrooms or berries you found in your backyard, and it’s not exactly illegal; it really doesn’t have anything to do with the FDA. Also, please don’t do that.

What is “tea”? Can any herb be a “tea” if I want it to?
No. Tea is one specific plant.

I quote from Steve DiFranco of the FDA:

From the regulatory point of view, tea is considered to be a conventional food (i.e., conventional beverage) that is made of the Camellia sinensis plant and could be marketed as a beverage with a “Nutrition Facts” label. Herbal “tea” products are made from a variety of plants other than C. sinensis, and although they are referred to as “tea” they are technically herbal infusions, and regulated much differently than color additives.

Where can I look for Food and Color additives, and GRAS ingredients?
Okay, so there are a few main places to search:

But I want to use [insert ingredient here]! What about that? There’s a help email from the FDA, after reviewing the above sources, if you have specific questions: They’re good people and this is all they do there.