Is your herbal ingredient GRAS?
A regulatory issue that comes up often for herbal companies is whether an ingredient is Generally Recognized as Safe (GRAS) for use in foods. This is particularly relevant for herbal companies that are selling food products (see this post on regulatory categories if you need an intro). Adding herbal medicinal ingredients to foods is a practice that has a long history in herbal traditions around the world. For herbal companies selling food products, however, it’s important to understand whether or not herbal ingredients are GRAS.
What is GRAS?
GRAS, or “Generally Recognized as Safe” is an FDA recognition for ingredients used in food products. GRAS does not apply to ingredients used in dietary supplements, just foods. For herbalists creating food products with herbal ingredients, the question of whether an ingredient is “GRAS” or not comes up regularly, especially in the realm of “functional foods.” When an ingredient is GRAS, it’s recognized to be a safe and appropriate additive to foods. Ensuring ingredient safety is one of the ways that FDA oversees food safety. GRAS applies to many types of food ingredients, including flavorings and colorings, but this post is going to focus on herbal ingredients.
What does GRAS apply to?
GRAS applies to ingredients used in food products, sometimes called “conventional foods,” and does not apply to dietary supplements or cosmetics. GRAS generally comes up with herbal ingredients used in food products, and especially for herbs that don’t have a history of use as a food or beverage flavoring, or don’t have a documented history in the U.S.
So how do you know if your ingredient is GRAS?
As a general guideline, if your ingredient is safe and was in common use in the food supply before 1958, then there’s a strong chance that the ingredient is GRAS. If it’s an ingredient that was used medicinally, but not in foods, then it’s likely not GRAS. If it’s an ingredient that was occasionally used in foods, or used in medicinal foods, then you might have some leeway. To determine use in foods prior to 1958, old cookbooks, government documents, and records of products sold in foods and in food ingredients can all be helpful.
Where can I find a list of GRAS ingredients?
Unfortunately, it’s not that simple. There’s no one list of all GRAS ingredients. Surprisingly, there’s no GRAS list of basic ingredients, such as grains, vegetables, or fruits. That said, there are a few places to look. Within the U.S. food regulations, there are a couple of lists of herbs (CFR 182.10) and essential oils or other extracts (CFR 182.20) that are GRAS for use in foods. GRAS has historically favored herbs with a history of use in European countries, as those herbs were the ones that regulators added to lists of herbs that are suitable for food flavorings. Other herbs can be GRAS, they just didn’t tend to make it on to the existing lists. Additional GRAS substances can be found in the FDA section of the Code of Federal Regulations (CFR), in sections 182, 184, and 186.
FDA maintains a list of “Substances Added to Food” and the “Food Additives Status List” which list many but not all food ingredients.
The other place to look is FDA’s GRAS notice page. When you look at this site, the key is to find your ingredient along with a note that says “FDA has no questions” which means that FDA didn’t find any safety concerns with the information that was submitted for the listed ingredient.
How do ingredients become GRAS?
If ingredients didn’t make it on to FDA’s original GRAS lists, there are two routes to getting GRAS status. One route is to petition FDA. This involves compiling a large amount of technical information and safety data on the desired ingredient. FDA reviews the data and either has “no questions,” or denies the petition. If they have no questions, that means that they generally agree that the herb is safe for the listed use. The full technical documents are available online. Here’s an example of a GRAS petition for cranberry extract.
The other route for GRAS status is “self-affirmed GRAS.” For this, most of the same information is put together as is done for the FDA petition, but instead of going to FDA, the information is reviewed by several scientists. The scientists are hired to review the information and decide if they agree that the ingredient is GRAS. If so, they document their agreement and any parameters for safe use of the food (i.e. amount used per serving in different types of food products).
Both of these routes are expensive and time-consuming. They require expert support in compiling evidence and addition experts to review the evidence. While any company can petition for GRAS or complete a self-affirmation, the cost of the process tends to make it so that only medium or large companies undertake the task.
Some ingredient suppliers, especially herbal extract suppliers, go through the GRAS process for their ingredients. In this case, product manufacturers may use the supplier’s GRAS affirmation, so long as the finished product is in line with the use and amount outline in the GRAS affirmation.
What ingredients are we talking about here?
Non-GRAS ingredients include popular botanicals and mushrooms like ashwagandha, echinacea, reishi, cordyceps, and many more. Again, some extract companies have gone through the FDA GRAS or the self-affirmed GRAS process for their extracts, so it’s possible to find GRAS extracts of these ingredients from suppliers.
What happens if non-GRAS ingredients are used in food products?
There are a couple of risks to using non-GRAS ingredients in foods. If the FDA takes notice of your product, you could end up with a warning letter from them which is not something that you want. In addition to the FDA, many chain stores and other retailers do their own regulatory review of products, so if you’re looking to get in to stores, then having the correct ingredients or the correct product positioning (i.e. positioning your product as a supplement rather than a food) can be the ticket to getting on shelf.
Want to know more? If you’re feeling like getting the nerdy history of GRAS, FDA has a good article here. You can find FDA’s guidance document on GRAS submissions here.
If you’ve got questions about your product, feel free to get in touch.