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GRAS: A Detailed Breakdown

Helen Timothy
March 4, 2021

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FDA attorney Marc Sanchez discusses the primary regulatory agencies in the United States, what’s regulated and why, sources of law, and practical suggestions to put that regulatory knowledge into practice.

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REJIMUS is a preeminent regulatory management consulting firm powering companies in the Food, Animal Feed, Dietary Supplements, Cosmetic, and Homeopathic industries. REJIMUS helps companies improve profitability and drive sales while enhancing quality operations under all applicable regulatory agency requirements.

REJIMUS specializes in consulting for FDA, USDA, and FTC with specific expertise in regulatory due diligence, quality optimization, technical marketing, and GRAS notifications. Founder and COO of REJIMUS, Jim Lassiter, explains what companies need to know about GRAS. 

Food Additive or Dietary Ingredient?

When determining what you should be classifying your substance as you need to first understand the differences. Food additives and dietary ingredients are different entities but vary only slightly. Essentially, a food additive is any substance added to a food item—either directly or indirectly (e.g., migration by packaging)—and controlled by regulations.

If it winds up in the food, it’s a food additive, and it will alter the characteristics of the food item. Generally Recognized as Safe (GRAS) items, however, are a subcategory of food additives—the “unless” portion of the food additive regulations—and receive an FDA designation because the experts consider them to be safe. So unless the material in question is GRAS, it’s a food additive and needs to be reviewed.

On the other hand, dietary ingredients are exempt from the food additive regulations and undergo a separate notification process, not an approval process. There are “old” dietary ingredients, which were in use before October of 1994, and “new” dietary ingredients—any ingredients in use after October of 1994. Nonetheless, dietary ingredients remain a class of food and are still subject to the same general regulations as food products.

Determining What You Have

Now that you know the differences between dietary ingredients and food additives, how do you determine your substance, and which path do you take to get it approved? Do you go with the New Dietary Ingredient Notification (NDIN), or do you go with a GRAS self-determination? Knowing your substance’s category is probably the biggest challenge you face in this process. Here are a few classification options:

What is it?

Mixture: Your substance can be categorized as a mixture when you have an extracted group of compounds (e.g., extracting essential oils from a tomato), or a blend of compounds that exists by deliberate creation of such a mixture.

Extract: The fundamental question you need to answer is whether the starting material is an article of food. For example, does the extract come from the tomato mentioned above, or does it come from a twig or exotic plant?

Synthetic: Often referred to as “nature identical,” synthetic substances describe something naturally occurring in foods. For example, ascorbic acid is identical to what you’d find in lemons and oranges, but you can create it chemically. You are not extracting this material from foods. Therefore a synthetic substance needs to either submit an NDIN or go through the GRAS determination. In ascorbic acid, the content is an “old” dietary ingredient and is also GRAS, so no additional work is needed.

Something Completely Different: If your substance doesn’t fall into the categories listed above, but rather is a chemical or physical modification of a substance, you would then need to submit an NDIN or go through the GRAS determination.

After you’ve determined what category your substance falls into—you know what your substance is— you will need to know precisely where it will go. Will it go into foods exclusively? Will it only be used in dietary supplements? Or will it be used in both?

The Next Determinations

Characterization: The key to characterization is understanding the source materials used to create your substance and identifying the substance itself. If it’s a blend, you need to determine everything included in that blend. 

Method of Manufacture: The manufacturer will become part of a food product, so the manufacturer used in processing needs to be considered part of the whole process. That can include, however, the use of unacceptable materials.

There are instances when GRAS substances exist, but the manufacturer of those substances involves using unacceptable materials in the processing. This is something that needs to be discussed and explained in the development of the GRAS notification. You also need to look at the equipment used in the production of the substance and determine if welds, filters, etc. are food grade.

When companies create new food additives to improve texture, taste, appearance, or give products longer shelf life, manufacturers can take two different paths to add a new additive to the GRAS list:

  • Scientific Procedures: The manufacturer has performed its due diligence and submitted a GRAS notification to inform the FDA of a determination that the use of a substance is GRAS. The FDA can then not question the basis for the decision, determine that the notification does not provide a sufficient basis for GRAS, or cease to evaluate the GRAS notice at the manufacturer’s request.

    The same procedures are required to obtain regular food additive approval – it requires the same documentation. This is a rule-making process with lots of data concerning make-up and composition, manufacturing processes, and the demonstration of the safety of the material. Companies can determine on their own—performing their research—that what they’re adding to their food product is safe. These companies then have no legal obligation to report their findings to the FDA, but can do so if they chose to.

  • Experience: For this procedure, one needs to prove a substantial history of consumption in the human diet. This history of use must go back to 1958 and before when Congress established the original food additive regulations. Proving this can be rather challenging to demonstrate, most GRAS determinations opt for path one.

How to GRAS

In terms of how-to, what you’re doing when you create one of these self-determination GRAS notifications is you’re submitting a “Notice of GRAS Exemption” – your presenting information that says this material intended in the inclusion in these food products at this particular level should be exempt.

The components of these notifications include:

  • Declaration of Exemption

    • Basis (scientific procedures or experience)

    • Agreement to allow review (regardless of whether it is notified)

  • Details of the identity of the substance (characterization)

  • Information on self-limiting levels of use

Time Frame

  • General study time frame: 4-6 months

  • Within 30 days: Acknowledgement

  • Within 90 days: Available for public viewing

  • Ongoing review: Q&A, amendments

Things to Look Out For

  • Level of controversy of the material – is anything controversial?

  • Source of the material – is it common?

  • What the data looks like (e.g., the quality) – is it reliable?

  • Can you achieve the level you wish by performing a GRAS self-determination?

  • Do you want to outsource based on expertise, and what can you expect?

  • Be prepared for every question that might be asked and identify any holes that might exist.

Our On-Demand Webinar, “Food Regulations 101,” breaks down further need-to-know regulatory details. Watch it here