Food Additive or GRAS?

Dietary supplement ingredient suppliers seeking to expand the scope of their business frequently look to offer their material for sale to mainstream food companies, gaining access to a larger marketplace and offering the opportunity for higher sales. In order to accomplish this objective, companies can choose one of two paths: entry into the market as a food additive or through a conclusion that their product is GRAS (generally recognized as safe). No matter which path a company chooses to pursue, the critical issue is demonstrating that consumers can ingest the product safely as it is intended to be used.

The concept of safe, as defined by FDA, is not absolute. Rather it incorporates the concept of a reasonable expectation that the substance will not cause harm to consumers. The relevant regulation, which can be found at 21 CFR 170.3(i), defines safety as being established in the minds of competent scientists that the substance is not harmful under the intended conditions of use. Thus, factors such as the likely frequency of use (general sweetener vs. weight loss fiber added to beverages) and intended consumer (everyone vs. women who are or may become pregnant) can be major factors in evaluating the GRAS status of an ingredient. Significantly, the regulation also acknowledges: it is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.

Under the Federal Food Drug and Cosmetic Act (FDCA), any substance that is included in food is considered a food additive subject to premarket review and approval by FDA. The primary exception is recognition that the substance in question is GRAS under the conditions of its intended use, or that it is otherwise excluded from the definition of food under FDCA. Examples of excluded substances include dietary ingredients intended for use in dietary supplements or color additives.

The FDCA and implementing regulations promulgated by FDA provide that a substance can be considered GRAS either through general recognition of scientific data that is available in the public literature or through general recognition of safety by virtue of experience based on common use in foods by a substantial number of consumers. Under either criteria, the data required for recognition must be of the quantity and quality that qualified experts in the field of food safety would find satisfactory. This requirement can make it challenging for GRAS determinations to be made by in-house staff without the assistance of outside consultants.

Another critical element of GRAS determination is the data upon which it is based must be publicly available. It is impossible for a substance to achieve general recognition based solely or even primarily on proprietary data. Under this standard, it may be difficult for dietary ingredients that are the byproduct of proprietary, novel, patented, trade secret processes to achieve GRAS status in the absence of extensive published data on the specific ingredient as opposed to data based on the original plant source of the ingredient.

The primary distinguishing factor between a GRAS ingredient and a food additive is the level of common knowledge about its use and/or safety. In the absence of publicly available data about an ingredient, submission to FDA for formal approval as a food additive is required. This can be a long process subject to notice and comment rulemaking. Prior to reaching any decision on a request for approval, FDA will require submission of privately held data and information about the substance for evaluation by FDA scientists. While FDA will make itself available for discussion of the data, it is the ultimate decision maker as to whether the substance is safe for consumption under its intended conditions of use.

One aspect of FDAs responses to companies seeking to introduce new ingredients has been consistent: make sure you know what you are producing and that you can demonstrate you are producing the same thing, the same way every time you make it. Setting aside all issues concerning the quality of data, failure to demonstrate to FDA that you understand precisely what it is you are seeking to introduce to the market for consumers to ingest is a guarantee for failure. Whether the substance in question is a New Dietary Ingredient (NDI) for use in dietary supplements, a GRAS ingredient or a new food additive, unless FDA can be assured that you can provide a precise chemical profile of the ingredient with a clear explanation of how you are assured that you are producing the same thing every time you manufacture the ingredient, your effort to get to market will be destined to fail.

Marc Ullman, Esq., partner at Ullman, Shapiro & Ullman (www.usulaw.com), represents clients in matters relating to FDA and Drug Enforcement Administration (DEA) matters, regulatory issues, FTC proceedings and litigation.