Updated: Feb 4, 2022
By George A. Burdock, Ph.D. and Mr. Johnel Lagabon
Occasionally, a GRAS needs to be amended. Other than expanding the list of food categories in which the ingredient may be used (a welcome reason), the need for amending a GRAS is often that the identity or specification of the primary ingredient has changed for one reason or another – an unfortunate circumstance. If the ingredient has changed to the point it no longer conforms to the original specifications, the GRAS is no longer valid, nor is the data supporting the safety of that ingredient; that is, while the original ingredient may have demonstrated safety in animal tests, those same tests are not valid for a changed ingredient because of a difference in purity, different naturally-present contaminants resulting from a new habitat or growing conditions or “side reactions” taking place during processing – to name only a few.
Before asking your consultant to initiate a GRAS, there are at least four key elements about your ingredient that should be evaluated prior to moving forward with a GRAS dossier: (1) ingredient specifications; (2) method(s) of detection for the ingredient and potential contaminants; (3) the ability of vendor(s) to consistently supply a product within specifications and ability of your manufacturing process to consistently produce a product within specifications and; (4) the ability of the ingredient to maintain specifications following stability (i.e., shelf-life) testing. Addressing these areas can not only make for the efficient completion of your GRAS program but can also ensure that you have ingredient specifications that work best for you.
While some ingredients may have certain specifications established by either prior use or from existing regulation, many ingredients do not have “official” or recognized specifications and it is up to you to establish them. Don’t take your vendor’s word for it, you have a responsibility under FSMA1 to ensure the ingredient is compliant. Establishing specifications is within itself, difficult, because they must be “reasonable” – with an element of precision and a measure of flexibility. Specifications that are too imprecise, having a broad range of values or too few parameters can result in a product that is essentially no different from other products or easily duplicated and the possibly sought-after uniqueness of your product is lost. At the other extreme, specifications that are too narrow may result in constraints making your product too difficult or expensive to consistently produce within specifications. Further still, you should consider the specifications as they relate to the shelf-life of the ingredient. Does the finished product stay within specifications for 1 to 2 years? Does it require special storage conditions or packaging to stay within specification?
Methods of detection for the final product, constituents and contaminants are as fundamental as the specifications themselves. Not only will the FDA want to be able to detect the ingredient in foods to ensure compliance with label statements and purity, but safety testing will require detection methodology to ensure the animals were given the correct amounts and exposure weighed against acceptable daily intake; for you, the manufacturer, detection is needed to ensure quantity and quality of the substance if purchased from a vendor or as a method for quality control of your final product. With such emphasis placed on creating descriptive and reproducible specifications, it is equally vital to ensure that the methods of collecting this data are reproducible, efficient and cost effective. While the methodology of the assays should be published in a peer-reviewed journal, it is preferable to utilize methods published in the Association of Official Analytical Chemists (AOAC) journal as their methods are widely used within industry. Use of a reliable method of detection is vital, for if FDA’s use of your method indicates a deviation in specification of a sample taken at your plant during a FSMA inspection, the sample could be declared out of compliance of the GRAS and subject to seizure. If a sample taken from a grocery store shelf does not indicate your product is in compliance with the label, the product could be declared adulterated. Each of these actions are time sensitive and represent increasing amounts of loss to you while you try to get a jerry-rigged methodology to work.
With a workable plan for establishing specifications and importance on ensuring adequate methods of detection, the next priority for many manufacturers is to evaluate their supply chain and manufacturing process. Can your vendor supply enough ingredient? Are there alternate sources of supply? How many day’s supply can be kept on hand in case of an interruption in the supply chain? And the all-important question, can your vendor’s ingredient or your manufacturing process meet your established ingredient specifications – this is especially true for botanicals and foreign-sourced ingredients. In the United States food industry, where so much relies on just-in-time supply, the supply chain is critical. Should the specifications be made broad enough, such that switching to an alternate supply is possible?
Lastly, can the new ingredient or final product meet the same shelf-life and stability standards? The slightly different variety of botanical or even one grown under different conditions may contain minute amounts of substances that can all-too-subtly change the final product, such that self-life is decreased by the substituted ingredient, or other changes such as color or taste which may not affect viability of the product, but turn off customers.
Achieving workable specifications for an ingredient is foundational to establishing a successful product, but often overlooked. As Abraham Lincoln once said, “give me six hours to chop down a tree and I will spend the first four sharpening the axe.”2 Before moving forward with a GRAS, let us help you ensure that the ingredient(s) going into your product are ready for GRAS.
If you are interested in learning more about how Burdock Group can help design specifications, a stability study or a GRAS program for you, please don’t hesitate to reach out at firstname.lastname@example.org.
Food Safety Modernization Act
Hughes, K. (2018) 25 of the Best Planning Quotes. https://www.projectmanager.com/blog/planning-quotes (site visited on March 13, 2020).