If a common green pea is added to canned beef stew, the pea is an added ingredient, but do you need to GRAS[1] the pea? The answer is no, because all foods have a presumption of safety and are GRAS and the pea is still a food in this circumstance, but when is this not true? When might a substance no longer be regarded as a food, possibly provoking a safety evaluation and GRAS determination or food additive petition? The following article examines how far it might be possible to speculate on FDA thinking,[2] theoretically extending the definition of a food and its addition, and proposing when it does not require additional regulatory scrutiny. Because the antioxidants of tea have gained so much notoriety in the past few years, the author will discuss the hypothetical example of tea (Camellia sinensis L.)[3], added to chewing gum.
Tea leaves, although sometimes eaten as a food, are most often prepared as a hot water extraction (i.e., a decoction) from green tea (with minimally processed leaves) or fermented black tea, of any one of several varieties of Camellia (or Thea) sinensis L. If the extraction process of the tea exceeds the technology ordinarily available in the home (i.e., a simple hot water decoction), the process may yield products described as “essential oils, oleoresins (solvent-free), and natural extractives (including distillates).” These extractives of tea (designated Thea sinensis L.) are regulated by FDA as GRAS ingredients (21CFR§182.20), where the extractives are included among substances “that are generally recognized as safe for their intended use” “Intended use” is not otherwise defined or designated in this regulation (more on this later).
It would seem logical that any process exceeding the hot water extraction of tea, could reasonably be presumed to cover use of an extract of tea in chewing gum, including those processes listed in 21 CFR§182.20; however, such a presumption is not without limits. It should be recognized that 21CFR§182.20 was promulgated many years ago (~1977) and could not have envisioned some of the more sophisticated laboratory extraction methodology widely available today (such as super-critical fluid extraction, sono-soxhlet extraction or, microwave assisted extraction). Indeed, the reasonable presumption is that the envisioned reach of 21CFR§182.20 would be confined to simple oleoresins (most often a steam distillate of the leaves) and other time-honored methods. To the extent that the tea extraction process can be defined as extract in these simpler terms, it will be easy to maintain that such an extract falls within the scope of 21CFR§182.20.
To the extent, however, that the producer relies on more sophisticated chemical isolation techniques, resulting in a product containing more highly purified chemicals (e.g., ECGC, polyphenon E, L-theanine), then the extractive becomes more likely that such a product would fall outside the realm of 21CFR§182.20, and thus, would likely need its own separate GRAS determination. This supposition of a separate GRAS would have even more validity if the stated goal (i.e. “intended use”) would be included in a newer genre of applications, such as an antioxidant.
The reason why the new extract might fall outside the safe use domain of 21CFR§182.20 (regardless of use) is two-fold: (1) the new use of the substance may surpass ordinary (known to be safe) consumption levels and, (2) possible breach of the “may have rendered” standard of §402 of the Food Drug and Cosmetic Act. On the first count, this concentrate now consumed in chewing gum could surpass all historical consumption of this substance as an ingredient in tea; that is, historically safe consumption of this substance at X ppm in tea, could now be many times that amount via chewing gum. What effects might occur at this much higher level of exposure? On the second count, similar to the first count, the substance in its new concentrated form may no longer be influenced by other substances in the less pure extraction, which may have had an ameliorating effect on the concentrated substance, allowing it now to exert a toxic effect. Analogously, the process to concentrate the substance may also have concentrated a toxin, normally present in tea, but when added to chewing gum, may be at toxic levels.
Therefore, adding a pea to beef stew constitutes adding one food to another or even adding wheat germ to cereal, although the latter being a physical extractive of the whole grain as opposed to a whole food, the wheat germ is as relatively harmless as the pea, in reasonable amounts. Likewise, simple extractives of common foods such as tea or coffee are safe, but when the extraction produces a narrow group of chemical entities, safety must be considered, especially if the exposure to the substance is greater than would be expected from the food from which it came and/or if the substance was unaccompanied by other substances that could theoretically have had potential ameliorating effect on the substance.
References
[1] GRAS = Generally Recognized as Safe
[2] Concepts and examples discussed in this article are for illustrative purposes only and do not constitute regulatory advice. The examples provided herein may not apply to your specific situation. Please contact us for an analysis of your particular circumstance to determine the best pathway for your product and team.
[3] Also known by its synonym, Thea sinensis L