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When Does a Food Become an Additive?

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.