Recent foodborne illnesses have raised questions about the legal status of tara (Caesalpinia spinosa) under United States food law. There are three legal pathways for ingredients to be used in food: generally recognized as safe (GRAS) status, a prior sanction, or an FDA food (or color) additive approval. The status of tara under these three pathways is summarized below and then an analysis follows.
No use of tara has been recognized as GRAS by the FDA. No public record of a prior sanctioned use of tara exists. No use of tara has been approved by the FDA as a food additive.
In addition, there has been no notification to the FDA of self-determination of GRAS status for a use of tara. However, GRAS notification is not required. GRAS status is self-implementing under the Food, Drug, and Cosmetic Act (FDCA). The use of purified tara gum as a thickener, stabilizer, emulsifier, and gelling agent in foods in the amount of 0.5% or less of the food is likely GRAS.
On the other hand, tara protein powder milled from the germ of the tara seeds does not have a GRAS use, does not have a published prior sanction, and is not an approved food additive (or color additive). As an unapproved food additive, any food containing tara protein powder is deemed adulterated as a matter of law.
The same conclusion is most likely true for “tara flour,” but there are conflicting descriptions of the nature of what is called “tara flour.” If the tara flour is tara gum powder, then the ingredient is mislabeled. Under U.S. law, tara gum must be labeling as “tara gum” or “tara gum from Caesalpinia spinosa.” If the “tara flour” is ground tara seed or ground other parts of the tara plant, the flour does not have a GRAS use and is an unapproved food additive.
The GRAS Standard
The generally recognized as safe (GRAS) provision in the FDCA provides an exemption from the law’s food additive definition and thus is an exemption from the food additive requirements. GRAS means that the substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
The degree of consensus among scientific experts required to be considered “generally recognized” as safe is not defined in the statute. However, over the years the courts and FDA have framed the meaning. Either a strong consensus or near unanimity is required. If there is a genuine dispute among experts, there is no general recognition. In addition, the evidence of safety must be public and common knowledge to the scientific community or there cannot be general recognition. This requirement for common knowledge of the safety for an intended use is the hallmark distinction of GRAS status and in this way, it is more stringent than the food additive requirements.
After the enactment of the Food Additives Amendment of 1958, the FDA published a list of substances and their uses that the agency deemed to be GRAS and added to the list several times. In 1973 FDA stopped adding to its GRAS listing and started a GRAS affirmation process. If FDA’s evaluation confirmed that the use of a particular substance was GRAS, then FDA issued a new regulation, affirming that finding of GRAS status. However, in 1997 FDA proposed replacing affirmations with a notification process. FDA operated the notification process from 1998 forward.
My research of the GRAS regulations revealed that no use of tara (Caesalpinia spinosa) has been recognized as GRAS by the FDA under either the initial FDA listings or in the later affirmation regulations. In addition, I reviewed the FDA GRAS notifications, and there are no notifications regarding tara. GRAS notification is voluntary, so lack of a notification does not indicate a lack of GRAS status because GRAS is self-implementing under the FDCA.
The use of purified tara gum as a thickener, stabilizer, emulsifier, and gelling agent in foods in the amount of 0.5% or less of the food is most likely GRAS. I based this conclusion on the reports from the EU Scientific Committee for Food (SCF), the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and the European Food Safety Authority (EFSA).
The limits of GRAS status
There are no GRAS substances, but only GRAS uses of substances. GRAS uses can and usually are limited to specific technical functions, the quantity permitted, in which foods it is permitted, and the purity and composition of the substance. For example, an accepted GRAS use of an ingredient as a thickener does not allow the ingredient to be used for added protein. Similarly, a GRAS use in the amount of 0.5 percent or less does not permit the ingredient to be added in amounts greater than 0.5 percent. Moreover, tara gum would have to be the purified polysaccharides obtained from the endosperm of the tara seeds and not the whole seed.
The specifications and purity matter. Many plant sources of food can be harmful if processed incorrectly or improperly purified. Therefore, a substance use that does not conform to the GRAS conditions is not GRAS. Moreover, a substance that does not meet the GRAS specifications and purity may be considered adulterated under the general, “ordinarily injurious” safety standard for adulteration, or it may be considered adulterated under the provision for food having been prepared, packed, or held under insanitary conditions “whereby it may have been rendered injurious to health.
Because the tara plant has additional non-food uses, there is a risk of cross mixing food and non-food sources. In addition, mycotoxin contamination is a possibility due to the potential for mold growth on the polysaccharides in this product. As an agricultural product, pesticide contamination is also a possibility. These scenarios would fall under the “may render injurious” adulteration standard or the unapproved pesticide residue adulteration standard.
There are two other exemptions from the food additive requirements:
- Prior sanctioned uses, and
- Single-ingredient foods
Prior sanctioned uses
Prior sanctioned substances are substances that were sanctioned or approved by FDA or USDA for use in food before the 1958 Food Additives Amendment. A prior sanctioned use is exempt from the food additive requirements. The FDA listed known substances to have a prior sanction in 21 C.F.R. Part 181. Tara is not listed as prior sanctioned.
Single ingredients are regulated differently than food additives. A single ingredient food is not considered a food additive because it does not become a component of a food (it is not added to a food) and does not affect the characteristics of a food because the ingredient is the food.
Whole foods do not need food additive approval, but they must still be safe (unadulterated) as defined by the Food, Drug, and Cosmetic Act. However, once a whole food is put into a recipe with other ingredients, that food becomes a food additive (unless that use is GRAS or prior sanctioned). That is, whole tara seeds by themselves are not a food additive until they are added to food, but once they are added to a food, the tara seed is a food additive.
The consequences of this distinction are significant because unapproved food additives are automatically adulterants. An unapproved food additive is presumed unsafe, and the proponent for use must prove safety to the FDA in a food additive petition. On the other hand, as a non-additive, whole food, the FDA must prove a risk of harm under the general adulteration provision, FDCA § 402(a)(1), the “ordinarily injurious” standard for non-added components of a food.
The Food Additive Standard
The “deeming” provisions
Section 402(a) of the Food, Drug, and Cosmetic Act states in part, “A food shall be deemed to be adulterated . . . (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409 of this title.” [Emphasis added.]
Under section 409 of the FDCA, “A food additive shall, with respect to any particular
use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 402(a) of this title, unless . . . . it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used . . .” [Emphasis added.]
A common misunderstanding of the law is a belief that a food with an unapproved food additive must be a health risk to be adulterated. This is incorrect. Unapproved food additives are “deemed” unsafe, and the food containing them is adulterated by law due to the lack of an FDA authorizing regulation. This deeming unsafe and adulteration operates as a matter of law irrespective of actual risk.
Tara as a food additive
Other than the use of purified tara gum as a thickener, stabilizer, and gelling agent in foods in a small amount of the final food, my research found no published information that other tara use would be GRAS. There are no listings of tara as prior sanctioned. Therefore, other uses of tara, such as the use of whole seed or use as a protein source, would be unapproved food additive uses.
One use of tara (Caesalpinia spinosa) gum appears to be GRAS, the use of purified tara gum as a thickener, stabilizer, emulsifier, or gelling agent in foods in small amounts of the final food.
On the other hand, tara protein powder milled from the germ of the tara seeds does not have a GRAS use, does not have a published prior sanction, and is not an approved food additive. As an unapproved food additive, any food containing tara protein powder is deemed adulterated as a matter of law.
The same conclusion is most likely true for “tara flour.” Tara gum is not approved for use as flour, and if the “tara flour” contains ground tara seed or ground other parts of the tara plant, the flour is an unapproved food additive.
About the author: Neal Fortin is a Professor in the Department of Food Science and Human Nutrition and Director of the Institute for Food Laws & Regulations at Michigan State University. He teaches courses in Food Regulation in the US, International Food Law, Codex Alimentarius, and Regulatory Leadership in Food Law. The views expressed are those of the author.
1. 21 U.S.C. § 321(s).
3. Fred Degnan, The GRAS Concept: Ensuring Food Safety and Fostering Innovation, at 27 Chapter 2 in FDA’S Creative Application of the Law: Not Merely a Collection of Words (2012).
4. Id. at 31.
6. FDA, Food Additives, Proposed Definitions and Interpretative Regulations, 23 Fed. Reg. 9511 (Dec. 9, 1958).
7. FDA, Substances Generally Recognized as Safe, 62 Fed. Reg. 18938 (Apr. 17, 1997).
8. FDA issued the final rule on GRAS notification in 2016. FDA, Substances Generally Recognized as Safe, 81 Fed. Reg. 54960 (Aug. 17, 2016).
9. I say “likely” because I did not conduct my own GRAS analysis but rather relied on the authoritative bodies.
10. Commission of the European Communities, Report of the Scientific Committee for Food (SCF) (26th series), Oct. 19, 1990.
11. Joint FAO/WHO Expert Committee on Food Additives (JECFA), Tara Gum, Monograph 1, Additive 455 (2006).
12. European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food, Alicja Mortensen, et al., “Scientific Opinion on the re-evaluation of tara gum (E 417) as a food additive,” EFSA Journal, 2017;15(6):4863, 37 pp. https://doi.org/10.2903/j.efsa.2017.4863.
13. E.g., casava root (Manihot esculenta) is a major food source, including tapioca, but improperly processed it can contain a variety of antinutrients and toxins, including cyanide poison.
14. FDCA § 402(a)(1) [21 U.S.C. § 342(a)(1)].
15. FDCA § 402(a)(4) [21 U.S.C. § 342(a)(4)] (FDA includes improper processing under a broad rubric for “insanitary conditions.” See, e.g., FDA, Compliance Policy Guide (CPG), Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin.)
16. FDCA § 402(a)(1) or § 402(a)(2)(B) respectively [21 U.S.C. § 402(a)(1) or § 402(a)(2)(B)].
17. See, United States v. Two Plastic Drums … Black Currant Oil, 984 F.2d 814 (1993).
18. 21 U.S.C. § 342(a)(1).
19. 21 U.S.C. § 342(a).
20. 21 U.S.C. § 348.
21. 21 U.S.C. § 342(a).
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