Agency Response Letter - Objection Vita Spelt® FALN No. 004 (Docket No. 2006FL-0017)
Neal D. Fortin
Attorney and Counselor at Law
Purity Foods, Inc.
PO Box 230
Okemos, MI 48805
Dear Mr. Fortin:
This is in regard to the notification dated December 23, 2005, that Purity Foods, Inc., submitted in accordance with section 403(w)(7) of the Federal Food, Drug, and Cosmetic Act (the Act). FDA received the notification on December 27, 2005 and designated it as FALN 004.
The subject of this notification is Vita Spelt®. The notification informs FDA of Purity Foods' view that, based on scientific evidence and other information, Vita Spelt® is not "wheat," as that term is used in section 201(qq) of the Act, and thus, is not a major food allergen, and that Vita Spelt® does not contain allergenic wheat protein.
The notification discusses the history of spelt, the scientific and vernacular use of "wheat" and "spelt," taxonomic classification of spelt, Codex Alimentarius standards for wheat flour and wheat grain, handling and manufacturing of Vita Spelt®, the digestibility of spelt, and a discussion of consumer confusion associated with identifying spelt as "wheat." Purity Foods' notification also includes a reference list, and appendices containing letters from the U.S. Department of Agriculture and the U.S. Manager for Codex regarding the taxonomic classification of spelt and several allergy questionnaires from consumers.
As an initial matter, FDA interprets "wheat" as used in section 201(qq) of the Act to mean all species in the genus Triticum. Because spelt is a species in that genus, spelt is a "major food allergen" and subject to the allergen labeling requirements in section 403(w) of the Act absent an exemption.
FDA objects to FALN 004. FALN 004 does not contain scientific evidence (including the analytical method used) that demonstrates that Vita Spelt® (as derived by the method specified in the notification) does not contain allergenic protein, as required by section 403(w)(7)(A)(i) of the Act. FALN 004 does not provide sufficient scientific evidence to determine that Vita Spelt® does not contain allergenic protein nor does FALN 004 otherwise meet the requirements of section 403(w)(7).
Spelt is "wheat"
Before addressing Purity Foods' contention that Vita Spelt® should be exempt under section 403(w)(7) because Vita Spelt® does not contain wheat allergenic protein, FDA addresses the initial question of whether "wheat" as used in section 201(qq) means all species in the genus Triticum, or only "common wheat. " Purity Foods asserts that "wheat" in section 201(qq) refers only to "common wheat" (T. aestivum), even though the notification acknowledges that "wheat" may refer either to the genus Triticum or the species Triticum aestivum ("common wheat"). Although "wheat" is identified in section 201(qq) as a "major food allergen," the law does not define the term "wheat."
Purity Foods argues that standard nomenclature and taxonomy support the view that "wheat" means "common wheat, " and therefore does not include other species of wheat, such as spelt. Our review of the nomenclature, as reflected in several recognized sources, does not support Purity Foods' claim. For example, the Merriam Webster Online Dictionary defines "wheat" as, "any of various annual grasses (genus Triticum and especially T. aestivum and T. turgidum) of wide climatic adaptability that are cultivated in most temperate areas for the wheat they yield." The International Union for the Protection of New Varieties of Plants (UPOV) council meeting at its thirty-ninth ordinary session, October 27, 2005, adopted document C/39/6, "List of the Taxa Protected by the Members of the Union." Part of this document is an "Index of Common Names in English" in which both the common names spelt and wheat are associated with the genus Triticum. Similarly, the Hortus Third (Bates, 1976) lists the common name "wheat" for the genus Triticum and refers to T. aestivum as "common wheat." In addition, the online version of Mansfeld's World Database of Agricultural and Horticultural Crops lists "wheat" as the English common name for the genus Triticum. Finally, the online Dictionary of Common Plant Names maintained by the Plant Press associates "wheat" with the genus Triticum as well as with T. aestivum, http://www.plantpress.com/Dictionary_of_Common_Names.45.0.html.
Similarly, our review of the relevant taxonomy does not support Purity Foods' position. Although there is controversy with regard to the taxonomy of the various wheats, it is clear, as acknowledged in the notification, that spelt is a "wheat" in the broad sense of that term. It is also clear that spelt is very similar genetically to common wheat. For example, "wheats," as defined by U.S. and Codex standards, can have either 28 chromosomes (e.g., for durum wheat) or 42 chromosomes (e.g., for common wheat or club wheat). Spelt has the same number of chromosomes and the same three "genome blocks" as common wheat and club wheat (Slageren, 1994). Furthermore, as discussed below, scientific evidence shows that there is a high percentage of homology between the proteins of spelt and those of common wheat.
Purity Foods also contends that defining "wheat" to mean "common wheat" would be more consistent with Congressional intent than defining it to mean all species in the genus Triticum. However, the legislative history of the Food Allergen Labeling and Consumer Protection Act (Pub. L. 108-282) (FALCPA) suggests that "wheat" was intended to mean more than just "common wheat," as it provides an example of the applicability of the allergen labeling requirements to a product containing durum wheat. S. Rep. No. 226, 108th Cong., 2nd Sess. 8 (2004). Furthermore, a broad reading of "wheat" is consistent with the central purpose of FALCPA, namely to alert allergic consumers, including wheat-sensitive individuals, to the presence of substances they need to avoid. Restricting the interpretation of "wheat" to "common wheat" would exclude all other species of wheat (such as durum wheat) from the labeling requirements of section 403(w), which could significantly reduce the protection potentially afforded by FALCPA to wheat-allergic consumers.
Having concluded that "wheat" in section 201(qq) means all species in the genus Triticum, FDA now addresses the contention that Vita Spelt® is entitled to exemption under section 403(w)(7) of the Act because Vita Spelt® does not contain wheat allergenic protein. Purity Foods maintains that Vita Spelt® differs from other cultivars of spelt, and that at least some wheat-sensitive individuals can tolerate Vita Spelt®. These points are addressed in turn.
Identity of Vita Spelt® and Characterization
Purity Foods states that it has successfully marketed spelt products since 1990 and that Vita Spelt® is a "proprietary cultivar of spelt specifically for human food," and that "other cultivars of spelt do not necessarily have the same characteristics as Vita Spelt®." In support of this statement, Purity Foods provides a single reference (Stallknecht et al.,1996) which asserts that "studies on the nutritional aspects of spelt report wide variability in the chemical constituents of the grain." The notification then asserts that the specifics of Purity Foods' production methods and procedures for Vita Spelt® are confidential and proprietary, and thus, the notification contains no data or evidence to describe these chemical or other differences that set Vita Spelt® apart from other commercial spelt varieties. Moreover, the notification includes no information on the identity or genetic characterization of the initial cultivar used to grow Vita Spelt® and no description of the specific cultivation practices that may differentiate Vita Spelt® from other spelt varieties. Without detailed information on the method of cultivation for Vita Spelt®, it is not possible to demonstrate that Vita Spelt® is different from or should be treated differently than other types of spelt in terms of whether it contains allergenic protein.
To demonstrate lack of allergenic protein in Vita Spelt®, it is imperative to show a significant degree of altered protein composition or structure in Vita Spelt® compared to other species of wheat. No such analysis was included in the notification. First, the notification does not provide any quantitative description or characterization, using analytical methods, of the proteins in Vita Spelt®. Without such characterization, it is not possible to conclude that Vita Spelt® is a substantially different ingredient, in terms of protein composition and structure, from other types of spelt or other species of the genus Triticum. Second, the notification provides no way to establish that Vita Spelt® does not contain allergenic wheat proteins or proteins known to bind IgE in wheat-sensitive individuals. Because spelt and common wheat are from the same genus, Triticum, a high percentage of homology between the proteins of spelt and those of common wheat is expected. This expectation is supported by data showing high specificity of real-time wheat PCR (using wheat gliadin oligonucleotide sequences) in detecting spelt and other Triticum genus species (Sandberg et al., 2003). The National Center for Biotechnology Information Entrez data base contains 97 sequences for spelt proteins and these spelt protein sequences are > 95% identical to "common wheat" protein sequences. In addition, the one sequence for a spelt protein that is known to be a wheat allergen, alpha-gliadin (accession ABB17533), is 99% identical to a homologous wheat protein (accession CAB76957).
Purity Foods acknowledges that its notification lacks in vitro and in vivo allergen studies demonstrating that wheat-sensitive consumers do not react to Vita Spelt®. FDA has reviewed information in the scientific literature on whether spelt contains proteins capable of binding IgE in wheat allergic individuals. The limited information that is available suggests that there may be at least some IgE cross-reactivity between spelt and common wheat. There is one case report in which a patient with inhalant allergies to both spelt and common wheat had an IgE-mediated reaction to a lipid transfer protein (LTP) in spelt, a protein that is highly homologous to a similar LTP protein in common wheat (Pastorello et al., 2001). Another report, involving in vitro radio-allergosorbent testing (RAST) using a pool of sera from wheat-allergic patients, showed that spelt and wheat extracts contained proteins with identical allergenic epitopes (Nordlee et al., 2006.)
The most reliable means to measure clinical reactivity is to test for allergic response in consumers sensitive to the food allergen in question. In its notification, Purity Foods acknowledges that it lacks research, such as in vitro and in vivo studies, on the allergenicity of Vita Spelt®. The notification provides information on the alleged improved digestibility characteristics of spelt, compared to common wheat, and on potential consumer confusion and limited food choices that could result if spelt is determined to be "wheat" under section 201(qq). This information has little relevance to the contention that Vita Spelt® does not contain allergenic protein.
Purity Foods' submission also includes statements from six individuals with self-proclaimed wheat sensitivity who claim they are able to tolerate Vita Spelt®. In addition, the submission cites two references (footnote 65 of the notification) to support the claim that spelt is tolerated by wheat-sensitive individuals. Under section 403(w)(7), however, a notifier must demonstrate that the ingredient that is the subject of the notification does not contain allergenic protein
The testimonials submitted with FALN 004 may support a conclusion that spelt may not result in clinical reactivity for some wheat-sensitive individuals. These statements, however, do not demonstrate that Vita Spelt® does not contain allergenic protein, for several reasons. First, the statements do not assert that the consumers' sensitivity to wheat had been diagnosed by a physician and thus, these statements do not establish that these individuals have an IgE-mediated allergy to wheat. Second, no clinical information about the severity or other characteristics of these individuals' wheat sensitivity is provided. Third, the notification includes only six consumer statements; these consumers are not shown to be a representative sample of the entire wheat allergic population. Fourth, these statements are subject to bias in that they are self-reported and not part of a controlled food challenge experiment to determine clinical reactivity.
Certain information in the notification undermines the claim of Purity Foods that Vita Spelt® does not contain allergenic protein. In particular, the notifier acknowledges that "some wheat-allergic individuals may be unable to consume spelt" and that "some individuals may become allergic to spelt." These admissions are consistent with existing evidence that wheat-allergic individuals react to spelt and strongly suggest that spelt contains allergenic wheat protein. For example, one case report in the literature documents that an individual with a demonstrated allergy to common wheat had several similar severe allergic (anaphylactic) manifestations after consuming spelt (Friedman et al., 1994). Given this report as well as other observations, clinicians as a whole recognize the risk of a potentially severe allergic reaction to spelt for at least some wheat-allergic individuals. Medical scientific opinion (Yunginger, 1994) and consumer advocacy groups (as evidenced by their recommendations for wheat-allergic individuals at http://www.foodallergy.org/allergens/wheat.html) both support the clinical notion that spelt contains protein(s) which is (are) allergenic for wheat-allergic individuals and that generally, wheat-allergic individuals should avoid spelt.
In FALN 004, Purity Foods contends that Vita Spelt® is not a major food allergen and does not contain allergenic protein. FDA interprets "wheat" in section 201(qq) of the Act to mean all species in the genus Triticum. Thus, spelt is a major food allergen and is subject to the Act's allergen labeling requirements absent an exemption. FDA objects to this notification because FALN 004 does not contain scientific evidence (including the analytical method used) that demonstrates that Vita Spelt® (as derived by the method specified in the notification) does not contain allergenic protein, as required by section 403(w)(7)(A)(i) of the Act. FALN 004 neither provides sufficient scientific evidence to determine that Vita Spelt® does not contain allergenic protein nor does FALN 004 otherwise meet the requirements of section 403(w)(7).
Scott Gottlieb, M.D.
Deputy Commissioner for Policy
Bates, D.M. (ed) (1976) Hortus Third: A Concise Dictionary of Plants Cultivated in the United States and Canada, Macmillan Press Co., NY, p. 1129.
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Friedman, HM, Tortolani, RE, Glick, J, et al. Spelt is wheat. Allergy Proc 1994;15(4):217-8.
Nordlee, J, Yunginger, J, Hefle, S, 2006. Spelt is still spelt wheat. Abstracts of the Annual Meeting of the Institute of Food Technologists. Available at http://www.ift.org.
Pastorello, EA, Farioli, L, Robino, AM, et al. A lipid transfer protein involved in occupational sensitization to spelt. J Allergy Clin Immunol 2001;108(1):145-6.
Sandberg, M, Lundberg, L, Ferm, M, et al. Real Time PCR for the detection and discrimination of cereal contamination in gluten free foods. Eur Food Res Technol 2003;217:344-349.
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Slageren, M.W. van (1994) Wild wheats: a monograph of Aegilops L. and Amblyopyrum (Jaub. & Spach) Eig (Poaceae). Wageningen Agriculture University Papers 1994-7, pp. 82-94.
USDA Germplasm Resources Information Network (GRIN) Website at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl?durum+wheat. Accessed on March 16, 2006.
USDA Plant Variety Protection Office Website at http://www.ars-grin.gov/cgi-bin/npgs/html/pvplist.pl. Accessed on March 16, 2006.
Yunginger, JW. Food ingredient labeling: how many ways can wheat be spelt? Allergy Proc 1994;15(4):219-20.
 Alternatively, a notification may contain a determination by FDA under section 409 of the Act that the ingredient in question does not cause an allergic response that poses a risk to human health; FALN 004 contains no such determination. In addition, there is a petition process under section 403(w)(6) by which a person may request that an ingredient be exempt from the allergen labeling requirements in section 403(w)(1); to receive an exemption under this process, the petitioner must provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the food ingredient (as derived by the method specified in the petition) does not cause an allergic response that poses a risk to human health. FALN 004 was submitted as a notification under 403(w)(7)(A)(i). Accordingly, the notification must demonstrate that the ingredient does not contain allergenic protein.