Balancing consumer protection and scientific integrity in the face of uncertainty: The example of gluten-free foods

Food and Drug Law Journal

Volumn 65, Issue 2, 2010, Pages

  McCabe, Margaret Sova ^a  

^a Franklin Pierce Law Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLERGENS; AUSTRALIA; CANADA; CELIAC DISEASE; CONSUMER PRODUCT SAFETY; DIET, GLUTEN-FREE; EUROPEAN UNION; FOOD ANALYSIS; FOOD LABELING; GLUTENS; HEALTH EDUCATION; HUMANS; NEW ZEALAND; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863301819     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (178)

1. "Celiac disease is a chronic inflammatory disorder characterized by mucosal damage to the small intestine leading to gastrointestinal illness, nutrient malabsorption, and a wide range of clinical manifestations." FDA, Center for Food Safety and Nutrition (CFSAN), Threshold Working Group, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food(Max. 2006), available at http://www.fda.gov/Food/LabelingNutrition/ FoodAllergensLabeling/GuidanceComplianceRegulatoryinformation/ucm106108.htm [hereinafter Threshold Working Group];
2. see also, Alessio Fasano, Surprises from Celiac Disease, SCIENTIFIC AMN., Aug. 2009, at 32, 35 (providing worldwide prevalence statistics, and noting more than 2 million Americans suffer from CD).
3. Nick Hughes, The Rise and Rise of Gluten-free, FOODNAVIGATOR.COM, Sept. 9, 2009, http://www. foodnavigator.com/Financial-Industry/The-rise-and-rise-of- gluten-free ("Since it was valued at a modest $580m in 2004, the market has grown at an average annual rate of 29 percent and last year was worth $1.56bn, according to Packaged Facts, which estimates the market in 2012 could be as worth as much as $2.6bn.").
4. But see Caroline Scott-Thomas, Gluten-fee Trend Could Fall Like a "House of Cards," FOODNAVIGATOR.COM, Mar. 23, 2010, http://www.foodnavigator-usa.com/Financial-Industry/Gluten-free-trend-could- fall-like-a-house-of-cards (reporting "people who have tried adhering to a gluten-free diet for reasons other than celiac disease are drifting back to gluten-containing foods" and that this trend will likely accelerate).
5. Caroline Scott-Thomas, Health issues back continued gluten-free growth, FOODNAVIGATOR-USA.COM, Mar. 18, 2009, http://www.foodnavigator-usa.com/ Financial-Industry/Health-issues-back-continued-gluten-free-growth ("Despite a lack of current medical evidence connecting gluten with autism, ADHD, irritated bowel syndrome and various other conditions, it does not deter a public seeking self-help ... The hard lines that medical professionals draw between a valid reason for a gluten-free diet and a fad do not exist among these patients and consumers.")
6. Gluten-free Labeling of Foods, Proposed Rule, 72 Fed. Reg. 2795 (Jan. 23, 2007) (to be codified at 21 C.F.R. Part 101).
7. Tiziana Fera, et al., Affective Disorders and quality of life in adult coeliac disease patients on a gluten-free diet, 15 EUROPEAN J. OF GASTROENTEROLOGY & HEPATOLOGY 1287, 1291-1292 (2003) (discussing CD patients' difficulties in adjusting to the diagnosis);
8. see also National Foundation for Celiac Awareness, GREAT Mental Health Program, http://www.celiaccentral.org/Education/GREAT-Healthcare/Mental-Health/ 247/ (last visited Dec. 24, 2009) (describing training program for medical care providers that work with CD patients to help them cope with stress of managing diet and disease).
9. FALPCA, Title II, Pub. L. No. 108-282, 118 Stat. 891 (2004) [hereinafter FALCPA or cited as appropriate to the United States Code].
10. Commission Regulation No. 41/2009, Concerning the Composition and Labeling of Foodstuffs suitable for people intolerant to gluten, 2009 O.J. (L16) 3 (Jan. 21, 2009; Codex Alimentarius Commission, Standard for Special Dietary Use for Persons Intolerant to Gluten, Stan. 118-1979 (as amended 1983, 2009) available at: http://www.codexalimentarius.net/web/standard-list.jsp [hereinafter Codex Stan. 118-1979];
11. see also Codex General Standard for the Labeling of Prepackaged Foods, Stan. 146-1985, available at: http://www.codexalimentarius.net/web/index-en.jsp.
12. Hughes, supra note 2.
13. Id. ("In the United States, a recent report from New Nutrition Business entitled 'Organic and All Natural Kids Snacks and Baby Foods' claimed that 15-25 per cent of American parents actively seek gluten-free food and drink. 'The driver is a belief among people that they, or their children, may have a gluten sensitivity - even though they are not diagnosed as having an allergy,' said the report. 'It's an example of how belief can be a more compelling reason to purchase than rational science.'").
14. See Gluten-Free Labeling of Food, Proposed Rule, 72 Fed. Reg. 2795;
15. Commission Regulation No. 41/2009, Concerning the Composition and Labeling of Foodstuffs suitable for people intolerant to gluten, 2009 O.J. (L16) 3 (Jan. 21, 2009);
16. Codex Stan. 118-1979 available at: http://www.codexalimentarius.net/web/ standard-list.jsp.
17. Cario Catassi, et al. A Prospective, Double-blind, Placebo-controlled Trial to Establish a Safe Gluten Threshold for Patients with Celiac Disease. 85 AM. J. CLIN. NUTR. 160, 164 (2009) ("The gluten microchallenge disclosed large interpatient variability in the sensitivity to gluten traces.").
18. S. Rep. No. 108-226, at 11 (2004).
19. 21 U.S.C. Ch. 9 (2006); 21 U.S.C. § 343(r) (2006).
20. See, e.g., Fasano, supra note 1, at 32 (tracing the discovery of CD to the ancient Greeks, and noting Dr. Samuel Gee is the "modern father of CD," but that he suggested treating children with CD with "thinly sliced bread, toasted on both sides.").
21. Examples of "fad diets" that have been recommended and then criticized include "fat free" and "no carb." See e.g. CENTER FOR SCIENCE IN THE PUBLIC INTEREST (CSPI), Press Release, CSPI Urges Crackdown on Carb Claims, Feb. 2, 2004, http://www.cspinet.org/new/200402021.html.
22. FDA, Consumer Health Information for Better Nutrition Initiative Task Force, Final Report (Jul. 10,2003) available at http://www.fda.gov/Food/ LabelingNutrition/LabelClaims/QualifiedHealth-Claims/ QualifiedHealthClaimsPetitions/ucm096010.htm.
23. Brenda Derby and Alan Levy, Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims, 34 (FDA, CFSAN, Office of Regulations and Policy, Division of Social Sciences, Working Paper No. 1, 2005) ("None of the different ways tested to communicate the strength of the science supporting a food label health claim performed very satisfactorily. The ways that the different disclaimers failed, however, may help us understand why it is so difficult to communicate strength of science to consumers.").
24. Bob's Red Mill, Wheat Free/Gluten Free/Dairy Free Brownie Mix, back panel (on file with author).
25. BERNDT VAN DER MEULEN and MENNO VAN DER VELDE, EUROPEAN FOOD LAW HANDBOOK 269 (2009)(quoting the EU's articulation of the precautionary principle: "In specific circumstances, where following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management is necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.").
26. For the purposes of this article, when the term precautionary principle is used, it means the adopted EU standard, though there are many different iterations of it; see Cass Sunstein, Beyond the Precautionary Principle, 151 U.PA.L.REV. 1003, 1011 (2003)("But what does the precautionary principle mean or require? There are numerous definitions, and they are not compatible with one another. We can imagine a continuum of understandings. At one extreme are weak versions to which no reasonable person could object; at the other extremes are strong versions that would appear to call for fundamental rethinking of regulatory policy.").
27. FALCPA §206, 21 U.S.C. § 343 (2009)("Not 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term 'gluten-free' on the labeling of foods.").
28. Gluten-free Labeling of Foods, Proposed Rule, 72 Fed. Reg. at 2803.
29. 21 U.S.C §403(j)(2009).
30. Betty Crocker, Gluten Free Cookie Mix, Chocolate Chip, Right Information Panel (2009)(on file with author).
31. Gluten-Free Labeling of Foods, Draft Report, 70 Fed.Reg. 35,258 (Jul. 14, 2005); Threshold Working Group, supra note 1, at Pt. III (A), Introduction.
32. FALCPA §202(6), 21 U.S.C. § 343 note (2006); see also Fasano, supra note 1, at 35 (quantifying the number of Americans with CD at more than 2 million).
33. Fasano, supra note 1, at 34 ("In 2003 ... the largest hunt for people with CD ever conducted in North America ... found that one in 133 apparently healthy subjects was affected ... meaning the disease was nearly 100 times more common than we thought.").
34. Threshold Working Group, supra note 1, at Pt. III (B), Mechanism of Pathogenesis.
35. Id. at (C), Range of Adverse Effects
36. Id.; see Jonas F. Ludvigsson et al, Small-Intestinal Histopathology and Mortality Risk in Celiac Disease, 302 J. OF THE AM. MED. ASSOC'N 1171, 1178 (2009).
37. Threshold Working Group, supra note 1, at (C), Range of Adverse Effects.
38. Id. at (E), Celiac Foods of Concern.
39. Codex Alimentarius Commission, General Standard for the Labeling of Prepackaged Foods, Stan. 1-1985;
40. General Standard the Labeling of and Claims for Prepackaged Foods for Special Dietary Uses, Stan. 146-1985, available at http://www.codexalimentarius. net/web/index-en.jsp.
41. Threshold Working Group, supra note 1, at (E).
42. Id. at (A) Introduction.
43. FALCPA §203(c); 21 U.S.C. §321(qq)(1)(definition of major food allergen).
44. Food Allergy and Anaphylaxis Network (FAAN), Wheat Card: How to Read a Label, https://www.foodallergy.org/shoppingcart/cgi-bin/msascartlist.dll/ ProductInfo?productcd=CWHE (last visited Oct. 6, 2009).
45. National Institutes of Health (NIH), Autism, http://www.niehs.nih.gov/ health/topics/conditions/autism/index.cfm (last visited Oct. 6, 2009).
46. E.g., Paul Ashwood and Judy van de Water, Is Autism an Autoimmune Disease? 3 AUTOIMMUNITY REVIEWS 557 (2004).
47. JENNY MCCARTHY, LOUDER THAN WORDS (2008) is a particularly well-known testament to the effects of the "diet," with some popular press characterizing its use as a "cure."
48. TACA, Gluten-free Casein-free diet, http://gfcf-diet. talkaboutcuringautism.org/index.htm (last visited Dec. 26, 2009);
49. DAN, Doctor Listing, http://www.autismwebsite.com/practitioners/us-lc.htm (last visited Dec. 26, 2009).
50. In re McDonald's French Fry Litigation, No. 06-C-4467 (ND. Ill. - E. Div.) (May 6, 2009) presents an interesting legal source for this proposition. The plaintiffs sought national class certification for all consumers who purchased McDonald's french fries and who had a medical diagnosis of celiac disease, autism, and wheat, gluten, or dairy allergies. The plaintiff's alleged McDonald's claimed their fries were gluten-free when they were not. The court summarized one of the defendant's experts testimony (by affidavit) as "most people with autism eat products containing milk, wheat, gluten, casein, and that there is no reliable evidence that any of these products contribute to or make worse a person's autism."
51. See also Gluten Free Casein Free Diets for Autism, http://www.webmd.com/ brain/autism/gluten-free-casein-free-diets-for-autism (last visited Dec. 9, 2009).
52. Scott-Thomas supra note 3.
53. E.g., Adam Voiland, Gluten-Free Diet: a Cure for Some, a Fad for Most, US NEWS AND WORLD REPORT (Oct. 31, 2008) available at: http://www.usnews.com/ health/family-health/digestive-disorders/articles/2008/10/31/ gluten-free-diet-a-cure-for-some-a-fad-for-most.html.
54. FALCPA, §202, 21 U.S.C. § 343 note (2006).
55. FALCPA, §206; 21 U.S.C. § 343 note (2006).
56. Codex Stan. 118-1979 available at http://www.codexalimentarius.net/web/ index-en.jsp.
57. Concerning the Composition and Labelling of Foodstuffs suitable for people intolerant to gluten, 2009 O.J. (L16) 3 (Jan. 21, 2009) (Commission Regulation No. 41/2009).
58. Australia New Zealand Food Standards Code 1991, Stan. 1.2.8 (16) (prohibiting gluten in products labeled "gluten-free," but permitting up to 20 ppm in foods labeled "low gluten"), available at www.comlaw.gov.au/coralaw/Legislation/.../FoodStandANZ91 .pdf.
59. Threshold Working Group, supra note 1, at IV(D), Gluten Threshold: Evaluation and Findings, Finding 9 ("The levels being considered by Codex seem to be based on anecdotal evidence ...").
60. FDA Docket 2005-N-0404, Doc. Id. FDA 2005-N-404-0124 (Carolyn Smith Pet'n Dec. 26, 2007 and FDA response June 27, 2008).
61. Gluten-free Labeling of Foods, Proposed Rule, 72 Fed. Reg. at 2801 (option two).
62. "The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme." For further information about its history and purpose, see http://www.codex-alimentarius. net/web/index-en.jsp (last visited Dec. 9, 2009);
63. see also WORLD HEALTH ORGANIZATION (WHO), CODEX ALIMENTARIUS FOOD LABELLING (5th ed. 2007).
64. Codex Stan. 118-1979.
65. Codex Stan. 118-1979, 2.1.1(a). The standard identifies wheat as all Triticum species, including durum wheat, spelt and kamut.
66. Codex Stan. 118-1979, 2.1.1(a), Fn. 1.
67. Codex Stan. 118-1979, 2.1.1.
68. Codex Stan. 118-1979. 2.1.1(b).
69. Codex Stan. 118-1979, 2.1.2.
70. Codex Stan 118-1979, 3.3.
71. See Codex Stan. 1-1985, General Standard for the Labeling of Prepackaged Foods; Codex Stan. 118-1979.
72. Codex Stan. 118, 4.1.
73. Codex Stan. 118, 4.2.
74. Codex Stan. 118, 4.3.
75. Id. The standard acknowledges that nations will likely need more detailed rules regarding naturally gluten-free food labeling.
76. Codex Stan. 118-1979, 5.1.
77. CODEX ALIMENTARIUS COMMISSION, Report of the 11th Session of the CCNFSDU, ¶ 55-70, (Oct. 23-27, 1978).
78. CODEX ALIMENTARIUS COMMISSION, Report of the 15th Session of the CCNFSDU, Appendix III, (July 4-15, 1983) (noting progress made on thresholds but consensus still not reached).
79. EC Reg. No. 41/2009 (Jan. 20, 2009).
80. EC Reg. No. 41/2009 (1).
81. Id. ai (6).
82. Id. at (7); Art. 3.
83. Id. at Art. 3 (1).
84. Id. at Art. 3 (2).
85. Id. at Art. 3 (5).
86. Id. at Art. 3 (3).
87. Id. at Art. 4 (1).
88. Food Safety Authority of Ireland [hereinafter FSAI], Report on Gluten-free Foods (2008) available at www.fsai.ie/assets/0/86/204/4a70f71b-7c15- 4e72-bd6f-c85deba481de.pdf.
89. FSAI, Update on Labeling Gluten-Free Foods (Mar. 2009), available at http://www.fsai.ie/.
90. Canada Gazette, Part I (July 26, 2008);
91. see also, The Bureau of Chemical Safety, Food Directorate, Health Canada, Health Canada Reviews Comments Received on Regulatory Project 1220, available at http://www.hc-sc.gc.ca/fn-an/label-etiquet/allergen/sum-comm-exa-eng.php [hereinafter Health Canada Comment Review].
92. Health Canada Comment Review at 2.
93. Id. at 4 ("once finalized, Health Canada and the Canadian Food Inspection Agency will aim to develop guidance, and compliance policy that clearly reflects the intent of the amendments with respect to gluten declaration.")
94. Id; see also Canada Food and Drug Regulations SOR/1995-444, s.2 (Can.) ("No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food unless the food does not contain wheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof.")
95. Id. at 3-4.
96. Id. at 7.
97. Australia New Zealand Food Standard Code, 1.2.8 (2003).
98. See supra note 56, discussing citizen's petition to FDA requesting zero gluten for gluten-free product label use.
99. FALPCA §201, 21 U.S.C. § 301 note, 343 note. See generally Laura E. Derr, When Food is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 Food & Drug L.J. 65 (2006).
100. Id. at §202(6); 21 U.S.C. § 343 note.
101. Id. at §202; 21 U.S.C. § 343 note; FALPCA § 203(c) amends the FDCA, 21 U.S.C. 321 (qq) by adding the term "major food allergen."
102. Sam Roe, Whole Foods Pull "Gluten-free" Products from Shelves after Tribune Story, Chicago Tribune, Dec. 31, 2008, http://www.chicagotribune. com/news/nationworld/chi-whole-foods-dec31,0,4055580.story.
103. Van's Voluntary Product Recall, http://www.vansfoods.com/homelvoluntary- product-recall(last visited Dec. 23, 2009);
104. see also Van's International Foods issues voluntarily product recall, Chicago Gluten-Free Food Examiner (Aug. 31, 2009) http://www.examiner.com/x- 13312-Chicago-GlutenFree-Food-Examiner~y2009m8d31-Vans-International-Foods- issues-voluntary-product-recall (last visited Dec. 23, 2009).
105. Email to author from Rhonda Kane, noting "As discussed on page 2803 of the FDA's proposed rule on gluten-free food labeling, the agency committed to conducting a safety assessment on gluten exposure in individuals with celiac disease. FDA has completed that assessment, which has undergone an expert peer review. FDA is now in the process of reviewing the comments of the peer reviewers to make whatever changes in the safety assessment are appropriate before its availability is announced in the Federal Register (FR). The agency expects to publish an FR notice in the near future to reopen the comment period on the proposed rule and to share the safety assessment. FDA will consider the comments received in response to this notice and on the proposed rule as well as the findings of the safety assessment and the other factors (i.e., ease of compliance and enforcement, stakeholder concerns, economics, trade issues and legal authorities) also mentioned in the proposal to develop a final rule. When the FR notice on the safety assessment is published, a link to it likely will be posted at FDA website http://www.fda.gov/Food/LabelingNutrition/ FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/ default.htm under the subheading "Gluten-Free;" therefore, interested parties may wish to check that website periodically for updates. The final rule will be published sometime after the comment period closes for the FR notice on the safety assessment and FDA has had a chance to review the public comments it receives. At the present time, FDA cannot predict the publishing date of the final rule." (July 16, 2009) (copy on file with author).
106. FDA rulemaking addressed requests for gluten-free label regulation as early as 1993. At the time, FDA decided to allow the use of the term "when as used it is not false or misleading." It further indicated its willingness to consider more specific rules if "petitioned with sufficient information, including analytical methodology for food analysis." 58 Fed. Reg. 2850, 2864 (Jan. 6, 1993). As we now know, that analytical methodology remains an issue.
107. 70 Fed. Reg. 29528 (May 23, 2005).
108. Id.; see also Threshold Working Group, supra note 1.
109. Food Advisory Committee, Notice of Meeting, 70 Fed. Reg. 35,258 (June 17, 2005).
110. FDA Response to Pubic Comments on the Draft Report "Approaches to Establish Thresholds for Major Food Allergens and Gluten in Food" available at http://www.fda.gov/Food/LabelingNutrition/FoodAllergens.
111. An Analytic Methods-Based Approach establishes a "regulatory threshold' by using the sensitivity of the analytic method(s) that can be used to verify compliance to determine the threshold. Threshold Working Group, supra note 1, at III (D).
112. Id. The Safety Assessment-Based Approach uses the degree of certainty and an assumption of negligible risk to assess public health issues and issues related to substances in food.
113. Id. A Risk Assessment approach evaluates systematic, scientific examination of possible negative health effects from exposure to a hazard and decides its severity by 1) hazard identification, 2) exposure assessment, 3) hazard characterization, and 4) risk characterization.
114. Id. The Statutorily Derived Approach establishes a threshold by extrapolating from an exemption established by Congress for another purpose.
115. Threshold Working Group, supra note 1, at Table 1 at 1; 12.
116. Id. (though it is not clear whether this comment was directed at food allergens, gluten, or both).
117. FDA Response to Pubic Comments on the Draft Report, supra note 113, at Consumer Association Comment.
118. Gluten-free Labeling of Foods, Public Meeting, 70 Fed. Reg. 41,356 (Jul. 19, 2005);
119. Tr. Of Public Meeting on Gluten-free Food Labeling (Aug. 19, 2005) [hereinafter Tr. of Public Meeting].
120. Comments of Jane DeMarchi, Coordinator of Technical and Export Programs, North American Millers' Association, Tr. of Public Meeting, supra note 119, at 48.
121. Id. at 50-51.
122. Id. at 56-57.
123. Id. at 58.
124. Comments of Dennis Gilliam, Executive Vice President, Bob's Red Mill Natural Foods, Tr. of Public Meeting, supra note 119, at 68-69.
125. Id. at 81.
126. Id. at 83.
127. Comments of Ms. Berger, Miss Roben's, Tr. of Public Meeting, supra note 119, at 86.
128. Id. at 88, 97.
129. Comments of Dr. William Hurkman, Tr. of Public Meeting, supra note 119, at 145-146.
130. Comments of Dr. Yeung, Tr. of Public Meeting, supra note 119, at 155-174. (This summary cannot do justice to the scientific expertise offered by Dr. Yeung regarding the various commercial test kits, and readers are encouraged to review Dr. Yeung's complete testimony for a full description.)
131. Id. at 160, 164, 179.
132. Comments of Ms. Mary Schluckebier, Executive Director, Celiac Sprue Association, Tr. of Public Meeting, supra note 119, at 183.
133. Id. at 193.
134. Id. at 194-195.
135. Comments of Ann Lee, Nutritionist, Celiac Disease Center, Tr. of Public Meeting, supra note 119, at 215.
136. Id. at 222.
137. Gluten-free Food Labeling, Proposed Rule, 72 Fed.Reg. 2795 (Jan. 23, 2007).
138. 72 Fed. Reg. at 2801-2802.
139. Id. at 2805.
140. Id. at 2806.
141. Id. at 2811.
142. Id. at 2812.
143. Id. at 2805.
144. 21 C.F.R. §101.60(b)(2009)("caloriefree");§101.60(e) ("sugarfree");§101.61(b)("sodiumfree"); §101.62(b)("fat free");§101.62(d)("cholesterol free").
145. 21 C.F.R. §101.62(b)(i).
146. Id. at 2802.
147. Id. at 2797.
148. See Kane email, supra note 105.
149. 21 C.F.R. § 101.62 (b)(1)(2009).
150. Readers should understand that FDA is researching consumer perception of gluten-free labels. Gluten-Free Labeling of Food Products Experimental Study, 74 Fed. Reg. 9822 (Mar. 6, 2009);
151. 74 Fed. Reg. 59188 (Nov. 17, 2009).
152. E.g., NIH, Consensus Development on Celiac Disease Conference Statement, June 28-30, 2004 available at http://consensus.nih.gov/2004/ 2004CeliacDisease118html.htm.
153. Compare Catassi, supra note 11 at 165 ("The threshold of 20 ppm keeps the intake of gluten from 'special celiac food' well below the amount of 50 mg/d, which allows a safety margin for the variable gluten sensitivity and habits of patients) with Pekka Colin, Letter to the Editor, A Safe gluten threshold for patients with celiac disease: some patients are more tolerant than others, 86 AM. J. CLINICAL NUTRITION 260 (2007) ("Whether the safe limit of gluten contamination should be 0, 20, 50, or 100 ppm remains to be seen. As the study by Catassi ... showed, celiac disease patients respond individually to small amounts of gluten.")
154. Sunstein, supra note 19, at 1014.
155. For an interesting and informative opinion about the precautionary principle, scientific evidence, and public health see David Kriebel and Joel Tickner, Reenergizing Public Health through Precaution, 91 AM. J. OF PUB. HEALTH 1351, 1353 (2001) (noting that "[t]he precautionary principle represents a call to reevaluate the ways in which science informs policy, and in particular the ways in which scientific uncertainty should be handled" [and that] "more and better investigation and communication of uncertainties (what we know, what we do not know, what we cannot know) in study results will assist a more open decision-making process.")
156. VAN DER MEULEN, supra note 19, at 271.
157. FALCPA § 208; 42 U.S.C. §243 note (2006).
158. E.g. Catassi, supra note 163.
159. Hossam M. Nassef, et al., Electrochemical Immunosensor for Detection of Celiac Disease Toxic Gliadin in Foodstuff, 80 ANALYTICAL CHEM. 9265, 9266 (2008) (reporting a new testing method capable of ppb with accuracy comparable to ELISA);
160. see also Jefferson Adams, Rapid Gluten Detection Test for Food Products Promises Better Product Labeling, Easier Gluten-free Shopping, (Nov. 19, 2008) http://www.celiac.com/articles/21695/Rapid-Gluten-Detection (last visited Dec. 29, 2009) (reporting on meaning of Nassaf research for those with CD).
161. VAN DER MEULEN supra note 19, at 272.
162. Id. at 272-273.
163. This is not a concern to take lightly. For example, the food industry's reaction to an earlier attempt at allergen labeling requiring gluten declaration resulted in "industry demand[s] that this provision be removed due to concerns about liability given the dearth of scientific knowledge about gluten tolerance levels." Derr, supra note 97, at 145.
164. VAN DER MEULEN supra note 19, at 273.
165. E.g. Belen Moron, et. al. Sensitive Detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide 87 AM. J. CLINICAL NUTRITION 405, 412 (discussing the evolution in gluten testing methodology and noting an emerging test, G12 MoAb, may be particularly well suited to studying oat avenins).
166. VAN DER MEULEN, supra note 19, at 272.
167. Sunstein, supra note 19, at 1015 (offering the conundrum of labeling of GMOs as an example of an "information disclosure precautionary principle").
168. See supra note 12 and accompanying text.
169. 21 C.F.R. §101.14(a)(1) (2009); see 21 U.S.C. § 343 (r)(3) (2006).
170. 164 F.3d 650 (D.C. Cir. 1999) (holding the First Amendment does not permit FDA to reject potentially misleading health claims unless the FDA reasonably finds that a disclaimer would not eliminate the potential for consumer deception).
171. Consumer Health Information Task Force Report, supra note 15, at 4.
172. E.g., Derby and Levy, supra note 17.
173. Clare Hasler, Health Claims in the United States: An Aid to the Public or a Source of Confusion, J. OF NUTRITION, S1216, S1218
174. (further analyzing FDA's working paper from CFSAN, Experimental Study of Health Claims on Food Packages, report (May 2007)).
175. Id. at S1219.
176. Gluten-Free Labeling of Food Products Experimental Study, 74 Fed. Reg. 9822 (Mar. 6, 2009).
177. 21 U.S.C. § 343(r)(3)(B)(i)(2006).
178. The Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, § 303 and 304, 21 U.S.C. § 403(r)(3) and (2)(2006) (permitting published, authoritative statements from NIH or CDC to form the basis of manufacturer's health claim).