Published online by Cambridge University Press: 01 January 2025
The prevention and control of ‘food fraud’, including false or misleading statements made about a product for economic gain, is now emerging as an important and discrete policy goal for governments and regulators in the interface between food and public health. The control and prevention of food fraud complements regulation to ensure microbial food safety. This article uses a case study of anti-ageing claims made in the labelling and advertising of açai berry superfood products to argue that Australia's new regulatory system for nutrient content and health claims on food (Australia and New Zealand Food Standards Code Standard 1.2.7) inadequately addresses ‘food fraud’. This article argues that the over-reaching claims on açai product labelling will potentially mislead consumers and subvert public health messages in a context of ‘gastro-anomy’ (confusion over appropriate norms for eating) and ‘healthism’ (individual responsibility for making healthy choices). This conduct can usefully be conceptualised as food fraud. Second, the article argues that although the substance of Standard 1.2.7 is well designed to avoid food fraud, the fact that the standard allows food businesses to self-substantiate evidence when making some health claims undermines the protection offered. Australian food regulators need to articulate a more strategic and proactive approach to the prevention and control of food fraud.
The research in this paper was partially supported by funding from Australian Research Council Discovery Project 140100484 A Sociological Analysis of the Anti-Ageing Treatment Market: The Dynamics of Expectations.
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13 See below nn 101–21 and accompanying text.
14 Ibid.
15 See below nn 122–42 and accompanying text.
16 See below nn 159–63 and accompanying text.
17 See below nn 31–3 and accompanying text.
18 European Parliament, European Parliament resolution of 14 January 2014 on the food crisis, fraud in the food chain and the control thereof (2013/2091(INI) (14 January 2014) <http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2014-0011&language=EN&ring=A7-2013-0434>.
19 Spink and Moyer, above n 9.
20 Ibid R160. The Spink and Moyer ‘Food Protection Risk Matrix’ incorporates 4 pillars of a food protection system: ‘food quality, food safety, food fraud and food defense’ within the umbrella concept of ‘food security’. The motivations (economic gain or harm such as public health, economic, or terror related harm) are represented in the matrix with reference to whether an action was ‘unintentional’ or ‘intentional’.
21 Ibid. Food fraud is further distinguished from ‘food defense’ in the ‘Food Protection Risk Matrix’ where although both ‘food fraud’ and ‘food defense’ are intentional acts, the motivation for ‘food defense’ is to cause harms to public health or economics.
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26 See, eg, the prosecution of a drinks company for the false description of a diluted concentrate of deionised apple juice with added preservative, as ‘99% apple juice, preservative free’: NSW Food Authority (Officer Ian Beer) v P & N Beverages Pty Ltd (Unreported, Local Court of NSW, Magistrate GJT Hart, 21 July 2008).
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28 See European Parliament, above n 18, where the Resolution includes within its scope ‘Regulation (EC) No 1924/2006 on nutrition and health claims made on foods and Regulation (EU) No 1169/2011 on the provision of food information to consumers’.
29 Common law ‘fraud’ initially required proof that the maker of a statement knew it was untrue. See, eg, Alati v Kruger (1955) 94 CLR 216. More recent common law fraud cases reveal a test of whether the maker honestly believed the representation to be true, see AIC Ltd v ITS Testing Services (UK) Ltd The Kriti Palm [2006] EWCA Civ 1601, 398. US courts have made it clear that ‘deceptive or misleading commercial speech can still be considered a form of fraud, undue influence, over-reaching, or other vexatious conduct’, Ohralik v Ohio State Bar Association, 436 US 447, 462 (1978) cited in Gostin, Lawrence, Public Health Law: Power, Duty, Restraint (University of California Press, 2000) 160.Google Scholar
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31 Competition and Consumer Act 2010 (Cth) sch 2 s 29; Competition and Consumer Act 2010 (Cth) sch 2 s 18(1) where a breach of the prohibition gives rise to civil remedies. See Chapter 4 of the ACL for criminal liability for certain breaches. Under the ACL, a graduated series of sanctions are provided for misleading or deceptive conduct, as opposed to civil penalties and remedies. The prohibitions are replicated in fair trading legislation in each State and Territory as part of the ACL: Fair Trading Act 1987 (NSW) s 28; Fair Trading Act 1989 (Qld) s 16; Fair Trading Act (SA) s 14; Australian Consumer Law (Tasmania) Act 2010 (Tas) s 6; Fair Trading Act 1999 (Vic) s 9; Fair Trading Act 2010 (WA) s 11; Fair Trading (Australian Consumer Law) Act 1992 (ACT) s 7; Consumer Affairs and Fair Trading Act 1990 (NT) s 27.
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34 Therapeutic Goods Act 1989 (Cth) s 3 provides the definition of therapeutic good, which excludes ‘goods (other than goods declared to be therapeutic goods under an order in force under s 7) for which there is a Standard (within the meaning of sub-s 4(1) of the Food Standards Australia New Zealand Act 1991)’ or ‘goods (other than goods declared to be therapeutic goods under an order in force under s 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented’.
35 See generally Commissioner Sarah Court, ‘Enforcement Priorities at the ACCC’ (Speech delivered at the Commonwealth Club of Adelaide, 24 September 2013) <http://www.accc.gov.au/speech/enforcement-priorities-at-the-accc>; See also ACCC, ‘ACCC Enforcement Guidance—Free Range Hen Egg Claims’ (Guidance Document, ACCC, 5 October 2015).
36 See, eg, Australian Competition and Consumer Commission v Pirovic Enterprises Pty Ltd [No 2] (2014) ATPR 42–483 (23 September 2014); Australian Competition and Consumer Commission v RL Adams Pty Ltd [2015] FCA 1016 (11 September 2015); Australian Competition and Consumer Commission v Turi Foods Pty Ltd [No 2] [2012] FCA 19 (23 January 2012); Australian Competition and Consumer Commission v Turi Foods Pty Ltd [No 4] [2013] FCA 665 (8 July 2013); Australian Competition and Consumer Commission v Pepe's Ducks Ltd [2013] FCA 570 (14 June 2013).
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42 FSANZ is obligated to consider the objects of Food Standards Australia New Zealand 1991 (Cth) s 18(1), which explicitly prioritised in the following descending order: ‘the protection of public health and safety’, the ‘provision of adequate information relating to food to enable consumers to make informed choices’ and the ‘prevention of misleading or deceptive conduct’.
43 Implementation Subcommittee for Food Regulation (‘IFSR’), ‘Health claims and Enforcement—How Regulators Will Enforce the Nutrition and Health Claims Standard’ (Guidance Document, Department of Health (Cth), 2015) 4. The associated ISFR, ‘Bi-National Food Labelling Compliance and Enforcement Strategy’ (Guidance Document, Department of Health (Cth), 2015) distinguishes the risk of ‘direct, acute, immediate threats to health’ from ‘indirect, long term impacts on health’ and the lowest risk to ‘consumer perceptions and ethical views’. Health claim compliance—preventative health/ indirect, long-term impacts on health—is the second priority for the attention of regulators, according to the Strategy. See Australia and New Zealand Ministerial Forum on Food Regulation, ‘Overarching Strategic Statement for the Food Regulatory System’ (Guidance Document, Department of Health (Cth), 2008).
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47 An ethnically mixed Amerindian and European/Portuguese settler group.
48 See Colapinto, above n 46.
49 Heinrich, Dhanji and Casselman, above n 45, 11.
50 Colapinto, above n 46.
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67 In Australia, açai berry products are advertised and sold online, in health food stores, pharmacies, supermarkets, cafes and gyms. All trademarks registered in Australia with the terms ‘açai’ or ‘amazon’ found on IP Australia were recorded and the Australian trademarked websites accessed. Details of açai products advertised for sale on the trademark related websites were compiled. The ‘açai’ term was applied in the search of the ASIC business and company names database. Entities with the word ‘açai’ in the name not initially identified through the use of a registered trademark were selected and searches of websites were conducted to collate details on the açai products for sale. The Australian Certified Organics (‘ACO’) database was accessed using the keyword ‘açai’ and a search was conducted. Company websites identified through ACO were searched and the details of further açai products available for sale compiled. Google searches using the terms ‘açai’ and ‘buy’ identified additional ‘açai’ products available for sale in Australia. Products were also identified in searches of Australian sellers on ebay.com.au. Those products not previously identified were added to the Excel spread sheet compilation.
68 Including one specialist café.
69 Images of packaging labels for each product available for review online were observed and information recorded. A total of five (5) Sydney located health food stores and pharmacies were visited in a search for the pills, juices and powdered açai products identified online in an effort to record any omitted information contained on labels at retail. Not all products were observed on the shelves of the visited retail stores. For the products located, photographs were taken and information presented on labels recorded with the compiled information. One cafe and one juice bar found to be selling the two frozen pulp products, respectively, was visited in Sydney and the product information detailed on the labels were recorded along with additional information provided in advertising pamphlets at point of sale. All information provided in the advertising (online content, label information and/or point-of-sale pamphlets) of the identified products was compiled into the Excel spread sheet to facilitate the analysis.
70 See below nn 95–8 and accompanying text.
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72 Ibid. Technically known as ‘reactive oxygen species’.
73 The US National Cancer Institute at the National Institute of Health defines antioxidants as ‘chemicals that interact with and neutralize free radicals’ (unstable molecules made by the process of oxidation during normal metabolism). Free radicals may play a part in cancer, heart disease, stroke, and other diseases of aging. Antioxidants include beta-carotene, lycopene, vitamins A, C, and E, and other natural and manufactured substances’. National Cancer Institute, Antioxidants and Cancer Prevention (16 January 2014) <https://www.cancer.gov/about-cancer/causes-prevention/risk/diet/antioxidants-fact-sheet>.
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75 In an example from our study, Natures Goodness® Açai Power™ claims ‘Açai Power™ is a potent source of antioxidants—substances which protect the body from the harmful effects of free radicals and oxidative damage …’.
76 In an example from our study, Amazon Power® Pure Açai pulp claims ‘Helps you look younger and live longer! With the highest concentration of antioxidants of any berry on the plant, açai helps reduce the signs of ageing and stress’.
77 In an example from our study, Bioglan® Açai + Berry powder claims ‘What: Açai Berry. Why: Originating in the Amazon these berries are packed full of nutrients, particularly antioxidants. … Antioxidants protect our body from damaging effects of inflammation, an aggravating factor in heart disease.’ The regulatory regime for high level health claims is discussed below nn 101–21 and accompanying text.
78 Khurana, Sandhya, Venkataraman, Krishan, Hollingsworth, Amanda, Piche, Matthew and Tai, T.C., ‘Polyphenols: Benefits to the Cardiovascular System in Health and in Ageing’ (2013) 5(10) Nutrients 3779, 3797–8.CrossRefGoogle Scholar Specifically, it is the ‘anthocyanins’ (a particular type of polyphenol) that are highly concentrated in the açai berry that is claimed to be of particular benefit. These anthocyanins are associated with the dark purple pigmentation in açai berries and are also found in cranberries, raspberries, blueberries, red grapes, red cabbage, eggplant skin and plums. See Carlos Espín, Juan, García-Conesa, Maria and Tomás-Barberán, Francisco, ‘Nutraceuticals: Facts and Fiction’ (2007) 68(22) Phytochemistry 2986, 2987.CrossRefGoogle Scholar See also, Schreckinger, Maria Elisa, Lotton, Jennifer, Ann Lila, Mary and de Mejia, Elvira Gonzalez, ‘Berries from South America: A Comprehensive Review on Chemistry, Health Potential and Commercialization’ (2010) 13(2) Journal of Medicinal Food 233.CrossRefGoogle ScholarPubMed
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80 See Rubio, Laura, Macia, Alba, and Motilva, Maria-Jose, ‘Impact of Various Factors on Pharmacokinetics of Bioactive Polyphenols: An Overview’ (2014) 15(1) Current Drug Metabolism 62.CrossRefGoogle ScholarPubMed See also Mena, Pedro, Martis, Nuria, Garcia-Viguera, Cristina, ‘Varietal Blends as a Way of Optimizing and Preserving the Anthocyanin Content of Pomegranate (Punica granatum L.) juices’ (2014) 62(29) Journal of Agricultural and Food Chemistry 6936.CrossRefGoogle ScholarPubMed For a discussion on the variability of measured antioxidant capacities and the effects of simulated digestion of dietary supplements in vitro, see Henning, Susanne, Zhang, Yanjun, Rontoyanni, Victoria, Huang, Jianjun, Less, Ru-Po, Trang, Amy, Nuernberger, Gloria and Heber, David, ‘Variability in the Antioxidant Activity of Dietary Supplements from Pomegranate, Milk Thilste, Green Tea, Grape Seed, Goji, and Açai Effects on in vitro Digestion’ (2014) 62(19) Journal of Agricultural and Food Chemistry 4313.CrossRefGoogle ScholarPubMed Further note that because laboratory-measured activity in vitro does not reflect the activity in the human body, such measurements ‘cannot be an indicator for its ‘goodness’ to the human body’, Espin, García-Conesa and Tomás-Barberám, above n 78.
81 In an example from our study, RioLife® 100% Organic Freeze-dried Açai powder claims ‘When measuring a food's antioxidant potential, scientists use a scale called ORAC (oxygen radical absorbance capacity). Using the ORAC scale, açai berries are one of the most potent sources of antioxidants you’ll ever find. In fact, while fresh fruit or veggies provide you with 890 to 2500 ORAC units per serving, just one 5 gram serving of 100% Certified Organic Açai powder packs in a whopping 4,695 ORAC units … so think of the antioxidant capacity of açai berries like this: one 5 gram tablespoon of 100% Certified Organic Açai powder contains about the same amount of antioxidants as 120 blueberries.’
82 United States Department of Agriculture Agricultural Research Service, Frequently Asked Questions: What is the Status of the USDA Database for the ORAC of Selected Foods? (15 August 2016) United States Department of Agriculture <http://www.ars.usda.gov/Main/docs.htm?docid=6233>.
83 Heinrich, Dhanji and Casselman, above n 45.
84 Magrone, Thea, de Heredia, Fatima, Jirillo, Emilio, Morabito, Giuseppa, Marcos, Ascension and Serafini, Mauro, ‘Functional Foods and Nutraceuticals as Therapeutic Tools for the Treatment of Diet-Related Diseases’ (2013) 91 Canadian Journal of Physiology and Pharmacology 387, 393.CrossRefGoogle ScholarPubMed The authors state that ‘further and more homogenous investigations in humans are needed to identify the bioactive ingredients in food involved in the modulation of low-grade inflammation in diet-related disease’. The US National Centre for Complementary and Alternative Medicine advises there is a lack of ‘definitive scientific evidence based on studies in humans to support the use of açai berry for any health-related purpose’: National Centre for Complementary and Integrative Health, Açai (12 April 2016) National Institutes of Health <http://nccam.nih.gov/health/açai/ataglance.htm>.
85 Nagle, Christina, Wilson, Louise, Hughes, Maria Celia, Ibiebele, Torukiri, Miura, Kyoko, Bain, Christopher, Whiteman, David and Webb, Penelope, ‘Cancers in Australia in 2010 Attributable to Inadequate Consumption of Fruit, Non-Starchy Vegetables and Dietary Fibre’ (2015) 39 Australian and New Zealand Journal of Public Health 422.CrossRefGoogle ScholarPubMed The review implies that ‘increasing the proportion of Australians who consume the recommended intake of fruit, vegetables and fibre could prevent up to 4% of all cancers’.
86 Dauchet, Lus, Amouyel, Phillippe, Hercberg, Serge and Dallongeville, Jean, ‘Fruit and Vegetable Consumption and Risk of Coronary Heart Disease: A Meta-Analysis of Cohort Studies’ (2006) 136 Journal of Nutrition 2588.CrossRefGoogle ScholarPubMed
87 See Mario Perez-Jimenez, Vos Neveu, Augustin Scalbert, ‘Identification of the 100 Richest Dietary Sources of Polyphenols: an Application of the Phenol-Explorer Database’ (2010) 64 European Journal of Clinical Nutrition S112, S114.
88 Philpott, above n 52.
89 For example, an açai berry fruit juice drink in Woolworths refers to ‘The açai berry from the Brazilian rainforest’ as ‘the tree of life’. Another line of açai juice products from MonaVie™ suggests that, ‘[f]or countless centuries, the people of the Amazon have revered this unique fruit for its nutritional content and prized it as a source of health and vitality’.
90 The recommended retail price for 50g of açai berry powder purchased online is in the range of $15 to $20, while a kilo of powder retails at around $250.
91 In an example from our study, Bioglan® Açai + Berry Powder claims ‘[n]ow you can unlock the energy of the Amazon & better health every day. Açai + Berry powder delivers a powerful dose of supercharged berries to revitalize your body. A combination of berries including the superfruits Açai, Goji and Pomegranate plus Blueberry, it delivers vital nutrients, minerals and loads of antioxidants in their natural form for purer health … This antioxidant rich supplement helps protect your cells from the damaging effects of free radicals. The more colour the better! These deep blue, purple and red berries are particularly rich in antioxidants, anthocyanins and polyphenols turning them from berries to SUPERBERRIES!’.
92 Colapinto, above n 46; see also Loyer, above n 53.
93 Puffery in advertising is the use of words or statements not intended to be statements of fact and therefore not a ‘representation’. See, for example, Magennis v Fallon (1828) LR 2 Ir 167; 2 Mol 561, 588. The legislative prohibitions on misleading or deceptive conduct make no distinction between representations and puffery; the courts decide on the basis of the facts.
94 For example, half-truths may be misleading due to the erroneous conclusion permitted to be drawn from insufficient information: see, eg, Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 634 (18 June 2014) (‘Baked Today, Sold Today’, ‘freshly baked’, ‘baked fresh’ claims on imported, par baked bread finished in store ovens). Allsop CJ cites Fraser v NRMA Holdings Ltd (1994) 124 ALR 548, 563. At [47], Allsop CJ noted, ‘Where advertising material uses simple phrases and words evoking attractive notions, but without necessarily precise meaning, ambiguity or reasonably available different meanings may well arise. Context and the “dominant message” will be important. If one or more of the reasonably available different meanings is misleading, the conduct may well be misleading or deceptive, or false and misleading’. Further, the Courts consider that ‘literal truths’ must not create false impressions: see Hornsby Building Information Centre Pty Ltd v Sydney Building Information Centre Ltd (1978) 140 CLR 216, 227. However, the protections do not extend to obvious exaggerations or conduct that is merely confusing: see Ballantyne v Raphael (1889) 15 VLR 538, 547; 11 ALT 34.
95 Anne Cronin makes the point that commodities, such as the açai berry in this survey, are ordered and re-ordered by marketing, converting conventional food to a new status: Cronin, Anne, ‘Regimes of Mediation: Advertising Practitioners as Cultural Intermediaries’ (2004) 7(4) Consumption, Markets and Culture 349, 364–5CrossRefGoogle Scholar, cited in Schneider and Davis, above n 65, 33.
96 Terminology coined in Herbert, Victor, ‘Health Claims in Food Labelling and Advertising: Literal Truths but False Messages; Deceptions by Omission of Adverse Facts’ (1987) 22(3) Nutrition Today 25.CrossRefGoogle Scholar
97 Joint FAO/WHO Codex Alimentarius Commission, Guidelines for Use of Nutrition and Health Claims: CAC/GL 23–1997, 8.1.3.
98 Therapeutic Goods Act 1989 (Cth) s 3. See above n 34 and accompanying text.
99 Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods [2006] OJ L 404/9, art 1.3 (‘Health Claims Regulation (EC) 1924/2006’).
100 Food Standards Australia New Zealand, ‘P293 Review Report—Nutrition, Health and Related claims’ (Review Report, FSANZ, 2012) 49.
101 Standard 1.2.7 s 2 provides that ‘health claim means a claim which states, suggests or implies that a food or property of food has, or may have, a health effect’. Standard 1.2.7 s 20 provides how health claims are to be made.
102 Ibid. ‘[H]igh level health claim means a health claim that refers to a serious disease or a biomarker of a serious disease’.
103 Ibid s 18(3)(b) where sch 6 prescribes the elements of a systematic review.
104 Ibid. A ‘general level health claim means a health claim that is not a high level health claim’.
105 Ibid s 18(1)(a) provides that to carry a health claim, foods must meet a value-based scheme critical of energy, saturated fatty acids, sugars and sodium levels.
106 See Standard 1.2.7 sch 5. For critical discussion see Gyorgy Scrinis and Parker, Christine, ‘Front-of-pack Labelling and the Politics of Nutritional Nudges’ (2016) 38(3) Law & Policy 234.Google Scholar
107 The Code, Transitional Standard on Health Claims Standard 1.1A.2 s 3.
108 See, eg, Williams, Peter, Yeatman, Health, Ridges, Leisa, Houston, Annalie, Rafferty, Jillian, Roesler, Anna, Sobierajski, Megan and Spratt, Bronwyn, ‘Nutrition Function, Health and Related Claims on Packaged Australian Food Products—Prevalence and Compliance with Regulations’ (2005) 15(1) Asia Pacific Journal of Clinical Nutrition 10Google Scholar; Williams, Peter, Yeatman, Heather, Zakrzewski, Sally, Aboozaid, Brooke, Henshaw, Simon, Ingram, Kendall, Rankine, Alex and Waleott, Sara, ‘Nutrition and Related Claims Used on Packaged Australian Foods—Implications for Regulation’ (2003) 12(2) Asia Pacific Journal of Clinical Nutrition 138Google ScholarPubMed, where 12.9% of 6662 products were non-complaint with Transitional Health Claim Standard 1.1A.2.
109 See, eg, Dragicevich, Helen, Williams, Peter and Ridges, Leisa, ‘Survey of Health Claims for Australian Foods Made on Internet Sites’ (2006) 63 Nutrition & Dietetics: The Journal of the Dietitians Association of Australia 139.CrossRefGoogle Scholar The survey of 1068 websites found 14.5% carried a health claim where 19.7% identified were high level of claims of therapeutic action.
110 Food Standards Australia New Zealand, ‘Proposal P293 Nutrition, Health & Related Claims Regulation Impact Statement’ (Regulatory Impact Statement, FSANZ, 2012) 6.Google Scholar
111 Australian Food and Grocery Council (AFGC) Code of Practice on Nutrient Claims in Food Labels and in Advertisements (Code of Practice, AFGC, 1995) <http://www.foodstandards.gov.au/publications/pages/codeofpracticeonnutr4709.aspx>.
112 Joint FAO/WHO Codex Alimentarius Commission, Guidelines for use of nutrition and health claims: CAC/GL 23–1997, as amended (Rome, Food and Agriculture Organization of the United Nations 2010) recommends inter alia at para 8, health claims be based on ‘current relevant scientific substantiation and the level of proof must be sufficient to substantiate the type of claimed effect and the relationship to health as recognised by generally accepted scientific review of the data and the scientific substantiation should be reviewed as new knowledge becomes available’, and ‘Any health claim must be accepted by or be acceptable to the competent authorities’ where ‘if the claimed effect is attributed to a constituent of the food, there must be a validated method to quantify the food constitute that forms the basis of the claim’.
113 A 2015 review of 28 jurisdictions revealed Barbados, Canada, Central America, Colombia, Ecuador, Europe, Indonesia, the Republic of Korea and the USA require newly established disease risk reduction claims to be positively assessed by a government authority. Argentina, Brazil, China, Japan and Singapore require approval of all disease risk reduction claims, previously approved claims included. The ‘health foods’ licensing regimes in China, Japan and Singapore require marketers to seek approvals to use disease risk reduction claims. De Boer, Allie and Bast, Aalt, ‘International Legislation on Nutrition and Health Claims’ (2015) 55 Food Policy 61, 65.CrossRefGoogle Scholar
114 Standard 1.2.7 s 2 provides that serious disease means ‘a disease, disorder or condition which is generally diagnosed, treated or managed in consultation with or with supervision by a health care professional’.
115 Ibid s 8.
116 Ibid sch 6.
117 Ibid s 19(1)(d)(ii).
118 Food Standards Australia New Zealand, ‘Proposal P293 Nutrition, Heath and Related Claims’ (Regulation Impact Statement, FSANZ, October 2021) 4.
119 Ibid.
120 Health Claims Regulation (EC) 1924/2006 art 1.
121 Model Food Act 2000 (Cth) s 1(b).
122 The EU register on nutrition and health claims permitted for use in the sale of foods can be accessed: <http://ec.europa.eu/nuhclaims/?event=register.home>.
123 Health Claims Regulation (EC) 1924/2006 art 10.
124 Bast, Aalt, Briggs, William, Calabrese, Edward, Fenech, Michael, Hanekamp, Jaap, Heaney, Robert, Rijkers, Ger, Schwitters, Bert and Verhoeven, Pieternel, ‘Scientism, Legalism and Precaution—Contending with Regulating Nutrition and Health Claims in Europe’ (2013) 6 European Food and Feed Law Review 401.Google Scholar
125 Health Claims Regulation (EC) 1924/2006 art 5.1.
126 The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies is chaired by Albert Flynn and representatives from 21 member states. It conducts the scientific assessment to evaluate health claims and publishes outcomes as scientific opinions in European Food Safety Authority Journal.
127 See European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘General guidance for Stakeholders on the Evaluation of Article 13.1, 13.5 and 14 Health Claims’ (2011) 9 European Food Safety Authority Journal 2135.Google Scholar
128 Flynn, A, ‘Scientific Substantiation of Health Claims in the EU’ (2012) 71 Proceedings of the Nutrition Society 120, 123.CrossRefGoogle ScholarPubMed
129 For a full understanding of all authorised and non-authorised food health relationships, a search of the European Register on Nutrition and Health claims can be performed. See the outcome from a search using these terms at <http://ec.europa.eu/nuhclaims>.
130 European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘Scientific Opinion on the Substantiation of Health Claims Related to Polyphenols in Olive and Protection of LDL Particles from Oxidative Damage’ (2011) 9(4) European Food Safety Authority Journal 2033.Google Scholar
131 European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘Scientific Opinion on the Substantiation of Health Claims Related to Various Food(s)/Food Constituent(s) and Protection of Cells from Premature Ageing (ID 1668, 1917, 2515, 2527, 2530, 2575, 2580, 2591, 2620, 3178, 3179, 3180, 3181, 4329, 4415), antioxidant activity, antioxidant content, and antioxidant properties (ID 857, 1306, 2515, 2527, 2530, 2575, 2580, 2591, 2629, 2728, 4327, 4365, 4380, 4390, 4394, 4455, 4464, 4507, 4694, 4705), protection of DNA, proteins and lipids from oxidative damage (ID 1196, 1211, 1216, 1306, 1312, 1440, 1441, 1666, 1668, 1692, 1900, 1914, 1948, 2023, 2158, 2517, 2522, 2527, 2575, 2591, 2620, 2637, 2639, 2663, 2860, 3079, 3276, 3564, 3818, 4324, 4329, 4351, 4397, 4416, 4424, 4507, 4527, 4528, 4542, 4611, 4629, 4659), and bioavailability of anthocyanins in black currants (ID 4220) pursuant to Article 13(1) of Regulation (EC) No 1924/2006’ (2010) 8(10) European Food Safety Authority Journal 1752, 17.
132 Ibid 18.
133 Ibid 20.
134 European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘Scientific Opinion on the substantiation of health claims related to flavonoids and ascorbic acid in fruit juices including berry juices (ID 1186); flavonoids from citrus (ID 1471); flavonoids from Citrus paradisi Macfad. (ID 3324, 3325); flavonoids (ID 1470, 1693, 1920); flavonoids in cranberry juice (ID 1804); carotenoids (ID 1496, 1621, 1622, 1796); polyphenols (ID 1636, 1637, 1640, 1641, 1642, 1643); rye bread (ID 1179); protein hydrolysate (ID 1646); carbohydrates with a low/reduced glycaemic load (ID 476, 477, 478, 479, 602) and carbohydrates which induce a low/reduced glycaemic response (ID 727, 1122, 1171); alfalfa (ID 1361, 2585, 2722, 2793); caffeinated carbohydrate-containing energy drinks (ID 1272); and soups (ID 1132, 1133) pursuant to Article 13(1) of Regulation (EC) No 1924/2006’ (2011) 9(4) European Food Safety Authority Journal 2082, 10.
135 European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and protection of cells from premature aging, antioxidant activity, antioxidant content and antioxidant properties, and protection of DNA, proteins and lipids from oxidative damage pursuant to Article 13(1) of Regulation (EC) No 1924/2006’ (2010) 8(2) European Food Safety Authority Journal 1489.Google Scholar
136 European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies, ‘Scientific Opinion Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health’ (2011) 9(12) European Food Safety Authority Journal 2474, 3.2.Google Scholar
137 21 C.F.R. 101.14(a)(1)(1).
138 See Office of Nutrition, Labelling and Dietary Supplements, Food and Drug Administration, Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims—Final (FDA 2009) <http://www.fda.gov>.
139 See U.S. Food & Drug Administration, Health Claims Meeting Significant Scientific Agreement (SSA) (10 May 2015) <http://www.fda.gov/Food/%20IngredientsPackagingLabeling/LabelingNutrition/ucm2006876.htm#Approved_Health_Claims>.
140 Dietary Supplement Health and Education Act of 1994 s101.93(f).
141 21 U.S.C 343(r)(6) and 21 C.F.R. 101.93.
142 See, for example, Richard Nowak, ‘DSHEA's Failure: Why a Proactive Approach to Dietary Supplement Regulation Is Needed to Effectively Protect Consumers’ (2010) University of Illinos Law Review 1045.
143 Standard 1.2.7 sch 4 s 5 provides copper, zinc and manganese may protect cell damage from ‘free radicals’; vitamins C and E ‘contributes to cell protection from free radical damage’; and selenium is ‘necessary for cell protection from some types of free radical damage’.
144 Ibid. The permitted food-health relationships related to ‘oxidative stress’ is limited to riboflavin and the heath effect: ‘contributes to the protection of cells from oxidative stress’.
145 FSANZ publishes notified food-health relationships to <http://www.foodstandards.gov.au>.
146 Food Standards Australia New Zealand Act 1991 (Cth) s 4.
147 De Boer and Bast, above n 113, 65.
148 Standard 1.2.7 s 2.
149 Ibid s 12, sch 4 s 3. Antioxidants, phytochemicals and polyphenols (or similar) are not included in the list of properties of food to which nutrient content claims can be made. Permitted as ‘presence/absence’ claims such as ‘contains polyphenols’, where that is true and correct.
150 Ibid s 2.
151 Health Claims Regulation (EC) 1924/2006 art 2.5 provides that health claim ‘means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health’.
152 Standard 1.2.7 sch 6 s 2(g).
153 Ibid s 19(1)(d)(ii).
154 Ibid s 10. See also Standard 1.1.1 s 8(2), which provides ‘if a provision of the Code requires a statement other than a warning statement to be used, that statement may be modified’ and ‘any modification must not contradict or detract from the effect of the statement’.
155 Dietary Supplement Health and Education Act 1994 s 343(r)(6)(B) provides a manufacturer must be able to substantiate its claims. How a claim is to be substantiated is not provided in law.
156 Food and Drug Administration, Guidance for Industry, Substantiation for Dietary Supplement Claims Made under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act (Guidance, FDA, 2008).Google Scholar
157 Standard 1.2.7 sch 6.
158 See, eg, Food Standards Australia New Zealand, ‘P293 Nutrition, Health and Related Claims Summary of Submissions to the March 2009 Consultation Paper—Preferred Options’ (Submissions, Food Standards Australia New Zealand, 2009) 22, where the Department of Health, Victoria submitted, ‘General Level Health Claims are marketing tools. The inclusion of a Standard to regulate marketing is a new approach; current food regulation is not designed to deal with this and proportionate enforcement tools would be needed’.
159 See, eg, Food Act 2003 (NSW) s 109E.
160 Standard 1.2.7 s 19(d) provides that if requested by a relevant authority, a person who notified FSANZ must provide records that demonstrate the systematic review was conducted in accordance with Schedule 6 and the notified relationship is a reasonable conclusion of the systematic review.
161 Implementation Subcommittee for Food Regulation, above n 43.
162 Condon-Paoloni, Deanne, Yeatman, Heather and Grigonis-Deane, Elizabeth, ‘Health-Related Claims on Foods Labels in Australia: Understanding Environmental Health Officers’ Roles and Implications for Policy’ (2013) 18(1) Public Health Nutrition 81.CrossRefGoogle ScholarPubMed
163 See the discussion of what is required for effective ‘meta-regulation’ (ie the government regulation of industry self-regulation) in Parker, Christine, The Open Corporation (Cambridge University Press, 2002), 245–92.CrossRefGoogle Scholar
164 Model Food Act 2000 (Cth) s 1.