Hotpot

In Zhang v The First Org Ltd (Strike Out) [2024] NZHRRT 11 the NZ Human Rights Review Tribunal has considered a claim of indirect marital status discrimination in relation to the serving of hotpot. 

The Tribunal states 

[1] Red Hill Restaurant (Red Hill) serves hotpot. On its menu Red Hill specifies that a minimum of two diners are required to order this dish. Mr Zhang alleges that this requirement or policy amounts to indirect marital status discrimination as it is less likely that a single person would be dining with another person who is prepared to share the cost of a hotpot meal. 

[2] Mr Zhang accepted that a person dining alone can still order hotpot but is required to pay the same price for that dish which is designed to be shared by (at least) two people. However, he says that charging a person eating alone the same price as two people eating hotpot is not justified. He said that previously he had been able to purchase hotpot for one at Red Hill and accepted that charging a bit over half the price for two diners would be justified (and therefore not discriminatory). 

[3] Red Hill denied that its actions were discriminatory. It said that the policy applied to everyone and was not limited to customers with a particular marital status. It admitted that it had previously allowed one paying customer to purchase a single portion of hotpot for less than the price of the menu item. However, in his affidavit supporting the application, Yutian Liu said that due to rising costs it was not economical for Red Hill to prepare a hotpot for one paying customer only. 

[4] Red Hill applied to strike out the claim on the basis that it: [4.1] Disclosed no reasonable cause of action; [4.2] Was frivolous, because the policy was common to many restaurants and because Mr Zhang’s essential complaint was about the quantum of the additional charge paid for those eating alone rather than discrimination per se; [4.3] Was vexatious, because it was brought to annoy or irritate Red Hill after it changed its policy; and [4.4] Was an abuse of process because it was manifestly groundless and without foundation. 

[5] Red Hill further argued that it would not be inappropriate to strike out the proceeding as there was no reasonable prospect of success, and that Mr Zhang’s right of access to the Tribunal was outweighed by the desirability of freeing Red Hill from the burden of defending groundless litigation. 

[6] The application is being dealt with on the papers pursuant to s 104(4A) of the Human Rights Act 1993 (HRA). The parties were given an opportunity to comment on whether it should be dealt with in this way and neither raised any objection. ... 

[14] The prohibition against discrimination in the provision of restaurant services is set out in s 44 of the HRA. 44 Provision of goods and services (1) It shall be unlawful for any person who supplies goods, facilities, or services to the public or to any section of the public— (a) to refuse or fail on demand to provide any other person with those goods, facilities, or services; or (b) to treat any other person less favourably in connection with the provision of those goods, facilities, or services than would otherwise be the case,— 

[15] Given the definition of marital status in s 21(1)(b) of the HRA, we have taken the status of single to be those who are not married, in a civil union or in a de facto relationship. 

[16] Mr Zhang accepts that Red Hill did not decline to provide hotpot to him because he is single. Nor does he claim it directly treated him less favourably for that reason. Rather his claim is its charging policy has the effect of treating him differently and is indirectly discriminatory by virtue of s 65 of the HRA. 

[17] The prohibition against indirect discrimination in s 65 reads: 65 Indirect discrimination Where any conduct, practice, requirement, or condition that is not apparently in contravention of any provision of this Part has the effect of treating a person or group of persons differently on 1 of the prohibited grounds of discrimination in a situation where such treatment would be unlawful under any provision of this Part other than this section, that conduct, practice, condition, or requirement shall be unlawful under that provision unless the person whose conduct or practice is in issue, or who imposes the condition or requirement, establishes good reason for it. 

[18] That section has been described by the Court of Appeal decision in Ngaronoa v Attorney-General in the following terms:  [119] Indirect discrimination under s 65 of the Human Rights Act can arise when a criterion in a law or policy, which is not on its face discriminatory, corresponds to a feature (or lack thereof) of all or part of a group and results in that group being treated differently on a prohibited ground. A Canadian example we will refer to is a policy in a public health system which does not fund the provision of translation services to deaf patients who could otherwise use state care. The provision did not mention deafness, and did not explicitly exclude deaf patients from the benefit of state care, but a failure to provide translation services to deaf patients effectively denied them equal access to important benefits that were available to other persons who were not deaf. … 

[19] The issues the Tribunal needs to consider are: [19.1] Does the indirect discrimination claim disclose a reasonable cause of action? and [19.2] Is the claim frivolous or vexatious? 

[20] We first consider whether the claim is frivolous. 

[21] The right to be free from discrimination is a fundamental human right. To avoid trivialising the non-discrimination right, the disadvantage arising from differential treatment, when viewed in context, must not be theoretical, innocuous or de minimus. 

[22] In this case, while Red Hill’s menu states that the hotpot for the specified price is for a minimum of two people, the plain inference is that when hotpot is ordered the diner will receive sufficient food for two people in return for the price payable. If anyone wants to order that quantity of hotpot for that price, there is no prohibition preventing any diner from doing so. Had Red Hill simply set out the price for hotpot, no exception could be taken. Any discrimination alleged is therefore merely theoretical and does not give rise to material disadvantage. 

[23] As a person dining alone, Mr Zhang objects to paying the full price for a serving of hotpot. He claims that he should be able to order a single portion of hotpot in return for which he agrees it is reasonable to pay more than half the price of the minimum two- person portion on offer. Given Mr Zhang accepted it would be appropriate to charge some additional amount for an individual serving size of hotpot, Red Hill argued that Mr Zhang’s principal complaint is about the amount he is required to pay, rather than about discrimination per se and is frivolous for this reason. 

[24] We agree that the essence of this claim is about the minimum charge for a serving of hotpot and how large that serving should be. For Mr Zhang to claim that the non- discrimination right is engaged by this question trivialises the right’s importance. 

[25] The claim’s overreach is demonstrated by the fact that, if successful, it would permit members of other groups such as Pacific people and Māori who are more likely to be on a lower income than the national average,  or women who are more likely to be on a  lower income than men, to also allege that restaurants which fail to serve them smaller portions of food at lower prices amounts to discrimination.   Further, while any commercial justification put forward by the restaurant would likely prevail, restaurant owners would still face the burden of responding to such claims (as would the Tribunal). 

[26] Mr Zhang’s claim lacks the seriousness necessary for it to proceed to trial. Having reached that decision, we consider the claim should be struck out on the ground that it is frivolous. 

27] Having struck the claim out on this basis, it is unnecessary to consider whether the claim is also vexatious because it was designed to annoy or irritate Red Hill after it changed its policy. 

[28] For completeness, however, we consider whether the claim should be struck out on the basis that it fails to disclose a reasonable cause of action. 

[31] Mr Zhang’s claim contains no particulars to support his contention that Red Hill’s policy regarding the two-person minimum price for a hotpot disproportionately affects those who are single or that it imposes a material disadvantage on single diners. Instead, the claim proceeds on the assumption that this is the case. We do not consider this is an appropriate matter over which to take judicial notice.

Capture

'The corporate capture of the nutrition profession in the USA: the case of the Academy of Nutrition and Dietetics' by Angela Carriedo, Ilana Pinsky, , Eric Crosbie, Gary Ruskin and Melissa Mialon in (2022) Public Health Nutrition comments 

The AND [Academy of Nutrition and Dietetics], AND Foundation (ANDF) and its key leaders have ongoing interactions with corporations. These include AND’s leaders holding key positions in multinational food, pharmaceutical or agribusiness corporations, and AND accepting corporate financial contributions. We found the AND has invested funds in corporations such as Nestlé, PepsiCo and pharmaceutical companies, has discussed internal policies to fit industry needs and has had public positions favouring corporations.... 

 

The rising global burden of non-communicable diseases has for decades been addressed by downstream efforts that focus on improving individual behaviours. However, recently upstream efforts focused on societal and environmental changes have led to important population-level approaches and policies implemented in several countries to improve non-communicable diseases, including obesity and diabetes. An important barrier to these approaches is the commercial determinants of health. These are actions, processes and ways in which commercial actors such as unhealthy commodity corporations (tobacco, alcohol and ultra-processed food and drink) influence health policy making and, in general, influence the environment to protect their interests. 

 

There is extensive literature that shows how unhealthy commodity corporations are involved in setting health policy and research agendas globally. In particular, they use instrumental (action-based) and discursive (argument-based) strategies to influence science and policy surrounding public health efforts to protect well-being and healthy environments. Furthermore, corporations lobby and litigate against health policies and capture science by recruiting and hiring scientists to influence public discourse and position corporate interests in the public agenda. One key strategy is to capture health professionals and health institutions as a vehicle to achieve its interests more broadly in the global health agenda. 

 

In the USA, one of the most important professional health associations is the Academy of Nutrition and Dietetics (AND). The AND’s relationship with the food and beverage industry has been described elsewhere. Founded in 1917 as the American Dietetic Association, the AND is the largest US-based organisation comprised of food and nutritional professionals, with approximately 100 000 dietitians and nutrition practitioners and students. It is established as a 501(c)(6) trade association and certifies dieticians and nutrition practitioners in the USA and abroad. The AND’s stated mission is ‘to accelerate improvements in global health and well-being through food and nutrition’. AND acts as a reference for dietetics curricula accreditation and as an authority in US food policy making. For instance, the Academy has been influential in the process of setting US Dietary Guidelines, which are then taken into consideration all over the world in order to develop vital nutrition policy decisions. The AND also provides ‘expert testimony’ including ‘comments and position statements for federal and state regulations on critical food and nutrition issues’. The ‘philanthropic arm’ of the AND is the AND Foundation (ANDF), established as a 501(c)(3) charitable organisation. The ANDF does not receive member dues and relies on donations. It focuses on scholarships, awards, food and nutrition research and public education. The AND and the ANDF report jointly their annual activities and achievements, without a clear distinction between each another. They also share staff, including the chief executive officer and chief of operations. 

 

The AND has been repeatedly criticised for its close ties to food and beverage corporations, including Coca-Cola, PepsiCo and General Mills, which may undermine ‘the integrity of the professionals most responsible for educating Americans about healthy eating’. Two years after the publication of a critical report about AND’s relationship with food corporations in 2013, the ANDF announced a partnership with the food company Kraft. This collaboration, which was seen as an endorsement of some of Kraft’s products as ‘healthy’ options to include in children’s menus at schools, caused further outrage among AND’s members, public health experts and the general public. 

 

Although the AND’s relationship with the food and beverage industry has been described before, little is known about its relationship with other unhealthy commodity industries as well as the dynamics and evolution of such relationships. This study is the first to obtain and review AND’s internal communications and interactions between the AND and the food and beverage, pharmaceutical and agribusiness industries. We explore how these interactions evolved over time and how they influence the politics and decision-making of an influential professional health association, by analysing documents obtained through freedom of information (FOI) requests, filed by US Right to Know (USRTK).

Regulation

'An Impossible Task? Australian Food Law and the Challenge of Novel Meat Analogues' by Hope Johnson and Christine Parker in (2022) Federal Law Review comments 

This paper asks what the regulatory assessment of the novel processed meat analogue products reveals about the nature of food regulation in Australia. We analyse Food Standards Australia and New Zealand’s (FSANZ) assessment of the recent application by Californian technology company Impossible Foods Inc to sell its proprietary burger products which contain a genetically modified protein that is said to make their burger ‘bleed’. We show that FSANZ’s assessment process has little capacity to engage with broader and longer term, social, ecological and public health implications of novel foods and changing food markets. FSANZ’s regulatory pre-approval process focuses almost exclusively on the safety of individual ingredients rather than the impact of novel foods on the food supply as whole and leaves broader issues to the market and consumer choice with limited support from laws addressing misleading labelling and marketing of foods. Extending the capacity of Australia’s regulatory regime for food to deal with more than the safety of individual ingredients will become more urgent as other novel foods, such as cell-based meats, enter the marketplace. 

The authors state

 Impossible Foods Inc (‘Impossible’), a Californian-based tech start-up that develops, manufactures and markets novel meat analogues, describes its mission as: ‘To drastically reduce humanity’s destructive impact on the global environment by completely replacing the use of animals as food production technology’.  Its signature product is its ‘bleeding’ plant-based burger, the ‘Impossible Burger’ available at major supermarkets and restaurants throughout the US, Hong Kong and Singapore. In July 2019, Impossible applied to the statutory authority Food Standards Australia New Zealand (‘FSANZ’) for approval to sell its products in Australia and New Zealand (‘the Impossible application’). Eighteen months later, after two calls for submissions and a notably ‘high volume of stakeholder interest in broader issues relating to the applicant’s Impossible meat analogue products’, FSANZ recommended that the product be approved. 

This paper shows that FSANZ’s assessment process for novel food pre-market regulatory approval has a narrow scope of considerations that defines out many concerns of stakeholders, and the most pressing social, ecological and justice issues facing the food system. FSANZ’s regulatory pre-approval process focuses almost exclusively on the safety of individual ingredients rather than the impact of novel foods on the food supply as a whole. It leaves broader issues to the market and consumer choice with limited support from laws addressing misleading labelling and marketing of foods. 

Under Australian and New Zealand food law, Impossible needed to apply for approval to sell its meat analogue products because they contain a novel protein ingredient, soy leghemglobin, naturally present in the root nodules of soy plants and now mass produced by Impossible using genetically modified yeast. According to Impossible, soy leghemglobin mimics the molecules in animal flesh that are ‘what makes meat taste so meaty’. As we shall show, Impossible, and other novel meat analogue developers and proponents, claim that their novel meat analogue products will disrupt the food system for the better by replacing animal-derived meat with foods that are more healthy, sustainable and ethical. These claims have gained significant traction due to the increasing institutional and academic support for interventions that enable more healthy and environmentally sustainable diets, as well as growing awareness regarding ethical issues with intensive animal agriculture. 

The claim that novel meat analogues will positively disrupt the food system has sparked debates in a multitude of jurisdictions, especially in the US, the EU and now Australia and New Zealand. Public health advocates, proponents of alternative, including agro-ecological, food systems and the meat industry have all contested the idea that novel meat analogues represent a positive future for food. Their various criticisms of novel meat analogues include that the novel analogue products are unhealthy, unwholesome and inferior compared to either animal-derived flesh, or whole food vegetarian products (such as vegetables and legumes), the way the novel products use food processing technology (including GM) and the fact that they are promoted by corporate interests (Silicon Valley tech companies, fast food retailers, supermarkets and even in some cases meat companies wishing to diversify their portfolio). These critiques extend to whether novel meat analogues should replace meat derived from animals including whether novel meat analogues can bring about healthier diets and make the food system more ethical and ecologically sustainable. 

The promise of a better food claimed by proponents of novel meat analogues, and the contestation of these claims, raise urgent public interest issues for the food system which deserve serious legal and policy attention. The debate extends beyond novel meat analogues as a new food category raising questions about how to address the interlinked social, environmental and ethical issues associated with food systems and the role of regulation in addressing these challenges. As a slew of new meat analogues, including new products based on cultured animal cells, are developed, the Impossible application can be seen as a ‘test case’ as to how FSANZ’s pre-market regulatory assessment system addresses these policy issues. 

Part II introduces and explains what we mean by ‘novel meat analogues’ and ‘novel proteins’. We show how novel meat analogue products, and their novel protein ingredients, are contested in public discourse around the world, and specifically within Australia, and the kinds of issues to which regulators are being called on to respond. In doing so, we draw on academic literature and our own thematic analysis of submissions to FSANZ’s assessment of the Impossible application. 

Part III analyses the relevant provisions of the Food Standards Australia New Zealand Act 1991 (Cth) (‘FSANZ Act’), the Australia New Zealand Food Standards Code (‘the Code’) and FSANZ’s assessment of the Impossible application to demonstrate the narrow scope and application of Australian pre-market regulatory assessment for novel foods. We show that the process is geared towards a narrow scientific risk assessment of the acute, direct safety and toxicity of individual novel ingredients and processes. This process is inadequate to address the policy concerns raised in public discourse over novel meat analogues in general and Impossible’s application in particular. In practice, the assessment process over-values economic interests and consumer choice and only deals with health and safety issues that are amenable to direct, biomedical measurement. FSANZ’s focus on particular issues and evidence, and to disengage from other social and ethical issues and evidentiary bases, seems neutral and apolitical, but has important political and policy ramifications. These debates are already spilling over into debates over how novel meat analogue products should legally be allowed to be described (for example through petitions to prohibit the use of terms such as ‘burgers’, ‘sausages’ and ‘plant-based meat’), and feed into ongoing concern about what FSANZ could be doing to limit the consumption of other processed foods. 

Part IV of the paper concludes that Australia’s food law and policy provides little opportunity to assess and debate the impact of novel food products (eg the Impossible burger as distinct from the novel ingredient, soy leghemoglobin) and whole categories of food (such as novel meat analogues and ultra-processed foods) including their combined effects on the diet of the population. It also provides very limited avenues for assessing the social, economic, ethical and environmental impacts of novel food ingredients, products and categories on the food system as a whole. The current regulatory approach leaves it to the market and consumer choice to determine the future of the food system, rather than providing for public democratic policy fora in which to discuss and debate larger questions of the desirable qualities and trajectory of food systems and technological change.

Food Advertising

'Monitoring complaints about food marketing to children under the Australian industry Codes 2015–20: a qualitative analysis' by Wendy L Watson, Amy Pagotto, Korina Richmond and Clare Hughes in (2021) 45(6) Australian and New Zealand Journal of Public Health 562 comments 

 Regulation of food marketing to children is widely recognised as key to addressing childhood obesity rates. A review of evidence-based obesity prevention interventions for the Australian context found legislation restricting television advertising of unhealthy foods a cost-effective obesity prevention initiative. Addressing marketing of unhealthy foods in publicly-controlled settings and marketing associated with sport and major community events were promising interventions. Reducing advertising of, and exposure to, unhealthy food and drinks was one of the top five focus areas raised by participants in the 2020 consultation on the National Obesity Strategy nd was listed in the draft National Preventive Health Strategy, released in March 2021. 

In 2009, the Australian food industry introduced two self-regulatory Codes to address food and beverage advertising to children, the Responsible Children's Marketing Initiative (RCMI) for grocery products and the Quick Service Restaurant Initiative for Responsible Advertising and Marketing to Children (QSRI) for fast food. Within the RCMI, healthiness of foods appropriate for advertising is defined by individual company criteria, and the QSRI includes specific energy and nutrient criteria for a ‘children's meal’ but no other fast food products. The Australian Association of National Advertisers (AANA) has self-regulatory Codes relevant to protecting children from unhealthy food advertising, the Code of Ethics, the Code of Advertising and Marketing to Children and the Food and Beverages Code. Previously, companies were voluntary signatories to the RCMI and QSRI, however, in June 2019 an additional clause in the Food and Beverages Code required compliance with the RCMI or QSRI, meaning all food and beverage advertising should comply with these Codes. From July 2020, these two Codes came under the management of the AANA. 

The self-regulatory Codes in Australia have not changed the rate of children's exposure to food advertising on television, or in outdoor settings. Globally, while industry-sponsored reports indicate high adherence to voluntary Codes, peer-reviewed papers show self-regulatory Codes have failed to reduce children's exposure to unhealthy food advertising. Since 2010, the World Health Organization (WHO) has had a set of recommendations to reduce both the exposure of children to, and power of, marketing of foods. The 2012 WHO framework for implementing those standards provides a broad range of options and factors to consider when developing a policy. The 2020 World Cancer Research Fund (WCRF) Building Momentum report has built on that framework and collated international experience on best practice policy in five main areas: legal measures needed, who should be protected, forms and levels of marketing to be restricted, and which foods and beverages should be restricted. 

A complaints program managed by Ad Standards supports the Australian advertising Codes. Complainants lodge complaints regarding advertising through an online form on the Ad Standards website or by post. Ad Standards convenes a Community Panel (the Board) responsible for reviewing these complaints. Decisions on the outcomes of complaints are reported on the website in a case report that summarises what the complainant/s said, the advertiser's response, deliberations and final outcome (dismissed or upheld). Complaints about the same advertisement are grouped together with, typically, one case report per advertisement. There has been no independent critique of these complaints to understand whether the Codes address complainants’ concerns. This paper aims to qualitatively analyse the case reports of complaints to Ad Standards, regarding unhealthy food marketing to children, published over the last six years, and compare the Codes with best practice recommendations from WCRF.

The authors note that case reports on complaints about food marketing to children under the five industry Codes – the Responsible Children's Marketing Initiative, the Quick Service Restaurant Initiative and the Australian Association of National Advertisers Code of Ethics, Code of Advertising and Marketing to Children and Food and Beverages Code – were qualitatively analysed. Reports on the Ad Standards website in the food/beverage groceries and food/beverage venues categories from 2015-2020 were investigated. The most common clauses from the Codes were identified and quotes from reports used to illustrate the determinations. Codes were compared with World Cancer Research Fund recommendations on policy to protect children. 

Only 14 of 119 complaints resulted in a reported breach of industry Codes, with the most common reason for dismissing complaints involved clauses requiring advertisements to be ‘primarily’ directed to children. The Codes did not align with best practice recommendations. Complaints by the public show concern for food advertising to children but the Australian industry Codes fall short of addressing those concerns. Government regulation is required to protect children from unhealthy food marketing.

Food

'Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury', a Staff Report for the U.S. House of Representatives Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform, comments 

Inorganic arsenic, lead, cadmium, and mercury are toxic heavy metals. The Food and Drug Administration and the World Health Organization have declared them dangerous to human health, particularly to babies and children, who are most vulnerable to their neurotoxic effects. Even low levels of exposure can cause serious and often irreversible damage to brain development. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufacturers of baby food in the United States, including both makers of organic and conventional products:

• Beech-Nut Nutrition Company (Beech-Nut) 

• Hain Celestial Group, Inc. (Hain), which sells baby food products under the brand name Earth’s Best Organic 

• Gerber 

• Walmart Inc. (Walmart), which sells baby food products through its private brand Parent’s Choice 

• Sprout Foods, Inc. (Sprout Organic Foods)

Four of the companies—Nurture, Beech-Nut, Hain, and Gerber—responded to the Subcommittee’s requests. They produced their internal testing policies, test results for ingredients and/or finished products, and documentation about what the companies did with ingredients and/or finished products that exceeded their internal testing limits. Walmart, Campbell, and Sprout Organic Foods refused to cooperate with the Subcommittee’s investigation. The Subcommittee is greatly concerned that their lack of cooperation might be obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products. 

FINDINGS 

1. According to internal company documents and test results obtained by the Subcommittee, commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function. Specifically, the Subcommittee reports that:

 ARSENIC was present in baby foods made by all responding companies. 

• Nurture (HappyBABY) sold baby foods after tests showed they contained as much as 180 parts per billion (ppb) inorganic arsenic. Over 25% of the products Nurture tested before sale contained over 100 ppb inorganic arsenic. Nurture’s testing shows that the typical baby food product it sold contained 60 ppb inorganic arsenic. 

• Hain (Earth’s Best Organic) sold finished baby food products containing as much as 129 ppb inorganic arsenic. Hain typically only tested its ingredients, not finished products. Documents show that Hain used ingredients testing as high as 309 ppb arsenic. 

• Beech-Nut used ingredients after they tested as high as 913.4 ppb arsenic. Beech-Nut routinely used high-arsenic additives that tested over 300 ppb arsenic to address product characteristics such as “crumb softness.” 

• Gerber used high-arsenic ingredients, using 67 batches of rice flour that had tested over 90 ppb inorganic arsenic.

 LEAD was present in baby foods made by all responding companies.

• Nurture (HappyBABY) sold finished baby food products that tested as high as 641 ppb lead. Almost 20% of the finished baby food products that Nurture tested contained over 10 ppb lead. 

• Beech-Nut used ingredients containing as much as 886.9 ppb lead. It used many ingredients with high lead content, including 483 that contained over 5 ppb lead, 89 that contained over 15 ppb lead, and 57 that contained over 20 ppb lead. 

• Hain (Earth’s Best Organic) used ingredients containing as much as 352 ppb lead. Hain used many ingredients with high lead content, including 88 that tested over 20 ppb lead and six that tested over 200 ppb lead. 

• Gerber used ingredients that tested as high as 48 ppb lead; and used many ingredients containing over 20 ppb lead.

CADMIUM was present in baby foods made by all responding companies.

• Beech-Nut used 105 ingredients that tested over 20 ppb cadmium. Some tested much higher, up to 344.55 ppb cadmium. 

• Hain (Earth’s Best Organic) used 102 ingredients in its baby food that tested over 20 ppb cadmium. Some tested much higher, up to 260 ppb cadmium. 

• Sixty-five percent of Nurture (HappyBABY) finished baby food products contained more than 5 ppb cadmium. 

• Seventy-five percent of Gerber’s carrots contained cadmium in excess of 5 ppb, with some containing up to 87 ppb cadmium.

 MERCURY was detected in baby food of the only responding company that tested for it.

• Nurture (HappyBABY) sold finished baby food products containing as much as 10 ppb mercury. 

• Beech-Nut and Hain (Earth’s Best Organic) do not even test for mercury in baby food. 

• Gerber rarely tests for mercury in its baby foods.

These results are multiples higher than allowed under existing regulations for other products. For example, the Food and Drug Administration has set the maximum allowable levels in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, and the Environmental Protection Agency has capped the allowable level of mercury in drinking water at 2 ppb. The test results of baby foods and their ingredients eclipse those levels: including results up to 91 times the arsenic level, up to 177 times the lead level, up to 69 times the cadmium level, and up to 5 times the mercury level. 

2. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.

• Nurture (HappyBABY) sold all products tested, regardless of how much toxic heavy metal the baby food contained. By company policy, Nurture’s toxic heavy metal testing is not intended for consumer safety. The Food and Drug Administration (FDA) has only finalized one standard—100 ppb inorganic arsenic in infant rice cereal—and Nurture set its internal standard for that product 15% higher than the FDA limit, at 115 ppb. 

• Beech-Nut set internal arsenic and cadmium standards at 3,000 ppb in additives, such as vitamin mix, and 5,000 ppb lead for certain ingredients like BAN 800. These standards are the highest of any responding manufacturer. 

• Hain (Earth’s Best Organic) set an internal standard of 200 ppb for arsenic, lead, and cadmium in some of its ingredients. But Hain exceeded its internal policies, using ingredients containing 353 ppb lead and 309 ppb arsenic. Hain justified deviations above its ingredient testing standards based on “theoretical calculations,” even after Hain admitted to FDA that its testing underestimated final product toxic heavy metal levels. 

3. The Subcommittee has grave concerns about baby food products manufactured by Walmart (Parent’s Choice), Sprout Organic Foods, and Campbell (Plum Organics). These companies refused to cooperate with the Subcommittee’s investigation. The Subcommittee is greatly concerned that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby food products, compared to their competitors’ products.

• Walmart sells Parent’s Choice and Parent’s Choice Organic products for babies as young as four months. 

• Sprout Organic Foods sells organic products for babies as young as six months. It is owned by North Castle Partners, a Greenwich, Connecticut– based private equity firm. 

• Campbell sells Plum Organics products for babies as young as four months. 

• Independent testing of Walmart, Sprout Organic Foods, and Campbell products has confirmed that their baby foods contain concerning levels of toxic heavy metals. 

4. The Trump administration ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods. On August 1, 2019, FDA received a secret slide presentation from Hain (Earth’s Best Organic), which revealed that:

• Corporate policies to test only ingredients, not final products, underrepresent the levels of toxic heavy metals in baby foods. In 100% of the Hain baby foods tested, inorganic arsenic levels were higher in the finished baby food than the company estimated they would be based on individual ingredient testing. Inorganic arsenic was between 28% and 93% higher in the finished products; 

• Many of Hain’s baby foods were tainted with high levels of inorganic arsenic—half of its brown rice baby foods contained over 100 ppb inorganic arsenic; its average brown rice baby food contained 97.62 ppb inorganic arsenic; and 

• Naturally occurring toxic heavy metals may not be the only problem causing the unsafe levels of toxic heavy metals in baby foods; rather, baby food producers like Hain may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix.

This presentation made clear that ingredient testing is inadequate, and that only final product testing can measure the true danger posed by baby foods. The Trump FDA took no new action in response. To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all. FDA has only finalized one metal standard for one narrow category of baby food, setting a 100 ppb inorganic arsenic standard for infant rice cereal. But this FDA standard is far too high to protect against the neurological effects on children. 

5. The Subcommittee makes the following recommendations:

• Mandatory testing—Baby food manufacturers should be required by FDA to test their finished products for toxic heavy metals, not just their ingredients; 

• Labeling—Manufacturers should by required by FDA to report levels of toxic heavy metals on food labels; 

• Voluntary phase-out of toxic ingredients—Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals, or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice; 

• FDA standards—FDA should set maximum levels of toxic heavy metals permitted in baby foods. One level for each metal should apply across all baby foods. And the level should be set to protect babies against the neurological effects of toxic heavy metals; and 

• Parental vigilance—Parents should avoid baby foods that contain ingredients testing high in toxic heavy metals, such as rice products. Instituting recommendations one through four will give parents the information they need to make informed decisions to protect their babies. 

6. Baby food manufacturers hold a special position of public trust. Consumers believe that they would not sell products that are unsafe. Consumers also believe that the federal government would not knowingly permit the sale of unsafe baby food. As this staff report reveals, baby food manufacturers and the Trump administration’s federal regulators have broken the faith.

TGA and therapeutic goods advertising

The Therapeutic Goods Administration, the inward-looking arm of the Health Department that is the Australian counterpart of the US FDA, will need to lift its game after the Health Minister's announcement that the national government has accepted all 22 recommendations in the Sinclair Review of the therapeutic goods advertising regime. 

In line with the Government's commitment made in 2018 to review the reforms to the therapeutic goods advertising framework within two years from implementation, the review examined the impact of the new advertising measures regarding the commencement of the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018, with reference to the advertising reforms from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR Review) and other initiatives announced by the Minister.

Sinclair's report states

The Review assessed the impact of the:

A. new advertising measures as included in the Therapeutic Goods Act 1989 (the Act), in particular, the effectiveness of: 

i. the amendments to the Therapeutic Advertising Code (No. 2) 2018 i.e. whether they have increased clarity and objectivity to support the compliance and enforcement powers in the Act and improved consistency between the requirements for medicines and medical devices; 

ii. the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public; and iii. broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods. 

B. other initiatives announced by the Minister in February 2018, namely:

iv. a comprehensive industry and consumer education program of the new advertising measures; 

v. public performance measures for advertising complaints management, i.e. an assessment of the suitability of the TGA’s key performance indicators for managing advertising complaints; and 

vi. stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the Therapeutic Goods Advertising Consultative Committee (TGACC).

It notes 

The Therapeutic Goods Administration (the TGA) is Australia’s regulatory authority for therapeutic goods. The TGA is part of the Australian Government Department of Health (the Department). On 24 October 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) (‘the MMDR Review’). 

The objective of that Review was to make recommendations to assist the Government to enhance the regulatory framework for medicines and medical devices so that: ▪ Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods, and ▪ areas of unnecessary, duplicative or ineffective regulation are removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia. 

The Expert Panel reported in two stages and made a total of 58 recommendations, which reflected an overarching intention to remove unnecessary regulatory burden and support the regulator and industry transition towards a more self-regulatory regime, without compromising the safety or quality of therapeutic goods or diminishing protections for the Australian public. The principles underpinning that Review are relevant to the consideration of progress on the seven recommendations which related to the advertising of therapeutic goods:

1 The role of regulation is to manage risk in order to protect public health and safety; 

2 The level of regulation should be commensurate with the risk posed by the regulated products; 

3 A risk-benefit approach to the regulation of therapeutic goods is appropriate; 

4 The regulation of therapeutic goods should take a whole-of-lifecycle approach; and 

5 The ultimate responsibility for medicines and medical devices regulation should remain with the Commonwealth.

Of the 58 recommendations seven related to the advertising of therapejutic goods. The recommendations reflected the Panel’s view that “...controls on advertising provide an important assurance that consumers have access to accurate information in making health choices”. The Australian Government Response to the Review (‘Government Response’) was released on 15 September 2016, following consultation with stakeholders including consumers, healthcare professionals and industry:

“This response presents a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia. It identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia.” 

Of the total 58 recommendations, 56 of the recommendations were supported by the Government. All the recommendations relating to the regulation of therapeutic goods advertising were accepted. This resulted in a suite of changes to the therapeutic goods advertising framework, with reforms led by the Department and more specifically, the TGA. 

This Review of the Therapeutic Goods Advertising Framework (‘the Review’) was intended to examine the impact and effectiveness of key changes to the advertising framework catalysed by the MMDR Review. The advertising framework components to be considered in this Review included the relevant changes to the Therapeutic Goods Act 1989 (Cth) (‘the Act’), which establishes the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. 

Specifically, the Review considered amendments to:

•  the Therapeutic Goods Advertising Code, as the instrument made under the Act that sets out the legislative requirements for therapeutic goods advertising; 

• disband the Complaints Resolution Panel and nominate a single-body to be responsible for the management of public complaints about the advertising of therapeutic goods; and 

• broaden the sanctions and penalties available to respond to breaches of advertising requirements.

The Review also examined a number of other initiatives announced by the Minister for Health (‘the Minister) that supported the intent of the MMDR recommendations and implementation of changes to the advertising framework. These initiatives are led by the TGA and included: ▪ a comprehensive industry and consumer education program regarding the new advertising framework; ▪ development of public performance measures for the reformed complaints management function; and ▪ engaging with stakeholders regarding therapeutic goods advertising, particularly through a forum of relevant stakeholder representatives in the Therapeutic Goods Advertising Consultative Committee (TGACC). 

Most of the changes regarding the therapeutic goods advertising framework noted above, have occurred within the last 12-18 months, with the TGA taking an approach of continuous improvement to implementing the reforms.

The Review's 'overall assessment' is 

The changes to the therapeutic goods advertising framework within scope of this Review have been implemented in the last 12-18 months. In this regard, the Review has taken place at a timely crossroads, to reflect on the early experiences of implementation of the reforms, and to inform further improvement to the effectiveness of the regulatory framework for therapeutic goods advertising and a strengthened strategic focus on implementation. 

The Review involved extensive stakeholder consultation, both with key stakeholder groups represented on the TGACC, and with a selection of Departmental staff members and senior executives. In undertaking these consultations, the Review noted a high degree of openness and highly thoughtful responses, which reflected an invested stakeholder base and a commitment to continuous improvement by the TGA. All stakeholders understood the importance of consumers having accurate information in making health choices. This was reflected in stakeholder commitment to supporting effective regulation of advertising in the interest of public health and safety. 

Conducting the Review in the COVID-19 environment posed some interesting challenges, leading to innovative and amended ways of completing the Review. As a result, most consultations were held via teleconference, and the work conducted by the review team mostly occurred online and offsite. The COVID-19 crisis required the TGA to develop and execute new strategies and approaches to cope with a public health emergency and as a result, the Review was able to identify some pertinent and significant changes in the operation of the TGA. A number of observations regarding this response have been captured in this review report. The COVID-19 environment provided an opportunity for the TGA to demonstrate the value to consumers of focusing on compliance priorities, taking a strategic approach to communication and education tasks, and adopting an agile approach to the use of its enhanced powers. The Review suggests there is much for the regulator and industry to learn from this recent experience. The Review noted that across all reform elements examined, the TGA has implemented the changes with a clear understanding of its accountability for public health and safety. The TGA has also demonstrated a positive and open-minded approach to continuous improvement to the regulatory framework and associated processes, such as through seeking feedback from stakeholders and reflecting on its approach in an iterative way. 

Overall, the changes that have been implemented by the TGA have moved in the right direction in giving effect to the intended outcomes and benefits noted in the MMDR Review and Government Response. In initiating and implementing the reforms to the therapeutic goods advertising framework, the TGA efforts to date have emphasised an approach of informing and assisting industry with regards to the advertising framework. This is a natural course given the shift to a self-regulatory landscape and the large suite of reforms to the rules and processes that regulate therapeutic goods advertising. In this way, the TGA has taken on a role of assisting industry to understand the new framework as the first step to enabling improved self-compliance. 

The Review notes that in some areas, such as with enforcement responses and developing educational materials, the TGA has gone to great lengths to support industry. The Review suggests that the TGA, with the regulatory framework and supporting processes for therapeutic goods advertising in place, is now well-placed to shift its approach and focus to achieve the aims of the reform program. For industry, the next phase will involve more responsibility, with industry further developing their practices for self-compliance, becoming responsible and accountable ‘partners’ in achieving the aims of the regulatory framework and the intended consumer protection outcomes. 

The Recommendations made as part of this Review are intended to facilitate this approach. For the TGA, the next phase will involve a more strategic approach to its responsibilities as the regulator of therapeutic goods advertising. The TGA should focus more directly on the intended outcomes and priorities of its compliance functions. A clearer vision of the outcomes and priorities of compliance activities should guide the TGA in updating its processes, performance measures, and aligning resources. The Recommendations made as part of this Review are intended to facilitate a more strategic and outcomes-focused approach to the TGA’s regulatory framework for therapeutic goods advertising. 

Summary assessment against Terms of Reference items 

The key observation to report is that while good progress has been made implementing the Government’s response to the MMDR Report, the focus has necessarily been tactical given the timeframes for implementation. With the benefit of the experience now gained over the last 12-18 months, and the need for rapid response in the early days of the COVID-19 pandemic, this Review finds that there has been progress in achieving the aims of the framework. The next phase in achieving further effectiveness and impact from the Therapeutic Good Advertising Framework will depend on a more strategic approach to a number of the review scope items. It should be noted based on stakeholder consultations, that the Department’s approach is already one of continuous improvement and that stakeholders are also committed to contribute to further improving the regulation advertising of therapeutic goods to the public. 

1.5.1 The amendments to the Therapeutic Advertising Code (No. 2) 2018 i.e. whether they have increased clarity and objectivity to support the compliance and enforcement powers in the Act and improved consistency between the requirements for medicines and medical devices 

The Review finds that the changes to the Code have resulted in improvement, with the new Code being clearer and easier to understand. Compliance is more straightforward for industry and advertisers and supports progress to a more self-regulatory regime. Assessment of advertising breaches is more straightforward for the TGA. There are opportunities for further refinement which are identified in the recommendations. 

1.5.2 The TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public The Review finds that the TGA is well-placed to be the single-body for managing complaints about the advertising of therapeutic goods. Stakeholders reported that TGA has the relevant scientific and regulatory knowledge to effectively regulate the quality and safety of therapeutic goods. The single body has reduced complexity and potential confusion in making complaints about advertising of therapeutic goods. A complaints management process has been implemented. There are opportunities for a more strategic approach to using complaints within the regulatory framework which are identified in the recommendations. 

1.5.3 Broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods 

The Review finds that the broadened sanctions and penalties provide an appropriate breadth of responses for the TGA in deterring misleading advertising and achieving compliance outcomes for consumer protection in a self-regulatory environment. There are opportunities for the TGA, having focused on its role to inform and educate industry, to build on its experience in using the full range of broadened sanctions and penalties. 

1.5.4 A comprehensive industry and consumer education program of the new advertising measures The Review finds the TGA has been effective in developing and distributing information about the advertising framework and Code requirements. The TGA has been very responsive to industry requests for further information. There are opportunities for the TGA to move to a more strategic approach to providing information and education for both industry and consumers including setting priorities based on key regulatory outcomes and working with industry as responsible and accountable partners in achieving better consumer outcomes. 

1.5.5 Public performance measures for advertising complaints management, i.e. an assessment of the suitability of the TGA’s key performance indicators for managing advertising complaints 

The Review finds significant opportunity for the TGA to revise its performance measures and key performance indicators to include a focus on priorities and outcomes for consumers rather than the current emphasis on timeliness of processes. The Review notes that the TGA has already begun work in this area through a focused concurrent management initiated review into the complaints management function. 

1.5.6 Stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the TGACC 

The Review found that the TGA applies considerable effort to stakeholder engagement with a very broad range of stakeholders. There is opportunity to engage more strategically with stakeholders, to provide focused opportunities for engagement and to shift from informing stakeholders to engaging them more effectively to build shared responsibility for achieving improved compliance outcomes.

Sinclair's  Summary of Recommendations for Further Improvement is

Regarding amendments to the Therapeutic Advertising Code (No. 2) 2018 

Recommendation 1: Case Studies To further increase clarity and objectivity of the Code, the TGA should consider using emerging case experience and decisions to create examples of the application and interpretation of the Code, including cases where provisions are considered by stakeholders to be ambiguous. 

The selection of case studies to publish may also be informed by the TGA’s compliance priorities (Recommendation 5) and education priorities (Recommendation 12). 

Recommendation 2: Focus Issues 

The TGA should maintain and share a log of Code issues that stakeholders confirm after discussions in TGACC sub-groups (Recommendation 20) as being unclear, inconsistent, or difficult to work with. Where case examples and educational materials are not sufficient to improve clarity and objectivity, the TGA should consider publishing policy clarification. 

Regarding the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods 

Recommendation 3: Maintain TGA as the single body 

The Government should maintain the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public. The TGA should continue to build its complaints handling capability and systems as outlined in Recommendations 4 to 7. 

Recommendation 4: Strategic Re-set 

The TGA should use the recommendations made in the concurrent management initiated review to reset the complaints management system to focus on achieving improved compliance outcomes through intelligence gathering, strategic triaging and integrated response. 

Recommendation 5: Compliance Priorities 

The TGA should develop and publish Compliance Priorities which are reviewed annually. In setting these priorities the TGA should develop factors to be considered, consult with stakeholders, and focus on consumer benefit. The Compliance Priorities should inform key performance indicators (KPIs) and reporting (Recommendations 14 and 15). 

Recommendation 6: Integrated Information - TGA 

The TGA should work to further integrate the management of complaints about advertising of therapeutic goods with other relevant areas within the TGA. This could be achieved by developing information-sharing practices across the TGA, to support: ▪ the compliance priorities across the TGA’s regulatory areas; and ▪ identification of trends identified across high-volume complaints regarding products, types of therapeutic claims made, manufacturers, or suppliers. 

Recommendation 7: Integrated Information – other Regulators 

The TGA should co-develop information-sharing protocols to facilitate active information-sharing with relevant regulators, including Food Standards Australia New Zealand (FSANZ) and the Australian Competition and Consumer Commission (ACCC) regarding complaints and trends on relevant cross- sector products or issues. This should be supported by focused engagement with regulators (Recommendation 21) to define information-sharing needs and priorities. 

Regarding broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods 

Recommendation 8: Regulatory Posture 

The TGA should develop and promote a clear regulatory position on its approach to the use of the broadened sanctions and penalties to protect public health and safety. This should include the balance of focus between educative and punitive responses, and the principles that guide the use of more punitive compliance tools. The position should be clearly communicated to Departmental staff involved in advertising compliance and other stakeholders. 

Recommendation 9: Skill development 

The TGA should provide focused skills development on compliance and enforcement practice to support the advertising compliance team in implementing the TGA’s regulatory position. This may include developing an understanding of case management and enforcement response at other regulators, and sharing lessons learned. 

Recommendation 10: COVID-19 Response 

The TGA should reflect on the lessons learned from the COVID-19 experience in responding to non- compliant advertising with sanctions and penalties in a timely manner. The COVID-19 experience also has useful learnings regarding the use of media and publicising the compliance actions taken by the TGA to raise awareness of the negative consequences of using non-compliant advertising. 

Regarding the industry and consumer education program of the new advertising measures 

Recommendation 11: Education Strategy 

The TGA should develop an Advertising Framework Education Strategy with clearly defined priorities that are aligned to Compliance Priorities and consumer outcomes. 

Recommendation 12: Education Priorities 

The TGA should develop Education Priorities to more effectively target educational activities. In setting these priorities the TGA should develop factors to be considered, consult with stakeholders and focus on consumer and industry benefit. The education priorities should be publicised and clearly communicated to stakeholders. The priorities should be reviewed annually. 

Recommendation 13: COVID-19 Communications 

The Review recommends that the TGA use the COVID-19 experience, particularly in priority-setting and developing activities and mobilising the media in support of agreed priorities, as part of developing a more strategic approach to its education program. 

Regarding the public performance measures for advertising complaints management 

Recommendation 14: Indicators for Outcomes 

The TGA should redevelop a suite of advertising compliance performance measures and indicators which focus on priorities and outcomes rather than processes and deadlines. In considering a new approach to measures and indicators, the TGA should use the recommendations made in the concurrent management initiated review of the complaints handling process. 

Recommendation 15: Performance Reporting 

Once the TGA has developed new performance indicators for advertising compliance and complaints management, the TGA should publicise the measures, and report performance against the measures using the TGA website and annual reporting and media channels. 

Regarding stakeholder engagement activities on therapeutic goods advertising 

Recommendation 16: Stakeholder Engagement Plan 

The TGA should ensure its Stakeholder Engagement Plan includes a focus on supporting effective regulation of therapeutic goods advertising. The stakeholder engagement plan should consider the TGA’s compliance priorities (in line with Recommendation 5) and education priorities (in line with Recommendation 12). The plan would define purpose and objectives, priorities, and engagement methods specific to TGA’s advertising compliance role. 

Recommendation 17: Communications Plan 

The TGA should ensure its Communications Plan reflects a strategic approach to communications including use of external channels (particularly media) to support its advertising framework compliance priorities, education strategy goals and stakeholder engagement strategy goals. Use of media and external channels should focus on increasing both consumer and industry awareness of the TGA’s regulatory position in regard to advertising compliance. Well-targeted consumer information and regular public reporting on regulatory decisions made and outcomes achieved would be elements of effective communication. 

Recommendation 18: TGACC Ways of Working 

The TGACC should be refocused to enhance its effectiveness as a collaborative forum focused on better outcomes for consumers through effective advertising compliance by industry. This may be achieved by updating the Governance Arrangements or developing an accountability charter which details: ▪ the refreshed objectives of the TGACC; ▪ roles and responsibilities of the TGA and members, which may include more opportunity for members to share their experiences, concerns or recent activities such as member education activities; and ▪ expectations of both the TGA and members. 

Recommendation 19: TGACC Work Plan 

The TGA should develop a list of key tasks and associated timeframes that require the input of the TGACC to finalise. This would include: ▪ developing annual compliance priorities; ▪ developing annual education priorities; and ▪ identifying significant case studies for use in the education program or media. 

Recommendation 20: TGACC Focus Sub-groups 

The TGA should consider hosting focused sub-groups with representation from the most relevant sector members from the TGACC. These should be hosted on an as-needed basis. A summary of key considerations and outcomes from these focused roundtables should be reported back to the wider TGACC group. 

Recommendation 21: Regulator Meetings 

The TGA should continue to hold regular meetings with other regulators to develop approaches and actions to address regulatory interface issues. A summary of key considerations and outcomes from the regulator meetings should be reported back to the wider TGACC group. 

Recommendation 22: Stakeholder Survey 

The TGA should develop a periodic (e.g. every two years) stakeholder survey to evaluate stakeholder satisfaction with stakeholder engagement efforts. The survey may also be used to gauge perceptions of the effectiveness of the TGA’s compliance framework, which may inform performance reporting. The survey should include input from key stakeholders consulted with and other partnering regulators. Areas of weakness or opportunities for improvement identified from the survey should inform updates to the TGACC Ways of Working, stakeholder engagement plan and communications plan.

Tag-Gag

"The Meaning of Meat' by Jareb A Gleckel and Sherry F Colb in (2020) Animal Law Review (Forthcoming) comments

 Plant-based and cell-based meat companies are vying to take over the trillion-dollar meat industry—and, in recent years, they have gained momentum. Responding to consumer demand and widespread fear about global climate change, investors like Bill Gates, Richard Branson, and even Tyson Foods began investing in alternative meat. Beyond Meat became a publicly-traded company and partnered with Dunkin’ Donuts, while Impossible Foods partnered with Burger King, bringing plant-based meat products into the mainstream. But many states with strong ties to animal agriculture have sought to impede the growth of the alternative-meat market. In August 2018, Missouri became the first state to restrict how alternative companies use the word ‘meat’ and related terms on their labels. Eleven more states have passed similar ‘Tag-Gag’ statutes. 

This Article reviews three primary constitutional challenges plant-based companies have leveled against such provisions—challenges based on the First Amendment, Due Process, and the Dormant Commerce Clause. After Part II evaluates the merits of these claims, Part III explores how they could advance or inadvertently undermine other animal and civil-rights lawyering strategies. To supplement the standard arguments, Part IV proposes ways for cause-driven plaintiffs like Tofurky—the first company to challenge Tag-Gag laws—to amplify their free speech claims. First, this Part suggests that although the statutes at issue appear to target mere commercial speech, courts have reason to view them as regulations of political speech calling for strict, rather than intermediate, scrutiny. Second, this Part suggests that plaintiffs could challenge Tag-Gag statutes not only under the First Amendment but also under the free speech provisions of state constitutions.

Fake Meat Patent Study

The IP Australia Meat expectations - an analytics report on substitute meats study analyses trends in meat substitute technologies, an emerging market as conscious consumerism and sustainability awareness grows. The report shows imitation meat technology is an area of growth and investment across the world, with a strong increase in patent filings since 2013. China dominates this sector, with the United States, Europe and Japan other major players. The report was prepared for the Department of Industry, Science, Energy and Resources to help support Australia’s meat and food industry.

The document states

This report analyses trends in meat substitute technologies, an emerging market as conscious consumerism and sustainability awareness grows. It considers two technologies; imitation meat and lab-grown meat. Recent patent data shows imitation meat technology is an area of growth and investment across the world. Between 2000 and 2012, patenting of imitation meat technologies maintained a low and relatively steady rate, with a significant increase since 2013. Large food companies are among the top applicants. 

China dominates this sector as both the largest source of innovation and the largest patent filing destination in imitation meat. It is also responsible for much of the recent growth in patenting in this technology with Guizhou Bezon Food Industry filing the largest number of patents in this sector. The United States, Europe and Japan are the other major players in this sector, with Australia ranking equal fifth, alongside Canada, as a patent filing destination. 

Lab-grown meat is a technology in its infancy, with only 10 patent families filed globally. This report outlines findings from an investigation of patent families filed since 2000, analysing trends, markets and commercial players in meat substitute technologies. .... 

258 patent families have been filed in imitation meat.  Patent family filings for imitation meat increased from 2013 onwards 85 per cent of imitation meat patent families are in an active state (in force or seeking patent protection) Guizhou Bezon Food Industry Company is the top global patent filer, with 18 patent families. China is the largest filing destination in the world for imitation meat patent families. Australia is equal fifth filing destinations for imitation meat. This report did not identify any patents filed by Australian applicants.

The study comments

As the basis for this study, worldwide patent databases were searched for all products and processes for producing foodstuffs that were intended to imitate animal meat in appearance, texture and/or flavour. The search returned a total of 258 relevant INPADOC patent families (Appendix A) filed from 2000 onwards. A majority of the patents were directed to imitation meat products derived from plants, such as soy, but some were also directed to technologies that used non-meat animal- derived products, such as milk and eggs. These were not specifically excluded from the search. The search strategy used a combination of keywords, International Patent Classification (IPC) symbols and Cooperative Patent Classification (CPC) symbols (Appendix B: Search Strategy). 

Analysing patent family filing across time can indicate growth or declines in innovation or interest in a technology. Figure 1 shows the number of patent families filed each year, both in total and by their legal status. The number of patents that are in an active state (ie that are either in force or for which protection is being sought, and are not lapsed, expired or withdrawn) provides an indication of whether applicants are continuing to protect their inventions. It is clear from Figure 1 that imitation meat is an area of growing interest. Patenting activity was low but regular up until 2012, after which the number of applications increased significantly. In 2016, 55 new families were filed. The data is not complete from 2017 onwards due to a lag in patent publication; the dip in 2017–18 reflects incomplete data rather than a trend decline. Much of the recent activity has been due to a few Chinese companies, who have submitted many applications in a short space of time. These companies will be discussed further below in the Markets and Top Applicants sections. ...

In relation to Lab Grown Meat the report states

 The search strategy used a combination of keywords, International Patent Classification (IPC) symbols and Cooperative Patent Classification (CPC) symbols (Appendix B: Search Strategy). Timeline We identified a total of 10 patent families filed for lab-grown meat, five in the early 2000’s and five between 2011 and 2017, see Figure 5. The data is incomplete from 2017 onwards due to a lag in patent publications. The search for lab-grown meat focuses on technologies for cell culture or tissue engineering of animal cells to create tissue similar to animal- derived meat. Culturing techniques for human cells, and culturing techniques directed at modifying the growth of cells in living animals, were not included in the analysis. With these restrictions in place, there is only a small number of patent families filed since 2000 that are directed to production of lab-grown meat for human consumption.