Voice

'Voice versus Rights: The First Nations Voice and the Australian Constitutional Legitimacy Crisis' by Gabrielle J Appleby, Ron Levy and Helen Whalan in (2023) 46(3) University of New South Wales Law Journal comments 

For almost three decades, Australia has been locked in a public and political debate about whether and how to ‘recognise’ Aboriginal and Torres Strait Islander peoples in the Australian Constitution. Omnipresent in all of these debates is the complex question of sovereignty. To many First Nations people, sovereignty is at the core of what they seek. Yet such aspirations seem to clash with the assumptions of many non-Indigenous people that the Australian state’s sovereignty is ultimate and exclusive – that is, fundamental and impinged by no other sovereignties. Such constitutional disagreements set up a chronic crisis of legitimacy. In this article, we examine the foundational purposes of substantive recognition reforms, and compare the two options that have dominated in the contemporary debate: rights and Voice. Recognition through rights is predominantly an attempt to redress the historical discrimination against Aboriginal and Torres Strait Islander people and prevent its future occurrence; or at least provide an avenue of redress for that potential. But this form of recognition, while it may do some work to support First Nations sovereignty and the right of self-determination, does not speak directly to them, and nor therefore to problems of constitutional legitimacy. We argue that recognition through First Nations Voice is a proposal that, unlike rights, relies on both deliberative and democratic characteristics to address the legitimacy problems that we outline. We identify this as a key implicit reason animating calls for an institutional political Voice from First Nations themselves, as expressed in the historic exercise of self-determination that culminated in the Uluru Statement. The Voice, operating as a vehicle through which First Nations can speak directly to the Parliament, has the potential to set up a deliberative and democratic process for the gradual working through of competing legitimacy claims.

Personhood and Zoocentrism

'AI inventors: deference for legal personality without respect for innovation?' by Ernest Kenneth-Southworth and Yahong Li in (2023) 18(1) Journal of Intellectual Property Law & Practice 58–69  comments 

 Thirty years ago, Lawrence B. Solum wrote a visionary article concerning the debate on the legal personhood of artificial intelligence (AI) and posed the following question:

Could an artificial intelligence become a legal person? As of today, this question is only theoretical.

Thirty years later, in the area of patent law, recent cases from the UK, the USA and Australia have resoundingly answered: ‘no’ to intellectual property rights (IPRs) for AI systems. While academic commentators have perhaps helped sensationalize the concept of an ‘AI inventor’, national patent offices and court judgments have taken a sober approach in opining that AI systems cannot possess or be subject to IPRs in patent law. This article argues that recent decisions, which have declined to grant IPRs to AI systems, are correct and pay deference to the requirement of legal personality, which is the foundation of law. Granting legal personhood to AI systems or machines, at least within the area of intellectual property, seems implausible. However, the article further argues that the deference given to legal personality in AI inventor cases raises the question of what impact this has on innovation. An approach that outcasts AI systems from patents may well respect the current order of legal personhood within the boundaries of most legal systems, but it may negatively impact the existing incentives for innovation provided by the IPR system. The article advocates for a reform of intellectual property laws to take into account the role of human creativity in enabling the creativity of AI systems

'Animal Rights in Colombia: A Critique from an Environmental Perspective' by Carlos Lozano in (2023) 54 Revista Derecho del Estado 345-380 comments 

Animal Rights are commonly understood as an expression of the Rights of Nature. However, one and the other are in open contradiction, due to the complex interactions of ecosystems and the place of fauna in them, poorly understood by the generators of animal law rules, since animal suffering is inherent in nature. Animal Rights in Colombia are not an expression of the Rights of Nature; on the contrary, they undermine them, and hinder the consolidation of an Environmental Law aligned with social justice that places the survival of ecosystems at the center. This is because animal law illegalizes critical ecological processes, gentrifies Environmental Law, fosters an artificial binarism between fauna and flora, contradicts certain forms of climate action, hinders conservation, stigmatizes cultural diversity, discriminates by class, impedes the control of invasive species, generates a protection deficit for other kingdoms of life, such as plants and fungi, and promotes a transition from anthropocentrism to a kind of zoocentrism. 

Capital, but the wrong kind

In Jarrad Lucas Dwyer v Br & I Pty Ltd [2023] FWC 171 the Fair Work Commission has addressed a sovereign citizen-style failure to follow procedure. 

The decision states 

 [4] On 8 September 2022, the Commission left a voicemail with the applicant requesting a return call regarding payment of the filing fee. An SMS was sent to the applicant’s nominated telephone number to the same effect. The Commission also posted information to the applicant on 8 September 2022 with details explaining how to pay the filing fee or make a waiver application. The letter put the applicant on notice that the matter was at risk of being dismissed in the absence of compliance. 

[5] On 14 September 2022, the applicant called the Commission. The applicant refused to open the 8 September 2022 letter from the Commission on the basis of concerns with the capitalisation of the letters on the envelope. The applicant also stated words to the effect that he was not making an application but rather a claim or contract, and he would not pay the filing fee until the Commission confirmed acceptance of his contract. The Commission advised the applicant that he was required to pay the filing fee or make a waiver application if he wanted the application to proceed. 

[6] On 23 September 2022, the Commission received an envelope from the applicant which contained illegible handwritten material. On 30 September 2022, the Commission’s 8 September 2022 correspondence was received by the Commission, marked “returned to sender” and stating “Jarrad lucas :Dwyer cannot open this article.” 

[7] On 5 October 2022, the Commission left a voicemail with the applicant requesting payment of the filing fee and advising that in the absence of payment, the application may be dismissed. The applicant returned the call seeking to speak with the specific Commission employee who left the voicemail, who was at the time unavailable. The applicant said he would call again later but did not do so. 

[8] On 7 October 2022, the applicant sent a lengthy email to the Commission. The email again raised concerns with the capitalisation of letters and suggested that the application should be referred to a Member. 

[9] On 19 January 2023, the Commission sent an email to the applicant’s email address, being the email account from which the applicant communicated with the Commission on 7 October 2022. The Commission advised the applicant that his application would be dismissed by close of business the following day for failure to pay the filing fee.

Discrimination

The ALRC has released a Religious Educational Institutions and Anti-Discrimination Laws: Consultation Paper seeking "stakeholder submissions on proposals to change the way Commonwealth anti-discrimination law applies to religious schools and other educational institutions'. 

The Consultation Paper sets out four general propositions supported by 14 technical proposals that would: 

•  make discrimination against students on the grounds of sexual orientation, gender identity, marital or relationship status, or pregnancy in schools and other religious educational institutions unlawful, by removing exceptions currently available under federal law, 
• protect teachers and other school staff from discrimination on the grounds of sex, sexual orientation, gender identity, marital or relationship status, or pregnancy, by removing similar exceptions, and 
• allow religious schools to maintain their religious character by permitting them to: give preference to prospective staff on religious grounds where the teaching, observance, or practice of religion is a part of their role (and it is not discriminatory on other grounds); and require all staff to respect the educational institution’s religious ethos.

The principles are

Principle 1: Human dignity is central to the expression and protection of all human rights. 

 

The recognition and protection of human dignity underlies and holds unconditional status in the international human rights framework. All of the human rights at issue in this Inquiry are important to human dignity. Although people may hold differing views about how difficult issues should be resolved, the methods used to resolve them should promote respect. 

 

Principle 2: All human rights engaged by this Inquiry are fundamentally important. 

 

All human rights are universal, inalienable, indivisible, interdependent, and interrelated. This Inquiry engages with a broad range of human rights. Respect for, and the protection and fulfilment of, each of these rights is fundamentally important. 

 

Principle 3: Human rights should be considered holistically. 

 

In managing intersections between human rights, the substance of the rights at issue should be preserved to the maximum degree possible. The broad range of rights relevant to education within religious educational institutions must be considered holistically. International human rights law provides a framework for managing the intersection of these rights. In situations where human rights appear to be in tension, ‘pragmatic elasticity’ is required to produce ‘practical concordance’ of all human rights involved, to the maximum degree possible.  Application of a competing or hierarchical lens, or engaging in a balancing act that produces ‘trade-offs’ should be avoided 

 

Principle 4: Education performs a key role in maintaining a pluralist and socially cohesive society. 

 

Australian society is diverse, with many different ethnic, racial, religious and social groups all living together. The Alice Springs (Mparntwe) Education Declaration, agreed on by all Australian Education Ministers in 2019 commits Australian governments to ensuring ‘education promotes and contributes to a socially cohesive society that values, respects and appreciates different points of view and cultural, social, linguistic and religious diversity’. 

 

Principle 5: Students are at the centre of this Inquiry. 

 

Students are the direct beneficiaries of education and are owed a duty of care by all institutions that deliver that education. The design of policy that impacts students must place at its heart the best of interests of those students. Parents, carers, and religious educational institutions and their staff, including teachers, perform an important role in supporting the educational and spiritual development, and wellbeing, of students. Staff also deserve safe workplaces and fair conditions of employment.

The consequent propositions are

A Discrimination against students on the grounds of sexual orientation, gender identity, marital or relationships status, or pregnancy 

1. Religious educational institutions should not be allowed to discriminate against students (current or prospective) on the grounds of their sexual orientation, gender identity, marital or relationship status, or pregnancy, or on the grounds that a family member or carer has one of those attributes.

2. Religious educational institutions should be permitted to train religious ministers and members of religious orders, and regulate participation in religious observances or practices, unfettered by sex discrimination laws. Where applicable, religious educational institutions should also continue to benefit from the exception available to charities in relation to the provision of accommodation. 

3. Religious educational institutions should be permitted to teach religious doctrines or beliefs on sex or sexual orientation in a way that accords with their duty of care to students and requirements of the curriculum. 

B Discrimination against staff on the grounds of sex, sexual orientation, gender identity, marital or relationships status, or pregnancy 

1. Religious educational institutions should not be allowed to discriminate against any staff (current or prospective) on the grounds of sex, sexual orientation, gender identity, marital or relationship status, or pregnancy. 

2. Religious educational institutions should be able to select staff involved in the training of religious ministers and members of religious orders, and regulate participation in religious observances or practices, unfettered by sex discrimination laws. Where applicable, religious educational institutions should also continue to benefit from the exception available to charities in relation to the provision of accommodation. 

3. Religious educational institutions should be able to require staff involved in the teaching of religious doctrine or belief to teach religious doctrine or belief on sex or sexuality as set out by that institution and in accordance with their duty of care to students and staff, and requirements of the curriculum. 

C Preferencing staff involved in the teaching, observance, or practice of religion on religious grounds 

1. In relation to selection, appointment, and promotion, religious educational institutions should be able to preference staff based on the staff member’s religious belief or activity, where this is justified because:

- participation of the person in the teaching, observance, or practice of the religion is a genuine requirement of the role; 

- the differential treatment is proportionate to the objective of upholding the religious ethos of the institution; and 

- the criteria for preferencing in relation to religion or belief would not amount to discrimination on another prohibited ground (such as sex, sexual orientation, gender identity, marital or relationship status, or pregnancy), if applied to a person with the relevant attribute. 

2. The nature and religious ethos of the educational institution should be taken into account in determining whether participation of the person in the teaching, observance, or practice of the religion is a genuine requirement of the role. 

D Ongoing requirements on all staff to respect the religious ethos of the educational institution 

1. Religious educational institutions should be able to expect all staff to respect their institutional ethos. A religious educational institution should be able to take action to prevent any staff member from actively undermining the institutional ethos of their employer. 

2. Religious educational institutions should be able to impose reasonable and proportionate codes of staff conduct and behaviour relating to respect for the institution’s ethos, subject to ordinary principles of employment law and prohibitions of discrimination on other grounds. 

3. Respect for an educational institution’s ethos and codes of conduct or behaviour should not require employees to hide their own sex, sexual orientation, gender identity, marital or relationship status, or pregnancy in connection with work or in private life, or to refrain from supporting another person with these attributes.

Fake Qualifications

'Are You for Real? Lessons for the Academy About Professors with Fake or Fraudulent Degrees' by Sarah Elaine Eaton and Jamie J Carmichael in Sarah Elaine Eaton, Jamie J Carmichael and Helen Pethrick (eds), Fake Degrees and Fraudulent Credentials in Higher Education (Springer, 2023) 251–267 comments 

In this chapter we demonstrate what can happen when professor and educational leaders have fake or fraudulent degrees or other qualifications. We present four key issues: (a) the threat to institutional reputation; (b) the threat to the credentials awarded by the institutions; (c) the impact on students; and (d) material costs to the organization. Then, we propose seven recommendations to prevent or address academic qualification fraud: (a) verify applicant credentials; (b) develop or update internal risk assessment plans; (c) conduct an internal qualifications audit; (d) develop or update institutional codes of conduct; (e) develop an internal process to investigate allegations of credential fraud; (f) develop and follow internal quality assurance processes for courses, programs, and curricula; and (g) Develop or update crisis communications plans to include credential fakery or fraud. We conclude by emphasizing that moral outrage will not solve the problem of academic credential fraud. Clear policies and procedures must be in place to prevent, investigate, and address qualifications fraud in educational contexts.

Pretendians

'Academia, Twitter wars, and suffocating social justice in Canada: the case of unrecognised Indigenous peoples by Michel Bouchard, Sébastien Malette and Jo-Anne Muise Lawless in (2022) Dialectical Anthropology comments 

The “woke movement” is now under fire globally. Seeking to right social injustice and battle racism, the woke movement has laudable intentions, but its implementation can exacerbate social inequalities. In the case of Canada, a social movement seeks to ferret out “Pretendians” or those White individuals deemed to be falsely assuming, and thus appropriating, Indigenous identity. Though this movement may seem righteous, the problem arises that individuals targeted are those who are Non-Status Indians and have yet to be recognised by the state, as well as Métis (or mixed-heritage people) whose historical communities have yet to be sanctioned by governments or courts, and who are also portrayed as being “Fétis” or fake Métis. Our challenge as researchers is to do the deep ethnographic, historical, and legal research to provide a nuanced understanding of indigeneity that does not constrain it solely to colonial models as the case studies provided will demonstrate.

The authors argue 

Social media has become the go-to tool for social justice activism. Through tweets and other digital media, individuals can successfully reach thousands, if not millions, globally. There are increasing concerns that the polarization of positions and the search for quick validation on social media may contribute to stifling academic exchanges, suffocating nuanced analysis, and discouraging discussions potentially leading to greater equity. As Beckerman (2022) highlights, online success necessarily requires resort to the use of algorithms which cater to a narrow spectrum of emotions, notably outrage, anger, and shame (Jones 2022). Though Twitter certainly fuelled large and important protests such as the Black Lives Matter movement, it arguably provides few pathways to lasting change, as this requires “[c]arefully crafted manifestos and patient debate” (Jones 2022). Rather, social media risks amplifying expressions of moral outrage, which is what is rewarded (Hathaway 2021). Those expressions in turn feed into moral panic, generating further social problems (Walsh 2020). Sociologically, a moral panic occurs when a mass movement propagates a false or exaggerated perception that some behaviour or group of people is deviant and poses a threat to society’s values and interests (Cohen 2011). Moral panic is generally fuelled by saturated media coverage of a perceived deviant behaviour. 

Recently, Canada has witnessed an uproar surrounding the legitimacy of those who are outside state-sanctioned spaces claiming Indigenous identity (Basken 2022; Martens 2021) As media attention on this topic grows, circles of activists and academics are trying to seize on these concerns with notions of pan-indigeneity, turning them into a crisis that can boost their own social influencer and righteous gatekeeper status. A consequence is disregard of concerns for diversity of Indigenous experiences within Canada’s colonial context—especially regarding Non-Status and “Other Métis” communities. Traditional media and online activists do not seek out those claiming a Métis identity outside of the state-sanctioned Métis Nation and Non-Status individuals who are not members of recognised bands. Instead, they publish anonymous accusations based on superficial analysis which, in turn, has led to individuals losing their jobs or having their work repudiated. Filmmaker Michelle Latimer is one example (Dowling 2021; Bresge 2018). Another is the Ardoch Algonquin First Nation community. Our paper examines those two cases within the larger colonial structure which has sought, and still seeks, to slowly limit and decrease the number of Indigenous identities in Canada. We also argue that, as online aggression builds, calls to censor academic research will increase as communities deemed to not exist a priori are deemed unworthy of research and the very act of studying these communities is described as promoting what Leroux (2019) termed “race-shifting”.

Homeopathy

Last month's Homeopathic Drug Products Guidance for FDA Staff and Industry document is described as representing the current thinking of the US Food and Drug Administration (FDA or Agency), does not establish any rights for any person and is not binding on FDA or the public. 

The Guidance states 

I. INTRODUCTION 

This guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health. 

The Agency anticipates that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enforcement and regulatory action as described in Section III below. 

For the purposes of this guidance, we define a “homeopathic drug product” as a drug product that is labeled as “homeopathic,” and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS). 

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 

II. BACKGROUND 

Homeopathy is an alternative medical practice that has a historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”); and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”). Proponents claim that a significantly diluted aqueous solution, consisting mainly of water molecules, retains therapeutic properties due to a “memory” of the substance diluted in it. 

Historically, homeopathic drugs have been identified through “provings,” in which substances are administered to healthy volunteers in concentrations that provoke overt symptoms. Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the substances. In other words, if a substance elicits a particular symptom, individuals experiencing that symptom would be treated with a diluted solution made from that substance. 

In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to the law recognizing the HPUS alongside its counterparts, the U.S. Pharmacopeia (USP) and the National Formulary (NF). Recent years have seen an increase in the sale of homeopathic drug products. In the past, these products were mostly prepared by homeopathic physicians for individual patients. Today they are frequently mass manufactured and widely marketed as over- the-counter (OTC) products. 

The definition of “drug” in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)) includes, among other articles, articles recognized in the HPUS or any of its supplements. As such, homeopathic drugs are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements. Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended, or suggested in the labeling. 

Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), before any “new drug” is marketed, it must be the subject of an approved application filed pursuant to section 505(b) or section 505(j) of the FD&C Act. The requirements in section 505 of the FD&C Act apply to biological products regulated under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262); however, as stated in section 351(j) of the PHS Act (42 U.S.C. § 262(j)), a biological product with an approved license under section 351(a) of the PHS Act (42 U.S.C. § 262(a)) is not required to have an approved application under section 505 of the FD&C Act. Accordingly, absent a determination that a homeopathic drug product is not a “new drug” under section 201(p), such a homeopathic drug product is subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are currently no homeopathic drug products that are approved by FDA. 

Under section 505G of the FD&C Act (as added by the CARES Act6)—which reforms and modernizes the OTC drug review process established in 1972—FDA now issues administrative orders to make GRAS/E determinations for certain nonprescription drugs marketed without an approved application. Prior to enactment of CARES, FDA had not reviewed any homeopathic drug products under the OTC Drug Review, because the Agency had placed homeopathic drug products in a separate category and deferred consideration of them. 

Subsequent to enactment of CARES, no GRAS/E determinations will be made for homeopathic drug products under section 505G, because section 505G does not apply to homeopathic drug products. 

Because at this time no homeopathic drug products have been determined by FDA to be GRAS/E, all homeopathic drug products remain subject to the premarket approval requirements. 

A. Compliance Policy Guide 400.400 In May 1988, the Center for Drug Evaluation and Research (CDER) issued Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” CPG 400.400 described the Agency’s enforcement priorities for homeopathic drugs. 

B. FDA’s Reexamination of its Enforcement Policies 

In light of the growth of the industry and passage of more than two decades since the issuance of CPG 400.400, FDA announced on March 27, 2015, that it was evaluating its regulatory framework for homeopathic drug products.  In April 2015, FDA held a public hearing to obtain information and comments from stakeholders about the current use of homeopathic drug products, as well as the Agency’s regulatory framework for such products.  FDA sought broad public input on its enforcement policies related to homeopathic drug products in an effort to better promote and protect the public health. 

Since the issuance of CPG 400.400, the Agency has encountered multiple situations in which homeopathic drug products posed a significant risk to patients. Such products either caused or could have caused significant harm, even though the product labeling and ingredient formulation appeared to meet the conditions of CPG 400.400. 

FDA has also documented many serious violations of Current Good Manufacturing Practice (CGMP) requirements by some manufacturers of homeopathic drug products, raising significant concerns about the safety of products made with inadequate process controls. 

As a result of the Agency’s evaluation of its regulatory framework, including consideration of the information obtained as a result of the public hearing and the recent growth of safety concerns associated with some homeopathic drug products, FDA believes that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to homeopathic drug products marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally. 

C. FDA’s Risk-based Approach 

Regardless of the product area, FDA generally applies a risk-based enforcement strategy. For example, FDA has generally employed a risk-based enforcement approach with respect to marketed unapproved new drugs. The Agency historically has prioritized compliance actions involving unapproved new drug products that have potential safety risks, lack evidence of effectiveness, are health fraud products, present challenges to the new drug approval process or the OTC Drug Review, are violative of the FD&C Act in other ways, or are reformulated to evade an FDA enforcement action. The Agency generally intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products, as described below. 

III. FDA’s ENFORCEMENT POLICY 

FDA is not required, and generally does not expect, to give special notice that a drug product may be subject to enforcement action. In the listing that follows, we clarify our general approach to prioritizing our enforcement and regulatory actions with regard to homeopathic drug products marketed in the United States without the required FDA approval. However, this guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time. 

Enforcement and Regulatory Priorities 

In developing a risk-based approach, FDA has identified certain categories of homeopathic drug products marketed without the required FDA approval as potentially posing higher risks to public health. FDA generally intends to prioritize enforcement and regulatory actions with respect to premarket approval requirements involving homeopathic drug products that are marketed without the required FDA approval that fall within the following categories:

• Products with reports of injury that, after evaluation, raise potential safety concerns. For example, MedWatch reports or other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues. 

• Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:

o An infectious agent with the potential to be pathogenic; 

o A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 802; 

o Multiple ingredients that, when used in combination, could result in possible interactions, synergistic effects, or additive effects of the various ingredients; or, 

o Ingredients that pose a risk of toxic, or other adverse effects, particularly when the ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process. 

• Products for routes of administration other than oral and topical. For example, injectable drug products and ophthalmic drug products in general pose a greater risk of harm to users because the routes of administration for these products bypass some of the body’s natural defenses. In particular, contaminated injectable and ophthalmic products can pose serious risks to the patient. 

• Products intended to be used for the prevention or treatment of serious and/or life- threatening diseases or conditions. Unapproved products for serious and/or life- threatening diseases or conditions raise public health concerns, in part, because they may cause users to delay or discontinue medical treatments that have been found safe and effective through the new drug application (NDA) or biologics license application (BLA) approval processes. 

• Products for vulnerable populations. For example, patient populations such as immunocompromised individuals, infants and children, the elderly, and pregnant women may be at greater risk for adverse reactions associated with a drug product, even if it contains only small amounts of an ingredient, due to the varying ability of individuals in these populations to absorb, metabolize, distribute, or excrete the product or its metabolites. These populations may also be at greater risk of harm as a result of foregoing the use of medical treatments that have been found safe and effective through the NDA or BLA approval processes or under the OTC Drug Review. 

• Products with significant quality issues. For example, products that are contaminated with foreign materials or objectionable micro-organisms, and/or are made in facilities with significant deviations from CGMP, pose a significant safety risk to patients.

The FDA notes that in 2016 its search of the FDA Adverse Event Reporting System (FAERS) database 

identified 99 cases of adverse events consistent with belladonna toxicity, including reports of infant deaths and seizures, possibly related to teething products. Multiple homeopathic drug products were identified as associated with this safety concern. Further investigation revealed that the poisonous belladonna alkaloids in some of the homeopathic teething tablet products far exceeded the labeled amounts, raising a serious safety concern. As another example, by 2009, FDA had received more than 130 reports of anosmia (loss of the sense of smell) associated with the use of Zicam homeopathic intranasal zinc products. FDA determined that if the products were used as labeled, a user would receive significant daily exposure to intranasal zinc, raising a serious safety concern. These are only two examples among many.

In 2019, as an example of enforcement, the FDA issued Warning Letters 

 to four companies that jointly manufacture and package Puriton Eye Relief Drops. The warning letters describe failures to conform to CGMP requirements due to improper methods, facilities or controls for manufacturing, processing and packing drugs. For example, multi-dose, preservative-free, homeopathic ophthalmic drug products were manufactured without any attempt to render them sterile. FDA tested multiple samples of these homeopathic ophthalmic drug products and found that they (1) were non-sterile (samples were found to be contaminated with Bacillus spp., high levels of particulate matter, or both), which could lead to eye infection; and (2) had a dangerously high pH level, which could lead to eye injury such as glaucoma, corneal scarring, and loss of vision. .