Frederick Bikeri Ochoiki v Jdt

JOHNSON & JOHNSON INC...........................................1 ST SERVICES RESPONDENT JOHNSON & JOHNSON (PTY) LTD................................................2 ND RESPONDENT JOHNSON & JOHNSON (K) LTD....................................................3 RD RESPONDENT KENYA BUREAU OF STANDARDS..................................................4 TH RESPONDENT PUBLIC HEALTH (STANDARDS) BOARD.........................................5 TH RESPONDENT CABINET SECRETARY MINISTRY OF HEALTH.................................6 TH RESPONDENT JUDGMENT INTRODUCTION 1. This Judgment concerns the determination of Constitutional Petition No. E510 of 2024, instituted in the public interest under Articles 22 and 258 of the Constitution by Frederick Bikeri Ochoiki, a civil rights activist, against Johnson & Johnson Services Inc., Johnson & Johnson (Pty) Ltd, Johnson & Johnson (K) Ltd, the Kenya Bureau of Standards, the Public Health (Standards) Board, and the Cabinet Secretary for the Ministry of Health. The Petition invites this Court to interrogate the constitutionality and legality of the continued manufacture, importation, sale, and distribution within the Republic of Kenya of talc-based Johnson & Johnson baby powder. 2. The Petitioner seeks, inter alia, orders prohibiting the manufacture, sale, and distribution of the impugned product; mandating the immediate withdrawal of all existing batches from the Kenyan market; directing the 4 th to 6th HCCHRPET. NO. E510 OF 2024 JDT P a g e 2 | 36

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Respondents to undertake comprehensive research, testing, and regulatory evaluation thereof and compelling the 1st to 3rd Respondents to disclose all material scientific and medical research in their possession relating to the alleged carcinogenic properties of the product. The Petitioner further prays for declaratory reliefs that the continued availability of the product violates the constitutional guarantees of the right to life, the right to the highest attainable standard of health, the right of access to information, and the rights of consumers under Articles 26, 35, 43, and 46 of the Constitution. 3. The gravamen of the Petition is that the talc-based baby powder in question is carcinogenic and poses a significant risk to public health. In advancing this contention, the Petitioner relies on the classification by the World Health Organization’s International Agency for Research on Cancer (IARC), published on 5th July 2024, categorising talc as Group 2A, being “probably carcinogenic to humans,” an elevation from its earlier Group 2B classification issued in 2006. The Petitioner further places reliance on comparative jurisprudence, particularly the decision in Ingram et al v. Johnson & Johnson in the United States of America, wherein a jury verdict subsequently affirmed on appeal found the product to have been contaminated with asbestos and causative of ovarian cancer, with punitive damages adjusted to approximately USD 2.1 billion. The Petition also draws support from regulatory actions in other jurisdictions, including Tanzania, the Republic of Congo, Sri Lanka, Zimbabwe, and Rwanda, where the product has been recalled, suspended, or prohibited pending further scientific assessment. HCCHRPET. NO. E510 OF 2024 JDT P a g e 3 | 36

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4. It is further contended that notwithstanding a global announcement made on 11th August 2022 by Johnson & Johnson to discontinue talc-based baby powder by the year 2023, the product remains available within the Kenyan market. The Petitioner relies on documentary material, including screenshots from various online retail platforms, to demonstrate its continued commercial availability. The Petitioner additionally avers that the 3 rd Respondent ceased trading in or about 2010, thereby implying that any products currently in circulation are imported, and faults the 4th Respondent for an alleged failure to discharge its constitutional and statutory mandate to protect consumers through adequate testing, surveillance, and recall mechanisms. 5. The Petition is opposed. The 1st to 3rd Respondents deny any liability or violation of constitutional rights, contending, inter alia, that the 1 st Respondent is a services entity with no involvement in the manufacture or sale of the product, that the 2 nd Respondent’s last shipment into Kenya occurred in June 2022 and that the 3 rd Respondent ceased trading in 2010. They further assert that the Petition discloses no reasonable cause of action, that the doctrine of constitutional avoidance is applicable, and that no credible evidence has been adduced to demonstrate that the product available in Kenya is contaminated with asbestos or is carcinogenic. In support of their position, they rely on expert evidence disputing any causal association between talc use and ovarian cancer. HCCHRPET. NO. E510 OF 2024 JDT P a g e 4 | 36

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6. The 4th Respondent, for its part, acknowledges awareness of a safety alert issued by the United States Food and Drug Administration (USFDA) concerning a specific batch of the product, namely batch number 22318RB, which had been reported to contain traces of asbestos. It, however, maintains that the said batch was never imported into Kenya. The 4 th Respondent avers that, in response to the alert, it undertook a series of regulatory interventions, including the initiation of a review of the applicable standards to incorporate mandatory asbestos testing, the requirement that all imported baby powder be subjected to testing under the Pre-Export Verification of Conformity (PVoC) programme, and the removal of talcum powder from the list of raw materials exempt from such inspection. It further contends that it has neither recorded any recent importation of the impugned product nor received complaints of adverse health effects associated therewith, and maintains that specialised toxicological and carcinogenicity assessments fall outside its present technical mandate. 7. In addition, the 1st to 3rd Respondents have raised a preliminary objection challenging the jurisdiction of this Court on grounds, inter alia, of improper service upon foreign entities and misjoinder. The resolution of that objection, together with the substantive issues arising from the Petition, now falls for determination. 8. The record before this Court comprises the following pleadings and materials. The Petitioner relies on the Petition dated 21 st September 2024, together with a witness statement, a further witness statement dated 10 th March HCCHRPET. NO. E510 OF 2024 JDT P a g e 5 | 36

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2025, and written submissions dated 25 th April 2025. The 1st to 3rd Respondents rely on their Notice of Preliminary Objection dated 18 th November 2024, Grounds of Opposition dated 4 th December 2024, a Replying Affidavit sworn by Julio Cesar Do Monte on 4 th December 2024, and Supplementary Affidavits sworn by Professor Gregory B. Diette on 17 th February 2025, William Sello Malete on 4 th March 2025, and Kristen Renee Fournier on 12th February 2025. The 4th Respondent relies on the Replying Affidavit sworn by Benson Bundi on 16th December 2024 and written submissions dated 26th May 2025, while the 6th Respondent relies on its Grounds of Opposition dated 22nd January 2025. THE PETITIONER’S CASE 9. The Petitioner avers that talc-based Johnson & Johnson baby powder is carcinogenic and, on that account, ought to be prohibited from the Kenyan market. In support of this proposition, he places reliance on the classification by the World Health Organization’s International Agency for Research on Cancer (IARC), published on 5th July 2024 and annexed as FBO-001, which categorises talc as Group 2A, being “probably carcinogenic to humans.” The Petitioner underscores that the said classification is predicated upon a finding of limited evidence of carcinogenicity in humans, particularly in relation to ovarian cancer, sufficient evidence in experimental animals, and strong mechanistic evidence demonstrating that talc exhibits key characteristics of carcinogens, including the induction of chronic inflammation and the disruption of cellular processes such as proliferation, apoptosis, and nutrient HCCHRPET. NO. E510 OF 2024 JDT P a g e 6 | 36

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supply. He emphasises that this classification represents the second highest level of scientific certainty within the IARC framework. 10. The Petitioner further anchors his case on comparative jurisprudence, notably the decision of the Missouri Court of Appeal in Ingram et al v. Johnson & Johnson. He submits that in that matter, the Court upheld findings that the 1st Respondent had, over several decades, knowledge of contamination of its talc products with asbestos but consciously elected not to employ pre-concentration testing methods for fear that such methods would yield higher detectable levels of asbestos. According to the Petitioner, the Court drew the inference that the 1 st Respondent, motivated by commercial considerations, disregarded the safety of consumers notwithstanding its knowledge of the attendant risk of ovarian cancer. 11. The Petitioner also places reliance on regulatory measures adopted in other jurisdictions. He points to a directive issued by the Tanzania Bureau of Standards on 19th April 2023, annexed as FBO-002, recalling all talc-based Johnson & Johnson baby powder products and instructing the public to cease their use, while directing importers, distributors, and retailers to halt further importation, sale, and distribution. He contends that, in contrast, the 4 th Respondent has failed to take analogous precautionary measures despite its statutory and constitutional mandate. Further reference is made to the suspension of importation and marketing of the product in the Republic of Congo on 3rd November 2020, the halting of imports by Sri Lanka pending HCCHRPET. NO. E510 OF 2024 JDT P a g e 7 | 36

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certification that the product is asbestos-free, and regulatory action by Zimbabwe’s Ministry of Health and Child Care banning the product. 12. On the constitutional plane, the Petitioner contends that the continued availability of the impugned product infringes Article 26 of the Constitution. He argues that cancer, being a life-threatening condition with no definitive cure, poses a grave risk to the right to life, particularly where exposure arises from prolonged and repeated use of the product. In this regard, he invokes General Comment No. 14 of the Committee on Economic, Social and Cultural Rights, which affirms that every individual is entitled to the highest attainable standard of health conducive to living a life in dignity, and that the right to health encompasses, inter alia, freedom from non-consensual exposure to harmful substances and the entitlement to a system of health protection that ensures equal opportunity for all. 13. The Petitioner further asserts that the failure to adequately warn consumers of the alleged carcinogenic risk violates Article 35 of the Constitution on the right of access to information. In support of this contention, he relies on Nairobi Bottlers Limited v Ndung’u & another (Civil Appeal 99 of 2018) [2023] KECA 839 (KLR), wherein the Court of Appeal underscored the centrality of product information in safeguarding consumer rights under Article 46, holding that proper labelling enables consumers to make informed choices and secures their health, safety, and economic interests. The Petitioner argues that the labelling of the impugned product merely cautions against inhalation risks, without disclosing any potential carcinogenic effects. HCCHRPET. NO. E510 OF 2024 JDT P a g e 8 | 36

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14. It is further the Petitioner’s case that the 4 th Respondent has failed to discharge its constitutional and statutory obligations under Article 46 of the Constitution and Section 4 of the Standards Act. Reliance is placed on Attorney General & another v Phoenix Global Kenya Limited & 6 others [2019] eKLR, where the Court affirmed that the Kenya Bureau of Standards bears a constitutional duty to ensure that goods in the market meet prescribed standards, and that the processes of sampling and testing are integral to the protection of consumers from harmful and substandard products. 15. On the question of propriety of parties and jurisdiction, the Petitioner contends that the 1st to 3rd Respondents are properly impleaded. He asserts that the 1st Respondent is the principal shareholder of the 3 rd Respondent, that the 2nd Respondent markets and sells the product through an online platform accessible within Kenya, as evidenced by the material annexed as FBO-005, and that the 3rd Respondent is a company duly registered within the jurisdiction. He further argues that the procedural requirements governing service outside the jurisdiction under the Civil Procedure Rules are inapplicable to constitutional litigation, which is governed by the Constitution of Kenya (Protection of Rights and Fundamental Freedoms) Practice and Procedure Rules, 2013 (the Mutunga Rules), and which do not require prior leave for such service. He maintains that service by electronic means was necessitated by the absence of a physical presence of the Respondents within the jurisdiction. HCCHRPET. NO. E510 OF 2024 JDT P a g e 9 | 36

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16. The Petitioner maintains that he has established a prima facie case warranting the grant of conservatory relief, and that the Petition raises substantial and weighty constitutional questions touching on the rights to life, health, access to information, and consumer protection, thereby justifying the intervention of this Court. 17. In the premises, the Petitioner urges this Court to intervene and grant the reliefs sought, including the prohibition of talc-based baby powder within the Kenyan market, or, in the alternative, to order its immediate withdrawal pending the conduct of rigorous and independent scientific testing. THE 1ST, 2ND AND 3RD RESPONDENTS’ CASE 18. The 1st to 3rd Respondents oppose the Petition in limine, contending that it is incompetent, misconceived, and an abuse of the process of this Court. To that end, they raise a Preliminary Objection on three principal grounds, namely: that this Court lacks jurisdiction by reason of failure to obtain leave to effect service outside the jurisdiction upon the 1 st and 2nd Respondent, that the 1st and 3rd Respondents have been improperly joined to these proceedings, they being neither necessary nor proper parties and that the Petition discloses no reasonable cause of action as against them. 19. On the question of service and jurisdiction, the 1 st to 3rd Respondents submit that the 1st and 2nd Respondents are foreign entities not domiciled within HCCHRPET. NO. E510 OF 2024 JDT P a g e 10 | 36

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Kenya, and that service upon them is governed by Order 5 Rules 21, 22, and 25 of the Civil Procedure Rules, which mandatorily require leave of the Court prior to effecting service outside the jurisdiction. In support of this proposition, reliance is placed on Law Society of Kenya v Martin Day & 3 others [2015] eKLR, where the court underscored that proper service of summons is foundational to the exercise of jurisdiction over a foreign defendant, and that mere knowledge of the existence of proceedings does not suffice. Further reliance is placed on Bildad Kanuri Kagai & another v Idemia (Formerly OT Morpho) & 2 others [2019] eKLR, the court held that the appointment of advocates does not cure non-compliance with the mandatory requirement for leave prior to instituting proceedings against foreign parties. 20. The Respondents reject the Petitioner’s contention that the Civil Procedure Rules are inapplicable to constitutional proceedings, placing reliance on Okoiti v The Cabinet Secretary, National Treasury and Planning & 13 others; Katiba Institute (KI) & 5 others (Interested Parties) (Petition E317 of 2021) [2022] KEHC 12116 (KLR), where the Court held that although the Constitution of Kenya (Protection of Rights and Fundamental Freedoms) Practice and Procedure Rules, 2013 (the Mutunga Rules) provide for service, they do not prescribe the mode thereof, thereby necessitating recourse to the Civil Procedure Rules. The same position, it is urged, was affirmed in African Centre for Corrective and Preventive Action & 11 others v Delmonte Kenya Limited & 7 others; Kenya National Human Rights Commission & 2 others (Interested Parties) [2025] KEHC 1602 (KLR), where the Court HCCHRPET. NO. E510 OF 2024 JDT P a g e 11 | 36

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recognised the applicability of the Civil Procedure Act and Rules in relation to service upon parties outside the jurisdiction. 21. On the issue of joinder, the 1st to 3rd Respondents submit that the 1st Respondent is a services entity with no involvement whatsoever in the manufacture, distribution, or sale of the impugned product, as evidenced by the apostilled certificate annexed as JCM-1. As regards the 3 rd Respondent, it is contended that it ceased operations in 2010 a fact acknowledged by the Petitioner and therefore cannot properly be impleaded in these proceedings. Reliance is placed on Order 1 Rule 3 of the Civil Procedure Rules, which circumscribes joinder to persons against whom a right to relief is alleged to exist, arising out of the same transaction or series of transactions. The Respondents further invoke Directline Assurance Company Ltd v AKM Investments Ltd & 6 others [2021] eKLR, wherein the Court drew a distinction between a necessary party, whose presence is indispensable to the constitution of the suit, and a proper party, whose presence facilitates a complete and effectual adjudication of the dispute. 22. With regard to the alleged absence of a cause of action, the 1 st to 3rd Respondents contend that the Petition fails to disclose any violation of constitutional rights attributable to them. They submit that this Court must be vigilant to guard against the improper invocation of its constitutional jurisdiction, and rely on Sanitam Services (EA) Limited v Tamia Limited & 16 others [2012] eKLR and Karuri and others v Dawa Pharmaceuticals Company Limited and others [2007] 2 EA 235, for the proposition that courts HCCHRPET. NO. E510 OF 2024 JDT P a g e 12 | 36

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retain an inherent jurisdiction to strike out pleadings that are frivolous, vexatious, or otherwise an abuse of process, notwithstanding that such claims are framed in constitutional terms. 23. The 1st to 3rd Respondents further invoke the doctrine of constitutional avoidance and the principle of exhaustion of statutory remedies. They submit that the present dispute is, in essence, a consumer protection claim improperly elevated to a constitutional question. In this regard, reliance is placed on Communications Commission of Kenya & 5 others v Royal Media Services Limited & 5 others [2014] eKLR, where the Supreme Court articulated the principle that constitutional issues ought not to be determined where a matter may be disposed of on another legal basis. They also cite Sumayya Athmani Hassan v Paul Masinde Simidi & Another [2019] eKLR, wherein the Court of Appeal held that where legislation has been enacted to give effect to a constitutional right, a litigant ought to pursue remedies under such legislation rather than directly invoking constitutional provisions, absent a challenge to the statute itself. 24. It is in that context that the 1st to 3rd Respondents contend that the Consumer Protection Act, Cap 51, and the Standards Act, Cap 496, provide a comprehensive statutory framework for addressing the grievances raised by the Petitioner. They point to Part X of the Consumer Protection Act, which establishes the Kenya Consumers Protection Advisory Committee with a mandate to advise and ensure appropriate action on consumer protection matters, as well as Sections 4(1) and 7(2) of the Standards Act, which HCCHRPET. NO. E510 OF 2024 JDT P a g e 13 | 36

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empower the 4th Respondent and the National Standards Council to undertake examination, testing, and investigative studies on commodities. The Respondents argue that the Petitioner has failed to exhaust these statutory mechanisms prior to invoking the constitutional jurisdiction of this Court. 25. On the merits, the 1st to 3rd Respondents rely on expert evidence in the form of the report of Professor Gregory B. Diette, who opines that the epidemiological literature demonstrates either no association or, at most, a weak and statistically insignificant association between perineal talc use and ovarian cancer, which may be attributable to bias, confounding factors, or chance. Professor Diette reviewed several large-scale studies, including the Nurses’ Health Study (2000 and 2010), the Gates Report (2010), the Women’s Health Initiative (2014), the Sister Study (2016), and the O’Brien Study (2024), all of which, he concludes, fail to establish a causal relationship between talc use and ovarian cancer. He further avers that there exists no reliable experimental evidence in humans demonstrating such a relationship, and that reliance on animal studies in prior litigation is scientifically tenuous. 26. The Respondents also rely on the affidavit of William Sello Malete, who deposes that the discontinuation of talc-based Johnson’s Baby Powder was a commercial decision aimed at transitioning to a cornstarch-based product line, as reflected in press releases dated 19 th May 2020 and 11th August 2022, and was not motivated by safety concerns. He further states that, within the European Union, talc has neither been prohibited nor recalled, but is subject HCCHRPET. NO. E510 OF 2024 JDT P a g e 14 | 36

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only to labelling requirements for products intended for young children. He clarifies that in Tanzania, regulatory action related to a specific batch, namely batch number 22318RB, and that the relevant publication was confined to that batch. He further avers that talc remains an approved substance under the regulatory framework of the United Kingdom Food Standards Agency. 27. In addition, the 1st to 3rd Respondents rely on the affidavit of Kristen Renee Fournier, who contextualises the litigation landscape in the United States. She deposes that, of the seventeen talc-related ovarian cancer trials that proceeded to verdict, plaintiffs have ultimately succeeded in only one, namely Ingram et al v. Johnson & Johnson, while the majority have resulted in defence verdicts or inconclusive outcomes. She further explains that the appellate court in Ingram was constrained to review the evidence in the light most favourable to the prevailing party, and did not make definitive findings of scientific causation. With respect to the New York Attorney General consent order, she avers that the same was entered into without admission of liability, without adjudication on the merits, and with the express intention that it would not constitute evidence in other proceedings. 28. It is the 1st to 3rd Respondents submission that the Petitioner has failed to discharge the requisite burden of proof in constitutional litigation. In this regard, they rely on Gwer & 5 others v Kenya Medical Research Institute & 3 others (Petition 12 of 2019) [2020] KESC 66 (KLR), where the Supreme Court held that claims alleging violation of constitutional rights demand a heightened standard of proof, requiring a petitioner to place before the Court HCCHRPET. NO. E510 OF 2024 JDT P a g e 15 | 36

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cogent and substantial material capable of sustaining the alleged violations. They contend that the Petitioner has fallen short of this threshold. 29. In light of the foregoing, the 1st to 3rd Respondents pray that the Preliminary Objection be sustained and that the Petition be struck out with costs. THE 4TH RESPONDENT’S CASE 30. The 4th Respondent, the Kenya Bureau of Standards, maintains that it has at all material times acted within the confines of its constitutional and statutory mandate and has not infringed the consumer rights guaranteed under Article 46 of the Constitution. It avers that upon receipt of the United States Food and Drug Administration (USFDA) alert in 2019 concerning a specific batch of the product namely batch number 22318RB it promptly activated its internal regulatory mechanisms. Through its Cosmetics Technical Committee, it convened a meeting with representatives of the 1 st and 2nd Respondents for purposes of establishing whether the said batch had been imported into Kenya. 31. The 4th Respondent further deposes that following the said engagement, it instituted a series of precautionary regulatory measures, including the initiation of a review of the East African Standard on body powders with a view to introducing a mandatory requirement for asbestos testing; the imposition of a requirement that all baby powder products imported into Kenya undergo asbestos testing under the Pre-Export Verification of Conformity (PVoC) programme and the removal of talcum powder from the HCCHRPET. NO. E510 OF 2024 JDT P a g e 16 | 36

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list of raw materials exempted from PVoC inspection. In justification of its regulatory restraint and statutory fidelity, reliance is placed on Republic v Sacco Societies Regulatory Authority & another Ex Parte Martin Njuhigu & 24 others [2017] eKLR, where the Court held that an order of mandamus will only issue where a duty is clearly established, plainly defined, and peremptory in nature, and not where a public authority retains discretion under statute. 32. The 4th Respondent submits that it cannot be compelled to undertake independent toxicological or carcinogenicity testing of the impugned product as sought by the Petitioner. It avers that it has no record of importation of the product into Kenya within the last two years, a position corroborated by the 1st and 2nd Respondents, who confirm that no recent imports have been effected. It further contends that its mandate under Section 4(1)(i) of the Standards Act is confined to conformity assessment against prescribed standards and does not extend to conducting medical or scientific determinations on toxicity or carcinogenicity, which fall within specialised biomedical domains. It is therefore the 4 th Respondent’s position that any order compelling it to undertake such functions would be in vain and ultra vires, as contemplated in Republic v Sacco Societies Regulatory Authority & another Ex Parte Martin Njuhigu & 24 others [2017] eKLR. 33. With respect to enforcement action, the 4 th Respondent contends that no sufficient basis has been laid for the issuance of the sweeping regulatory and coercive orders sought by the Petitioner. It argues that regulatory HCCHRPET. NO. E510 OF 2024 JDT P a g e 17 | 36

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intervention must be grounded on specificity, verifiable evidence, and demonstrable risk within the jurisdiction, including identification of the particular batch, its provenance, and subjecting the same to appropriate conformity assessment. In this regard, it points to the Petitioner’s own annexures, particularly FBO-004, which indicate that the sample product allegedly purchased in June 2023 within Kenya was manufactured in South Africa, thereby necessitating a clear evidentiary nexus before any inference of contamination or systemic defect may be drawn. Further, the laboratory report annexed as FBO-003 identifies batch number 22318RB, which was the subject of the USFDA alert, and the 4 th Respondent reiterates that it undertook due regulatory verification and confirmed that the said batch was not imported into Kenya at any material time. 34. The 4th Respondent therefore maintains that the Petition seeks a blanket prohibition and regulatory intervention unsupported by localized evidence of harm, and which would amount to an impermissible extension of its statutory mandate. It reiterates that its role is confined to conformity assessment against applicable standards, and not the undertaking of scientific determinations on toxicity or carcinogenicity, which lie within specialised biomedical and research domains. THE 6TH RESPONDENT’S CASE 35. The 6th Respondent opposes the Petition in its entirety and submits that it is misconceived, legally untenable, and devoid of factual foundation. It contends that the Petition fails to meet the threshold of reasonable precision HCCHRPET. NO. E510 OF 2024 JDT P a g e 18 | 36

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in constitutional pleading as articulated in Anarita Karimi Njeru v Republic, in that it does not clearly and specifically set out the manner in which the alleged constitutional violations have been committed, nor does it establish a coherent nexus between the impugned conduct and the alleged infringement of rights. 36. It is further the 6th Respondent’s case that the Petition is founded on conjecture, speculation, and hearsay, rather than probative evidence of constitutional injury or identifiable affected persons. In its view, the Petition improperly invites this Court to engage in abstract adjudication divorced from demonstrable harm or concrete factual substratum. 37. On that basis, the 6th Respondent urges this Court to dismiss the Petition in its entirety with costs. ANALYSIS AND DETERMINATION 38. Upon consideration of the pleadings, affidavits, written submissions, and authorities placed before this Court, this Court finds that the following issues commend themselves for determination: i. Whether the petition offends the principle of constitutional avoidance and the doctrine of exhaustion of remedies, given the existence of statutory mechanisms under the Consumer Protection Act and the Standards Act. HCCHRPET. NO. E510 OF 2024 JDT P a g e 19 | 36

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ii. Whether the Petitioner has established, to the required standard of proof, that the talc-based Johnson & Johnson baby powder sold in Kenya is carcinogenic and violates the rights to life under Article 26, the right to the highest attainable standard of health under Article 43, the right to access information under Article 35, and consumer rights under Article 46 of the Constitution. iii. Whether the 4th Respondent has fulfilled its constitutional and statutory obligations to protect consumers, and whether orders should issue compelling the 4th to 6th Respondents to undertake further research and testing. iv. What appropriate orders, including costs, should the Court grant. Whether the petition offends the principle of constitutional avoidance and the doctrine of exhaustion of remedies, given the existence of statutory mechanisms under the Consumer Protection Act and the Standards Act 39. The principle of constitutional avoidance is deeply embedded in our constitutional jurisprudence. The Supreme Court in Communications Commission of Kenya & 5 others v Royal Media Services Limited & 5 others (supra) held that a court will not determine a constitutional issue where a matter may properly be decided on another basis. The Court further underscored that where an alternative remedy exists under statute, a party ought to pursue that remedy before invoking the constitutional jurisdiction of the Court. HCCHRPET. NO. E510 OF 2024 JDT P a g e 20 | 36

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40. This principle has been consistently applied by our courts. In Southlake Panorama Limited v Kenya Electricity Transmission Company Limited & 3 others [2021] KEELC 2675 (KLR), the Court emphasized that constitutional jurisdiction should not be invoked to determine ordinary disputes. Similarly, in Ajab Hardware Limited v County Government of Tana River [2024] KEHC 13316 (KLR), citing John Harun Mwau vs. Peter Gastrow & 3 Others [2014] eKLR, the Court reiterated that where a remedy exists under statute, the Court will ordinarily decline to determine whether there has been, in addition, a breach of constitutional rights. 41. The Petitioner’s claim, stripped of its constitutional garb, is essentially a consumer protection dispute. The allegation that talc-based Johnson’s Baby Powder is dangerous, carcinogenic, and ought to be banned from the Kenyan market falls within the realm of product liability and consumer safety. Although Article 46 of the Constitution guarantees consumer rights, Article 46(3) mandates Parliament to enact legislation to give effect to those rights. Parliament has done so through the Consumer Protection Act, No. 46 of 2012 and the Standards Act, Cap 496. 42. The Consumer Protection Act establishes mechanisms for consumer redress. Section 3 sets out its objectives, while Part X establishes the Kenya Consumers Protection Advisory Committee, whose functions under Section 90 include addressing consumer complaints and advising on appropriate regulatory action. Complaints may be lodged and referred to relevant regulatory bodies or tribunals. HCCHRPET. NO. E510 OF 2024 JDT P a g e 21 | 36

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43. The Standards Act, Cap 496, establishes the 4 th Respondent and provides for the testing and regulation of commodities. It further establishes the National Standards Council, which may conduct examinations and tests upon request, and provides for enforcement measures, including penalties for noncompliance. The Act also establishes a dispute resolution framework through the Standards Tribunal, with a further right of appeal to the High Court. 44. The Court of Appeal in Hassan v Simidi & another [2019] KECA 107 (KLR) affirmed that where legislation has been enacted to give effect to a constitutional right, a litigant ought not to found a cause of action directly on the Constitution without first engaging with that statutory framework. Similarly, in Francis Gathungu Waithaka v Kenyatta University [2012] KEHC 2706 (KLR), the Court affirmed that not every failure by a public authority amounts to a constitutional violation, particularly where statutory remedies exist. 45. The Petitioner has not demonstrated exhaustion of these statutory remedies. He has not lodged a complaint under Section 90 of the Consumer Protection Act, invoked the National Standards Council under Section 7(2) of the Standards Act, or pursued any recourse before the Standards Tribunal. He has also not demonstrated that a request for information under Article 35 was made and declined, as required in Andrew Omtatah Okoiti v Attorney General & 2 others [2011] eKLR. HCCHRPET. NO. E510 OF 2024 JDT P a g e 22 | 36

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46. The Court recognizes that exceptions to the doctrine of exhaustion exist, including where a constitutional violation is clear, where the alternative remedy is inadequate, or where resort to statutory mechanisms would be futile. However, no such exceptional circumstances have been demonstrated in this case. 47. In the circumstances, the dispute falls squarely within a comprehensive statutory framework enacted to give effect to Article 46 of the Constitution. The Petitioner has not shown that the mechanisms under the Consumer Protection Act and the Standards Act are unavailable, ineffective, or incapable of addressing the grievances raised. 48. The Petitioner has urged the Court to assume jurisdiction on account of the public interest nature of the claim, particularly given the potential impact on public health. While the Court does not diminish the importance of the issues raised, the existence of a constitutional or public interest dimension does not, in itself, displace the requirement to exhaust statutory remedies. A party must demonstrate that the statutory framework is inadequate or unsuitable, which has not been done here. 49. The evidence before the Court further demonstrates that the regulatory framework is functional. The 4th Respondent has undertaken regulatory interventions following the USFDA alert, including revising the applicable standards to require mandatory asbestos testing for baby powder products and imposing Pre-Export Verification of Conformity (PVoC) requirements. HCCHRPET. NO. E510 OF 2024 JDT P a g e 23 | 36

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These measures indicate that the statutory regime is capable of responding to consumer safety concerns. 50. Accordingly, the Court finds that the Petition is properly situated within an existing statutory dispute resolution framework and that the Petitioner has failed to exhaust the remedies provided therein. The Petition therefore offends both the doctrine of exhaustion of remedies and the principle of constitutional avoidance. 51. On that basis, the Petition would be liable for dismissal. Nonetheless, and for completeness of the record, the Court proceeds to consider the remaining issues for determination. Whether the Petitioner has established, to the required standard of proof, that the talc-based Johnson & Johnson baby powder sold in Kenya is carcinogenic and violates the rights to life under Article 26, the right to the highest attainable standard of health under Article 43, the right to access information under Article 35, and consumer rights under Article 46 of the Constitution. 52. Notwithstanding the foregoing finding on constitutional avoidance and exhaustion, and only for completeness of the record, the Court proceeds to consider whether the Petitioner has discharged the evidential burden required to establish the alleged constitutional violations. HCCHRPET. NO. E510 OF 2024 JDT P a g e 24 | 36

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53. The law on burden and standard of proof in constitutional litigation is well settled. The Supreme Court in Gwer & 5 others v Kenya Medical Research Institute & 3 others (supra) held that constitutional claims attract a higher evidentiary threshold than ordinary civil claims. The Court stated: “The petitioners’ case is set around the constitutional right of freedom from discrimination Constitution of Kenya, 2010, article 27). It is already the standpoint of this Court, as regards standard of proof, that this assumes a higher level in respect of Constitutional safeguards, than in the case of the ordinary civil-claim balance of probability. The explanation is that, virtually all constitutional rights-safeguards bear generalities, or qualifications, which call for scrupulous individual appraisal for each case.” 54. The statutory framework reinforces this position. Section 108 of the Evidence Act provides that “the burden of proof in a suit or procedure lies on that person who would fail if no evidence at all were given on either side,” while Section 109 provides that “the burden of proof as to any particular fact lies on the person who wishes the court to believe in its existence.” 55. This Court in Raila Odinga & others v Independent Electoral & Boundaries Commission & others, Petition No 5 of 2013, similarly held that a petitioner bears the initial burden of proof before the evidential burden can shift. HCCHRPET. NO. E510 OF 2024 JDT P a g e 25 | 36

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56. It follows that the Petitioner bears the overriding obligation to place before the Court credible and cogent material establishing a demonstrable constitutional violation, and not merely a perceived or speculative risk. 57. The Petitioner’s principal scientific reliance is the World Health Organization International Agency for Research on Cancer classification of talc as Group 2A (probably carcinogenic to humans), annexed as FBO-001. However, the IARC Monographs themselves expressly qualify the nature of such classification. The summary indicates that a causal relationship could not be fully established due to methodological limitations in the underlying studies. It further notes that: “A causal role for talc could not be fully established because biases in how talc use was reported in epidemiological studies could not be ruled out with reasonable confidence, and confounding by co-exposure to asbestos could not be excluded.” 58. The IARC classification further indicates that Group 2A denotes “limited evidence of carcinogenicity in humans and sufficient evidence in experimental animals,” and is therefore a hazard identification, not a determination of actual risk or causation at consumer exposure levels. 59. The precautionary principle, while recognised in public health and environmental law, does not operate in abstraction. It requires an evidential basis indicating a plausible risk within the relevant jurisdiction. In the absence HCCHRPET. NO. E510 OF 2024 JDT P a g e 26 | 36

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of such localised evidential grounding, it cannot displace the legal burden of proof. 60. The Petitioner also relies on the Missouri Court of Appeal decision in Ingram et al v. Johnson & Johnson (supra). However, as clarified in the affidavit of Kristen Renee Fournier, that decision arose in a jury trial context governed by a deferential standard of appellate review. The appellate court was not making an independent scientific finding of causation but merely assessing whether there was any probative evidence to sustain the jury’s verdict. As stated in the judgment: “The appellate court was required to view the evidence in the light most favourable to the verdict, giving the plaintiff the benefit of all reasonable inferences, and disregarding unfavorable evidence.” 61. The Court further observed that reversal would only occur where there is “a complete absence of probative fact to support the jury’s conclusion.” Properly understood, the decision is therefore procedural in nature and not determinative of scientific causation. Foreign judgments, while persuasive, are not binding and must be evaluated within their procedural and evidential context. 62. In contrast, the 1st to 3rd Respondents have adduced expert evidence through Professor Gregory B. Diette. His report constitutes the most probative scientific material before this Court. The Petitioner has not tendered any expert evidence in rebuttal. HCCHRPET. NO. E510 OF 2024 JDT P a g e 27 | 36

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63. Professor Diette concludes, after reviewing major epidemiological studies, that there is no statistically significant association between perineal talc use and ovarian cancer. These include the Nurses’ Health Study, the Women’s Health Initiative, the Sister Study, and the O’Brien pooled analysis, all of which consistently found no reliable causal link. 64. On asbestos causation, Professor Diette further concludes that even where asbestos is hypothesised, there is no plausible biological mechanism for translocation to the ovaries at cosmetic exposure levels. He distinguishes occupational exposure scenarios involving high-dose industrial inhalation from consumer cosmetic use, noting that the epidemiological literature on ovarian cancer and asbestos exposure is sparse and inconclusive. 65. The regulatory position across jurisdictions further supports this evidential assessment. As deposed by William Sello Malete, talc remains legally permitted in the European Union subject only to labelling requirements. In Tanzania, the alert relied upon by the Petitioner concerned batch number 22318RB originating from the United States, and it is confirmed that: “This batch was never imported into Kenya.” 66. The Republic of Congo and other jurisdictions cited by the Petitioner have not been shown to have conducted verified local testing. Regulatory divergence across jurisdictions does not, without more, establish carcinogenicity in the Kenyan market context. HCCHRPET. NO. E510 OF 2024 JDT P a g e 28 | 36

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67. The Petitioner has also not established a violation of Article 35. In Prof. Njuguna S. Ndung’u vs. The Ethics & Anti-Corruption Commission & Others, the Court held that a request for information must first be made and refused before judicial enforcement is invoked. No evidence has been placed before this Court of any such request having been made. 68. The claim under Article 43 is similarly unsubstantiated. While Article 43 guarantees the right to the highest attainable standard of health, it is subject to progressive realisation. No evidence has been adduced demonstrating any verified case of cancer in Kenya attributable to the product, nor any tested contamination of products in the Kenyan market. 69. The Court is alive to the precautionary principle in appropriate cases of scientific uncertainty. However, as already observed, its application must be anchored on credible evidential material demonstrating a real and not speculative risk. In the absence of any tested or verified contamination within Kenya, the principle cannot be invoked as a substitute for proof. 70. This position finds support in the decision of the Court in Matalinga and Others vs Attorney General [1972] E.A. 578, where it was held that: “Before a declaration can be granted there must be a real and not a theoretical question in which the person raising it must have a real interest and there must be someone with present interest in supporting it.” HCCHRPET. NO. E510 OF 2024 JDT P a g e 29 | 36

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71. In the final analysis, the Petitioner’s case is founded on hazard classification, foreign litigation outcomes, and regulatory developments in other jurisdictions, none of which establish that the talc-based Johnson & Johnson baby powder sold in Kenya is carcinogenic or that it has caused or poses a demonstrable constitutional risk within Kenya. 72. The Court therefore finds that the Petitioner has failed to discharge the evidential burden required in constitutional litigation. The claims remain speculative and unsubstantiated, and no violation of Articles 26, 35, 43, or 46 of the Constitution has been proved. Whether the 4th Respondent has fulfilled its constitutional and statutory obligations to protect consumers, and whether orders should issue compelling the 4th to 6th Respondents to undertake further research and testing 73. The 4th Respondent, the Kenya Bureau of Standards, has demonstrated that it took prompt and proactive regulatory measures upon receipt of the USFDA alert concerning batch number 22318RB. The minutes of the Cosmetics Technical Committee meeting held on 11th August 2020, annexed to the affidavit of Benson Bundi, show that the 4 th Respondent summoned representatives of the 1st and 2nd Respondents to clarify the status of the affected batch and its entry into the Kenyan market. HCCHRPET. NO. E510 OF 2024 JDT P a g e 30 | 36

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74. Following this engagement, the 4th Respondent instituted a series of regulatory interventions, including initiating the revision of the East African Standard on body powders to introduce a mandatory requirement for asbestos testing in baby powder, requiring that all baby powder imports be subjected to asbestos testing under the Pre-Export Verification of Conformity (PVoC) programme, and removing talcum powder from the list of raw materials exempted from PVoC inspection. 75. The revised standard, KS EAS 425-2:2023, annexed to the 4 th Respondent’s affidavit, expressly provides that baby powder shall be tested for asbestos, with Table 1 prescribing “Asbestos – Absent” as a mandatory requirement and Annex A setting out the applicable test method. Further, the letter dated 15th September 2022 addressed to PVoC agents directs that all body and face powders, including baby powders, must be tested for absence of asbestos prior to certification under the PVoC programme. The PVoC Exemption Procedure dated 3rd September 2022 similarly removes talcum powder from the list of raw materials exempted from inspection. 76. The 4th Respondent has further confirmed that it has no record of importation of the product into Kenya within the last two years and is not in receipt of any consumer complaint relating to adverse effects from its use. It has also confirmed that batch number 22318RB, which was the subject of the USFDA alert, was never imported into Kenya. HCCHRPET. NO. E510 OF 2024 JDT P a g e 31 | 36

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77. The 4th Respondent has explained that toxicology and carcinogenicity assessments fall within the domain of medical and scientific research institutions and are outside its statutory testing mandate, which is confined to conformity assessment against applicable standards. In this regard, its mandate under Section 4(1)(i) of the Standards Act is limited to providing facilities for the examination and testing of commodities in relation to applicable standards, and does not extend to conducting independent medical or carcinogenicity studies. The Court finds this to be a reasonable and legally grounded position. 78. In Republic v Sacco Societies Regulatory Authority & another Ex Parte Martin Njuhigu & 24 others (supra) the court held that mandamus does not issue as a matter of course, and that courts will not compel performance unless the duty in question is clearly established, plainly defined, and peremptory in nature. In the present case, the Petitioner has not demonstrated that the 4th Respondent is under a specific statutory or constitutional obligation to conduct toxicology or carcinogenicity testing of the product in question. 79. Accordingly, the measures undertaken by the 4 th Respondent fall within the scope of its statutory mandate and reflect a reasonable and proportionate regulatory response to the information available. The Court cannot issue coercive orders requiring a public body to act outside its statutory mandate or to undertake speculative investigations unsupported by evidence of local risk or contamination. HCCHRPET. NO. E510 OF 2024 JDT P a g e 32 | 36

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80. The Court further notes that the 4 th Respondent has not remained passive. It has already implemented concrete regulatory reforms, including the revision of the East African Standard to require asbestos testing in baby powder, the imposition of mandatory PVoC testing for all imported baby powders, and the removal of talcum powder from exempted categories under the PVoC regime. 81. These interventions constitute evidence-based regulatory action taken within mandate and in fulfilment of its obligations under Article 46 of the Constitution and Section 4 of the Standards Act. The Court is therefore satisfied that the 4th Respondent has discharged its constitutional and statutory obligations, and that no basis has been laid for the issuance of further coercive orders against the 4th to 6th Respondents. CONCLUSION 82. The Court has carefully evaluated the pleadings, affidavits, submissions, and authorities placed before it, together with the evidentiary material relied upon by the parties. This includes the WHO IARC classification, the foreign judicial decisions and regulatory actions cited by the Petitioner, the regulatory and factual responses by the Respondents regarding the status of the product in Kenya, the preliminary objection on jurisdiction and misjoinder raised by the 1st to 3rd Respondents, the expert opinion of Professor Gregory B. Diette on the relevant epidemiological literature, and the regulatory measures undertaken by the 4th Respondent in response to the USFDA alert, including revisions to the applicable standards and the PVoC framework. HCCHRPET. NO. E510 OF 2024 JDT P a g e 33 | 36

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83. From the foregoing analysis, the Court finds that the Petition offends the principle of constitutional avoidance and the doctrine of exhaustion of statutory remedies. The dispute, properly characterised, falls within the statutory framework established under the Consumer Protection Act, No. 46 of 2012 and the Standards Act, Cap 496, which provide adequate mechanisms for consumer protection, regulatory oversight, and redress. The Petitioner has not demonstrated that those mechanisms were unavailable, inadequate, or incapable of addressing the issues raised. 84. The Court further finds that the Petitioner has failed to establish, to the required standard of proof, that the talc-based Johnson & Johnson baby powder sold in Kenya is carcinogenic or that it violates the rights to life under Article 26, the right to the highest attainable standard of health under Article 43, the right to access information under Article 35, or consumer rights under Article 46 of the Constitution. The material relied upon by the Petitioner does not constitute proof of causation or localised risk, and no expert evidence was adduced to controvert the scientific opinion placed before the Court. 85. In addition, the Court is satisfied that the 4 th Respondent has discharged its constitutional and statutory mandate. The evidence demonstrates that it took timely and proportionate regulatory action upon receipt of the USFDA alert, including the revision of the relevant East African Standard to incorporate mandatory asbestos testing, the strengthening of PVoC requirements for imported baby powders, and the removal of talcum powder HCCHRPET. NO. E510 OF 2024 JDT P a g e 34 | 36

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from exempted categories. It has also been confirmed that the batch referenced in the USFDA alert was never imported into Kenya, and no consumer complaints have been received locally. In the circumstances, no legal basis has been laid for the grant of coercive orders compelling further testing or research beyond its statutory remit. 86. Accordingly, and for the reasons set out above, the Court finds no merit in the Petition and hereby dismisses it in its entirety with no order as to costs Orders accordingly. File Closed Accordingly. DATED, SIGNED AND DELIVERED VIRTUALLY THIS 29TH DAY OF APRIL 2026. ________________________ BAHATI MWAMUYE MBS JUDGE In the presence of: Counsel for the Petitioner -Mr. Wanjihia h/b Mr. Mugaka Counsel for the 1st to 3rd Respondents – Ms. Kirimi Counsel for the 4th Respondent – No Appearance Counsel for the 5th Respondent- No Appearance HCCHRPET. NO. E510 OF 2024 JDT P a g e 35 | 36

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Counsel for the 6th Respondent- No Appearance Court Assistant – Mr. Sanja HCCHRPET. NO. E510 OF 2024 JDT P a g e 36 | 36

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