Kenvue (KVUE) risk factors, FY2024 10-K

Kenvue's FY2024 10-K, filed Feb 24, 2025, lists 66 risk factors in 6 groups. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
666 groups
Section length
26k wordsItem 1A

Kenvue's biggest risks in the FY2024 10-K

  • Kenvue faces heavy litigation risks tied to talc and Tylenol products.

The risks most specific to Kenvue

  • Risks Related to Government Regulation and Legal Proceedings

    In addition, our affiliate Johnson & Johnson Consumer Inc., now known as Kenvue Brands LLC (“New JJCI”), has been named in cases alleging that prenatal exposure to Tylenol®, an acetaminophen product, is associated with the development of autism spectrum disorder and attention-deficit/hyperactivity disorder in children

    Our affiliate Kenvue Brands LLC faces lawsuits alleging prenatal exposure to Tylenol causes autism and ADHD in children, and the FDA's advisory committee concluded that oral phenylephrine is ineffective.

  • Risks Related to Government Regulation and Legal Proceedings

    Legal proceedings related to talc or talc-containing products, such as Johnson’s® Baby Powder, sold outside the United States and Canada and other risks and uncertainties related to talc or talc-containing products could adversely affect us

    We face numerous personal injury claims alleging that talc and talc-containing products like Johnson's Baby Powder cause cancer, along with related government subpoenas.

  • Risks Related to Government Regulation and Legal Proceedings

    We cannot predict with certainty the amount or timing of Talc-Related Liabilities that LTL or J&J will be required to pay, whether in connection with the bankruptcy proceedings or otherwise

    We cannot predict the timing or amount of talc-related liabilities that LTL Management or Johnson & Johnson will be required to pay, or if we will be held liable.

  • Risks Related to Our Operations

    Volatility in the cost or availability of raw materials and other inputs for our products, including due to military conflicts, has adversely affected, and could in the future continue to adversely affect us

    Manufacturing and distributing our products involves volatile costs for raw materials like resins, silicon, pulp, paper, and vegetable oils, as well as energy and labor.

  • Risks Related to Our Business and Industry

    The rapidly changing retail landscape, including our increasing dependence on key customers in developed markets, changes in the policies of our customers and the emergence of e-commerce and other alternative retail channels, could adversely affect us

    We face increasing dependence on key retail customers in developed markets, retail buying alliances, and the rapid growth of e-commerce.

  • Risks Related to Our Business and Industry

    Counterfeit, intellectual-property-infringing, or other unauthorized versions (“Counterfeit Copies”) of our products, particularly in our OTC business, could harm consumers and adversely affect us

    Illegal counterfeiting of our products, particularly in our over-the-counter business, could harm consumers and our brand.

All 66 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Industry

  1. 01Our brands are critical to our success, and damage to our reputation or our brands could adversely affect us
  2. 02We operate in highly competitive product markets and competitive pressures could adversely affect us
  3. 03If we are unable to anticipate, understand, and respond appropriately to market trends and rapidly changing consumer and customer preferences in a timely manner, we could be adversely affected
  4. 04If our marketing efforts are not successful, we could be adversely affected
  5. 05An inability to successfully expand our global operations could adversely affect our business, results of operations, or financial condition
  6. 06We may face challenges in implementing our digital strategy, which could adversely affect us
  7. 07Uncertainty in the development, deployment, use and regulation of artificial intelligence in our internal processes, manufacturing operations, products and services, as well as our business more broadly, could adversely affect us
  8. 08The rapidly changing retail landscape, including our increasing dependence on key customers in developed markets, changes in the policies of our customers and the emergence of e-commerce and other alternative retail channels, could adversely affect us
  9. 09We cannot predict with certainty when or whether we will be able to develop products and technologies, or otherwise license or acquire new products and technologies, and whether they will be commercially successful
  10. 10We have pursued, and expect to continue to pursue, acquisitions and divestitures, which exposes us to additional risks that could adversely affect us
  11. 11Counterfeit, intellectual-property-infringing, or other unauthorized versions (“Counterfeit Copies”) of our products, particularly in our OTC business, could harm consumers and adversely affect us

Risks Related to Our Operations

  1. 12We rely on third parties in many aspects of our business, including to manufacture certain of our products, which exposes us to additional risks that could adversely affect us
  2. 13Disruptions to our manufacturing or supplier operations could adversely affect us
  3. 14manufacturing facility, or supplier could nonetheless have an adverse effect on our business, results of operations, or financial condition
  4. 15Disruptions to our distribution operations could adversely affect our ability to deliver our products to consumers and customers
  5. 16Volatility in the cost or availability of raw materials and other inputs for our products, including due to military conflicts, has adversely affected, and could in the future continue to adversely affect us
  6. 17If we are unable to accurately forecast demand for our products, we could be adversely affected
  7. 18We may not fully realize the expected cost savings and/or operating efficiencies associated with our restructuring programs, including the 2024 Multi-Year Restructuring Initiative, or our strategic initiatives, which could adversely affect us
  8. 19An information security incident, including a cybersecurity breach, or the failure of an information technology or operational technology system owned or operated by us or a third party, could adversely affect us
  9. 20supply chain attacks on companies generally and our interdependency on third-party partners increase the potential for supply disruptions and service outages
  10. 21Our business depends on our ability to attract and retain talented, highly skilled employees who reflect our consumers and on the succession of our senior management
  11. 22Labor disputes, strikes, work stoppages, or other labor relations matters could adversely affect us
  12. 23Climate change, or legal, regulatory or market measures to address climate change, could adversely affect us
  13. 24health, and safety laws and regulations, and the impact of any obligations under these laws and regulations could adversely affect us.”
  14. 25Increasing scrutiny, emerging legal requirements, and rapidly evolving expectations from stakeholders regarding ESG matters could adversely affect us
  15. 26Insurance coverage, even where available, may not be sufficient to cover losses we may incur
  16. 27Significant product returns or refunds could adversely affect us

Risks Related to Government Regulation and Legal Proceedings

  1. 28We are subject to a broad range of laws and regulations in the United States and around the world, and compliance with or enforcement actions related to these laws and regulations could adversely affect us
  2. 29We are, and could become, subject to significant legal proceedings and regulatory investigations that may result in significant expenses, fines, and reputational damage
  3. 30Concerns about the reliability, safety, or efficacy of our products or their ingredients could result in litigation, regulatory action, reputational damage, product recalls, product reformulations, or product withdrawals, which could adversely affect us
  4. 31In addition, our affiliate Johnson & Johnson Consumer Inc., now known as Kenvue Brands LLC (“New JJCI”), has been named in cases alleging that prenatal exposure to Tylenol®, an acetaminophen product, is associated with the development of autism spectrum disorder and attention-deficit/hyperactivity disorder in children
  5. 32Legal proceedings related to talc or talc-containing products, such as Johnson’s® Baby Powder, sold outside the United States and Canada and other risks and uncertainties related to talc or talc-containing products could adversely affect us
  6. 33We cannot predict with certainty the amount or timing of Talc-Related Liabilities that LTL or J&J will be required to pay, whether in connection with the bankruptcy proceedings or otherwise
  7. 34We may not be able to successfully establish, maintain, protect, and enforce intellectual property rights that are, in the aggregate, material to our business
  8. 35A breach of privacy laws or unauthorized access, loss or misuse of personal data could adversely affect us
  9. 36Our extensive operations and business activity throughout the world expose us to a variety of laws and regulations related to anti-corruption and human rights, and the impact of any obligations related to these laws and regulations could adversely affect us
  10. 37We are subject to a broad range of environmental, health, and safety laws and regulations, and the impact of any obligations under these laws and regulations could adversely affect us
  11. 38Changes in tax laws or exposures to additional tax liabilities could adversely affect us
  12. 39which the law change is enacted. For additional information, see Note 14, “Income Taxes,” to the Consolidated Financial Statements included herein

Risks Related to Financial and Economic Market Conditions

  1. 40We face a variety of risks associated with conducting business around the world, including foreign currency fluctuations, and these risks will increase as we continue to expand our global operations
  2. 41marketing efforts will be successful in any particular market, and it is possible that positive returns on our investments in a market will not be achieved
  3. 42Acts of war, military actions, terrorist attacks, or civil unrest could adversely affect us
  4. 43Uncertain or unfavorable economic or market conditions could adversely affect us
  5. 44Impairment of our goodwill and other intangible assets would result in a reduction in net income
  6. 45Changes to our credit ratings or disruptions in credit markets or to our banking partners may reduce our access to credit or overall liquidity

Risks Related to Our Relationship with J&J

  1. 46Our historical financial information included herein may not necessarily reflect the results that we would have achieved as an independent, publicly traded company or may not be a reliable indicator of our future results
  2. 47We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect us
  3. 48If we fail to fully achieve some or all of the benefits expected to result from the Separation, or if the benefits are delayed, our business, results of operations, or financial condition could be adversely affected
  4. 49We have incurred and continue to incur significant charges in connection with the Separation and incremental costs as an independent, publicly traded company
  5. 50The transfer of certain assets and liabilities from J&J to us contemplated by the Separation has not been completed and may be significantly delayed or not occur at all
  6. 51The transfer of certain contracts and other assets and rights from J&J to us may require the consents or approvals of third parties and governmental authorities, and failure to obtain these consents or approvals could adversely affect us
  7. 52J&J may fail to perform under the Transition Agreements, or we may fail to have replacement arrangements in place when these agreements expire
  8. 53Potential indemnification obligations to J&J in connection with the Separation could adversely affect us
  9. 54We may be affected by significant restrictions, including on our ability to engage in certain corporate transactions, for a two-year period after the Exchange Offer, in order to avoid triggering significant tax-related liabilities
  10. 55In connection with the Separation, J&J agreed to indemnify us for certain liabilities. However, we cannot assure you that the indemnity will be sufficient to protect us against the full amount of such liabilities or that J&J’s ability to satisfy its indemnification obligation will not be impaired in the future
  11. 56We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with J&J

Risks Related to Ownership of Our Common Stock

  1. 57We cannot be certain that an active trading market for our common stock will be sustained
  2. 58The market price of shares of our common stock may be highly volatile and fluctuate significantly due to a number of factors, some of which may be beyond our control
  3. 59If we are unable to implement and maintain effective internal control over financial reporting in the future, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares of our common stock could be adversely affected
  4. 60We are directly subject to reporting and other obligations under the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the rules and regulations of the SEC and the NYSE
  5. 61Your percentage ownership in us may be diluted in the future
  6. 62We have debt obligations that could adversely affect us
  7. 63We are a holding company and our only material assets are our equity interests in our subsidiaries. As a consequence, we depend on the ability of our subsidiaries to pay dividends and make other payments and distributions to us in order to meet our obligations
  8. 64We cannot guarantee the payment of dividends on our common stock, or the timing or amount of any such dividends
  9. 65If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could be adversely affected, resulting in a decrease in the market price of shares of our common stock
  10. 66Certain provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock

Other Kenvue 10-Ks

  • FY2025 10-K risk factors
    77 risks23 new12 dropped26 reworded

    The proposed Kimberly-Clark transaction dominates the new risks, from closing conditions and regulatory approvals to integration and employee retention.

    Filed Feb 20, 2026

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.