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Except as set forth below, as of the date of this report, there are no material changes or updates to the risk factors previously disclosed in Part I, Item 1A "Risk Factors" in the Compa ny's Annual Report on Form 10-K for the fiscal year ended March 31, 2022 .
−Removed: The Company may be required to cease further sale of e-liquids products containing nicotine derived from tobacco pending determinations on applications filed with the FDA.
−Removed: The Company and Purilum’s nicotine-containing vaping products are subject to substantial and evolving regulation by the Food and Drug Administration (the “FDA”).
−Removed: The FDA has authority to regulate e-liquids, e-cigarettes and other vaping products that contain (or are used to consume e-liquid containing) tobacco-derived ingredients (e.g., nicotine) as “tobacco products” under the federal Food, Drug and Cosmetic Act (the “Food, Drug and Cosmetic Act”), as amended by Family Smoking Prevention and Tobacco Control Act of 2009 (the “Tobacco Control Act”).
−Removed: Via the issuance of the “Deeming Regulation” that became effective on August 8, 2016, the FDA began regulating e-liquids, e-cigarettes, and other vaping products that qualify as “tobacco products” under the Food, Drug and Cosmetic Act's requirements added by the Tobacco Control Act.
−Removed: The Deeming Regulations extended the FDA's “tobacco products” authorities to apply to most previously unregulated products that meet the statutory definition of “tobacco product,” including e-liquids, e-cigarettes and other vaping products that contain (or are used to consume e-liquid containing) tobacco-derived ingredients (“Deemed Tobacco Products”).
−Removed: Beginning August 8, 2016, Deemed Tobacco Products became subject to all existing statutory controls initially applicable only to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco (including components, parts, and accessories of such products) as well as some existing and some new FDA regulations related to the sale and distribution of tobacco products.
−Removed: The Food, Drug and Cosmetic Act requires that any Deemed Tobacco Product that was not commercially marketed as of the “grandfathering” date of February 15, 2007 obtain premarket authorization before it can be marketed in the United States.
−Removed: However, the FDA has announced a compliance policy for such Deemed Tobacco Products that qualify as “new tobacco products” under which the agency will not enforce these requirements for non-finished products (i.e., those intended solely for use in future manufacturing), which include certain products manufactured by Purilum.
−Removed: As modified by orders issued by the United States District Court for the District of Maryland, the FDA’s compliance policy also generally allows companies to market finished Deemed Tobacco Products that qualify as “new tobacco products” but that were on the U.S.
−Removed: market on August 8, 2016, until September 9, 2020, and the continued marketing of such products without otherwise-required authorization for up to one year during the FDA's review of a pending marketing application submitted by September 9, 2020.
−Removed: FDA authorization to introduce a “new tobacco product” (or to continue marketing a “new tobacco product” covered by the compliance policy for Deemed Tobacco Products that were on the U.S.
−Removed: market on August 8, 2016) could be obtained via any of the following three authorization pathways:
−Removed: (1) submission of a premarket tobacco product application (“PMTA”) and receipt of a marketing authorization order;
−Removed: (2) submission of a substantial equivalence report and receipt of a substantial equivalence order;
−Removed: or (3) submission of a request for an exemption from substantial equivalence requirements and receipt of a substantial equivalence exemption determination.
−Removed: Since there were few, if any, e-liquid, e-cigarette or other vaping products on the market as of February 15, 2007, there is no way to utilize the less onerous substantial equivalence or substantial equivalence exemption pathways that traditional tobacco corporations can utilize for cigarettes, smokeless tobacco, and other traditional tobacco products.
−Removed: In order to obtain marketing authorizations, manufacturers of practically all e-liquid, e-cigarette or other vaping products would have to use the PMTA pathway.
−Removed: The continued sale of any e-liquid product containing nicotine derived from tobacco for which a PMTA was filed by September 9, 2020 and continues to remain subject to pending FDA review is subject
−Removed: to the FDA’s enforcement discretion, as the one-year period following the September 9, 2020 application deadline has expired even though the FDA had not yet taken action to approve or deny the PMTA.
−Removed: The Company’s remaining e-liquid subsidiary, Twelfth State Brands, filed a PMTA for its respective line of finished Deemed New Tobacco Products by the September 9, 2020 deadline.
−Removed: The PMTA remains subject to FDA review.
−Removed: The Company cannot predict whether the PMTA filed by its subsidiary will ultimately be approved by the FDA to permit continued sale of its products.
−Removed: Further, the Company cannot predict whether the FDA, in its exercise of enforcement discretion with respect to the products being sold by the Company's subsidiary while the PMTA is under pending review by the FDA, will continue not to seek enforcement to prohibit the sale of such products or that if it seeks enforcement will seek merely to cease any further sale of the products and not any additional remedies, including fines or penalties.
−Removed: The failure to ultimately obtain FDA marketing authorizations in response to its PMTA could prevent the Company’s subsidiary from marketing and selling vaping products containing tobacco-derived ingredients in the United States and, thus, may have a material effect on the business, financial condition, and results of operations of the Company.
−Removed: Order dated August 21, 2020 of the U.S.
−Removed: Bankruptcy Court for the District of Delaware Approving the Adequacy of the Disclosure Statement and the Prepetition Solicitation Procedures and Confirming the Amended Joint Prepackaged Plan of Reorganization in Case No.
−Removed: 20-11570 (LSS), In re:
−Removed: Pyxus International, Inc.
−Removed: et al ., incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K of Old Holdco, Inc., filed on August 24, 2020 (File No.
−Removed: Amended Joint Prepackaged Chapter 11 Plan of Reorganization of Pyxus International, Inc.
−Removed: and Its Affiliated Debtors dated August 13, 2020, incorporated by reference to Exhibit 2.2 to the Current Report on Form 8-K of Old Holdco, Inc., filed on August 24, 2020 (File No.
−Removed: Executive Employment Agreement executed on October 27, 2021, with an effective date of November 1, 2021, between Flavia Landsberg and Pyxus International, Inc., incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of Pyxus International, Inc., filed on November 15, 2021 (File No.
+Added: The impact of potential regulations to prohibit the sale of cigarettes in the United States other than low-nicotine cigarettes, if they are adopted and become effective, is uncertain, but they could materially adversely affect our business, results of operations and financial condition.
+Added: In June 2022, the U.S.
+Added: Food and Drug Administration (the "FDA") announced its plan to publish a proposed rule in 2023 that would prohibit the sale of cigarettes in the United States other than cigarettes having significantly reduced levels of nicotine.
+Added: The definitive provisions of such a proposed rule have not yet been announced and any rule proposal is subject to public comment prior to being adopted by the FDA.
+Added: Accordingly, the terms of any such final rule are uncertain and the date of effectiveness of such a rule is also uncertain.
+Added: While the FDA announced that reducing the nicotine levels of cigarettes would reduce consumption of cigarettes by future generations and facilitate current smokers to stop consuming cigarettes, it is uncertain whether such potential regulations, if they are adopted and become effective, will have such effect.
+Added: While the impact of such potential regulations on the Company is also uncertain, such regulations, if they are adopted and become effective, could materially adversely affect our business, results of operations and financial condition.
+Added: Amendment and Restatement Agreement dated as of June 2, 2022 among Intabex Netherlands B.V., Pyxus International, Inc., Pyxus Parent, Inc., Pyxus Holdings, Inc., Alliance One International, LLC, Alliance One International Holdings, Ltd, Alliance One International Tabak B.V., the other guarantors party thereto, the Lenders party thereto, and Alter Domus (US) LLC, as administrative agent and collateral agent, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of Pyxus International, Inc., filed on June 7, 2022 (File No.
+Added: Fourth Amendment and Restatement Agreement dated 27 June 2022 among Pyxus International, Inc., Pyxus Parent, Inc., Pyxus Holdings, Inc., Alliance One Tobacco (Malawi) Limited, Alliance One Tobacco (Tanzania) Limited, Alliance One Zambia Limited and Eastern and Southern African Trade and Development Bank, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of Pyxus International, Inc., filed on July 6, 2022 (File No.
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
10 unchanged sentences
Pyxus International, Inc.
−Removed: February 10, 2022
+Added: August 11, 2022
/s/ Philip C.
−Removed: Vice President - Chief Accounting Officer and Controller
+Added: Vice President - Chief Accounting Officer
(Principal Accounting Officer)
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.