Tobacco + Nicotine

Regulatory

• Guide clients on all aspects of FDA requirements. We regularly advise on premarket tobacco authorization strategies, compliance with marketing granted orders, disputes in respect of marketing denial orders, warning letters, ingredient listings, inspections, recalls, quality control, tobacco product manufacturing practices, marketing compliance, and strategies regarding FDA enforcement against unlawful actors. We have assisted clients in obtaining hundreds of FDA marketing orders, including under the PMTA, SE and exemption pathways and in virtually all product categories, including electronic nicotine delivery systems (ENDS), cigarettes, cigars, RYO and hookah tobacco. We also represent clients in meetings with the FDA.
• Assist clients in compliance with federal and state labeling requirements for tobacco products and advise clients on advertising issues, including FDA requirements, Federal Trade Commission truth-in-advertising considerations, and California Proposition 65 requirements.
• Serve as counsel to numerous cigarette companies in connection with MSA compliance issues, including state directory requirements, negotiations with state regulators, and litigation in state and federal courts.
• Advise clients regarding regulatory issues associated with starting a tobacco manufacturing and distribution businesses.
• Advise clients regarding starting up and conducting online retail businesses, including compliance with the Prevent All Cigarette Trafficking (PACT) Act and state laws regulating remote sales.
• Complete and file applications to enable client businesses to operate under permits and/or licenses by relevant state and federal agencies.
• Assist clients with Freedom of Information Act requests and administrative appeals.

Litigation, Enforcement Actions, and Investigations

• Represent multiple tobacco companies in investigations by state and local agencies related to state and local regulation of tobacco products.
• Represent an ENDS importer and distributor in litigation with the FDA regarding the marketing denial order of a PMTA, successfully obtaining a stay of enforcement.
• Represented a major tobacco company in multiple state settlements, including assisting the client implement a post-settlement compliance program.
• Represented a regional tobacco manufacturer in the first-ever multistate settlement of "released claims" arising under state tobacco escrow statutes.
• Represented a retailer in investigations by state attorneys general regarding alleged unfair and deceptive product marketing practices.
• Obtained a verdict following a four-day bench trial in favor of a regional tobacco company, affirmed on appeal, in a declaratory judgment action implicating a sale of $70 million in qualified settlement fund escrow accounts.
• Represented tobacco product manufacturers in commercial disputes with distributors. Obtained a $5.2 million judgment on behalf of a cigarette manufacturer against a distributor after a two-day trial.
• In the course of approximately one year, obtained three preliminary injunctions and/or temporary restraining orders as lead counsel on behalf of tobacco companies in disputes with states and the federal government.
• Represented a tobacco product manufacturer in a regulatory dispute with the Virginia attorney general. Court held the attorney general lacked authority to exclude the manufacturer from a directory of approved tobacco product manufacturers based on nonpayment of a proposed penalty for alleged violation of a statute.
• Represented a cigarette distributor in multimillion-dollar RICO litigation against a major tobacco manufacturer.
• Engaged in administrative and litigation practice when required to protect and enforce rights under relevant regulations.

Tax

• Represented a tobacco machinery company in a case of first impression regarding a ruling issued by the Tobacco Tax and Trade Bureau of the U.S. Treasury Department. Obtained a preliminary injunction against TTB's ruling.
• Represented multiple tobacco distributors and retailers in tax disputes, including the successful defense of distributors in tax disputes with state departments of revenue. In the course of one year, our team successfully disputed almost $50 million in tobacco tax assessments and obtained refunds in excess of one million dollars.
• Advise tobacco manufacturers, distributors, and retailers (both online and brick-and-mortar) regarding federal and state taxation issues.

Branding and Intellectual Property

• Advise on intellectual property strategies to identify, protect, police, and enhance value of intellectual property; prosecute infringement of trademarks, patents, service marks, and copyrights and perform company-wide intellectual property and website audits.

Transactional

• Served as counsel to numerous companies in connection with the purchase of tobacco manufacturing businesses, which included conducting due diligence and providing advice regarding associated federal and state regulatory issues.
• Handled numerous transactions involving development, acquisitions, sales, leasing and licensing of technology and large equipment, and services.
• Reviewed, drafted, and negotiated financing, distribution, manufacturing, broker services, consulting, employment, confidentiality, noncompetition, and other agreements for ongoing operations.
• Provided advice regarding web strategies including web hosting, ASP, Terms of Use, Privacy Statements, marketing, advertising, sweepstakes, and promotions.