Strategies helps businesses and individuals solve the complexities of dealing with the government at every level. Our team of specialists concentrate exclusively on government affairs, representing clients nationwide who need assistance with public policy, advocacy, and government relations strategies.
Troutman Pepper Locke’s program for Startup and Early-Stage Entrepreneurial Development
This unique program provides innovative and affordable opportunities to startups and early-stage emerging companies with a solid technology or scientific foundation. We help companies that have a quality management team in place and do not have other significant legal representation.
Market leading eDiscovery and data management services.
eMerge’s lawyers and technologists work together to deliver strategic end-to-end eDiscovery and data management solutions for litigation, investigations, due diligence, and compliance matters. We help clients discover the information necessary to resolve disputes, respond to investigations, conduct due diligence, and comply with legal requirements.
Our national team helps clients navigate the legal and policy challenges in the highly scrutinized and evolving tobacco and nicotine industry. With nearly 100 years of collective experience, we advise clients across the entire supply chain and all product segments, including e-cigarettes and other electronic nicotine delivery systems, modern oral nicotine products, cigarettes, cigars, pipe tobacco, and hookah tobacco.
Our multidisciplinary team, including attorneys with substantial experience in-house and with relevant government agencies, provides unique insights and solutions for federal, state, and local regulatory matters. We work with manufacturers, distributors, retailers, suppliers, and service providers to develop business strategies and navigate regulatory complexities.
We regularly handle litigation and administrative disputes involving federal and state government entities, including bet-the-company matters adverse to the Food and Drug Administration (FDA), state attorneys general, and state taxing authorities.
Services
Regulatory Counseling: We advise on all federal and state tobacco regulatory matters, including FDA premarket authorization requirements, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, and requests for exemption from substantial equivalence.
Enforcement Actions and Investigations: We handle enforcement actions and investigations by state regulators and have exceptional experience with the 1998 Tobacco Master Settlement Agreement (MSA) and other settlements with State Attorneys General. Our State Attorneys General team complements our tobacco expertise when necessary to provide clients with holistic and strategic solutions.
Licensing and Taxation: We assist with federal and state licensing and taxation questions, help obtain necessary licenses and permits, and resolve tax disputes.
Litigation: We serve as lead counsel in state and federal courts, focusing on regulatory disputes involving states or the federal government.
Branding and Intellectual Property: We protect, police, and enforce trademarks, patents, copyrights, and other intellectual property rights.
Transactions: We assist with the formation, acquisition, merger, and sale of corporate entities and business assets, providing unique experience with tobacco transactions involving complex regulatory matters.
Providing timely analysis and perspectives on recent changes in the law, upcoming regulatory deadlines, and significant judicial opinions that may impact your business
Guide clients on FDA requirements, including premarket tobacco authorization strategies and compliance with marketing 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 cigarette companies on MSA compliance issues, including state directory requirements and litigation.
Advise clients on starting 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.
Represented multiple tobacco companies in investigations by state and local agencies.
Successfully obtained a stay of enforcement in litigation with the FDA regarding a marketing denial order for an ENDS importer and distributor.
Represented a major tobacco company in multiple state settlements and assisted with post-settlement compliance programs.
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.
Obtained a $5.2 million judgment for a cigarette manufacturer in a commercial dispute with a distributor.
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.
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.
Advise on intellectual property strategies and prosecuted infringement of trademarks, patents, service marks, and copyrights.
Provided advice regarding web strategies including web hosting, ASP, Terms of Use, Privacy Statements, marketing, advertising, sweepstakes, and promotions.
Served as counsel in the purchase of tobacco manufacturing businesses, including due diligence and regulatory advice.
Handled transactions involving development, acquisitions, sales, leasing, and licensing of technology and large equipment.
Reviewed, drafted, and negotiated financing, distribution, manufacturing, broker services, consulting, employment, confidentiality, noncompetition, and other agreements for ongoing operations.
Strategies helps businesses and individuals solve the complexities of dealing with the government at every level. Our team of specialists concentrate exclusively on government affairs, representing clients nationwide who need assistance with public policy, advocacy, and government relations strategies.
Troutman Pepper Locke’s program for Startup and Early-Stage Entrepreneurial Development
This unique program provides innovative and affordable opportunities to startups and early-stage emerging companies with a solid technology or scientific foundation. We help companies that have a quality management team in place and do not have other significant legal representation.
Market leading eDiscovery and data management services.
eMerge’s lawyers and technologists work together to deliver strategic end-to-end eDiscovery and data management solutions for litigation, investigations, due diligence, and compliance matters. We help clients discover the information necessary to resolve disputes, respond to investigations, conduct due diligence, and comply with legal requirements.
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