Daniel McGee advises manufacturers, distributors, and suppliers of tobacco products, including cigars, e-vapor, hookah, and nicotine, as well as cannabis, hemp, and cannabinoid (CBD) products, on regulations by federal agencies such as the U.S. Food and Drug Administration (FDA), as well as on matters of state law compliance.
With respect to his Tobacco and E-Vapor practice, Daniel advises companies on compliance with the requirements of FDA, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Federal Trade Commission (FTC), as well as state and local authorities. Daniel is well versed on the Family Smoking Prevention and Tobacco Act, as well as FDA’s “Deeming Rule,” having assisted multinational corporations before, during, and after these industry-changing regulatory events. Among other things, Daniel counsels clients on preparing submissions such as premarket tobacco product applications (PMTAs), tobacco product master files (TPMFs), and substantial equivalence (SE) reports. He also assists clients in responding to FDA marketing denial orders, by developing corrective action plans in response to warning letters issued by the Agency. Additionally, Daniel’s vast experience serves him well in advising on labeling and warning statement requirements for covered tobacco products and their packaging. When necessary, Daniel consults with Keller and Heckman’s in-house scientists to strategize on analytical and stability testing, scientific literature reviews, age-verification procedures, and environmental assessments to address potential safety and health concerns. Daniel also advises clients on the Prevent All Cigarette Trafficking (PACT) Act and state law compliance, including licensing.
Prior to joining Keller and Heckman, Daniel served as in-house counsel for several tobacco, e-vapor, and CBD/hemp companies, where he gained valuable insight on the issues facing these industries. This perspective gives Daniel a unique outlook on how to best protect the interests of his clients by providing a greater understanding of their needs and supporting them in navigating the rapidly changing landscape of tobacco, e-vapor, and cannabis/CBD/hemp products.
- Identified a suitable distribution and warehouse facility in western North Carolina for a well-capitalized hemp company to expand their footprint and better serve their clients in the Southeastern United States; brokered favorable lease terms for a client with the landlord of the 40,000 sq/ft facility, including free rent and the ability for a client to take possession of the facility in less than 45 days
- Structured and drafted an exclusive supply agreement for a national manufacturer of hemp consumer goods products with a hemp cultivator to ensure stable pricing and a quality supply of hemp flower
- Assisted clients with navigating complex state and federal regulatory requirements to bring tobacco, vape, and hemp products to market, including preparation and review of appropriate packaging and advertising materials, in addition to working closely with a network of established customs brokers and freight forwarders to import tobacco products, including cigars, cigar wraps, vapes, and other tobacco products into the United States
- Developed cost-effective and actionable legal strategies to address local, state, and federal compliance issues and regulatory challenges on behalf of clients, including state registrations, the Prevent All Cigarettes Tracking Act (PACT Act), and addressing local, state, and federal administrative matters impacting the taxation and salability of tobacco and hemp products
- Negotiated and drafted commercial contracts, including procurement, vendor, outsourcing, supply chain, marketing, sponsorship, licensing, IP, and technology agreements, as well as nondisclosure agreements, memoranda of understanding, and scopes of work
- Food and Drug Law Institute (FDLI), Tobacco and Nicotine Products Committee
- Association of Corporate Counsel (ACC)
- American Bar Association (ABA)
- Phi Alpha Delta