Representative matters include
Advised on product labeling and marketing materials for numerous dietary supplements, over-the-counter pharmaceutical products, and electronic cigarettes to identify and mitigate potential risks and to ensure compliance with federal law
Conducted FDA regulatory due diligence on a multi-national premium cigar company in connection with stock acquisition in order to identify regulatory and compliance-related risks and reviewed and revised related transaction documents to address such risks
Prepared and submitted over 250 tobacco product-related filings with FDA, including grandfathered submissions, Substantial Equivalence reports, and follow-up responses to information requests regarding such submissions
Assisted a client in navigating interactions with multiple federal agencies in connection with a proposed agency action and prepared comments and correspondence advocating on behalf of the client
Conducted audit of various companies’ websites and social media channels regarding compliance with federal law
Advised on state and city statutes, regulations, and ordinances related to the regulation of certain tobacco products and drafted opinion letters for use by clients
Summarized laws in 50 states on various legal questions, including the legality of online sales of various types of tobacco- and nicotine-containing products and the legality of hemp and CBD (derived from hemp or otherwise) in food and personal care products
Drafted privacy statement for U.S. pharmaceutical company to address developments in state data privacy laws
Advised on approval pathway for biologic product, including application/user fees, informed consent requirements, tax benefits associated with designation as an orphan drug, implications of public disclosure, and CMC requirements
Assisted client in navigating FDA medical device regulations regarding exemption from certain laser product requirements
Counseled client on best practices regarding FDA inspections and assisted in the preparation of client’s SOP regarding such inspections
Advised on state excise tax implications for various regulated tobacco products