Life Sciences

In This Section

    Team Leaders

    Team Leader

    About

    Steptoe & Johnson’s interdisciplinary Life Sciences Team has the representative experience and ability to bring a client’s product from idea to market, then assist with ongoing business and regulatory matters, and occasional unexpected issues.

    Our Life Sciences practice spans a multitude of industries including food, dietary supplements, sports nutrition, medical devices, nutraceuticals, and natural products, including hemp products, cannabidiol (CBD), and other hemp-derived cannabinoids.

    Our team routinely assists U.S. and foreign clients with navigating the legal, regulatory, business, and litigation matters that arise throughout a product’s entire life cycle — from development, formulation, manufacturing, and production, through claims review, labeling, packaging, omni-channel marketing, product distribution and sale.

    We know your products operate in highly competitive markets, and we understand how regulations by federal and state agencies, such as the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), can impact your business.

    We understand the need for prompt, practical, business-focused legal advice, and action which facilitates: entity formation and acquisitions; negotiating and documenting commercial transactions; ensuring import and export compliance; protecting and exploiting intellectual property; structuring logistics optimization; regulatory compliance; risk mitigation; pursuing claims and defending the business; ensuring supply chain security; labeling; marketing; and product promotion.

    Our business-focused legal experience brings a unique perspective in assuring that our clients achieve their business and strategic goals. Our team offers experienced attorneys, several of whom have worked in-house at national and international life sciences manufacturers, distributors, brick and mortar, and E-commerce retailers.

    Representative Experience
    • Advised international dietary supplement company on compliance with the FDCA and FTC regulations governing product claims by assisting with the production of labels, marketing materials and website
    • Furthered commercialization of intellectual property through merchandising agreements with national companies, creating revenue streams for intellectual property owners
    • Co-lead counsel defending large pharmaceutical distributor in more than 3,000 opioid lawsuits in state and federal courts nationwide; responsibilities include developing arguments for and implementing removal of state court suits to federal court
    • Negotiated terms of international licensing, supply, and distribution agreements on behalf of international medical foods manufacturer
    • Provided general counsel services to wholesale distributor of Delta-8 THC products in six states, comprising federal and state compliance under both the Controlled Substances Act and Federal Analogue Act, as well as compliant labeling and provision of sale under the Food, Drug, and Cosmetic Act
    • Prepared employment and D&O indemnification agreements, handled board and executive compensation, and stock-based incentive compensation plans and administration for a major international dietary supplement company
    • Advised multi-state hemp-derived cannabinoid distributor on federal and state compliance matters concerning labeling, advertising, and product marketing
    • Assisted clients in resolution of supplement related matters before the United States Department of Justice
    • Represented the largest wholesale distributor of hemp-derived cannabinoid products throughout Appalachia
    How We Have Helped
    • Compliance with Food, Drug, and Cosmetic Act (FDCA), including the Dietary Supplement Health and Education Act (DSHEA) and Foreign Supplier Verification Program (FSVP)
    • Defense against regulatory actions from FDA, FTC, and state attorneys general, including responses to FDA warning letters
    • Commercial transactions related to product innovation, development, and marketing
    • Compliance and audits with Good Manufacturing Practices (cGMPs)
    • Advertising, marketing, and product claims
    • Intellectual property - copyright, trademark, licensing, royalty agreements, and branding
    • Influencer and social media-based advertising
    • Negotiate and defend competitor challenges to advertising
    • Navigate labeling and packaging issues
    • Substantiation from clinical and other studies
    • Defense against products liability claims
    • Unfair trade practices, antitrust violations, business fraud, and other business torts
    • Manufacturing, distribution, supply, franchise, and licensing agreements
    • eCommerce, privacy, and cybersecurity

    Team Members

    Ryan D. Ewing

    Of Counsel

    Anders W. Lindberg

    Member, Chair, Litigation Department