Cynthia L. Meyer is a partner who joined the firm in 2011 and practices primarily in food and drug law and advertising law. She regularly provides counsel and advocates on behalf of clients in the pharmaceutical, dietary supplement, food, medical device, cosmetic, and consumer product industries on legal and regulatory matters involving the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Department of Agriculture (USDA), the U.S. Consumer Product Safety Commission (CPSC), and other related federal and state agencies. Ms. Meyer works with clients to understand their goals and assist them in strategically navigating the legal and regulatory landscape relevant to their business, throughout the product life cycle.
Selected matters include:
- Serving as the legal representative on client’s Promotional Review Committees (PRCs or MLRs) for prescription drug brands
- Counseling on all aspects of advertising and marketing of drugs, dietary supplements, food, and cosmetics, including labeling and claims review
- Assessing potential applicability of over-the-counter (OTC) drug monograph to proposed product formulation and dosage form, labeling requirements, and whether proposed claims are consistent with any applicable monograph
- Advising on compliance with the Dietary Supplement Health and Education Act of 1994, including assessing the regulatory status of ingredients and whether a new dietary ingredient notification is required, advising on appropriate structure-function claims, and reviewing claims substantiation
- Assisting clients with responding to complaints or inquiries from or before FDA, the FTC, the National Advertising Division of the Council of Better Business Bureaus (NAD), or similar entities
- Assessing the regulatory status of a potential medical device, including whether the product would require 510(k) or PMA submission or could be considered a general wellness device or laboratory developed test (LDT)
- Corresponding with FDA on behalf of the client to facilitate release of import entries subject to FDA hold
- Preparing and submitting successful petition for removal from Import Alert Detention Without Physical Examination (DWPE or “Red List”) status
- Advising on cGMP issues, FDA inspections, and recalls
- Reviewing and drafting proposed legislative language or comments to proposed FDA regulations or guidance
Prior to joining the firm, Ms. Meyer worked as a judicial fellow at the D.C. Superior Court and as a biologist at the National Cancer Institute at NIH. She received her B.S. in Biology from Duke University and her J.D. from Georgetown University Law Center.