With a practical, business-minded approach, Cynthia L. Meyer focuses her practice on advising and advocating on behalf of clients in legal and regulatory compliance matters related to the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). She also advises clients on related matters involving the U.S. Department of Agriculture (USDA), Consumer Product Safety Commission (CPSC), the Alcohol and Tobacco Tax and Trade Bureau (TTB), and other federal and state agencies.
Cynthia represents companies in the pharmaceutical, dietary supplement, food & beverage, cosmetic, cannabis/hemp, medical device, and consumer product industries. In addition to counseling on regulatory strategy and compliance and reviewing labels and claims from a cross-cutting FDA/FTC perspective, she has assisted clients in their interactions with and submissions to FDA, including those related to voluntary recalls, Form FDA 483 cGMP inspectional observations, Warning Letters, FDA import detentions, import alert removal petitions, 510(k) clearance, and trade complaints. She advises on prescription drug advertising and promotion issues and has served as the legal representative on in-house prescription drug promotional review committees. She has also provided regulatory due diligence review in M&A and investment transactions and has assisted with regulatory disclosures in filings for the U.S. Securities and Exchange Commission (SEC).
A skilled advertising lawyer, Cynthia frequently provides guidance on claims substantiation, social media marketing, and use of influencers and testimonials in advertising. She has represented clients in advertising disputes in front of the National Advertising Division (NAD) of BBB National Programs, Inc. and assisted clients with responding to FTC Civil Investigative Demands (CID) and access letters.
Cynthia frequently speaks and writes on a host of FDA and advertising issues, including prescription drug advertising and promotion, dietary supplement labeling and structure-function claims requirements, advertising claims substantiation, and the regulation of hemp/CBD. She has authored or co-authored chapters and articles in multiple publications, such as A Practical Guide to FDA’s Food and Drug Law Regulation (multiple editions), Bringing Your Pharmaceutical Drug to Market (2015), and Law360. She has served on the Food and Drug Law Institute’s Advertising & Promotion for Medical Products committee and its Food Advertising, Labeling, and Litigation committee.
Before joining Kleinfeld, Kaplan & Becker, Cynthia worked as a biologist at the National Cancer Institute of the National Institutes of Health, conducting immunology research.
Representative 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
- Advising on the current legal and regulatory status of hemp and CBD in FDA regulated products
- Representing clients in advertising disputes before the National Advertising Division (NAD)
- 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, or other regulators
- 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
Publications & Speaking Engagements
- “The Regulation of Dietary Supplements,” Co-Author, A Practical Guide to FDA’s Food and Drug Law Regulation 7th edition (August 2020).
- “The FTC Issues Proposed Rule Regarding ‘Made in USA’ Claims, Raising Questions of its Appropriate Scope,” Co-Author, KKB Insight (July 22, 2020).
- “FTC’s ‘Made In USA’ Rule Could Apply To Online Marketing,” Co-Author, Law360 (July 20, 2020).
- “FDA Updates Enforcement Policy Related to Face Masks and Respirators During the COVID-19 Public Health Emergency,” Co-Author, KKB Insight (June 18, 2020).
- “U.S. FDA and the Products it Regulates,” Co-Author, Kirk-Othmer Encyclopedia (2019).
- “The Regulation of Dietary Supplements,” Co-Author, A Practical Guide to FDA’s Food and Drug Law Regulation 6th edition (September 2017).
- “Off-Label Communications and Intended Use: What’s Happening Now?” Author, KKB Insight (March 23, 2017).
- “Continuing the Discourse: FDA’s Public Hearing on Off-Label Communications,” Editor, Update EXTRA (November 2016).
- “Health Groups and Pediatricians Sue FDA for Cigarette Graphic Warning Regulations,” Co-Author, KKB Insight (October 8, 2016).
- “FDA Updates Nutritional Labeling Rules,” Author, KKB Insight (June 4, 2016)
- “Labeling,” Author, Food and Drug Law Institute (FDLI) Bringing Your Pharmaceutical Drug to Market (April 2015).
Recent Speaking Engagements
- “The Rise of Wellness Products: Legal Issues for Supplement Health Benefit Claims and Foods that are More Than Just Food,” Panelist. Food and Drug Law Institute (FDLI) Food Advertising, Labeling, and Litigation Conference (virtual conference), September 22, 2020.
- “Maximizing Sales by Minimizing Risks,” Panelist. American Herbal Products Association (AHPA) Hemp-CBD Supplement Virtual Congress (virtual conference), August 27, 2020.
- “Concept Building, Proving and Prototyping” course. Expert Guest. Culinary Institute of America Food Business School (virtual interview), August 2020.
- “Workshop: NDI-GRAS for Hemp-CBD,” Speaker. American Herbal Products Association (AHPA) Hemp-CBD Supplement Virtual Congress (virtual conference), August 18, 2020.
- “Working Group on Substantiating Advertising Claims for FDA-Regulated Consumer Products: OTC Drugs, Food, Dietary Supplements, and Cosmetics,” Speaker. American Conference Institute’s Annual Legal, Regulatory and Compliance Forum on Advertising Claims Substantiation (New York, NY), January 30, 2020.
- “Case Study on Pharmaceutical Advertising and Promotion” Panelist. Food and Drug Law Institute (FDLI) Advertising and Promotion for Medical Products Conference (Washington, DC), October 17, 2019.
- “GRAS/NDI Workshop,” Speaker. American Herbal Products Association (AHPA) Hemp-CBD Supplement Congress (Denver, CO), August 15, 2019.
- “Clarifying the Legal Pathway for Hemp-Derived CBD in Food and Dietary Supplements,” Panelist. American Conference Institute (ACI) Dietary Supplement Regulatory and Compliance Forum (New York, NY), June 18, 2019.
- “Advertising: The Federal Trade Commission and Private Rights of Action,” Speaker. FDLI/CFSAN In-House Training Course (College Park, MD), August 7, 2018.
Recognition & Professional Activities
- Food and Drug Law Institute (FDLI) Food Advertising, Labeling, and Litigation Committee (2020)
- Food and Drug Law Institute (FDLI) Advertising & Promotion for Medical Products Committee (2019)
B.S., Duke University