Bar Admissions

  • Virginia
  • District of Columbia

Court Admissions

  • U.S. District Court for the Eastern District of Virginia
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. Supreme Court

Education

  • J.D., cum laude, George Mason University School of Law, 2004

    Treasurer, Association for Public Interest Law

    Member, Jessup International Moot Court Team

  • B.S., Biopsychology and Cognitive Science, University of Michigan, 1999

    Golden Key National Honor Society

    Psi Chi National Honor Society

Memberships

  • American Bar Association

    Virginia Bar Association

    American Health Lawyers Association

T +1 202.344.4492
F +1 202.344.8300
 

Michelle C. Jackson

Partner

Ms. Jackson's practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution, and promotion of foods, dietary supplements, drugs, medical devices, and cosmetics. She handles matters involving regulation and enforcement by federal and state agencies, including the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the United States Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC).  She also regularly handles matters involving self-regulatory bodies such as the National Advertising Division of the Council of Better Business Bureaus (NAD) and the National Advertising Review Council’s Electronic Retailing Self-Regulation Program (ERSP).  In addition, Ms. Jackson provides valuable assistance to clients in litigation and settlement negotiations.

Ms. Jackson represents numerous clients, helping them to navigate the complex regulations governing foods, food contact substances, dietary supplements, animal supplements, medical foods, over-the-counter (OTC) drugs, homeopathic drugs,  medical devices, cosmetics, and consumer products in various stages of the product lifecycle.  Ms. Jackson assists clients from the beginning stages of product development, advising on product formulation and design.  She also assists clients in obtaining product clearance, approval, or permits, such as 510(k) clearance for medical devices or USDA import permits for animal-derived products.  She likewise assists clients in submitting required notifications, such as new dietary ingredient (NDI) or GRAS notifications.  With regard to product manufacture and distribution, Ms. Jackson advises clients on FDA’s good manufacturing practice (GMP) requirements and the CPSC’s requirements with regard to child-resistant packaging and certification for consumer products.  She also assists with product and facility registration and listing.

With regard to product promotion, Ms. Jackson has a strong understanding of both labeling and marketing requirements.  She routinely advises clients on all aspects of product labeling, with particular experience  in the labeling of OTC drugs, foods, and dietary supplements.  She is extremely familiar with the types of claims permitted for dietary supplements, including health claims, qualified health claims, structure/function claims, and nutrient content claims.  She also advises clients concerning the use of the term “organic" on product labeling.  Of particular importance, Ms. Jackson understands the expectations of regulators and self-regulatory bodies with regard to claim substantiation.  She regularly advises clients on the FTC regulation of product advertising via the Internet, television, print media, and radio.  Ms. Jackson has assisted with the successful defense of advertising claims before the NAD and ERSP, as well as successful challenges of competitor advertising.

With regard to agency enforcement, Ms. Jackson advises clients concerning FDA inspections and helps clients respond to inspectional observations (form 483).  Likewise, she has significant experience helping clients respond to Warning Letters from the FDA, civil investigative demands (CIDs) from the FTC, and subpoenas from the FTC or State Attorneys General.  Ms. Jackson also helps clients with product recalls and with issues relating to the importation or exportation of FDA-regulated goods, such as import detentions and export certificates.