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.
Ms. Jackson has also been involved in litigation concerning constitutional and administrative law issues before the FDA, the FTC, and the federal courts.
Ms. Jackson is a member of Venable's Advertising and Marketing team, which was selected in 2010 as a recipient of the Chambers USA Award of Excellence and recognized by Legal 500.
Industries
Dietary Supplements, Cosmetics and Functional Foods
Drugs, Medical Devices and Biologics
Life Sciences
Consumer Products and Services
Memberships
American Bar Association
Virginia Bar Association
Publications
July 2011, FDA's NDI Guidance Will Impact About 90% of the Dietary Supplement Industry
Todd A. Harrison, Claudia A. Lewis-Eng, Michelle C. Jackson
Client Alerts
December 2010, New Consumer Product Safety Commission Database Sharply Raises Regulatory Risks and Product Liability Exposure for a Surprisingly Broad Range of Products and Substances
Jill B. Deal, Bruce R. Parker, Michelle C. Jackson
August 2007, Cosmetics: Regulators' Next Target?
Michelle C. Jackson, Jeffrey D. Knowles
Electronic Retailer
April 2007, Consumer Products Regulatory Report, Q1 2007
Claudia A. Lewis-Eng, Todd A. Harrison, Michelle C. Jackson
March 2007, Dietary Supplements Are Still Getting a Bad Rap
Jeffrey D. Knowles, Michelle C. Jackson
Electronic Retailer
June 24, 2006, Pet Supplements Primer
Todd A. Harrison, Michelle C. Jackson
Nutraceuticals World
Events/Speaking Engagements
Past Events
March 9, 2012, "Claiming to be the Best: Understanding How to Substantiate Your Claims" at Engredea 2012
Michelle C. Jackson
September 14, 2011, "Ask the NDI Legal Experts: Q&A Session" for Natural Products Insider
Michelle C. Jackson
December 13, 2010, "November 2010 Consumer Protection Update," ABA Section of Antitrust Law's Consumer Protection, Private Advertising Litigation, and Corporate Counseling Committees
Todd A. Harrison, Claudia A. Lewis-Eng, Michelle C. Jackson
March 13, 2010, "GMP Compliance: A Panel Discussion" at the Natural Products Expo West Conference in Anaheim, CA
Michelle C. Jackson
October 12, 2009, "FDA Regulatory Strategy" class presented to students in the Master's of Science in Engineering (M.S.E.) in Bioengineering Innovation and Design Program at Johns Hopkins University
Michelle C. Jackson
September 23, 2009, "Is Your GMP Paper Trail a Highway To The Danger Zone?" at the Natural Products Expo East Conference in Boston, MA
Michelle C. Jackson