Kaitlyn H. Johnson

Kaitlyn Johnson assists domestic and international clients on U.S. Food and Drug Administration (FDA) matters relating to food, food ingredients, dietary supplements, as well as tobacco and nicotine products. She helps clients achieve their marketing goals within applicable legal frameworks and counsels them on all aspects of product development and marketing, including food and dietary ingredient regulatory status, product labeling, advertising, promotional materials, and claim substantiation.

A significant portion of Kaitlyn's practice focuses on tobacco and nicotine regulation. She counsels manufacturers, distributors, retailers, and suppliers on FDA, state, and local requirements relating to tobacco products, electronic nicotine delivery systems (ENDS), synthetic nicotine products, nicotine analog products, oral nicotine pouches, as well as hemp-derived cannabinoid products, including CBD. She advises clients on matters relating to the Family Smoking Prevention and Tobacco Control Act, state Premarket Tobacco Product Application (PMTA) directory and certification requirements, flavor restrictions, product registration, licensing, excise taxation, and other regulatory developments affecting the tobacco and nicotine industries.

Prior to joining Keller and Heckman, Kaitlyn earned an M.S. in Environmental Policy and Sustainability Management and worked for a New York-based environmental consulting firm. During law school, she served as a Staff Editor of the Journal of Health Care Law & Policy, and interned with the Federal Highway Administration and the U.S. Securities & Exchange Commission.

Representative Matters

• Reviewed food labeling and promotional materials, including ingredient declarations, nutrition and allergen labeling, nutrient content claims, structure/function claims, and marketing claims related to GMOs, organic products, sustainability, and novel ingredients
• Assessed the regulatory status of food ingredients and dietary supplement ingredients
• Advised clients on regulatory and litigation risks associated with labeling, advertising, and marketing claims, including advising on consumer class action trends and responding to demand letters and threatened litigation
• Advised clients regarding tobacco and e-vapor regulation under the Family Smoking Prevention and Tobacco Control Act and assisted with Substantial Equivalence (SE) reporting to FDA
• Provided guidance and opinion letters regarding the regulatory status of tobacco, synthetic nicotine, nicotine analog, oral nicotine, and CBD products
• Advised manufacturers, distributors, suppliers, and retailers on compliance with state tobacco and nicotine product laws, including PMTA directory requirements, flavor restrictions, product registration, licensing, and excise taxes