Kristen R. Klesh

Kristen Klesh advises clients on a broad range of Food and Drug Administration (FDA), Federal Trade Commission (FTC), and related state law regulatory compliance matters throughout all stages of product lifecycle. With deep knowledge of FDA regulations and claim substantiation requirements, marketers and distributors of food, drug, medical device, and cosmetic products rely on Kristen to provide creative and pragmatic solutions to product development initiatives, marketing and advertising campaigns, and quality and safety compliance. With respect to post-market compliance, Kristen routinely achieves favourable results for clients when responding to FDA warning letters and Form 483 inspection observations, FTC and State Attorneys General investigations, National Advertising Division (NAD) competitor challenges, and class action complaints involving product advertising claims.

In the device industry, developers and marketers of mobile apps, wearable devices, in vitro diagnostic tests, and “general wellness” products turn to Kristen to advise on potential FDA obligations and options for reducing regulatory risk. She represents medical device companies in obtaining 510(k) premarket clearance, advises on labeling and advertising claims, and evaluates responsibilities under the FDA’s Quality System Regulation and medical device reporting requirements.

Clients in the food, cosmetic, and drug industries seek Kristen’s advice on ingredient safety, clinical research initiatives, FDA and United States Department of Agriculture (USDA) labeling compliance and claim substantiation standards under NAD decisions and FTC rules. She routinely counsel clients on the requirements for “structure/function” claims, health claims, nutrient content claims, organic claims, endorsements and testimonials, and cosmetic claims across various media platforms. Marketers and advertisers of hemp and CBD products also rely on Kristen to evaluate compliance with FDA regulations and state-law requirements for the marketing, sale, and distribution of cannabis-derived products. In the regenerative medicine sector, Kristen advises physician practices and clinics issues related to FDA oversight and develops business-oriented solutions to reduce regulatory risk.

With respect to the pharmaceutical industry, Kristen has conducted compliance reviews of labeling and marketing materials and served as outside counsel on promotional review committees. She has also advised clients on promotional efforts involving speaker engagements, HCP consulting arrangements and the use of reprints and responses to unsolicited requests. Kristen represented a working group of major pharmaceutical companies in drafting an FDA Citizen Petition regarding the definition and scope of scientific exchange and has liaised with FDA’s OPDP in responding to warning letters regarding drug promotion issues.

For clients seeking auditing and transactional assistance, Kristen routinely performs compliance audits and due diligence assessments of food, drug, medical device, and cosmetic clients to evaluate compliance with FDA, FTC, and USDA regulations, state law regulators, and risk of competitor or class action challenges.