Kristi Wolff has extensive experience advising clients whose products are within the overlapping jurisdictions of the FDA and FTC, including food, drugs, dietary supplements, medical devices, personal care, cannabis, and consumer health products. With her in-house counsel experience in the healthcare and food products industries, Kristi is particularly attuned to balancing business objectives with legal considerations.
Kristi provides trusted counsel on product and advertising compliance issues as well as contested matters and transactional due diligence. Her close collaboration with her clients’ business, legal, and marketing teams helps her tailor risk assessments and guidance to each client’s objectives.
Kristi handles issues that span the complete product lifecycle, including concept analysis, claim substantiation, label review, quality and recall scenarios, and contested matters involving the FTC, FDA, National Advertising Division (NAD), State AGs, and class action litigation.
Notably, Kristi advises on specific advertising issues such as country of origin and “Made in U.S.A.” claims, automatic renewal compliance, price advertising, and “green” claims.
In the cannabis industry, she advises regarding a range of state-level compliance issues, including advertising and licensing. Her business-oriented mindset also adds value for her clients when advising on transactions, agreements, and other strategic initiatives that implicate product regulatory and advertising issues.
Clients appreciate Kristi’s practical approach to their legal challenges. Creative and thorough, Kristi is adept at considering the bigger picture to help clients make informed and thoughtful decisions. Her skill in the advertising and consumer protection area earned her peer recognition including selection in Best Lawyers in America for advertising law.
Before joining Kelley Drye, Kristi served as associate general counsel at Nestlé HealthCare Nutrition, Inc., a subsidiary of Nestlé S.A., the world’s largest health, nutrition, and wellness company. She also worked as senior counsel at Assurant Health, performing risk management functions, including litigation and regulatory tasks.
Represented a leading weight loss program in an FTC investigation relating to advertising practices. The FTC closed the matter without a closing letter.
Represented a multinational food company with respect to an FTC investigation into marketing claims. The FTC did not pursue action on one of the two originally investigated claims.
Represented a nationwide retailer in an FTC investigation of price advertising practices. The FTC closed the investigation without a closing letter.
Represents a dietary supplement manufacturer in responding to a state attorney general civil investigative demand regarding product sourcing, safety and efficacy issues.
Assisted a national dairy and juice producer in responding to FDA Warning Letters regarding misbranding concerns.
Successfully negotiated multimillion-dollar contract manufacturing and distribution agreements for a food client.
Counsels celebrity endorser with regard to development, testing, launch and marketing of a cosmetics line. Managed multiple label review projects for a national retail chain involving the review and modification of thousands of private label food, dietary supplement, OTC drug, cosmetic and medical device labels.
Counsels multiple apparel companies with regard to substantiation, FDA clearance process and advertising of health benefits of wearable technology products.
Lead associate in successful NAD challenge and NARB appeal regarding competitive advertising of water filtration products.
Lead associate representing a money transfer company in an investigation by 44 state attorneys general regarding the effectiveness of the company’s anti-fraud program.
Counsels Fortune 500 health care company with regard to structuring a telemarketing compliance program and campaigns.
Lead associate representing a major retailer in a settlement with the FTC regarding the Textile Act compliance and environmental marketing of textiles.
Lead associate representing a national retailer in an investigation by the FTC regarding compliance with the Fur Products Labeling Act. The case closed by the staff without formal action.
Assisted a network television show in structuring an advertising promotion to benefit the American Red Cross and, specifically, victims of Hurricane Sandy.
Lead associate representing multinational fuel manufacturer in the development of claims substantiation and launch of a national marketing campaign.
The Best Lawyers in America© (Woodward/White, Inc.), Advertising Law, 2018-2024.
Recommended in US Legal 500 for her work in the Marketing & Advertising area, 2018-2019.
Recognized by Super Lawyers as a Washington D.C. “Rising Star,” 2015.