Kristi L. Wolff


Phone number
(202) 342-8805

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.

As an in-house attorney, I learned first-hand the challenges and pressures my clients face. Now I focus on solving problems in ways that are legally sound, practical, and smart for my clients’ business.”

Representative Contested Matters

Challenged cosmetic company’s use of an in-home use test relying on subjective findings to support objective benefit claims at the NAD. NAD completely rejected the test as the basis for supporting the challenged claims.

Successfully defended OTC drug client against NAD compliance challenge asserting that client had failed to comply with NAD’s recommended label modifications.

Assisted water filtration client in successful NAD challenge and NARB appeal against competitor in a case involving product performance and disparagement claims.

Represent OTC drug distributor relative to resolving state health authority enforcement and FDA warning letter regarding sub-potent hand sanitizer.

Guided cosmetics company in responding to FDA enforcement, including agency engagement relative to product legality (a point the agency eventually conceded), label and website changes, and development of MoCRA compliance program.

Assisted a national dairy and juice producer in responding to FDA Warning Letters regarding misbranding concerns.

Provide FDA regulatory expertise in consumer false advertising class action matters involving food and beverage products.

Represented a dietary supplement manufacturer in responding to a state attorney general civil investigative demand regarding product sourcing, safety and efficacy issues. The AG closed the matter without pursuing enforcement.

Served on a team that represented a money transfer company in an investigation by 44 state attorneys general regarding the effectiveness of the company’s anti-fraud program.

Represented a national retailer in an FTC investigation regarding compliance with the Fur Products Labeling Act. Staff closed the case without formal action.

Represented a global direct seller in an investigation and negotiations with the FTC arising out of alleged unfair and deceptive acts concerning its multi-level marketing program and how it represented its business opportunity. Successfully negotiated a settlement that permitted the company to continue to operate and the case was closed.

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.

Representative Counseling Matters

Conducted multiple regulatory due diligences and drafted memoranda providing analysis and recommendations related to compliance with advertising and food and drug law issues.

Successfully negotiated multimillion-dollar supply, contract manufacturing and distribution agreements for a food industry 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 and technology companies with regard to claim substantiation, FDA compliance and advertising of health benefits associated with wearable products and applications.

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.