KRISTI L. WOLFF
Partner
(202) 342-8805 (202) 342-8805
KRISTI L. WOLFF Partner

Kristi Wolff’s practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues.  She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Kristi handles matters 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 attorneys general and class action litigation.  In addition, she regularly counsels clients on issues pertaining to direct-selling compliance, and works with several lifestyle brands in the apparel, jewelry and fur industries.  Notably, Kristi also advises on all areas of country of original marketing and advertising claims, such as “Made in U.S.A.”

Having served as in-house counsel in the health care and food products industries, Kristi is particularly attuned to balancing business objectives with legal considerations.  Clients appreciate Kristi’s practical approach to their legal challenges.  Detail-oriented, Kristi is able to synthesize and communicate even the most complex information and ideas in a manner that is easy-to-understand.  Creative and thorough, Kristi is adept at taking into account the bigger picture to help clients make informed and thoughtful decisions.  Her skill in the consumer protection area was recently recognized, where she was named Washington, D.C., “Rising Star” by Super Lawyers magazine.

Kristi is able to analyze matters and legal issues through the eyes of her clients, specifically taking into account their objectives and resources.  Prior to 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, where she performed risk management functions, including litigation and regulatory tasks.  During law school, Kristi worked at the Wisconsin Department of Justice and the U.S. Court of Appeals for the Ninth Circuit.

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.

Recognized by Super Lawyers as a Washington D.C. “Rising Star,” 2015.

About

Kristi Wolff’s practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues.  She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Kristi handles matters 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 attorneys general and class action litigation.  In addition, she regularly counsels clients on issues pertaining to direct-selling compliance, and works with several lifestyle brands in the apparel, jewelry and fur industries.  Notably, Kristi also advises on all areas of country of original marketing and advertising claims, such as “Made in U.S.A.”

Having served as in-house counsel in the health care and food products industries, Kristi is particularly attuned to balancing business objectives with legal considerations.  Clients appreciate Kristi’s practical approach to their legal challenges.  Detail-oriented, Kristi is able to synthesize and communicate even the most complex information and ideas in a manner that is easy-to-understand.  Creative and thorough, Kristi is adept at taking into account the bigger picture to help clients make informed and thoughtful decisions.  Her skill in the consumer protection area was recently recognized, where she was named Washington, D.C., “Rising Star” by Super Lawyers magazine.

Kristi is able to analyze matters and legal issues through the eyes of her clients, specifically taking into account their objectives and resources.  Prior to 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, where she performed risk management functions, including litigation and regulatory tasks.  During law school, Kristi worked at the Wisconsin Department of Justice and the U.S. Court of Appeals for the Ninth Circuit.

Experience

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.

Honors

Recognized by Super Lawyers as a Washington D.C. “Rising Star,” 2015.