James Holloway

• Developed a 55-page Modernization of Cosmetics Regulation Act (MoCRA) compliance manual for a major cosmetics and personal care trade organization.
• Advised a global fragrance ingredient manufacturer on legal risks associated with expanding into finished cosmetic product manufacturing and risk mitigation strategy.
• Advised companies on whether certain features of phone applications would be regulated as a medical device under FDA regulations and policies, including the FDA’s General Wellness Policy and Mobile Medical Applications Policy.
• Counseled a multinational dietary supplement company launching new U.S. products on labeling requirements, claim substantiation, price transparency, endorsements, sweepstakes, and ensuring favorable FDA classifications.
• Conducted regulatory diligence of food, beverage, dietary supplement, and cosmetic company acquisition targets.
• Provided advice on compliance with marketing and consumer protection standards, including the FTC’s Endorsement Guides, Green Guides, and Consumer Reviews and Testimonials Rule.
• Counseled a major consumer packaged goods (CPG) company on mitigating risks associated with the use of AI to moderate and display consumer reviews.
• Defended a leading alcohol company in an FTC investigation involving allegations of marketing to minors.
• Advised consumer-facing brands on litigation risks stemming from labeling and advertising claims, helping clients to develop effective marketing materials while minimizing the risk of class-action challenges.
• Secured favorable pre-litigation outcomes in Proposition 65 and deceptive advertising challenges to food and dietary supplement companies.
• Represented CPG advertisers and challengers in National Advertising Division of the Better Business Bureau (NAD) matters.

James Holloway advises clients on FDA regulation of cosmetic, food, dietary supplement, drug, and medical device products, as well as advertising and consumer protection matters. James regularly counsels consumer products companies on strategies to reduce FDA, FTC, state, and class action risk while supporting commercial objectives. His experience includes advising on product labeling, regulatory classification, Proposition 65 compliance, mobile medical applications, strategic engagement with regulators, enforcement matters, and implementation of the Modernization of Cosmetics Regulation Act (MoCRA).

James previously served as a judicial extern for Judge Ketanji Brown Jackson in the U.S. District Court for the District of Columbia.

Languages

• Spanish

Bar Admissions

• California

Education

• Harvard University (J.D., 2021)
• Harvard College (B.A., 2016)

Memberships