PLG’s Cosmetic and OTC Drugs practice provides comprehensive counsel to companies across the beauty, personal care, and wellness sectors, from established global brands to emerging startups. Our team helps clients navigate the evolving regulatory landscape for cosmetics, over-the-counter drugs, and hybrid formulations that may overlap with medical device categories.
We advise on every stage of the product life cycle, from formulation and labeling to marketing, distribution, recalls, and post-market compliance. Our work spans traditional cosmetics as well as clean beauty, natural, and organic products, helping clients bring innovative and compliant products to market with confidence.
Representative Services
- Supporting compliance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), including facility registration, product listings, labeling updates, safety substantiation, and U.S. Agent services.
- Advising on product classification and permissible claims for cosmetics, cosmetic-drug combinations, and cosmetic devices.
- Conducting ingredient reviews and monitoring state and federal developments, including California’s Proposition 65, states’ ingredient restrictions, and state-level reporting obligations.
- Reviewing labeling, packaging, and advertising to ensure compliance with FDA, FTC, and NAD standards, while balancing marketing goals with legal obligations.
- Designing and overseeing clinical studies and safety testing to support product claims substantiation.
- Counseling on good manufacturing practices, recordkeeping, product recalls, and FDA inspections.
- Representing clients in regulatory enforcement actions, responding to Warning Letters and 483 Inspection Observations, and addressing FTC and competitor challenges.
- Drafting and negotiating industry specific contracts including, but not limited to, supply chain, sales representative, distribution, vendor, influencer and endorser, and licensing agreements.
- Assisting with evaluation of recyclability under California’s SB 343 Accurate Recycling Labels.
- Evaluation of producer obligations and reporting under various states’ Extended Producer Responsibility (EPR) laws.
- Training marketing, quality, and customer service teams on compliance and risk mitigation.
Industry Insight
We understand the unique demands of companies operating at the intersection of beauty, health, and sustainability. Our counsel reflects both regulatory depth and market awareness—helping clients develop compliant, transparent, and consumer-trusted products that align with brand values and business strategy.