Cosmetic Regulatory

Service Areas

We provide counsel on the FDA regulation of cosmetics, including:

– Assisting with regulatory classification (e.g. cosmetics vs. drugs), related compliance requirements, and business risk management
– Counseling on safety and testing of ingredients, including California Proposition 65
– Assisting with color additive regulations and batch certification testing requirements
– Assisting with good manufacturing practices and recordkeeping requirements
– Counseling on pre- and post-market responsibilities
– Managing product recalls, including determining the possibility of limiting recall scope, drafting FDA and consumer notifications, and recall termination processes
– Assisting with import/export issues
– Management of third-party laboratory testing
– Management of FDA inspections and responses to Warning Letters, untitled compliance letters, and Forms FDA-483
– Management of import detentions, import refusals, and requests for reconditioning
– Providing counsel on Import Alerts including petitioning companies from removal from Import Alert, and other import/export issues
– Assisting with petitions for mitigation of liquidated damages assessed by U.S. Customs

Regulatory Experience

Our experience includes representing domestic and international businesses, and import and export matters regulated by FDA, CBP, USDA, and EPA.

Representative Cosmetics Regulatory Experience

• Advised on FDA enforcement history for hair growth cosmetic products and identified regulatory risks for proposed claims
• Successfully narrowed cosmetic recall scope and drafted customer and FDA communications
• Assisted with product classification as cosmetics or drugs and advised on applicable product compliance requirements
• Counseled on product copies, including labeling and claims compliance, and display unit labeling for large cosmetic brand
• Advised on regulatory compliance provisions for Vendor Terms agreement for large cosmetic retailer
• Advised on protected plant ingredients and CITES requirements for ingredient’s use in cosmetic shampoos
• Advised on GMP requirements and best practices for FDA inspection, for a cosmetics contract manufacturer
• Provided counsel on import of cosmetics for U.S. tradeshow

Why Work With Us?

• Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.

• Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.

• Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.

• Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.

• Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.

Cosmetic products clients include:

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