Cosmetics & Personal Care Products

Overview

Our practice is known for its pragmatic and creative approach to solving problems. Its clients include manufacturers and distributors of cosmetic and personal care products of all sizes, headquartered in the US and around the world. We work with companies to identify potential regulatory and business challenges and help overcome obstacles and team with clients to provide value in a cost-efficient manner, balancing regulatory objectives with real-world business considerations.

We help clients understand and successfully navigate the federal and state regulatory framework for cosmetic or personal care products, which depending upon the stated intended uses, may be classified by the Food and Drug Administration (FDA) as either cosmetics, topical drugs, or even medical devices. We help companies formulate products that meet national and state requirements and to label and promote those products within regulatory and competitive boundaries.

Our attorneys are experienced in cosmetic and topical product industry issues, including prior service with the national cosmetic trade association CTFA, now PCPC) and the Cosmetic Preservative Council.  We offer practical and effective counseling in areas including cosmetic production, manufacturing and other agreements, import and export procedures, compliance assistance, and labeling an advertising review and defense before the FDA, Federal Trade Commission (FTC), National Advertising Division of the Council of Better Business Bureaus (NAD), and state consumer protection agencies.

Experience

  • Leading representation of indemnitor contract manufacturer in federal class action litigation brought against national drug store chain for alleged false and deceptive claims involving health supplement products.

  • Represented Israel-based provider of personal care medical products in revising social media, website and  product labeling in accordance with FDA and FTC requirements. Helped client revise clinical protocol for study to support performance claims for skincare product.

  • Assisted a European manufacturer of skin care products with manufacturing and quality systems agreements for OTC drug sunscreen products, proper labeling for the products, and  quality control testing.

  • Counseling a New York-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA’s labeling and promotional requirements.

  • Counseling a Montreal-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Serving on client review board for a North Carolina-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

  • Serving on client review board for a Montreal-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

  • Counseling a Georgia-based medical services manufacturer on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Counseling an Alabama-based manufacturing company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.