Olshan lawyers guide food, drug, dietary supplement and cosmetics sector clients through the often-complex maze of regulatory measures, substantiating product safety and marketing claims, representing them in regulatory matters and helping execute major transactions with retailers, suppliers, manufacturers and investors.
Regulatory Compliance
Fast-paced, exciting and ever-evolving, the food, health and beauty industry is subject to a host of regulatory challenges as companies research, develop, manufacture and market products across international platforms. Before a product hits the shelves, it must go through a rigorous and complicated regulatory process. With extensive experience in regulatory compliance and defense, we work with client teams across all aspects of advertising and marketing messaging to ensure that campaigns comply with applicable standards, including rules regarding claim substantiation, testimonials and health and performance claims.
With expertise across practices, including Advertising, Marketing & Promotions, Intellectual Property, Corporate/Securities Law, Litigation, Real Estate Law, Tax & Personal Planning, and other business-related legal practices, Olshan is well-positioned to address the myriad of legal issues and challenges that can arise, ensuring compliance and guiding clients in bringing products to market.
We steer clients through the regulatory requirements imposed by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) on food, drug, dietary supplements and cosmetics, which many view as onerous landmines. From product efficacy, pricing and natural products claims to health benefits and safety assertions, Olshan lawyers help clients succeed by making certain they understand and comply fully with all product-related legal and regulatory requirements.
Our lawyer teams bring to each matter comprehensive client-oriented solutions, delivering decades of experience in advertising law, trademark and overall IP management and protection, FDA issues, corporate and securities law, litigation, employment practices, retail leasing and other business-related issues.
We work closely with client advertising and marketing messaging groups, reviewing product names and marketing campaigns and all other advertising elements to make certain the testimonials and health and performance assertions are consistent with the applicable regulatory pathway and are appropriately substantiated. This includes taking a step back to carefully assess each ad’s overall impression – including its appearance, images, text, product name, and express and implied claims – to ensure all possible consumer interpretations can be substantiated.
Our reviews also include a close examination of the product’s disclosure requirements. We help clients assemble and draft disclosure documentation; review collateral materials, including endorsements, testimonials, influencer statements, before and after images, and videos; and determine whether tests, analyses, research and scientific studies meet the reliable scientific evidence standard to demonstrate accurate and reliable results.
Regulatory Review
Should regulatory inquiries, investigations or enforcement actions arise, our lawyers are well-prepared with a strong defense and the skills needed to resolve matters as favorably as possible. We have successfully represented clients in federal and state regulatory actions and private Lanham Act claims relating to product marketing and compliance. We also represent clients in matters before state regulatory authorities and frequently appear before self-regulatory boards such as the National Advertising Division in matters regarding advertising challenges and investigations.
Litigation
Our litigation lawyers bring to each matter a strong track record of success in defending clients facing allegations that their marketing claims are inconsistent with their regulatory pathway, misleading, unsubstantiated, deceptive or otherwise violate truth-in-advertising laws.
Global Reach
Collaborating with an international network of product experts and local counsel, we support our clients large and small across the globe, providing sophisticated counsel to foreign clients looking to tap United States markets and helping American enterprises to expand into fast-growing and lucrative foreign jurisdictions. In both cases, we counsel on regulatory requirements ranging from product labeling, warnings, ingredient listings and country of origin.
Transactions
Clients worldwide also rely on Olshan to structure and negotiate a wide array of critically important manufacturing, supply and other commercial arrangements, including collaboration, co-development, product licensing, and marketing, distribution and promotion agreements, and to advise them on branding materials and brand management.
The following representative matters demonstrate the range of FDA and FTC issues our attorneys regularly handle on behalf of food, drug and cosmetic industry clients.
- Serving as acting outside general counsel for an innovative generic drug manufacturer, including negotiating development, manufacturing and distribution agreements, reviewing marketing claims, and responding to regulatory inquiries.
- Serving as outside general counsel to a leading international cosmetic and anti-aging product developer and global distributor, including establishing international corporate facilities and negotiating international manufacturing and distribution arrangements.
- Counseling numerous dietary supplement marketers on defensibility and substantiation of health claims.
- Defending leading nutritional supplement direct marketer in connection with an FTC investigation and enforcement action.
- Resolving numerous district attorney task force dietary supplement and health claim enforcement actions.
- Serving as outside compliance counsel for a leading dietary supplement marketing agency.
- Advising an innovative cosmetic marketer on health and beauty claims.
