Dietary Supplements and Food Regulation

Our attorneys help clients legally market their products in the U.S. by setting up manufacturing and distribution processes and other systems to meet U.S. Food and Drug Administration (FDA) standards, as well as advising clients on substantiating ingredients and promotional labeling claims. This includes international companies looking to import products into the U.S. We also guide clients through FDA processes to secure New Dietary Ingredient Notifications (NDINs), Generally Recognized as Safe (GRAS) designations and food additive petitions, among others. Our team also advocates for clients regarding competitive or regulatory threats regarding organic certification and "structure/function" claims.

We also advise clients regarding compliance on product claims, endorsements and other marketing initiatives, as well as in responding to investigations by the Federal Trade Commission (FTC) and state attorneys general and in challenges before the National Advertising Division.

In addition, Holland & Knight helps clients manage regulatory inspections and respond to California Prop 65 warnings, FDA Form 483 reports and other enforcement actions. We also advise clients on their responses to adverse events and product recalls, as well as help establish corrective action plans.

Legislative and Regulatory Experience

Our lawyers and policy advisors leverage decades of experience in Washington to offer strategic guidance and lobbying for clients regarding the entire federal legislative and regulatory process involving food and supplements, from Congress and the White House to the FDA and other key departments and agencies.

Additionally, our team:

• provides regulatory strategy for market entry of products
• provides regulatory compliance advice for food, dietary supplement and cosmetic requirements, including on current Good Manufacturing Practices (cGMPS)
• counsels clients on FDA-483s inspectional findings, reportable food reports, adverse events, market withdrawals, recalls, untitled letters and warning letters
• performs regulatory due diligence, including product compliance and claim substantiation for investors in food, dietary supplement and cosmetic companies
• drafts and negotiates contracts for food, dietary supplement and cosmetic manufacturers, suppliers, distributors and importers
• advises companies on FDA marketing rules and labeling claims
• represents companies before FDA, state and local officials
• lobbies Congress and relevant stakeholders in support of FDA applications
• provides advertising counsel and regulatory advice to startups and leading Fortune 500 companies in the food and beverage industries
• provides consumer protection defense and compliance counsel for food and beverage clients
• provides counsel on online and social media marketing campaigns
• advises on import and export requirements for food, dietary supplements and cosmetic companies
• provides labeling advice for third-party claims such as organic, non-GMO and kosher

Representative Matters

• Provided regulatory strategy, counsel and advice to the developer/manufacturer of a dietary supplement as the company applies for FDA authorization to market its product, including analyzing submissions by other companies with similar products and crafting plans for stakeholder and scientific support for the application
• Advised on a new cosmetic ingredient that requires a new color additive
• Advised a food manufacturer on potential product recall issues and work hand-in-hand with the company's legal, operations and logistics departments to better understand the problem, its root cause and remediation
• Conducted food safety and advertising compliance training for a Fortune 500 company's legal and compliance teams
• Represented a food manufacturer in an emergency FDA inspection involving the recall of multiple products and daily interaction with the FDA and U.S. Centers for Disease Control and Prevention (CDC)
• Guided a food marketer on celebrity endorsement claims about its product to comply with FTC and other regulations
• Advised a major beverage maker on health claims made about one of its products during the COVID-19 pandemic
• Counseled a grocery chain on pricing and promotional language for weekly newspaper inserts
• Drafted celebrity endorsement contracts for food and dietary supplement companies
• Represented food companies before the National Advertising Division, an industry association that determines if advertising claims are truthful and accurate for consumers
• Represented clients on Capitol Hill to support individual client priorities and to seek legislative changes to govern a product class
• Applied for appropriate product codes to facilitate tracking and future payment of FDA-regulated products
• Represented client interests during FDA and other agency rulemaking proceedings
• Litigated patent, trade secret, license and false advertising cases in the food chemistry sector