Food, Health & Dietary Supplement Legal Services
Montague Law advises food companies, dietary supplement brands, functional food innovators, and health and wellness businesses on the regulatory, corporate, and transactional challenges of operating in one of the most heavily regulated consumer product sectors. From early-stage supplement brands launching their first product line to established food companies navigating FDA enforcement and pursuing M&A transactions, our team delivers counsel grounded in deep familiarity with FDA, FTC, and state-level regulatory frameworks.
The food and supplement industry sits at the intersection of consumer safety regulation, evolving science, sophisticated marketing, and intense competition. Companies must navigate complex labeling requirements, substantiation obligations for health and structure/function claims, manufacturing quality standards, and an enforcement landscape that is becoming more aggressive. Montague Law provides the regulatory expertise and commercial judgment to help companies bring products to market confidently and compliantly.
FDA Regulatory Compliance
Food and dietary supplement companies face extensive FDA regulation governing manufacturing practices, labeling, ingredient safety, and marketing. Montague Law advises on compliance with Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, food safety requirements under FSMA (Food Safety Modernization Act), New Dietary Ingredient (NDI) notifications, GRAS (Generally Recognized as Safe) determinations for food ingredients, food facility registration, and the FDA inspection process. We help companies design compliance programs that satisfy FDA expectations while supporting operational efficiency.
Labeling & Claims Compliance
Product labeling and marketing claims are among the highest-risk areas for food and supplement companies. We advise on Nutrition Facts and Supplement Facts panel compliance, ingredient listing and allergen disclosure requirements, structure/function claims and the required FDA disclaimer, health claims and qualified health claims, nutrient content claims, and the substantiation requirements that apply to each claim type. We also advise on state-level labeling requirements — including California Proposition 65 — that impose additional obligations beyond federal standards. Our goal is to help companies make compelling, legally defensible claims that differentiate their products in the marketplace.
FTC Advertising Compliance
The Federal Trade Commission regulates advertising for food and dietary supplement products, with particular focus on health-related claims. Montague Law advises on FTC substantiation requirements, clinical study design and evaluation for advertising support, endorsement and testimonial compliance under the FTC Endorsement Guides, social media and influencer marketing compliance, and responses to FTC inquiries, civil investigative demands, and enforcement actions. We work with companies to develop advertising strategies that are both effective and defensible.
Product Development & Ingredient Compliance
Bringing a new food or supplement product to market requires navigating ingredient-level regulatory requirements. We advise on dietary ingredient regulatory status, new dietary ingredient notification strategy, GRAS self-determination and FDA notification processes, novel food ingredient approval pathways, and the regulatory treatment of emerging ingredient categories — including CBD, adaptogens, nootropics, and other functional ingredients with evolving regulatory status. We help companies evaluate the regulatory risk associated with specific ingredients and develop strategies that support product launches.
Supply Chain & Manufacturing Agreements
Food and supplement companies rely on complex supply chains involving ingredient suppliers, contract manufacturers, co-packers, and fulfillment partners. We draft and negotiate supply agreements, contract manufacturing agreements, quality agreements, co-packing arrangements, and private label agreements. Our agreements address the regulatory dimensions of these relationships — including cGMP compliance allocation, specification and testing requirements, recall procedures, and the allocation of liability for adulteration or misbranding events.
Food & Supplement M&A
Montague Law advises food and supplement companies and their investors on mergers, acquisitions, and strategic transactions. Industry M&A raises distinct due diligence considerations including FDA compliance history, product claim substantiation, customer concentration in retail channels, brand and trademark valuation, and the evaluation of supply chain stability. We structure transactions that account for the regulatory and operational complexities of consumer product businesses.
E-Commerce & Direct-to-Consumer Compliance
The shift toward direct-to-consumer distribution has created new legal requirements for food and supplement companies. We advise on state-level food and supplement sales regulations, sales tax and nexus considerations, subscription program compliance with state automatic renewal laws, customer data privacy obligations, and the regulatory implications of selling food and supplement products through Amazon, Shopify, and other e-commerce platforms.
Illustrative Engagement: Functional Beverage Brand Launch
A consumer wellness company developing a line of functional beverages containing adaptogenic mushroom extracts engaged Montague Law to advise on regulatory strategy and commercial launch. Our team conducted a regulatory analysis of each adaptogenic ingredient’s status under DSHEA and food additive regulations, drafted compliant product labeling including Supplement Facts panels and structure/function claims with required disclaimers, reviewed and revised the company’s digital marketing materials and influencer agreements for FTC compliance, negotiated a contract manufacturing agreement with a cGMP-certified beverage co-packer, and advised on state-level registration requirements for supplement products sold through e-commerce channels.
This illustrative engagement is a hypothetical composite and does not represent any specific client matter. It is provided to demonstrate the types of work Montague Law handles for food and supplement companies.
Frequently Asked Questions
What is the difference between a food and a dietary supplement?
The regulatory classification depends on how the product is marketed, labeled, and intended to be used. Dietary supplements are products intended to supplement the diet that contain dietary ingredients such as vitamins, minerals, herbs, amino acids, or other substances. They are labeled with Supplement Facts panels and are regulated under DSHEA. Conventional foods are labeled with Nutrition Facts panels and are regulated under the FDCA’s food provisions. The classification has significant implications for allowable claims, manufacturing requirements, and ingredient approval pathways.
Do I need to register my supplement with the FDA?
Dietary supplement products do not require FDA pre-market approval. However, companies that manufacture, process, pack, or hold dietary supplements must register their facilities with the FDA. Additionally, if a product contains a New Dietary Ingredient (NDI) — one not marketed in the U.S. before October 1994 — the manufacturer must submit an NDI notification to the FDA at least 75 days before marketing the product. We advise companies on their registration and notification obligations.
What claims can I make about my supplement?
Dietary supplements may bear structure/function claims (e.g., “supports immune health”) without FDA pre-approval, provided the claims are truthful, not misleading, substantiated by competent and reliable scientific evidence, and accompanied by the required FDA disclaimer. Health claims linking a nutrient to a disease require FDA authorization. All advertising claims must meet FTC substantiation standards. We advise on claim strategy that maximizes marketing effectiveness while managing regulatory risk.
What is Proposition 65 and does it affect my products?
California’s Proposition 65 requires businesses to provide warnings before exposing consumers to chemicals known to cause cancer or reproductive toxicity. Many food and supplement products contain ingredients or contaminants (such as heavy metals) that trigger Prop 65 requirements. Non-compliance can result in significant private enforcement lawsuits. We advise on Prop 65 testing, safe harbor levels, warning placement, and defense strategies for Prop 65 claims.