Label & Claims Counsel

At MyFDALawyers.com, PC, our FDA label and claims counsel focuses on delivering top quality legal representation to businesses. We help companies with the full range of commodities, including dietary supplements, human and pet foods, cosmetics, OTC drugs, and medical devices. A proactive approach is a must. If you have any specific questions or concerns about labels or claims for these commodities, we are here to help. Contact our FDA lawyers today for a fully confidential, no-obligation consultation.

An Overview of Label & Claims Review

All human and pet food, beverage, dietary supplement, cosmetic, and over-the-counter drug products marketed in the U.S. must comply with FDA labeling regulations. A label & claims review ensures that all required disclosures, formatting, and statements are accurate, substantiated, and legally compliant. The claims analysis includes examining each claim against the Federal Food, Drug, and Cosmetic Act (FDCA), commodity specific regulations & policies, and the claims requirements enforced by the Federal Trade Commission.

Importantly, a ‘label’ refers specifically to the display of written, printed, or graphic matter directly on the immediate container of a product, (e.g., printed information on a bottle or package). In contrast, ‘labeling’ encompasses a broader scope, including not only the label itself but also all accompanying materials that convey information about the product, such as package inserts, promotional brochures, user manuals, websites, social media posts, and marketing collateral. FDA and FTC regularly monitor and enforce product labeling with ease, making noncompliance a significant regulatory risk.

You Need to Get Label and the Labeling Right: Illegal or unsubstantiated claims on product labeling or in marketing on websites and social media may prompt FDA or FTC enforcement, including Warning Letters, Import Alerts, Import Refusals, or even FTC lawsuits for money penalities.

We Help Companies With All Types of Commodities

MyFDALawyers.com, PC is a boutique law firm that helps businesses with product labels and claims review for all FDA-regulated products. A compliant label, adhering to FDA regulations to avoid enforcement actions, must also be supported by adequate scientific substantiation to prevent FTC litigation and private lawsuits. Our firm provides strategic legal review of product labels, labeling, and marketing materials. We help businesses navigate compliance issues before products reach the market. Our FDA lawyers have experience with:

• Supplements: We advise dietary supplement companies on FDA compliance under the Dietary Supplement Health and Education Act (DSHEA), including proper labeling, Structure Function claims, and claims substantiation.
• Foods: Our FDA lawyers assist food manufacturers and brand owners in meeting FDA labeling standards, including allergen disclosures, and nutritional content claims.
• Cosmetics: We help cosmetics companies ensure their labels, claims, and marketing materials comply with the FDCA and the Modernization of Cosmetics Regulation Act (MoCRA). We support cosmetic product compliance at every stage of development.
• OTC drugs: Our firm advises over-the-counter (OTC) drug companies on labeling compliance under the FDA monograph system, including compliance with the applicable monograph, Drug Facts labeling, and advertising claims.
• Medical Devices: Our firm counsels device manufacturers on FDA classification, labeling, and marketing claims in line with 21 CFR Part 801 and applicable guidance documents. We also review promotional materials to reduce the risk of making claims beyond the device clearance.
• Pet Foods: Pet foods are subject to FDA regulations and many state-based regulations. We support pet food and animal supplement companies with FDA and AAFCO compliance, including labeling, claims, and ingredient declarations.

Common Issues that May Lead to FDA (or FTC) Problems

Your products could run into labeling or claims issues with the FDA or the Federal Trade Commission (FTC) for many reasons. Some of the most common issues that cause problems for FDA-regulated businesses are:

• Unsubstantiated Claims: Label claims must be supported by competent and reliable scientific evidence. Both the FDA and FTC aggressively target products that make claims without proper substantiation.
• Insufficient Labels: Failing to include required elements such as Net Quantity, Statements of Identity, or required warnings cause a product to be misbranded.
• Dual Language Violations: When a product label includes information in a non-English language without all required information also in that language, it violates FDA regulations, readily attracting scrutiny.
• Missing/Incorrect Information: Omissions or errors in ingredient lists, Nutrition Facts or Supplement Facts panels, or OTC Directions For Use can trigger compliance issues. Seemingly minor labeling mistakes can lead to significant business impacts—financially and legally—in FDA-related enforcement action.
• Unapproved Claims: Certain label or advertising claims, like structure/function claims on cosmetics or disease claims on dietary supplements, can reclassify a product as an unapproved new drug under FDA regulations. Device claims exceeding 510(k) clearance or drug claims beyond OTC monograph limits misbrand the product, rendering it unapproved or illegal.

How Our FDA Label and Claims Counsel Can Help

The review process for product labels & claims to be compliant with federal law, Food and Drug Administration (FDA) regulations and compliance policy is notoriously complex. The applicable standards consist of hundreds of pages and dozens of rules. Companies can benefit from skilled, experienced legal representation. Our attorneys Bill Senior and Rick D. Quinn have been working closely with FDA-regulated businesses for more than two decades. They are proactive and provide personalized, detail-focused representation. Among other things, our FDA lawyers can help your business with:

• Label Review: We are proactive in labeling reviews. Our FDA lawyers conduct comprehensive reviews of product labels to ensure full compliance with applicable law, and FDA regulations and policy, including formatting, required elements, and disclosures. Among other things, our team reviews label claims, technical elements like Supplement and Nutrition Facts panels, required disclosures, and ingredient declarations. We help clients avoid problems before they arise.
• Claims Review: Our FDA lawyers will carefully review your advertising and website claims for legal compliance. We focus on whether the claims meet regulatory requirements that apply and what kind of substantiation may be needed. Then we provide guidance on how to adjust claims to reduce the risk of FDA enforcement and lawsuits from FTC or private plaintiffs.
• Advocacy: Strong advocacy is essential to protect product labels and claims from regulatory and litigation challenges, ensuring market success and countering predatory attacks. Our firm provides strategic representation before federal and state agencies, addressing FDA Warning Letters, Inspection findings, Import Detentions, and defending against California Proposition 65 and Class Action lawsuits.