Labeling is far broader than the sticker on your product. The FDA defines it to include the container and carton labels, package inserts, instructions for use, and any written, printed, or graphic material that accompanies or promotes the product—including brochures, sell sheets, retailer listings, and your website. This is why a claim made anywhere in your marketing can create the same liability as a claim on the physical package.

Most failures happen because a well-intentioned benefit statement crosses into disease territory. Saying a product “supports a healthy immune system” is generally a lawful structure/function claim, while saying it “prevents the flu” is a disease claim that reclassifies the product as an unapproved drug. The distinction is narrow, the language is easy to get wrong, and many companies never have their claims reviewed before publishing them. 

Once your product is treated as an unapproved new drug, it is automatically considered misbranded and adulterated under the law. It cannot be legally marketed, and you become exposed to Warning Letters, mandatory corrective action, product seizures, injunctions, and import alerts—even if the product itself is perfectly safe. 

21 CFR Part 111 establishes the current Good Manufacturing Practice (cGMP) requirements for dietary supplements, covering everything from quality controls to labeling-related obligations. Compliance with Part 111, combined with the claim rules under DSHEA, is essential to keep your supplement lawfully on the market. JJCC Group reviews your claims and labeling within this framework. 

Yes. We draft complete, compliant labeling from scratch—principal display panels, information panels, Drug Facts or Supplement Facts panels, Nutrition Facts panels, ingredient and allergen statements, net quantity declarations, warnings, and directions—built to the exact regulatory framework that governs your product category. 

Both. We audit your current finished product labels, boxes, cartons, inserts, and secondary packaging against current FDA requirements, identify every deficiency, and deliver a prioritized remediation plan. Existing labels often carry hidden risk from regulatory changes that occurred after the label was first printed. 

Absolutely. Websites, e-commerce listings, social media, and printed marketing are all fair game for FDA enforcement. We review your entire promotional ecosystem to ensure it is consistent with your compliant labeling and free of claims that could trigger regulatory action.

A structure/function claim describes how a nutrient or ingredient affects the normal structure or function of the body (for example, “calcium supports strong bones”). A disease claim states or implies that a product diagnoses, treats, cures, mitigates, or prevents a disease. Supplements may make properly disclaimed structure/function claims but may not make disease claims without drug approval. 

Yes. Structure/function claims on dietary supplements must be accompanied by the mandatory disclaimer stating that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. We verify the disclaimer is present and properly formatted on every applicable label and marketing piece.  

The FDA reviews labels, websites, and marketing during routine surveillance and inspections. When it finds disease claims, missing mandatory statements, or other violations, it issues a Warning Letter that identifies the problems and usually demands a written corrective response within about fifteen working days. These letters are public and can escalate if not addressed. 

Quality assurance, production, laboratory, and management personnel should participate, since FDA interviews staff across functions. The mock audit also trains employees on how to interact with an investigator.

We cover all six major FDA-regulated categories: drugs (prescription and OTC), medical devices, dietary supplements, food and beverages, tobacco and nicotine products, and cosmetics. This lets a single partner handle a mixed product portfolio under one consistent compliance strategy. 

The Modernization of Cosmetics Regulation Act expanded FDA oversight of cosmetics, including facility registration, product listing, adverse event reporting, and labeling considerations. We help ensure your cosmetic labels and claims stay within the cosmetic boundary and do not inadvertently create drug status, while meeting the updated obligations. 

Under 21 CFR Part 830, most medical devices must carry a Unique Device Identifier in both plain text and machine-readable form, with corresponding submission to the Global UDI Database. We incorporate UDI requirements into your device labeling alongside indications, instructions for use, and required cautionary statements. 

Timelines depend on the number of products, the complexity of the category, and the volume of marketing materials involved. After an initial scoping conversation, we provide a clear estimate. Many claim and label reviews can be completed quickly enough to keep your launch or relabeling schedule on track. 

Reach out to schedule an initial consultation. We will discuss your product categories, your current labeling and marketing assets, and your immediate priorities, then propose a tailored engagement—whether that is drafting new labeling, auditing existing labels, reviewing health claims, or a combination of all three.