Labeling Compliance Services | Labeling Compliance

Comprehensive Labeling Compliance Services

Drugs | Medical Devices | Dietary Supplements | Food | Tobacco | Cosmetics

Your label is your first FDA inspection

Labeling problems are among the most common reasons for FDA Warning Letters, and many start with a website or social media post. To FDA, “labeling” includes the package, inserts, websites, product listings and ads that accompany the product. JJCC Group reviews all of it against the rule that applies to your product.

One Partner for Every Regulated Product Category

Each FDA-regulated category operates under its own framework, and a strategy that satisfies one set of rules can create violations in another. JJCC Group brings specialized expertise across all six major categories, so you do not have to assemble a patchwork of advisors who each understand only a slice of your portfolio.

Dietary supplements

21 CFR Part 101, including section 101.36 (Supplement Facts) and section 101.93 (structure/function claims)

Food

21 CFR Part 101: Nutrition Facts, ingredients, allergens, nutrient content and health claims

OTC drugs

21 CFR Part 201, including section 201.66 (Drug Facts)

Medical devices

21 CFR Part 801; UDI under Part 830

Cosmetics

21 CFR Parts 701 and 740; MoCRA contact and professional-use labeling

Tobacco

21 CFR Part 1143 warnings; Part 1140 advertising and sales rules

What JJCC Group Does for You

Our labeling services span the full lifecycle of a product label—from a blank page to a finished, market-ready package, and through every revision afterward.

Create new labels

for new products, from statement of identity to fact panels.

Review and fix existing labels

with a prioritized findings report.

Review websites, Amazon listings, social media and ads

for claims.

Claims strategy

substantiation files.

Structure/function notifications

to FDA for supplements.

Ongoing monitoring

as rules change.

The Trap: When a Supplement Becomes a “Drug”

Here is the reality most dietary supplement companies underestimate: the majority of supplements on the market fall short on health-claim compliance. The mechanism is deceptively simple. The moment a manufacturer describes a benefit as treating high blood pressure, curing anxiety, preventing cancer, reversing diabetes, or healing infection, the FDA stops viewing the product as a dietary supplement and reclassifies it as an unapproved new drug. An unapproved drug cannot legally be marketed, which means the product is now misbranded and adulterated under federal law—regardless of how safe or effective it actually is.

The FDA enforces this line aggressively. Every week, the agency issues Warning Letters citing the same recurring problem: a supplement manufacturer incorrectly described the health benefits of its product and, in doing so, made disease claims that pushed the product into drug territory. These letters are public, they damage brand reputation, they often demand corrective action within fifteen working days, and they can escalate to seizures, injunctions, and import alerts. The pattern is so consistent that it is entirely avoidable—if the claims are reviewed correctly before they are ever published.

JJCC Group ensures that you do not fall into this trap. We know exactly which words and phrases the FDA treats as disease claims, how to reframe legitimate benefits as compliant structure/function statements, and how to document the substantiation that supports them. We catch the problem at the draft stage—before it becomes a printed label, a live web page, or the subject of a Warning Letter.

How We Help You Meet and Satisfy FDA Requirements

Compliance is not a single document—it is a defensible, well-documented system. JJCC Group delivers a structured engagement designed to satisfy regulators and withstand inspection:

Comprehensive labeling gap assessment against the exact regulations governing your product category.
Drafting of new, fully compliant labels, panels, inserts, and packaging copy.
Line-by-line claim review for foods, supplements, cosmetics, and OTC products, with disease-claim risk flagged and rewritten.
Website, e-commerce, and marketing material audits to align promotional content with compliant labeling.
Substantiation review to confirm every retained claim is supported by adequate evidence.
Clear, prioritized remediation reports your team can act on immediately.
Ongoing monitoring and revision support as regulations and your product line change.

The cost of getting labeling wrong—recalls, destroyed inventory, blocked shipments, legal exposure, and lost consumer trust—vastly exceeds the cost of getting it right the first time. JJCC Group gives you the confidence that your labels, your packaging, and your public-facing claims will meet and satisfy FDA requirements, so you can focus on growing your business instead of defending it.