Misleading vs. Misbranding: What Every Food Business Needs to Know

When we think of food labeling, most of us picture the physical package—the box, bottle, or wrapper that consumers see on the shelf. But under U.S. law, labeling goes further. A “label” also includes websites, digital content, and any materials connected to the sale of the food.

If your product packaging lists a website—or if you sell it online—then the information on that website is considered part of your labeling. Therefore, both the words on your box and the claims on your website must be accurate, truthful, and not misleading.

Misleading: When Labels Confuse Consumers

FDA considers a label misleading if it creates a false impression, even if the statement is not entirely false. It’s about the message the consumer takes away.

Examples include:

• A fruit drink with pictures of strawberries on the package, but no real strawberries inside.
• A product labels itself as “natural” without meeting the FDA's rules for that claim.
• Suggesting health benefits without scientific evidence.

Consequences of misleading claims:

• Loss of consumer trust and brand credibility.
• Complaints from competitors or consumers.
• Warning Letters – formal FDA notifications suggesting corrective actions for violations.

Misbranding: When Labels Break the Rules

Misbranding happens when a product fails to meet the mandatory requirements of FDA regulations (21 CFR Part 101). Unlike misleading claims, which focus on consumer impressions, misbranding is about clear violations of the law.

A food is misbranded if the label fails to declare:

• The common or usual name of the food.
• Net quantity of contents.
• Ingredient statement with allergens clearly disclosed.
• Manufacturer or distributor name and address.
• Nutrition information (unless exempt).

Other misbranding issues include:

• Not declaring artificial flavors, colors, or preservatives.
• Failing to mark a food as “imitation” when required.
• Not disclosing the percentage of fruit or vegetable juice in beverages.
• Using fonts so small that the information is unreadable.

Consequences of misbranding:

• FDA may detain or refuse imports that don’t meet U.S. standards.
• Products may face enforcement actions such as recalls.
• Brands risk financial penalties and reputational damage.

The Consequences: From Warning Letters to Recalls

FDA enforcement can escalate depending on the violation:

• Warning Letters – official notifications that highlight significant regulatory problems and require voluntary compliance before stronger legal action.
• Import Actions – shipments can be detained or refused entry into the U.S. if labels are not compliant, especially if issues cannot be corrected (e.g., non-English labeling).
• Recalls – the most serious consequence. A recall involves removing or correcting a product that the FDA considers unsafe or in violation of the law. Recalls are public, costly, and damaging to brand reputation.

?? Of all enforcement tools, a recall is the worst outcome—it disrupts your business, damages consumer confidence, and can result in major financial losses due to product withdrawals, logistics costs, and lost sales.

Why This Matters for Your Business

Whether your labels are on physical packaging or online, they must:

• Be truthful.
• Be complete.
• Be conspicuous (easy to read).

Both misleading and misbranding violations can trigger FDA enforcement. And once your brand faces Warning Letters, import refusals, or recalls, the damage can be long-lasting.

How Nutrilab Helps

At Nutrilab, we specialize in helping businesses make compliant panels and navigate these complexities with specialized consultations. With expertise in FDA and LATAM regulations, we can:

• Review your packaging and online content for compliance.
• Identify risks of misleading or misbranded claims before they cause problems.

With Nutrilab, you can confidently sell your products, knowing your labels—and your online presence—meet regulatory standards.

References

• AIB Course of Nutrition Labeling
• United States Code (USC): http://uscode.house.gov/
• Electronic Code of Federal Regulations (eCFR): https://www.ecfr.gov/
• Compliance Policy Guide: FDA Compliance Policy Guidance Manual
• Food Guidance Documents: FDA Food Guidance
• Industry Guidance for Recalls: FDA Recalls Guidance
• Warning Letters: FDA Warning Letters