NEWS & BLOGS

FDA Labeling Errors: The Top Cause of U.S. Import Delays & Launch Failures

Provision Consulting Group
Aug 4
2 min read

Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a "labeling error."

Many companies focus on the quality, ingredients, and efficacy of their products, but often overlook the critical step of creating a label that complies with U.S. FDA regulations. However, when the FDA inspects imported products, it looks at the label first, not the product itself.

All consumer products—whether they are dietary supplements, medical devices, foods, or cosmetics—must have an FDA-compliant label to be legally distributed in the United States. This isn't just about following rules; it directly impacts import clearance and sales approval. For this reason, a label is not just a piece of packaging design—it is considered a legal document.

This has become even more critical since the Modernization of Cosmetics Regulation Act (MoCRA) was enacted in late 2023. Under MoCRA, cosmetic labeling requirements have been strengthened, and the FDA’s market surveillance has become more precise.

Why Is Labeling So Crucial?

A label is far more than just "packaging design." The FDA uses the information on your product's label (ingredient names, efficacy claims, intended use, warnings, manufacturer information, etc.) as its primary standard for judging suitability. If this information is not compliant, your product could face the following consequences:

Import detention or refusal by U.S. Customs
Sales suspension on e-commerce platforms like Amazon and eBay
An FDA Warning Letter or a product recall
Damage to your brand image and consumer trust

Furthermore, with online platforms like Amazon now enforcing stricter labeling compliance, it is more important than ever for e-commerce businesses to conduct a thorough label review.

Common FDA Labeling Mistakes

Here are some of the most frequent errors we see:

Using unauthorized health claims (e.g., "prevents diabetes," "treats immune deficiencies").
Errors in the 'Supplements Facts' or 'Drug Facts' panel.
Omission of U.S. English terminology and formatting (e.g., incorrect units, ingredient names).
Product category mismatch (e.g., a food product labeled in a way that makes it appear to be a drug).
Missing manufacturer information and U.S. Agent details.

These errors may seem like simple typos or wording mistakes, but from the FDA’s perspective, they can be considered "intentional false advertising." The first step to successful U.S. export is an FDA label review. Start yours today.