Most US label problems are found by the wrong person at the worst time: an FDA or CBP officer, after the goods have crossed the ocean. FDA does not approve labels in advance, so the label you print is the label that gets judged at the border.

Below are four real cases from GOL's label review work. Two clients followed the review and launched cleanly. Two did not, and paid for it. Client names are withheld. Each case maps to one of the three rulebooks every US label has to pass: FDA, FTC and California Proposition 65.

The three rulebooks, side by side

Case 1: "Made in USA" on a product made overseas

What happened. The product was manufactured outside the US, but the packaging carried a "Made in USA" symbol. Our review flagged it and recommended a revision. The client decided to ship with the existing label.

Result. The goods were held at the US port and the client was required to revise the label before the products could be distributed.

The rule. Under the FTC Made in USA Labeling Rule, an unqualified "Made in USA" claim means all or virtually all of the product is made in the US. Separately, CBP requires imported goods to be marked with their actual country of origin. A foreign-made product with a US origin mark fails both.

Case 2: A supplement label the client checked themselves

What happened. GOL handled this client's FDA registration and recommended a label review before shipping. The client declined, saying they had already checked the label themselves.

Result. The shipment was refused at the US port and had to be destroyed.

What was wrong. Two things a self-check missed:

• The Supplement Facts panel did not follow FDA's format. FDA sets the font, type sizes, layout and design of the panel, and the label did not match them.
• The declared amounts did not match the product. When FDA tests a supplement, naturally occurring ingredients must contain at least 80% of the amount on the label, and added ingredients must contain at least 100%. The values on this label were not supported by what was actually in the product.

Case 3: A Prop 65 chemical caught before launch

What happened. The client asked for a Proposition 65 review. We found an ingredient on California's list of chemicals known to cause cancer.

Result. With time still on the clock, the client reformulated the product and redesigned the label before it entered the market.

The rule. Businesses with 10 or more employees must give a clear and reasonable warning before exposing California consumers to a listed chemical. The list has more than 900 chemicals. Penalties can reach $2,500 per violation per day, and most cases are brought by private enforcers, often against the retailer or marketplace as well as the brand.

Case 4: Untruthful claims caught in 48 hours

What happened. A cosmetics brand from India needed a review under all three rulebooks, fast. The FTC part of the review found two problems: the pack promised "100% satisfaction", and it said 96% of users saw improved results, based on a clinical test the brand ran itself on a very small sample.

Result. The "100% satisfaction" claim was removed, and the 96% figure got an asterisk explaining how it was calculated and where it came from. Both were fixed before sales started, and three full review rounds were completed in 48 hours. Read the full case study.

The rule. The FTC requires that claims are truthful, not misleading, and backed by evidence when they are made. Health and performance claims need competent and reliable scientific evidence.

What the four cases have in common

• Every problem was on the label before it shipped. A review before printing would have caught all four.
• Cost grows with every step you skip. A fix at artwork stage costs a revision. At the port it costs storage, relabeling or the whole shipment.
• A self-check is not a review. In Cases 1 and 2 the client chose not to act on, or not to get, a review, and those were the two shipments that ran into trouble at the port.

Before you print: a quick checklist

1. FDA: identity, net quantity, ingredients, Facts panel format, allergens, warnings, and manufacturer or distributor details.
2. FTC: every claim, badge and origin mark can be supported.
3. Prop 65: formula and packaging checked against the list if any unit could reach California.
4. The artwork you send to print is the same version that was reviewed.

Shipping cosmetics through Amazon? See what you need to sell cosmetics on Amazon US. Already stuck at the port? Read how to clear an urgent FDA shipment and our FSVP detention case study.

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