FDAストーリー #010 — タイのココナッツミルク生産者がPrior Noticeなしで12コンテナを出荷

A specialty coffee company in Medellín had a beautiful English-language website built for the US market. Great photography, compelling brand story, detailed product descriptions. On the homepage, in a trust badge section, it said: 'FDA Approved.'

The company's web designer had added it to signal credibility. The marketing team approved it. It looked professional alongside their organic certification and fair trade logos.

There was one problem: the FDA does not approve food products. The FDA does not approve food facilities. Using the phrase 'FDA Approved' in connection with a food product is a misrepresentation of the facility's regulatory status.

何が起きたか

The FDA monitors websites and online marketplaces for misleading claims. A compliance reviewer flagged the website during a routine review of coffee imports from Colombia. The FDA sent an email to the facility's US Agent — which, at the time, was a mailbox service that took three weeks to forward it.

By the time the company saw the FDA's communication, the response deadline had nearly passed. They contacted us in a panic.

解決策

We removed the 'FDA Approved' claim from the website within hours. We drafted a response to the FDA explaining that the claim was a marketing error, not an intentional misrepresentation, and that it had been corrected. We also audited the entire website and their Amazon listing for any other claims that could trigger FDA scrutiny — and found two more: 'clinically tested' (on a food product, which implies a drug claim) and 'prevents heart disease' (a health claim that food products cannot make without FDA authorization).

All three claims were removed. The response was submitted to the FDA within the deadline. No Warning Letter was issued.

教訓

The words you put on your website, your Amazon listing, and your social media are marketing materials that the FDA monitors. 'FDA Approved,' 'FDA Certified,' 'FDA Registered' (as a trust badge implying approval), and any disease prevention or treatment claims on food products are violations. FDA registration is a compliance filing — not an endorsement. If your marketing materials use any of these phrases, take them down now. If you need help auditing your claims, contact fdabridge.com/contact.