The FDA's three questions, and why one of them is the buying method

Why this case matters

The FDA lists three questions for spotting a counterfeit drug. Two are about the medicine. The third is not:

Did you buy the drug from an online pharmacy?

That is an unusual thing for a regulator to put in a list of signs. It is not evidence about the tablet in your hand — it is a statement that the purchase channel is itself the risk factor, and it belongs in the same diagnostic list as a strange side effect.

The closed system

The FDA’s framing explains why. The United States operates a “closed” drug distribution system, created by federal and state law: manufacturers, wholesalers, and licensed pharmacies, with the chain of custody documented at each step.

A drug inside that system has a traceable history. A drug outside it has none, and no amount of inspecting the packaging substitutes for the history.

That is why the advice reduces to buy only from state-licensed pharmacies rather than to a checklist of things to look for. The DEA’s parallel red flags — no prescription required, prices far below market, prices in a foreign currency, no state licence or DEA registration shown, packaging in a foreign language, no expiry date — are useful, and they are all downstream of the same question.

What a counterfeit actually contains

The FDA’s list is worth quoting in full, because people tend to assume counterfeit means weaker:

the wrong ingredients, too much, too little or no active ingredient at all, or other harmful ingredients

All four are dangerous, and they fail differently. No active ingredient means an untreated condition. Too much means an overdose of the right drug. Other harmful ingredients is the one that is killing people, and the FDA records an increase in overdose deaths related to fentanyl-laced counterfeit drugs.

It is not only controlled substances

The counterfeit products the FDA has warned about in the US supply chain are more varied than the opioid story suggests: Ozempic (semaglutide), warned about in December 2023 and updated twice since; alli (orlistat), found at US online retailers in June 2025; Botox, found in multiple states in April 2024.

Weight-loss drugs in particular have created a new and large market of people who want a specific, expensive, hard-to-obtain medicine — which is the exact demand profile these operations exist to serve.

Where to check, and where to report

BeSafeRx provides a lookup for state-licensed online pharmacies, and state boards of pharmacy will verify a licence directly.

For reporting: MedWatch for an unexpected experience or side effect, and the FDA’s unlawful-sales route for a website you believe is selling medicine illegally.