FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business

The market for FDA registration services targeting foreign manufacturers is plagued by scams, misleading practices, and outright fraud. Foreign manufacturers — particularly those in developing countries who are navigating US regulatory requirements for the first time — are frequent targets of companies that charge exorbitant fees for services that cost a fraction of what they charge, that promise 'FDA approval' for products that the FDA does not approve, that issue fake 'FDA certificates' that have no legal value, or that simply take payment and disappear. The damage from these scams goes beyond financial loss — manufacturers who believe they are registered when they are not face shipment detentions, import refusals, and lost business when they discover the truth.

Common types of FDA registration scams

The most prevalent scam is the fake FDA certificate. Fraudulent providers issue official-looking documents with FDA logos, registration numbers, and stamps that purport to certify that a facility or product is 'FDA approved' or 'FDA registered.' These certificates are worthless — the FDA does not issue registration certificates, does not approve food or cosmetic facilities, and does not authorize third parties to issue certificates on its behalf. A legitimate FDA food facility registration produces a registration number viewable in FDA's system, not a physical certificate. Another common scam involves inflated government fees — providers who claim that FDA registration requires payment of a government fee (food facility registration is free) and who charge hundreds or thousands of dollars for the fictitious fee.

Other fraudulent practices include providers who complete the registration but enter incorrect information (wrong facility name, wrong address, wrong product categories), rendering the registration useless when the FDA actually needs to communicate with the facility or when the registration is checked against shipment data. Some providers register the manufacturer under the provider's own name rather than the manufacturer's legal name, which means the manufacturer does not actually hold its own registration and loses access if the relationship with the provider ends. And some providers charge for services they never perform — they collect fees for DUNS number acquisition, US Agent services, or renewal tracking but never follow through.

How to verify a legitimate FDA registration

The FDA provides public tools that manufacturers can use to verify their registration status. For food facilities, the FDA's online system allows registered facilities to log in and view their registration details. For drug establishments, the Drug Establishment Current Registration Site (DECRS) is a public database where anyone can search for registered drug establishments. For device establishments, a similar public listing is maintained. If a provider claims to have completed your registration, you should verify the registration by checking the appropriate FDA database or by contacting the FDA directly. A legitimate provider will give you the login credentials to your own FDA account and will demonstrate the registration in the FDA's own system — not just provide a PDF certificate.

Red flags that indicate a fraudulent provider

Several warning signs should alert manufacturers to potentially fraudulent FDA registration providers. Any provider that claims to offer 'FDA approval' for food, cosmetics, or OTC drug products (the FDA does not approve these product categories — it registers facilities and lists products). Any provider that charges a 'government fee' for food facility registration (there is no government fee). Any provider that issues a physical certificate or stamp and calls it an 'FDA certificate' (the FDA does not issue such certificates). Any provider that will not give you access to your own FDA account. Any provider that charges dramatically above market rates without explaining what additional services justify the premium. Any provider that completes the registration in days and claims no information is needed from the manufacturer (a legitimate registration requires accurate facility information, product categories, and DUNS data).

What legitimate FDA registration service looks like

A legitimate FDA registration service provider asks detailed questions about your facility, products, and existing regulatory status before quoting a price. They explain exactly what filings are needed and which are not. They provide transparent pricing without hidden fees. They complete the registration in the FDA's own systems and provide you with access to verify the filing. They serve as your US Agent (if applicable) and are actually available during US business hours to receive FDA communications. They track renewal deadlines and notify you before the renewal window opens. And they tell you honestly when a specific filing is not needed for your situation — rather than upselling unnecessary services.

How FDABridge protects its clients from these risks

FDABridge operates with full transparency — we complete registrations in FDA's own systems, provide clients with verification of their filings, charge published prices with no hidden fees, and serve as a genuine US Agent that responds to FDA communications during US business hours. We never issue fake certificates, never claim that the FDA 'approves' facilities or products, and never charge government fees that do not exist. Visit fdabridge.com to see our services and pricing or fdabridge.com/contact to speak with our team.