FDA Regulations for Coffee & Tea in the US

Every foreign facility that manufactures, processes, packs, or holds food for consumption in the US must register with the FDA under Section 415 of the FD&C Act (as updated by FSMA). For coffee and tea brands, this includes roasting facilities, blending operations, and packaging facilities — even if the coffee or tea is grown and initially processed overseas.

Registration is free via FDA's Unified Registration and Listing System (FURLS). Facilities must re-register biennially (October 1 – December 31 of even-numbered years). Failure to register — or failure to maintain active registration — gives FDA grounds to deny admission of your products into the US.

The FDA's Food Safety Modernization Act (FSMA) requires that US importers of food products (including coffee and tea) implement a Foreign Supplier Verification Program (FSVP). This means your US importer — whether a distributor, broker, or your own US entity — must verify that your foreign facility is producing products in a manner that meets US food safety standards.

FSVP requires: hazard analysis for your product, supplier verification activities (records review, on-site auditing, or product testing), and documentation. If you're self-importing (setting up a US entity), you take on FSVP obligations directly. Many brands avoid this complexity by working with an experienced US food importer who already has FSVP processes in place.

Coffee and tea products sold in the US must bear a Nutrition Facts panel (if packaged and sold for retail) meeting FDA's 21 CFR Part 101 requirements. For plain black coffee or pure tea with no additives, many brands qualify for the 'two-ingredient exemption' — but flavored coffees, tea blends, and ready-to-drink products require full Nutrition Facts disclosure.

Ingredient lists must disclose all added ingredients in descending order of predominance. Flavors added to coffee or tea must be disclosed as 'natural flavor' or 'artificial flavor.' 'Natural flavor' claims require substantiation — flavors must be derived from natural sources. Organic claims require USDA National Organic Program (NOP) certification.

The USDA 'Certified Organic' seal is a significant commercial asset in the US premium coffee and tea market — particularly in Whole Foods, specialty grocery, and direct-to-consumer channels. To use the USDA Organic seal, your product must be certified by a USDA-accredited certifying agent.

For imported coffee and tea, both the farm/origin and any processing facility must be certified. If the origin country has an NOP equivalency agreement with the USDA (EU, Canada, Japan, UK, South Korea have agreements), certification from an accredited certifier in that country is accepted. Without an equivalency agreement, you need a USDA-accredited certifier operating in your country of production.

All food shipments imported into the US require prior notice to the FDA before or upon arrival. Prior notice must be submitted electronically via FDA's Prior Notice System Interface (PNSI) or through US Customs' Automated Broker Interface (ABI). Prior notice must include: FDA food facility registration number, article description, anticipated arrival date and port of entry, shipper information, and country of origin.

Your US customs broker typically handles prior notice filings as part of standard import documentation. Shipments without prior notice will be refused at the US border.

While not legally required, Fair Trade (Fair Trade USA or Fairtrade International), Rainforest Alliance, and Direct Trade certifications carry significant commercial weight in the US premium coffee and tea market. Whole Foods, Starbucks' supplier relationships, and specialty independent coffee retailers all weight these certifications in buyer decisions.

Fair Trade USA is the most US-market-relevant certification — it has its own standards separate from Fairtrade International and is the label most recognized by US consumers. Budget 6–12 months for certification and approximately $1,500–$5,000 in annual license fees depending on volume.