Exporting Tea and Coffee to the United States: FDA Requirements Foreign Producers Overlook

Tea and coffee are among the most traded agricultural commodities in the world, and the United States is one of the largest import markets for both. Yet foreign tea and coffee producers frequently underestimate the FDA requirements that apply to their products — in part because tea and coffee seem like simple, traditional products that should not attract significant regulatory scrutiny. In reality, both categories face specific FDA compliance requirements that go beyond standard food facility registration, and both are subject to elevated import screening due to the frequency with which shipments are found to contain pesticide residues, mycotoxins, filth, or labeling violations.

FDA facility registration for tea and coffee processors

Foreign facilities that process, pack, or hold tea or coffee for export to the United States must register with the FDA under the Bioterrorism Act. This includes tea gardens that perform primary processing (withering, rolling, oxidation, drying), coffee processing facilities that perform roasting, grinding, or blending, and warehouses or export facilities that hold finished tea or coffee products. The registration requires a DUNS number and a designated US Agent. Farms that grow tea or coffee but do not perform any processing beyond harvesting may be exempt from registration under the farm exemption, but any processing activity — even basic drying or sorting — may bring the facility within the registration requirement depending on the specific activities performed.

Pesticide tolerances and residue limits

Pesticide residues are one of the most common reasons tea and coffee shipments are detained at US ports. The EPA establishes pesticide tolerances under 40 CFR Part 180, and the FDA enforces these tolerances at the border. For tea, specific tolerances exist for pesticides commonly used in tea cultivation — including but not limited to endosulfan, cypermethrin, acetamiprid, and imidacloprid. For coffee, tolerances are established for pesticides used in coffee production. Any pesticide residue found at levels exceeding the established tolerance renders the product adulterated under Section 402(a)(2)(B) of the FD&C Act. Green tea and herbal teas are particularly vulnerable because they may be produced in regions where pesticide application practices differ from those assumed in the tolerance calculations.

Import Alert 99-08 targets food products containing illegal pesticide residues, and tea from specific countries has been flagged under various import alerts due to repeated violations. Foreign tea and coffee producers should test their products for pesticide residues using analytical methods capable of detecting residues at levels below the applicable US tolerances, and should maintain certificates of analysis documenting test results for each lot or shipment.

Mycotoxins and contaminant concerns

Coffee is susceptible to ochratoxin A (OTA) contamination, a mycotoxin produced by certain Aspergillus and Penicillium species that can develop during drying and storage. While the FDA has not established a formal action level for OTA in coffee, the agency monitors OTA levels in imported coffee and may detain shipments with elevated levels as adulterated. The European Union has established maximum limits for OTA in roasted coffee (5 µg/kg) and instant coffee (10 µg/kg), and foreign producers exporting to both markets should test for OTA regardless of whether the US has a formal limit. For tea, heavy metals (lead, arsenic, cadmium) and PAHs (polycyclic aromatic hydrocarbons from certain drying methods) are emerging contaminant concerns that the FDA monitors through its Total Diet Study and targeted sampling programs.

Labeling requirements for tea and coffee

Tea and coffee labels must comply with all standard FDA food labeling requirements. Single-ingredient products (100% coffee, 100% tea) may qualify for exemption from the Nutrition Facts panel if they contain insignificant amounts of all required nutrients, but blended products, flavored coffees, sweetened teas, and tea or coffee beverages with added ingredients must carry a full Nutrition Facts panel. Organic claims must comply with USDA National Organic Program regulations — the product must be certified organic by a USDA-accredited certifying agent, and the certifier's name and organic certification number must appear on the label. Fair trade, direct trade, and other sustainability claims are not regulated by the FDA but must be truthful and not misleading.

Herbal teas and botanical ingredients

Herbal teas present additional regulatory complexity because they may contain botanical ingredients that the FDA classifies differently from conventional food ingredients. A herbal tea sold as a food must contain only ingredients that are GRAS or authorized food additives. If the product makes health claims or structure/function claims (such as 'supports immune health' or 'promotes relaxation'), it may be classified as a dietary supplement rather than a food, which triggers different labeling and compliance requirements under DSHEA. Some botanical ingredients commonly used in herbal teas in Asian or European markets may not have GRAS status in the United States, which would make the product an unapproved food additive if sold as a conventional food.

How FDABridge helps tea and coffee exporters

FDABridge provides FDA food facility registration, US Agent services, and labeling guidance for foreign tea and coffee producers and exporters. We ensure your facility registration accurately reflects your processing activities and product categories, and we help identify labeling and ingredient issues before your products reach the US border. Visit fdabridge.com/food to see our food services or fdabridge.com/contact to discuss your tea or coffee export compliance.