FDA Requirements for Nutmeg: Aflatoxin, FSVP and Prior Notice

09.11.2026 Spice Guides

All the nutmeg used by US food manufacturers comes from abroad, and Indonesia grows more of it than any other country. This guide summarizes the main FDA requirements that apply when nutmeg enters the United States, and the questions to ask your supplier so that shipments clear smoothly and your product stays safe.

Aflatoxin: the FDA action level

Aflatoxins are toxic compounds produced by certain molds that can grow on crops in warm, humid conditions. Because nutmeg is grown and dried in the tropics, aflatoxin is one of the key safety parameters for this spice.

The FDA may consider human food with total aflatoxins (B1, B2, G1 and G2) above 20 ppb to be adulterated, as set out in Compliance Policy Guide Sec. 555.400. Keep in mind that an action level is not a permitted level of contamination, and that a lot above the action level may not be blended with other product to bring it below the limit. Many buyers therefore specify their own, tighter limits; as a nutmeg importer in the USA, we offer most grades below 20 ppb or below 10 ppb.

FSVP: verifying your foreign supplier

Under the Food Safety Modernization Act, US importers of food must have a Foreign Supplier Verification Program (FSVP). In short, the importer must:

identify the known or reasonably foreseeable hazards for each food, such as aflatoxins and pathogens in spices;
evaluate the risk posed by the food and the performance of the foreign supplier;
carry out verification activities, such as reviewing the supplier's food safety records, audits or test results;
keep an FSVP for each food from each foreign supplier and re-evaluate it at least every three years, or sooner when new information comes to light.

Food facility registration and prior notice

Facility registration: foreign facilities that manufacture, process, pack or hold food for consumption in the US must be registered with the FDA, and the registration must be renewed every two years.
Prior notice: the FDA must receive prior notice before imported food arrives in the US.

Microbiological safety and sterilization

Spices can carry pathogens such as Salmonella, so many US buyers require a validated microbial reduction step, especially for spices used in ready-to-eat foods. The common options are steam sterilization and ethylene oxide (ETO). In January 2025, the US Environmental Protection Agency issued an interim decision that restricts which dried herbs and spices may be treated with ethylene oxide, so check the current status for your product before specifying ETO. Steam sterilization leaves no chemical residues.

Questions to ask your nutmeg supplier

What is the maximum total aflatoxin level, and do you provide analysis results for each lot?
How is the nutmeg sorted, for example by hand and by UV selection?
Which sterilization method do you use, and is it validated? For which log reduction?
Which food safety certification does the processing plant hold, such as FSSC 22000?
Is the facility registered with the FDA, and which documents can you provide for my FSVP?