Every spice manufacturing company and exporter that sends products to the United States must register its facility with the U.S. FDA before shipping its first consignment. This includes whole spices, ground spice blends, seasoning mixes, and condiments made of spices.If the facility is not properly registered, shipments may face delays, detention, or even denial of entry into the United States.
Since the United States is one of the major destinations for Indian spice exports, it is important for Indian spice manufacturers and exporters to understand U.S. FDA Registration for Spice Manufacturers. This guide deals with the whole process of registration and its consequences if not done.
What Is FDA Registration for Spice Manufacturers
Spice Facility Registration with the FDA is an obligatory facility registration with the U.S. FDA in compliance with the FSMA and Bioterrorism Act for those facilities that manufacture, process, pack, or hold any food items that can enter the U.S. market.
This is not a certificate or quality seal on your product; rather, it is an obligatory facility registration procedure that will allow FDA to have information about facilities producing food products destined for the U.S. market. All registered facilities will be provided with an FDA Registration Number that U.S. Customs use it during the checking of imported products at the border.
Spices covered under this requirement include:
- Whole spices such as cumin, coriander, cardamom, black pepper and other raw spices
- Grounded and powdered spices
- Spices and masalas
- Mixes for seasoning
- Dried herbs used for seasoning
Do Spice Manufacturers Need FDA Registration
Yes. Any factory based outside of the U.S. which manufactures, processes, packs, and holds spices for exportation to the U.S. has to be registered with the FDA, irrespective of whether the company is big or small.
There is no exception based on the number of employees or on the number of items shipped annually. FDA registration of factories making foods available for export into the U.S. is necessary because of the exportation process, not because of any annual income or number of exports.
A frequent misconception: many food manufacturers believe that having a FSSAI license or Spices Board of India Export Certificate takes care of FDA registration. It does not. Compliance within India and compliance for the U.S. import are two different regulatory processes.
Can I Export Spices to the USA Without FDA Registration
Number. Exporting spices into the United States without registering with the FDA is risky because CBP compares the import entries with those on FDA’s list of registered facilities at the port of entry.
Without registration, exporters can face:
- The goods are detained in the port of entry before clearance
- The entry of the products into the country is rejected
- Intense examination of future consignments from a given processing facility
- Consequences to the U.S. importer as well as under the FSVP program
U.S. FDA Registration for Spice Manufacturers in India – Step-by-Step Process
Registration follows a fairly linear path once a facility has its documentation in order. Here’s how it typically plays out for Indian spice exporters.
- Facility eligibility confirmation – ensure that the facility engages in the manufacturing, processing, packaging or holding of food meant for the consumption in the United States.
- Designating a U.S. Agent – a U.S.-based point of contact is essential before the registration process.
- Registration on the FDA’s FURLS/FFRS website – input the relevant information about the facility, ownership and the products to be produced.
- FDA Registration Number – make sure the number is on the shipping documentation.
- Biennial registration renewal – the registration is due for renewal every second year from October 1 to December 31.
Indian Compliance vs U.S. FDA Registration – What’s Different
Spice exporters in India often juggle multiple compliance frameworks, and it helps to see where each one applies.
U.S. Agent Requirement for Foreign Spice Facilities
Each foreign establishment that registers with the FDA must appoint a U.S. Agent — an individual or firm located in the U.S., which serves as the FDA’s contact for the particular facility.
U.S. Agent is not just some legal formality; this person is expected to facilitate the FDA-foreign facility correspondence, receive official communications from the FDA, and be available to FDA staff when the facility is being inspected or the product is placed under hold. The U.S. Agent must have a real physical location in the U.S. and a foreign consulate cannot be a U.S. Agent.
FSVP Compliance for Spice Exporters
FSVP (Foreign Supplier Verification Program) is a separate FSMA regulation, which makes the U.S. importer responsible for the verification of food safety measures rather than the foreign producer of spices; however, this regulation is important for the exporter of spices to know because it determines whether the U.S. purchaser will continue to import the product from him/her.
According to FSVP, the U.S. importer of record has to ensure that the foreign supplier applies food safety controls and for this reason, he/she may ask for documents that confirm the results of the hazard analysis, the audit report, and preventive controls according to 21 CFR Part 117. Exporters of Indian spices should expect to be requested to provide such documentation by the buyers as part of their FSVP compliance.
Good practice: keep hazard analysis documentation on the risk factors related to spices, e.g., the risk of Salmonella in low moisture foods, heavy metals, pesticides residues, and irradiation documentation if necessary.
U.S. FDA Registration for Spice Manufacturers: Registration vs Approval
FDA registration is a facility registration process whereas FDA approval is a pre-market approval process, which specifically refers to regulated products such as drugs and some food additives. Spices do not need FDA approval but only FDA registration.
This is relevant to how labels are made. If a company claims that its products are “FDA Approved” while only registering the facilities, then this is false, and can cause trouble. The packaging of these products should use the term “registration.”
Common Mistakes Spice Exporters Make
- With the assumption that having an FSSAI license/Spices Board certification fulfills U.S. regulatory requirements
- Once registering but forgetting about the biennial renewal period
- Appointing a non-contactable and unresponsive U.S. Agent for inspections
- Failing to keep FSVP documentation that U.S. purchasers are expected to ask for
- Labeling the product as “FDA Approved” when only the manufacturing site is FDA registered
Best Practices for Spice Exporters
Registration is simple if the prerequisites have been put in place, but timing is crucial. The facilities should apply for registration well before their first U.S. shipment – preferably two to three months before that date – to give time for the appointment of a U.S. Agent and completing FURLS/FFRS application.
It may also be beneficial to consider the U.S. FDA registration as part of your overall strategy and not just one isolated action. Many companies registering via US FDA registration for one product group end up diversifying to other product groups, and the next registration is much simpler due to previous experience.
Key Takeaways
- Spice Manufacturer’s FDA Registration is a mandatory requirement for all foreign companies that export their spices to America, irrespective of their size.
- The requirement entails having a U.S. agent who has a physical office in America and a phone number.
- The FSSAI license and registration from the Spices Board are two different things altogether; thus, it does not satisfy FDA Registration.
- FDA Registration needs to be renewed every two years during October 1 to December 31 of even-numbered years.
- FDA Registration is not FDA Approval – only FDA Registration is needed.
Conclusion
FDA Registration for Spice Manufacturers in the U.S. is a compulsory requirement at the facility level and cannot be considered an additional activity for any Indian exporter of spices to the U.S. It will save exporters from the problems of port clearance and hold-ups when the export order is delayed due to failure in getting the U.S. Agent designation, FURLS/FFRS registration and FSVP documentation completed prior to the dispatch of goods. Manufacturers who work with Legal4sure for their FDA compliance in the U.S. usually incorporate this into their export schedule beforehand. You can also read our article on U.S. FDA Registration for Bakery Products for more such information.
Frequently Asked Questions
Do spice manufacturers need FDA registration?
Yes – all facilities that manufacture, process, pack, or hold spices for export to the U.S. should be registered with the FDA irrespective of the size of the business.
Can I export spices to the USA without FDA registration?
No – non-registered businesses may face shipment delays, rejection by the point of entry, and compliance challenges for their customers in the USA.
What is the U.S. FDA Registration for spice manufacturers in India?
This is the process through which FDA facilities listing is mandatory for Indian spice producers who intend to export to the USA.
What are the FDA requirements for spice exporters to the USA?
FDA facility registration, U.S. Agent, renewal every two years, and documentation supporting FSVP of U.S. importers.
How long does FDA registration take to complete?
The FDA registration process via FURLS/FFRS takes place in a few business days, provided that the paperwork and the information about the U.S. Agents are available.
Does FDA registration expire?
Yes, FDA registration expires every even year, from October 1 to December 31.
Is FDA registration the same as FDA approval?
No, FDA registration differs from FDA approval, which is a pre-market approval process not applicable to spices.