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The short answer
What decides how a Nigerian herbal product is regulated abroad is mainly what you claim it does. In the UK, a herbal product sold to treat a condition is a medicine that needs a Traditional Herbal Registration, granted only for minor conditions; in the US, a supplement that claims to treat or cure a disease is regulated as a drug. Sell it as food or a supplement with no disease claims, or register it as a medicine.
The question that decides everything: what do you claim?
Agbo, bitters, herbal teas, roots and powders are sold in Nigeria with claims about typhoid, malaria, fertility, blood pressure or "cleansing". Abroad, a claim like that usually turns the product into a medicine. The same jar can be a food, a supplement, a cosmetic or a medicine depending on its label, website and social media posts.
Regulators look at the whole presentation, not only the label. A product listed as a tea but promoted in a video as a cure for diabetes will be judged on the video.
United Kingdom: the THR route
MHRA guidance on GOV.UK says you need a Traditional Herbal Registration (THR) before marketing a traditional herbal medicinal product in the UK. Its main conditions:
- THRs are only for minor health conditions where medical supervision is not required, such as a cold. Products for serious conditions need a full marketing authorisation.
- You must show at least 30 years of traditional use. For UK-wide sale, 15 of those years must relate to the EU/EEA; for Great Britain only, the MHRA may accept evidence from a wider range of countries.
- The indication must be on the MHRA permitted indications list.
- You need a quality dossier, an expert safety report, a draft summary of product characteristics, a label and leaflet carrying the THR certification mark.
- The MHRA usually takes 210 days to evaluate a valid application; fees are on its fees page.
The guidance notes that some herbal products may instead be food supplements or cosmetics, and that some herbal ingredients are banned or restricted. Herbal practitioners can supply remedies they make on their own premises after a one-to-one consultation without a licence, but that exemption does not cover shop or online sales.
United States: supplement claims
Under 21 CFR 101.93, a dietary supplement can carry a structure or function statement, such as "supports digestion", if the firm notifies the FDA within 30 days of first marketing and prints the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." A disease claim, stated or implied by the name, pictures or citations, makes the product a drug.
If FDA detains a shipment and the importer cannot bring it into compliance, it is refused: FDA's import refusals page says it must then be exported or destroyed within 90 days, and FDA cannot extend that.
Canada and elsewhere
Health Canada regulates herbal remedies as natural health products. Manufacturers, packagers, labellers and importers need product and site licences and must meet good manufacturing practice. Other countries have their own regimes; check the medicines regulator where you will sell before you order stock.
Claims you should not make
| Claim type | Example | Likely status abroad |
|---|---|---|
| Disease treatment | "Cures typhoid", "for hypertension" | Medicine or drug |
| Serious condition, even softly | "Helps manage diabetes" | Medicine; outside THR scope in the UK |
| Minor condition | "Relief of cold symptoms" | Traditional herbal medicine in the UK, needs THR |
| General function | "Supports digestion" | Supplement in the US, with notice and disclaimer |
| No health claim | "Traditional Nigerian herbal tea" | Usually food rules apply |
The Nigerian export side
NAFDAC's export guideline lists the certificates it issues: a Certificate of Pharmaceutical Product for drugs, a combined Certificate of Manufacture and Free Sale for registered food, cosmetics and other products, and a Health Certificate for processed food. The exporter applies to the Ports Inspection Directorate with its NAFDAC registration, NXP, NEPC registration, samples and certificate of analysis, and NAFDAC tests and inspects. A product with no NAFDAC registration in Nigeria will struggle to get any of these. See NAFDAC export permits.
You carry the risk as the importer
When a regulator abroad finds a problem, it deals with the business that placed the product on its market, which is usually you, not the Nigerian maker. Keep a file for each product: the supplier's details, batch numbers, certificates of analysis, labels as sold, every claim you have published and where each batch went. If a batch has to be withdrawn, that file is what lets you act quickly and show you took care.
Herbal soaps, oils and creams that make no medical claims may fall under cosmetics rules instead. Those have their own duties, see selling Nigerian beauty brands online abroad.
What to check first
- Write down every claim the supplier and you make, including online.
- Decide the category in your market: food, supplement, cosmetic or medicine.
- Ask the supplier for its NAFDAC registration and a recent certificate of analysis.
- Check the ingredients against your regulator's banned or restricted herbs.
- Prepare labels in the local language with ingredients, see labelling Nigerian food for sale abroad.
- Order a small first batch, and test the route with samples first.
Where Pryme fits
Pryme Business Accounts come with a Compliance agent that can prepare a checklist of claims and documents for each product for you to review. It prepares; you decide. Supplier payments go out from the business account with the rate and fee shown before you approve.
Questions people ask
Can I sell agbo or bitters in the UK?
Only within the rules. If it is presented as treating a condition, it is a herbal medicine needing a THR, which is limited to minor conditions. Without health claims, food rules may apply instead.
What claims can I make for a Nigerian herbal supplement in the US?
Structure or function claims with an FDA notice and the mandatory disclaimer. Claims to treat, cure or prevent a disease make it a drug.
How long does an MHRA traditional herbal registration take?
The MHRA says it usually takes 210 days to evaluate a valid application. Fees are listed on its fees page.
Does the Nigerian supplier need NAFDAC approval to export herbal products?
NAFDAC issues export certificates for registered products after document checks, inspection and testing. An unregistered product will struggle to get them.
Sources
- GOV.UK (MHRA): Apply for a traditional herbal registration (THR) · accessed Oct 2026
- eCFR: 21 CFR 101.93, statements for dietary supplements · accessed Oct 2026
- FDA: Import refusals · accessed Oct 2026
- Health Canada: Natural and non-prescription health products regulation · accessed Oct 2026
- NAFDAC: Guideline for export of regulated products (2018) · accessed Oct 2026
This article is general information, not financial, legal or tax advice. Products described are provided under the terms on this site and are subject to regulation and eligibility.