Malaysian Herbal Teas and Wellness Drinks: Food or Traditional Medicine?

In Malaysia, who regulates a pack of “herbal tea” is not decided by what the packaging says, but by the ingredient ratios, whether there are dosage instructions, and whether there are therapeutic claims. At the lighter end it falls under the Ministry of Health's Food Safety and Quality Division (FSQD) as an ordinary food under the Food Regulations 1985; at the heavier end it is deemed by the National Pharmaceutical Regulatory Agency (NPRA), under the Control of Drugs and Cosmetics Regulations 1984, to be a Finished Herbal Product (FHP) that must complete registration and obtain a MAL number ending in T before it can go to market. Misclassification is the most common — and most damaging — compliance failure: selling as a food something that should have been registered amounts to selling an unregistered medicine without a licence.

Two competent authorities and the “Food–Drug Interphase”

Herbal drinks sit precisely in the grey zone between food and medicine, known in the industry as the Food–Drug Interphase (FDI). To keep decisions consistent, NPRA and FSQD set up a joint FDI committee back in 2000, specifically to review applications that are “unclear whether food or drug” and decide which authority takes the lead.

You can start by grasping four key criteria:

Ingredients other than green tea exceeding 20% require registration

The technical line herbal teas most easily cross is the 20/80 ratio principle in NPRA's Guidance on Classification: when active herbal ingredients other than the tea plant (Camellia sinensis, i.e. green/black tea) make up more than 20% of the formula, the product is regarded as a registrable finished herbal product and falls under NPRA rather than being treated as an ordinary tea drink. In other words, a product marketed as a “wellness blend” with large amounts of non-tea herbs — even if it looks like a tea bag — is very likely to fall under NPRA's jurisdiction.

In addition, as soon as an ingredient touches the FDI Negative List (currently around 61 plant and animal ingredients, subject to the latest official notice), the product is regulated by NPRA as a medicine regardless of ratio or claims.

Therapeutic claims are the fastest “switch button”

Even with simple ingredients, making any medical/health therapeutic claim on the packaging or in marketing — for example “lowers blood sugar,” “detoxifies and protects the liver,” “improves insomnia” — pulls the product into NPRA's jurisdiction and requires prior registration as a finished herbal product. To keep food status, claims must be confined to flavour and general consumption, and must not touch wording about treating, preventing or managing specific diseases or organs.

How labelling follows classification

• As a food (FSQD): label the product name, ingredients, net content, expiry date, manufacturer and importer and so on under the Food Regulations 1985, with no therapeutic claims permitted.
• As a finished herbal product (NPRA): registration must be completed first, the label must carry the MAL number (ending in T), be labelled according to the approved uses and directions, and comply with the warnings and claim restrictions for traditional medicines.

For a fuller understanding of how the T category differs from other MAL categories, read on with the category codes of the Malaysian MAL registration number and the drug/food/cosmetic classification map; to go through the NPRA registration process, see the traditional medicine registration process and this category's pillar article, an overview of Malaysian traditional medicine and MAL registration.

Common mistakes

• Selling a registrable FHP as a food: non-tea herbs exceeding 20% or touching the Negative List, yet listed only as a tea drink, amounts to selling an unregistered medicine.
• Food status but making therapeutic claims: once you claim to treat illness, you automatically fall into NPRA's jurisdiction, and the original food notification cannot save you.
• OEM/importer each judging separately: brand, contract manufacturer and importer understand the classification differently, resulting in the wrong labelling and registration. Clarify with the FDI committee before going to market.

Frequently asked questions (FAQ)

Q: Should my herbal tea go to FSQD or NPRA? First self-check three things: whether active herbs other than green tea exceed 20%, whether there is a dose/directions, and whether there are therapeutic claims. If any one holds, it leans towards an NPRA finished herbal product; only if none holds and the ingredients are simple might it remain an FSQD food. When unsure, submit through the FDI interphase mechanism for the committee to decide.

Q: Do ready-to-drink canned cooling teas also need registration? Ready-to-drink beverages that are purely thirst-quenching, with no dosage instructions and no therapeutic claims, usually fall under FSQD as food; but if the formula touches the 20/80 rule or the Negative List, or makes therapeutic claims, it may still be required to register as a finished herbal product.

Q: What about imported ready-made herbal teas? The importer must first confirm the product's correct classification in Malaysia. If it is a finished herbal product, a local licence holder must complete NPRA registration and obtain a MAL number; you cannot carry over the exporting country's food status and list it directly.

Q: Do words like “health” and “wellness” count as therapeutic claims? General wellness and flavour wording carries lower risk, but “manage,” “improve” or “treat” a specific symptom counts as a medical claim and triggers NPRA jurisdiction. When the wording is borderline, it is safer to treat it strictly as a therapeutic claim.

Pre-market self-check

• [ ] Calculated the proportion of active herbs other than green tea and confirmed whether it exceeds 20%
• [ ] Checked whether the ingredients fall on the FDI Negative List
• [ ] Checked whether the packaging and marketing contain therapeutic claims
• [ ] Determined whether it falls under FSQD (food) or NPRA (finished herbal product) and designed the label accordingly
• [ ] If a finished herbal product, a local licence holder has completed registration and obtained the MAL (T) number

In summary: compliance for herbal teas lies not in the name but in the three pivots of “ratio, dose, claims.” Settle the classification first, so that labelling and registration are not done in vain.

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This article is compiled from official sources and is for reference only; actual compliance is subject to the latest official text and review by the competent authorities.