The EU and the US treat botanical ingredients through different systems. The EU asks whether the ingredient is a novel food. The US asks whether it is lawful as a dietary ingredient or a food, and whether the claims on the label are allowed. This article is about raw-ingredient sourcing, not about finished products or health claims, and it is not legal advice.
EU novel food: where does ashwagandha sit?
A food or ingredient is a novel food in the EU if it was not consumed to a significant degree in the Union before 15 May 1997. A novel food needs authorisation before sale. Whether a particular plant part or extract counts is checked against the Commission's novel food catalogue, and national authorities may differ in practice. Ashwagandha has been the subject of national positions and debate in the EU, so do not assume it is cleared. Read the EU novel food rules for Indian botanicals and confirm the current status for your exact form with the authority in the country where you will sell.
A practical point: write the intended use into your purchase order and your specification. A supplier who knows the lot is for supplements will treat identity, contaminants and traceability more carefully than one who thinks it is a general herb. It also helps you later if a regulator or a customer asks what you bought and why.
US dietary supplement rules for botanicals
In the US, botanical ingredients sold for supplements fall under the dietary supplement framework, administered by the Food and Drug Administration. The company that puts the product on the market is responsible for safety, for labelling and for the claims it makes. Ingredients first sold after 1994 may need a notification, and the supplement manufacturer must follow the manufacturing practice rules for supplements. See the rules for selling botanicals as supplements in the US. As raw-ingredient buyer, you supply identity and quality evidence for the ingredient.
How psyllium sits in each regime
Psyllium husk has a long history of use as a food fibre in both markets, so it is generally not treated as a novel food in the EU. In the US, it is sold both as a food ingredient and in supplements. What is allowed on the label, such as a fibre claim, depends on the regime and the wording, so a regulatory adviser should check it. The import side is covered in how to import psyllium husk.
What a raw-ingredient buyer should ask the supplier
Whatever the regime, a buyer needs the following from the Indian supplier:
- Botanical name, plant part and form, written in the specification.
- Identity testing to show the plant part is correct and not mixed with leaf or another plant.
- Heavy metal, pesticide and microbial results from an accredited lab. Heavy metals in herbs explains the testing.
- Food safety certification and traceability records.
- A statement of the processing aids and solvents used, if any.
Next step
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