NHPD Revises Stevia Guidelines

June 17, 2009 By


The NHPD has posted new guidelines on the maximum amount of stevia that can be added to natural health products as a medicinal and non-medicinal ingredient.

The previous stevia guidelines were posted in the September, 2006 NHPD Monthly Communiqué. As a medicinal and non-medicinal ingredient, the maximum allowable daily intake of steviosides was 1 mg/kg/day, which is 70 mg/day for a 70 Kg adult. The maximum intake of stevia leaf powder was 280 mg/day for an adult.

These regulations have recently been revised, as per the Natural Health Product Ingredients Database. Stevia leaf powder is still allowed as a medicinal ingredient up to 280 mg/day. However, when used as a non-medicinal flavour enhancer/sweetening agent the quantity used should be according to conditions of Good Manufacturing Practice. That is, the amount added to a natural health product in manufacturing and processing should not exceed the amount required to accomplish the purpose for which that non-medicinal ingredient is permitted to be added, and should not exceed the safety-based maximum without cautionary labelling of 4 mg/kg bw/day expressed as steviol content. This is equivalent to 50 mg/kg bw/day of stevia leaf, based on a maximum stevioside content of 20%. Therefore, in order to include stevia as a non-medicinal ingredient without the warning “consult your health care practitioner prior to use if you have high blood pressure or diabetes” and without having to submit additional safety evidence, the maximum daily amount for a typical 70 kg adult is 280 mg/day of steviol or 3500 mg/day stevia leaf or 700 mg/day steviosides.

Stevia rebaudiana whole plant is only permitted as a medicinal ingredient. For the Stevioside/mixed steviol glycosides components, the maximum daily limit without cautionary labelling and additional safety evidence is set at 4 mg/kg bw/day expressed as steviol content. This is equivalent to 10 mg/kg bw/day for stevioside or mixed steviol glycosides. For a typical 70 Kg adult, this is 280 mg/day steviol or 700 mg/day steviosides/mixed steviol glycosides.

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