Black/White Pepper - Piper Nigrum

What is it used for?

Powdered Piper nigrum fruit (unextracted)

• Traditionally used in Ayurveda to improve digestion [Source note 2].

• Traditionally used in Ayurveda as a vermifuge/anthelmintic [Source note 3].

For multi-ingredient products:

• To prevent the product from being represented as a “traditional medicine”, any indicated traditional use claim must refer to the specific active ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Black pepper is traditionally used in Ayurveda to improve digestion).

• When ALL of the active ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

Piperine isolated from the fruit

No claim (safety only)

Who does this guide cover?

Adults 18 years and older

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Application form for reference-based applications.

Quantities

Ayurvedic claims

Method of preparation: Powdered*

250-420 milligrams of dried fruit, per day [Source note 4].

*Note: The method of preparation ‘powder’ is defined as a dried and ground preparation (= unextracted).

Piperine isolated from the fruit - No claim (safety only)

Not to exceed 14 milligrams of piperine, per day [Source note 5].

How is it used?

The reference does not require an additional label statement in this section. This does not establish an absence of risk.

How long is it used?

Products containing Piper nigrum fruit to improve digestion; Products containing piperine isolated from the fruit (Class II/III)

Ask a healthcare professional for use beyond 12 weeks [Source note 6].

Note: At subtherapeutic quantities, this duration of use statement is not required for products providing 25 mg or less Piper nigrum fruit per day for source review category II and III.

Vermifuge/anthelmintic

For occasional use only.

Warnings and precautions

All products

• Ask a healthcare professional before use if you are pregnant or breastfeeding.

• Ask a healthcare professional before use if you are taking medications or any other health products, as black/white pepper/piperine may alter their effectiveness [Source note 7].¹

¹Note: At subtherapeutic quantities, the risk statement regarding the alteration of effectiveness is not required for products providing 25 mg or less Piper nigrum fruit per day for source review category II and III.

Improve digestion

Ask a healthcare professional if symptoms persist or worsen.

Vermifuge/anthelmintic

Ask a healthcare professional if symptoms worsen or persist for more than 2 weeks.

When should it be avoided?

The reference does not require an additional label statement in this section. This does not establish an absence of risk.

Possible side effects

The reference does not require an additional label statement in this section. This does not establish an absence of risk.

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

Conditions for combined preparations

• Combination of Piper nigrum fruit and piperine within this reference (Class I) is not permitted as this reference only includes Ayurvedic medicine claims and the isolation of the constituent piperine is not a traditional method of preparation used in Ayurvedic medicine.

• Combination of Piper nigrum fruit and piperine outside this reference for safety only is allowed if the total amount of piperine does not exceed 14 mg per day.