Voluntary Program for Dietary Supplements: Stimulant Laxatives

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Adopted:
Mar. 8, 2001

With the exception of those products containing senna, cascara sagrada, or aloe that are labeled in accordance with the Tentative Final Monograph for OTC laxatives, or the leaf gel of Aloe vera, Consumer Healthcare Products Association (CHPA) members agree voluntarily that any product that contains as an ingredient any of the herbs listed below shall include the following information on its label:

  1. The standard common name and plant part should be listed on all labeling and literature as follows:

Botanical Name

Common Name

Plant Part

Aloe spp.

Aloe

dried latex

Frangula alnus

frangula

bark

Frangula purshiana

cascara sagrada

bark

Rhamnus cathartica

buckthorn

fruit

Rheum officinale

Chinese rhubarb

root

Rheum palmatum

Chinese rhubarb

root

Senna spp.

senna

leaf

Senna spp.

senna

fruit or pod

 

NOTE: Senna was formerly listed in the genus Cassia, including the following species: Cassia angustifolia, C. obtusifolia, C. senna, and C. tora. Bulk raw materials labeled as a species of Cassia should be identified on finished consumer packages as "senna."

  1. A dietary supplement including a claim in an OTC monograph per the Final Rule on structure/function claims and containing a quantity of stimulant laxative to warrant such a claim, shall also include on the label all warnings pertaining to that claim as found in the applicable OTC monograph, as stipulated in FDA’s final rule on structure/function claims [Fed. Reg. 65: 1031, 2000].

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