Comments
Voluntary Program for Dietary Supplements: Stimulant Laxatives
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:
- 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."
- 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].