Voluntary Program for Pyrrolizidine Alkaloids

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Mar. 8, 2001

Consumer Healthcare Products Association (CHPA) members agree voluntarily to the following provisions pertaining to pyrrolizidine alkaloids. All products with botanical ingredients which contain toxic pyrrolizidine alkaloids * should not be taken orally and should therefore bear the following cautionary statement on the label:

"For external use only. Do not apply to broken or abraded skin. Do not use while nursing."

Including but not limited to: Alkanna tinctoria (alkanet), Anchusa officinalis (bugloss), Borago officinalis* (borage), Crotalaria spp., Cynoglossum spp., Erechtites hieraciifolia, Eupatorium cannabinum (hemp agrimony), Eupatorium purpureum (Joe Pye), Heliotropium spp., Lithospermum officinale (European gromwell), Packera candidissima, Petasites spp. (e.g., Butterbur), Pulmonaria spp. (e.g., lungwort), Senecio jacobaea (European ragwort), Senecio vulgaris (groundsel herb), Symphytum spp. (comfrey), and Tussilago farfara (coltsfoot).

*Borage seed oil is specifically exempt from the above label recommendation.

In view of the fact that by statutory definition botanicals that are not orally ingested are not dietary supplements, pyrrolizidine alkaloids encompassed by this voluntary program are not dietary supplements.