Regulatory Status. Regulated in the United
States as a dietary supplement. Capsicum (red
pepper, cayenne pepper) and paprika are
GRAS as natural seasonings and flavorings
(§182.10). Their essential oils, solvent-free
oleoresins and natural extractives are also
GRAS (§182.20); paprika and paprika oleo-
resin are also approved as color additives for
food use exempt from certification (§73.340
and §73.345). Capsaicin-containing topical
products are approved in over-the-counter
and prescription drug form in the United
States.
Standardized capsaicin products are ap-
proved in Germany for topical therapeutic use
in painful muscle spasms in the shoulders,
arms, and spine. Low capsaicin-containing
Capsicumproducts are the subject of a nega-
tive German monograph; efficacy for diges-
tive disturbances, and supportive treatment of
heart and circulatory functions has not been
scientifically established (BLUMENTHAL1).
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