
Ephedra:
Guidelines For Dosage And Label Warnings
October
2000
The
following guidelines for dosage levels and label warnings for ephedra
have now been adopted by all of the trade associations for herbal
product manufacturers.
These
guidelines were first drafted in March 1994 by the American Herbal
Products Association (AHPA)
in close collaboration with the National Nutritional Foods Association
(NNFA) and the
Utah Natural Products Association (UNPA). This current version was
revised in January 2000, and was adopted in August 2000 by the Consumer
Health Products Association (CHPA).
Serving
(dosage) limits
Products
are not to contain in excess of 25 mg of total ephedrine alkaloids
per serving; usage instructions should limit daily consumption to
100 mg of total ephedrine alkaloids.
Labeling
The
label of the goods should bear an adequate cautionary statement,
which shall at a minimum include the following language, or comparable
language:
Not
intended for use by anyone under the age of 18. Do not use this
product if you are pregnant or nursing. Consult a health care
professional before using this product if you have heart disease,
thyroid disease, diabetes, high blood pressure, psychiatric condition,
difficulty in urinating, prostate enlargement, or seizure disorder,
if you are using a monoamine oxidase inhibitor (MAOI) or any other
prescription drug, or you are using an over-the-counter drug containing
ephedrine, pseudoephedrine or phenylpropanolamine (ingredients
found in certain allergy, asthma, cough/cold and weight control
products).
Exceeding
recommended serving will not improve results and may cause serious
adverse health effects.
Discontinue
use and call a health care professional immediately if you experience
rapid heartbeat, dizziness, severe headache, shortness of breath,
or other similar symptoms.
The
product label shall list the amount of ephedrine alkaloids per serving.
Herbs
of Commerce conformity
Label
identification must be in conformity with the standard common name
listed in Herbs of Commerce.
Synthetic
ingredients
Neither
finished consumer goods nor raw materials used in their manufacture
are to contain any synthetically derived ephedrine alkaloids or
their salts (e.g., ephedrine sulfate; pseudoephedrine hydrochloride;
phenylpropanolamine hydrochloride).
Marketing
No
claims shall be made that the product may be useful to achieve an
altered state of consciousness, euphoria, or as a "legal" alternative
for an illicit drug.
|