1. ------IND 2005 0116 S-- EN ------ 20050322 --- --- PROJET
1 adopted on xx 2005.
In pursuance of Section 2 of the Pharmaceutical Products Order (1992:1752), the
Medical Products Agency prescribes, in respect of the Agency’s administrative provisions (LVFS 1995:9) on the application of the Pharmaceutical Products Act
(1992:859) to certain products, the insertion of a new point 12 into the administrative provisions, to read as follows.
12. ephedra alkaloids, including plant extracts containing ephedra alkaloids
_________________
These provisions shall enter into force four weeks after the date on which the statute is reported to be published in the Statute Book of the Medical Products
Agency.
Medical Products Agency
Gunnar Alvan
Anna Maria Åslundh-Nilsson
LVFS
2005:xx
Published on

Maria Gustafsson
5.5.2004
Draft administrative provisions amending the Medical Products Agency’s administrative provisions (LVFS 1995:9, most recently amended and reprinted as
LVFS 2001:2) on the application of the Pharmaceutical Products Act (1992:859) to certain products
SUMMARY
Products containing ephedrine constitute a risk to health. From the point of view of supervision (market supervision and in connection with the import of products into the country) it is desirable for all products containing ephedrine to be classified as pharmaceutical products.
The draft amends LVFS 1995:9 to include “ephedra alkaloids” in the administrative provisions on the application of the Pharmaceutical Products
Act (1992:859) to certain products.
BACKGROUND
Products containing ephedrine alkaloids are sold on the Internet, at gyms and other sales outlets as aids to weight loss/fat burning supplements and as a stimulant.
Ephedrine alkaloids can be extracted from herbs belonging to the genus Ephedra (“Ma huang”) and possibly also from the herb Sida cordifolia .
Pharmacological effects
Ephedrine is sympathomimetic and has a direct and indirect effect on adrenergic receptors.
Ephedrine affects both alpha and beta receptors and stimulates the central nervous system. In therapeutic doses, it raises blood pressure by increasing cardiac activity and causing peripheral vasoconstriction. Ephedrine also causes bronchodiliation, stimulates the respiratory centre, reduces tone and motility of the intestinal tract, has a relaxant effect on the bladder and detrusor muscle, but contracts the sphincter muscle in the bladder.
Undesirable effects
Side-effects and effects of overdose correspond to overstimulation of the sympathetic nervous system. Effects on the central nervous system can be agitation, anxiety, tremors, insomnia, confusion, irritability and psychotic states. Possible effects on the cardiovascular system are high blood pressure, tachycardia, palpitations, cardiac arrhythmia, angina and cardiac arrest.
Hypotension with dizziness and fainting can also occur. Other effects include difficulties passing water, urine retention, shortness of breath, a feeling of weakness and headache.
If ephedrine is combined with other stimulants, e.g. caffeine, it can lead to side-effects occurring at lower doses than if taken separately. The toxicological division of the National

Food Administration considers products containing ephedrine alkaloids to be capable of presenting a serious risk to health and they should therefore not be permitted to be sold as foodstuffs. Recently, the FDA prohibited the sale of dietary supplements containing ephedra alkaloids.
Current regulation
Product
Tablets, synthetic ephedrine
Classification
Pharmaceutical product on account of the pharmaceutical substance (asthma, coughs)
Tablets, natural ephedrine, medicinal claims Pharmaceutical product in accordance with
Section 1 of the Pharmaceutical Products Act
Tablets, natural ephedrine, aid to weight loss/fat burning supplement
Covered by the Pharmaceutical Act under
LVFS 2001:2, point 3, because ephedrine has an effect on the central nervous system
Tablets, natural ephedrine, not an aid to weight loss/fat burning supplement or unmarked tablets in a bag
Foodstuff or alternatively drug precursor depending on whether the ephedrine can be regarded as easily extracted or not
The National Food Administration has maintained that the content of ephedrine alkaloids in foodstuffs shall constitute grounds for a ban on sale, as such products should be considered harmful to health. However, it is the local municipal environmental and health authorities who decide on sales bans.
For the purpose of supervision, it would be desirable for products containing ephedrine alkaloids to be more clearly classified as pharmaceutical products . Cases concerning these product otherwise fall within a grey area between the areas of responsibility of the National
Food Administration and the Medical Products Agency. Theoretically, a product can change in a matter of seconds from a pharmaceutical product to a foodstuff as a result of a new version of the product information being posted on the Internet.
The general public, customs, the media and other authorities find it difficult to know what applies. The Medical Products Agency has been urged by customs to clarify the classification.
DRAFT
The Medical Products Agency has the option of deciding that pharmaceutical products shall include products which, in terms of their properties or use, are similar to pharmaceutical products. This is accomplished through the administrative provisions (LVFS 1995:9, most recently amended and reprinted as LVFS 2001:2) on the application of the Pharmaceutical Products Act
(1992:859) to certain products.
The draft amends the aforementioned provisions to include “ ephedra alkaloids
”.
Ephedra alkaloids, which can be extracted from herbs, are primarily ephedrine, but pseudoephedrine, norpseudoephedrine, norephedrine, methyl ephedrine, methyl pseudoephedrine and other closely related alkaloids also occur naturally in the herbs in varying concentrations. Ephedrine is the substance for which the effects have been studied most. The effects of the other alkaloids are less well known.

Some of the basic data for this draft come from Ulla Beckman-Sundh from the toxicological division of the National Food Administration. Per Claeson has been consulted with regard to the chemistry of alkaloids. The draft was briefly presented in the “performance group” containing representatives from, for example, the Swedish Customs Service, the National
Board of Health and Welfare, the Health Food Council, the National Food Administration, the police and the Anti-Doping Hot Line.