Ephedrine HCl Not Banned
Ephedra was banned and not Ephedrine
The aim of this article is to describe the basic disparity between Ephedra
and Ephedrine Hydrochloride. Generally all the OTC [Over-the-counter] sold
Bronchodilator or Expectorants formulations are mainly Ephedrine based whereas the majority
of the dietary supplements have the Ephedra or Ephedrine Alkaloids known as Ephedrine. This
can further be explained as: The Foods and Drugs Administration or The FDA in the United
States during December 2003 banned the use of Ephedra in any form for Diet Supplementary
formulations which clearly indicates that any such supplements that contain Ephedrine has
totally not effected the company’s selling of OTC drug Products Containing Ephedrine
HCl. However, the most remarkable difference between the two Ephedra and Ephedrine HCl could
be quoted as the Ephedrine HCl formulation contain ‘Drug Facts’ on its label
claims and boxes whereas Ephedra or Ephedrine preparations contain ‘Supplementary Facts’
on its label claims and boxes hence only the latter products are affected by the US FDA’s
regulatory prohibition on sale of Ephedra or Ephedrine dietary supplement formulations.
The FFDCA the term for The Federal Foods, Drugs and Cosmetics Act and the US FDA the term
for The US Foods and Drugs Administration regulations are considering the Dietary Supplementary
products and the other OTC drug formulations categorically. Dietary Supplements are not officially
accepted to be safe and efficient by such agencies. The OTC drug preparations could exclusively
be sold if the FDA has considered them as safe and effective products. The term Ephedra is
generally used for the Dietary Supplements that consist of Ephedrine Alkaloids or the naturally
produced Ephedrine. It used to be sold as the unprocessed botanical herb or as the extract
form the botanical resources. It is also popularly known by the other names like Ma Huang
or the Chinese Ephedra. However, its raw botanical or its extracts contains a few alkaloids
of which a few could be named like Ephedrine, Pseudoephedrine, Non-Pseudoephedrine, Norephedrine,
Methylephedrine and Methylepseudoephedrine. Until The US FDA reported the specific or dangerous
risk factors of harm on human life by the use of Ephedra based Diet Supplementary formulations,
its formal approval or clearance to market and sell such products, they were widely sold
were never affected by the prohibitions.
In quite opposite the OTC products containing Ephedrine HCl were sold
in accordance to the FDA’s Final Monograph for Colds, Coughs, Allergies, Bronchodilators
and Anti-asthma preparations for human consumptions. The Final Monograph describes several
ingredients certified to be safe and effective for specific usage when complied under specialized
label claim regulations set by the FDA and the formulator uses it for some particular ingredients
of such approved list. The FDA also included Ephedrine under The Final Monograph based on
its research that it cab be recognized as safe and effective if labeled in accordance with
the monograph regulatory norms. Furthermore, Ephedrine HCl was neither sold
as the dietary supplement nor ever claimed of its effectiveness in regards to weight loss
or energy increment in its label claim of the particular product. Had it undergone such practice,
the FDA would have banned it considering it to be ineffective and un-approved drug formulation.
In short the FDA has declared the prohibition of selling Ephedra dietary supplements and
not the Ephedrine HCl OTC drugs formulations at all.
To conclude it can be quoted as Ephedra dietary supplements and Ephedrine HCl OTC Drug
preparations are completely different entities hence the ban imposed by the FDA on Ephedra
dietary supplements has totally no impact on the Ephedrine HCl OTC drug products and its
producers are free to market or sell OTC Ephedrine HCl drug formulations.
|
Asia Black
