Ephedrine: Big Government’s Ban of Free Choice (part 1)
(originally published Dec. 2004 – FreeMarketNews.com)
Ah, the good old days! Way back in the long forgotten past of 1994 there was enacted a federal bill by the name of The Dietary Supplement Heath and Education Act (DSHEA), which allowed the legal sale of numerous dietary supplements and herbs free of arbitrary regulation by the FDA.
This excellent bill was a boon to the free-market sale and distribution of vitamins, herbs, alternative medicines, and athletic enhancement agents. It also sparked an amazing proliferation of new products and research that created something of a dietary and nutritional industrial revolution. Old-time herbs and remedies were studied to find what made them tick while new research and technologies expanded in all directions.
Yes, this was also an era of “buyer beware”, but as in any good free market, numerous private watchdogs emerged to monitor and unofficially regulate the new offerings flooding the market. Still other businesses came forth and began investing heavily in independent laboratory assays and sports science research to better educate the public and sort fact from fiction.
Ah yes, quite a time to be alive and involved in the health and fitness industry!
But like all nostalgic eras of yore, those days are gone. The protections granted by the DSHEA have been reduced not once, but twice in the past year alone – and more changes are expected to ensue. The most recent infringement can be found in the Anabolic Steroid Control Act of 2004 (which I’ll cover in depth in another article), but the one this editorial is concerned with is the ban on the popular energy and weight loss product “ephedrine”.
As of April 12th, 2004, all dietary supplements containing ephedra/ephedrine became illegal for sale or distribution. Why this is such a blow to our personal freedom of choice – contrary to much of what you’ll hear about in the mainstream media – will be covered in depth. Keep reading…
WHAT IS EPHEDRINE?
Ephedrine is the active ingredient in the Chinese herb “ma huang”, which is part of the plant genus Ephedra. Known as one of the world’s oldest medicines, ma huang has been used in China for more than 5000 years as a treatment for breathing disorders, upper respiratory ailments, fever, swelling, allergies, and bone pain. Today, ephedrine is used for a variety of applications, the most common medical usage being the temporary relief of asthma. However, ephedrine also stimulates the central nervous system, thus causing a rise in energy levels and sometimes dramatic losses of body fat even in individuals who don’t exercise.
The word “ephedrine” is a general term thrown about in common usage, but there are two important versions of the chemical. Ma huang, or ephedra, is the raw herbal form (from the stems of an Ephedra plant) while ephedrine usually refers to ephedrine hydrochloride (or similar derivations) of synthetic preparations. Studies have shown that the herb is typically easier for the body to tolerate, whereas the synthetic versions are stronger and more prone to the highly publicized negative effects (which I’ll cover shortly). Interestingly enough, these synthetic versions are still legal in over-the-counter (OTC) medications such as Primatene Tablets and various cold medicines, but the herbal equivalents are banned in all dietary supplements (i.e. products with a non-medicinal purpose).
WHY (AND HOW) WAS IT BANNED?
According to the FDA, ephedrine use poses too great of a health risk to the general population due to side effects, some of which are, admittedly, quite serious. However, the degree of risk is what’s at question and has been the subject of mountains of debate. This being the case, a second reason for pursuing legislation against ephedrine was for its use as an agent in the preparation of the illegal drugs methamphetamine (“Speed”) and methcathinone (“Cat”). And despite the government’s posturing on health dangers, the ultimate means by which ephedrine was banned was from this link to the so-called “War On Drugs”.
The “how” of the ephedrine ban, however, is a great deal more complicated than the “why” of the ban. If ever you had any doubt as to the bloated nature of our government, you have only to read the origins of bills that are passed to quickly realize that things have really gotten out of hand. Personally, I got a headache after sorting through it all. To save you from the same fate, I will endeavor to give you only the highlights:
Ephedrine is a listed chemical within the Chemical Diversion and Trafficking Act (CDTA) of 1988. This act set a threshold for bulk sale of ephedrine at 1 kilo (roughly equal to 48,000 25mg tablets). This was amended when the Drug Enforcement Agency (DEA), citing the purchasing of over-the-counter products as the primary source of ephedrine used in methamphetamine production, eliminated the threshold altogether, making any and all amounts subject to reporting and record keeping requirements of the Controlled Substances Act (CSA) of 1993.
The Domestic Chemical Diversion Control Act (DCDCA) of 1993 in turn amended the CSA by removing exemptions for the sale of certain products marketed or distributed under the Federal Food, Drug and Cosmetic Act (FD&C Act), which at the time included ephedrine and many other dietary supplements. Then, due to some heavy lobbying and few conclusive studies available to support the supposed ill effects of ephedrine, ephedrine was included in the aforementioned Dietary Supplement Health and Education Act (DSHEA) of 1994, making it available for use as an OTC supplement in herbal form only.
Under the DSHEA, manufacturers can bring products to market they’ve deemed safe without having to first pass testing and certification by the FDA. There are labeling requirements, of course, but many unscrupulous companies often abuse the leniency. Once a product enters the market, however, the FDA is then free to pursue action against any such product they deem to be a danger or misleading in its label claims. Beginning in 1997 and continuing throughout much of 2003, the FDA did just that in its vendetta against ephedrine.
In June 1997, the FDA first proposed limits on ephedrine’s use, including a required labeling on ephedra-containing dietary supplements warning that ephedra is hazardous and should not be used for more than seven days. If you’ve ever read the label of the most popular weight loss ephedrine products, you will have seen a very long list of directions and warnings for how, when, how much, and by whom the product should be used. Certainly such precautionary measures would be enough…right?
Wrong (at least according to the FDA).
In February 2003, the agency announced a series of measures that included strong enforcement actions against firms making so-called “unsubstantiated” claims about their ephedra products. The agency also took action against dietary supplements containing synthetic ephedrine (since the synthetic form doesn’t meet the requirements of a “dietary supplement” under the DSHEA). The dominos were beginning to fall.
In response to a number of consumer complaints and a mere handful of sensationalistic lawsuits, several enforcement actions were brought in conjunction with the Federal Trade Commission (FTC) challenging “deceptive” claims about safety and side effects for products marketed as bodybuilding aids and energy boosters.
An interesting aside regarding these actions shows how little incentive our bloated government needs to act…many of the lawsuits were brought by people who admittedly misused the product in direct opposition to label directions. Further, in the series of hearings before Congress leading up the ban, speakers were strongly encouraged NOT to comment on the perceived benefits of ephedrine, regardless of supporting research.
In short, the government’s bias was showing even before pen was ever put to paper to draft the final ruling.