The FDA Gets Spanked Again!
by Randy Drake
federal court has once again overturned the FDA’s ban on a natural substance. This is but the latest in a series of defeats for the FDA in their ongoing attempt to purge the shelves of safe and effective natural supplements.
Federal judge Tina Campbell’s ruling prevents the FDA from stopping the sale of ephedra, and forces them to follow rules that Congress set forth in the Dietary Supplement Health & Education Act of 1994 (DSHEA). That law requires the FDA to prove that a supplement is dangerous before it can stop the sale of that supplement. Instead of proving its danger (which would be very difficult to do in the face of a large body of scientific research attesting to its safety), the FDA inappropriately applied a “risk/benefit” test to the supplement. Judge Campbell noted that their logic makes about as much sense as applying a risk/benefit test to potato chips! The bottom line is that if the FDA cannot prove a supplement is dangerous, they cannot ban the supplement. Read the actual court ruling for yourself (PDF, 1.5 MB).
A brief history of the FDA v. ephedra
For hundreds of years ephedra was used for the treatment of asthma and bronchitis. It is presumed that any herb that has been successfully ingested for hundreds of years is safe for human consumption. While that is a good starting point, modern dietary supplements are subjected to scientific research to prove safety and efficacy, much like pharmaceuticals, but on a smaller scale. For many natural substances on the market today, scientists do research, conduct unbiased clinical trials, review epidemiological data, and come to conclusions based on science. Such is not the case with the FDA’s crusade against ephedra.
During the 1980s and ’90s ephedra became increasingly popular as the major herbal ingredient in dietary supplements intended to aid weight loss. About the same time, phen/fen (a protocol that combined phentermine & fenfluramine) was being prescribed to obese people for the same purpose. Both ephedra and fen/fen were enormously successful in helping people lose weight, which is what eventually led to their downfall. (More on the sad tale of phen/fen in a future article.)
In 1997 the FDA proposed severely restricting the availability of ephedra as a dietary supplement, but the U.S. General Accounting Office (GAO) stopped the implementation of those restrictions in 2000. They questioned the veracity of the FDA’s adverse event report (AER) data and criticized the “sophomoric” research they used in formulating the ruling. In retaliation for being spanked by the GAO, the FDA redoubled its effort to “prove” ephedra’s danger.
Under the guidance of the FDA’s propaganda machine, the news media gave widespread coverage to a few anecdotal incidents involving high-profile athletes. It was not widely reported that the amount of ephedra those athletes consumed was far in excess of the recommended dosage. No big problem existed with ephedra before the FDA released several scary and misleading press releases, but soon afterward a flood of AERs began to appear, most likely due to the nocebo effect (adverse side effects reported when taking a placebo). The pattern of AERs was studied and the results reported at the 1999 International Ephedra Symposium: “exceptional spikes in adverse event reports [were] filed in the days immediately following FDA press releases and media coverage of ephedra.”
Independent scientific research
Interestingly, several clinical trials were started in direct response to the FDA’s proposed ban, in order to prove or disprove their claim. A 2002 study
published in the International Journal of Obesity concluded that the commonly used combination of herbal ephedra and caffeine “promoted body weight and fat reduction and improved blood lipids without significant adverse effects.”
“...without significant adverse effects.”
That bears repeating for the benefit of people who get their opinion of ephedra from TV news instead of actual scientific research. A six-month trial of three commercial ephedra-containing supplements on 150 overweight patients at the Texas Nutrition Institute concluded that “all three dietary supplements were efficacious with few or no adverse events or undesired symptoms occurring that were not common to overweight individuals in general.”
“...few or no adverse events or undesired symptoms...”
See the pattern here? The FDA did, too, so to bolster its case against ephedra, it ignored the body of published studies that showed ephedra’s safety and hired a doctor to “study” ephedra and render an opinion. But in contrast to the studies cited above, the FDA’s “hired gun” didn’t actually study the effects of oral ingestion of ephedra or ephedrine (the active part of ephedra); he studied the effects of injected epinephrine — adrenaline — and equated the effects of the two substances. Using that twisted logic, coffee and cola drinks are the next to be banned, because the FDA can simply equate the caffeine in a beverage with the amphetamines in smoked crystal meth! The FDA committed outright scientific fraud by using bogus science and inflated AERs, but was finally successful in banning the sale of ephedra in April 2004.
Why the ban could not stand
Ephedra is not a drug; technically, it’s a food. An herb, to be exact, like oregano and chili powder. How can the FDA ban a food? They simply declare that the product is “adulterated.” Adulterated with what? Ephedra! They decree that ephedra is an adulterant, as if it were a pesticide or raw sewage. But like oregano and chili powder, ephedra has been used for hundreds of years without adverse effects. Moreover, there is a large body of scientific evidence — yes, actual clinical trials! — which show that ephedra is safe and effective in recommended quantities (< 100 mg of ephedrine/day). Actual scientific research stands in stark opposition to the FDA’s “junk science” and breathless hand-wringing about how “dangerous” ephedra is.
The intent of DSHEA was to affirm the individual’s right to decide which herbs and food supplements to put into their body. As long as a supplement is not provably harmful, it is up to each individual to evaluate the benefit (or lack thereof) of supplements. That’s the precise reason that they’re in the same category as foods. No one has to prove to the government that potato chips are beneficial — no “risk/benefit” test is administered by the Federal Potato Chip Administration. In fact, a convincing argument could be made that the hydrogenated fats and empty carbohydrates are actually harmful to your health, but the FDA does not have the authority to “save you” from potato chips; it is your decision to make. (Why isn’t the FDA trying to ban tobacco? A huge amount of scientific evidence has shown that that herb is harmful, even lethal, to humans!)
What were they thinking?
Why the FDA’s vendetta against ephedra and all things natural? If you start with the assumption that the FDA is in the pocket of the big drug companies, it all begins to make sense. (Where do top FDA regulators go when they retire? Many become high-paid “consultants” to big drug companies!) Big drug companies know that the public will not pay several dollars for a dose of their latest “miracle drug” if they can pay a few cents per dose for natural supplements that are just as effective. So, they need to remove the competition from cheap and effective natural supplements, and the only agency empowered to do that is the FDA. So just as the FDA banned the natural antidepressant L-tryptophan (March 22, 1990) before Prozac was announced (March 26, 1990), so ephedra must be removed from the market before the next prescription weight-loss drug is released.
Ephedra works by increasing endogenous norepinephrine levels to stimulate beta-3 receptors, which in turn induce thermogenesis and promote weight loss. Caffeine is synergistic in this effect. Big drug companies have spent big bucks developing beta-3 agonists to do the same thing, and the last thing they want is people choosing a 15-cent natural herb over their upcoming $3.00 pill. The reason that this method of weight loss is so promising is that it is both safe and effective. The slight (!) elevation in blood pressure and heart rate that is seen with acute use of ephedra in the recommended dose goes away with chronic (> 26 weeks) use, but the thermogenic effect and accompanying weight loss remains — and even increases — with chronic use: “...most, if not all of the undesirable side-effects of ephedrine exhibit tachyphylaxis [desensitization], whereas the thermogenic effects are preserved or even enhanced by chronic treatment.” [Int J Obes Relat Metab Disord. 1993 Feb;17 Suppl 1:S1-2.]
While obesity and its corresponding medical events climb to epidemic proportions and cost Americans millions of healthcare dollars, big drug companies remain interested only in their bottom line. And the FDA is all too willing to be complicit in protecting drug company profits, to the detriment of the American public.
No one is happy with the way the FDA uses and abuses its power over natural supplements. It’s time to remove dietary supplements from the jurisdiction of the federal agency that has jurisdiction over prescription drugs. Congress should set up a separate agency to monitor and regulate only herbs and natural substances, patterned after Germany’s Commission E. Commission E’s sole purpose is to regulate and approve natural substances in Germany, using actual historical and scientific evidence instead of media propaganda and bogus science designed to support a preconceived result.