FDA bans ephedra?

Get it Right!

Too bad there’s not an equivalent of a White House in the dietary supplement world. If there was, the Press Secretary could schedule a media briefing and finally, at long last, get everyone on the same page concerning ephedra.

Here’s how the briefing might go

Word for word

Press Secretary: Before I take questions regarding last week’s federal court ruling that challenged the so-called “FDA ban of ephedra,” I’d like to straighten out one important detail. For years now most of the reporters here in the press pool have been using the wrong terminology. As a result, the controversy surrounding ephedra has been completely misrepresented. So starting today, I want everyone to get it right. Pencils out? Okay. Write this down:

Ephedra is an herb that is reasonably safe when used in a balanced formulation administered by experienced herbalists. And this may come as a shock to some of you, but herbal ephedra has not been banned. In 2004 the FDA banned the sale of “dietary supplements containing ephedrine alkaloids.”

Ephedrine is the active ingredient of ephedra. And “ephedrine alkaloids” refers to the synthetic, hyped up version of ephedrine that some manufacturers combine with caffeine (a potentially dangerous mix) to produce super-charged weight loss supplements.

When ephedrine is not taken as directed, or taken by someone with a history of heart problems, you’re playing with fire at a gas pump. But for most people, herbal ephedra is safe when taken as directed in the treatment of asthma, common colds and other conditions that require bronchial dilation.

So every time you write that “ephedra” has been banned you’re getting it wrong. Even worse, you’re slandering ephedra. Ephedrine alkaloids have been banned. Herbal ephedra is perfectly legal.

Q. & A.

Press Secretary: Okay, I’ll take a few questions.

Reporter One: Uhare you sure that ephedra hasn’t been banned?

PS: Read my lips: NO! Do you guys do ANY research or do you just reword press releases? Learn to use an Internet search engine for gosh sakes. HealthDay News got it right. Mary Duenwald of the New York Times got it right. It’s not brain surgery.

Reporter Tw Would you comment on the decision last week by a federal court in Utah that struck down the FDA ban of ephedra?

PS: (Pulling his hair.) Jumpin’ Jupiter! Am I talking to myself here? The court decision last week had NOTHING to do with herbal ephedra! In a nutshell, here’s what happened in Utah:

Nutraceutical Corporation (a supplement manufacturer that once offered an ephedrine product) filed a suit alleging that the FDA had not proved that low doses of ephedrine-alkyloid supplements were dangerous.
Judge Tena Campbell of the US District Court of Utah agreed, stating that the agency had not met the standard for banning low doses of ephedrine-alkyloids (under 10 mg).
Judge Campbell ordered the FDA to conduct a study that would determine dose-dependent toxicology so the ban of ephedrine alkyloid supplements can be set at a proven toxic level.
A spokesperson for the Nutraceutical Corporation stated that the FDA ban had been overturned.
But an FDA spokesperson stated that the ban is still in effect for higher doses (above 10 mg) of ephedrine products and added that the agency is considering its options “with respect to next steps.”
What does that mean? We’ll have to wait for the FDA to figure that out and get back to us.
Bring on the demon

Reporter Three: If ephedra has not been banned, why is the complementary and alternative medicine community upset about the ban on synthetic ephedrine?

PS: Good question. There are two reasons. First, as the federal decision in Utah demonstrates, FDA officials have shown a willingness to overstep their bounds when it comes to regulating dietary supplements. And second: demonization of the word “ephedra.”

Because of the wide misuse of the word ephedra to refer to both herbal ephedra and synthetic ephedrine, all the problems (including a number of deaths) associated with synthetic ephedrine have been attributed to ephedra. As the highly emotional case has been built against the use of synthetic ephedrine, the generic use of the word “ephedra” has become demonized, from the halls of Congress to the locker rooms of professional sports franchises.

But herbal ephedra isn’t banned, so why would an herbalist be upset? Simple: Insurance premiums.

So many lawsuits have been launched against makers of synthetic ephedrine products that insurance company executives have become skittish. They hear the word “ephedra” and product liability insurance premiums go through the roof, if they even offer coverage at all. That’s why many herbal suppliers and herbal formulators have reluctantly stopped dealing in ephedra and ephedra formulas because they can’t meet the insurance demands. You could call it a “soft ban.”

Reporter One: So, you’re saying that the reputation of herbal ephedra has to unfairly bear the bad reputation of synthetic ephedrine resulting in higher prices and meager supplies for consumers who need the herb?

PS: Holy mackerel! You’ve got it!

Sources:
“Ephedra Ban Lifted by U.S. District Judge” HealthDay News, 4/14/05, healthday.com
“Nutraceutical May Resume Ephedra Sales After Court Overturns Ban” NutraIngredients-USA.com, 4/18/05, nutraingredients-usa.com
“High-Dose Ephedra Pills Still Illegal, FDA Says” Reuters, 4/15/05, reuters.com
“Despite FDA Ban, Ephedra Won’t Go Away” Mary Duenwald, The New York Times, 2/17/04, nytimes.com