FDA COULD DO NOTHING ELSE BUT BAN EPHEDRA (1-2004)

A few years ago, ephedra, also known as ephedrine and ma 
huang, was one of the most popular herbal supplements sold 
over the counter in the U.S. because it helped many 
overweight people shed pounds, and it gave bodybuilders and 
athletes a little extra boost of energy.

Unfortunately, as with all herbal supplements, the Food and 
Drug Administration was prohibited by law from regulating 
its dosage or distribution. Manufacturers could even make 
outrageously exaggerated claims as to its effectiveness and 
safety.

Ephedra is one of the primary ingredients in many over-the-
counter diet pills. Some pills, known as “the stack,” 
combine ephedra with caffeine and aspirin. Many dieters 
claim “stacking” not only helps them to lose weight, but 
also to increase their energy.

But ephedra also has some nasty side effects, many of which 
are dangerous, even deadly.

For at least 18 years, the FDA has known that ephedra, if 
used improperly, could be dangerous. Yet all the agency 
could do was to gather as much evidence as possible in 
support of its suspicions about the dangers of the 
supplement. That’s because current law does not allow the 
FDA to regulate natural herbal extracts the way it can 
regulate drugs.

Only after it had gathered sufficient evidence to prove 
that ephedra posed a significant public health risk could 
the FDA legally ban its sale.

The FDA now says it has met its burden of proof and has 
moved to ban the sale of ephedra. The ban, announced last 
week, will probably take effect in March.

Sales of ephedra have been plummeting for months. Yet it 
has remained very popular among many athletes and dieters, 
even after receiving much negative publicity. There have 
been at least 155 deaths attributed to the use of ephedra. 
Thousands of others have suffered from heart arrhythmias, 
palpitations, hypertension, and even heart attacks and 
strokes, all linked to the use of ephedra.

Many supporters of the product, however, believe the 
government’s ban is unwarranted. Some supplement companies 
and nutritionists had been pushing for tougher labeling 
regulations.

They point to scientific studies that showed no serious 
side effects from using ephedra in doses of 20 milligrams, 
three times a day.

The problem seems to stem from the misuse of the product by 
many of those who take it, or by the high doses that some 
manufacturers recommend. For example, some ephedra tablets 
contain 250 milligrams, 10 times the recommended safe 
dosage. And some users have been known to pop more than one 
of these pills at a time.

Jonny Bowden, certified nutrition specialist and author of 
a number of books on nutrition, says he is not a promoter 
of the use of ephedra, but he believes it is safe when used 
properly. “While I’m no great fan of ephedra, it has also 
been blamed for an awful lot of things it doesn’t deserve,” 
Bowden wrote in his latest book.

Supporters of the ban, however, believe it has been a long 
time coming. Some believe the FDA has been dragging its 
feet by not banning it sooner, given the number of deaths 
associated with ephedra’s use.

The bottom line is that, by banning this supplement, the 
FDA has created the potential for a new black market. Those 
who swear by the supplement will probably find a way to buy 
it, despite the ban. 

The government already spends hundreds of millions of 
dollars trying to control the traffic of other illicit 
drugs, like marijuana. Now it has one more illegal 
substance it must try to regulate.

But, in the end, the FDA could do little else. Ephedra is a 
dangerous supplement, especially when not used as 
recommended. And since the FDA is prohibited by law from 
mandating dosage and labeling requirements for herbal 
supplements, the only thing it could do was ban ephedra 
outright, once it had established firm evidence of the 
dangers associated with its use.

Maybe it’s time for Congress to modify the law that 
hamstrings the FDA when it comes to regulating questionable 
dietary supplements. Maybe a total ban on ephedra was 
overkill, but given the current laws, there wasn’t much 
else the FDA could do.