FDA issues ‘smart drug’ warning

Wednesday, April 10, 1996

Public bulletin deems ephedrine hazardous to healthBy Susan
Lee

Daily Bruin Contributor

Even better than the real thing ­ at least that’s what
students who pop "alternative drugs" such as Herbal Ecstasy, Cloud
9 and Ultimate Xphoria are eager to believe.

The drugs, which are marketed as legal "smart" drugs, are
thought to give a natural high akin to their illegal
counterparts.

But according to the Food and Drug Administration(FDA), those
looking for a "natural high" should pause before popping another
pill.

The organization issued a public health warning last week
cautioning consumers against the consumption of products containing
ephedrine, an active ingredient products purporting to give a legal
high.

The warning was issued after the FDA learned of 15 deaths caused
by ephedrine-related supplements. In addition, at least 400 users
have had adverse reactions to products containing ephedrine since
1993.

But while the FDA recognized the danger, the organization
couldn’t issue a blanket ban on all ephedrine products.

According to the 1994 Dietary Supplement and Food Education Act,
the FDA must act on a case-by-case basis ­ in some instances,
waiting until people are harmed by a particular product before
taking action. Sales can not be stopped before it is proven that
each particular product is harmful, explained Rosario Vior, a
public affairs specialist for the FDA in Los Angeles.

"The new law requires that something happen before we can do
anything about it," Vior said. "The burden of proof has fallen on
us to prove that something is dangerous before we can pull it off
the market."

However, in light of the the fatalities, the FDA is "moving
quickly" to investigate ephedrine supplements, Vior said.

"There seems to be a number of significant side effects that it
would seem that the effects of ephedrine would be somewhat body
altering," Vior said. "But to what degree and how much, we don’t
really know yet."

Although the warning is meant to inform the public of possible
risks associated with ephedrine, some students believed the FDA
warning won’t curb usage.

"I think if people want to use it, then they’re going to use it,
no matter what," said Andrea Chanawatr, a first-year international
economics student. "It (the warning) might deter some people from
trying Herbal Ecstasy, but not all people out there will stop doing
it."

Companies which market ephedrine products often maintain that
users can achieve a natural high, euphoria or heightened sexual
feelings without any serious side effects.

Similar to amphetamines, Ephedrine is a stimulant that can cause
serious side effects for the nervous system and heart. The
statement also cited heart attacks, headaches and even psychosis as
results of ephedrine usage.

Ephedrine in its pure chemical form has been banned from
manufacture in the United States by the FDA. Despite this fact, it
is still used in many over-the-counter medicines and in drugs such
as Herbal Ecstacy.

Manufacturers of Herbal Ecstasy at World Global Media
Corporation in Venice declined to comment. But in an earlier
interview, they praised their product and its legal high.

"The chemical stuff is a lot more intense, it’s a lot harsher.
(With Herbal Ecstacy,) you get the physical effects, but not the
mental effects," said Norris Preston, a supervisor affiliated with
the distributor.

Despite claims that some ephedrine products are FDA-approved,
Vior said that ephedrine dietary supplements have never been
approved.

Aahs, a novelty store in Westwood, stopped selling Herbal
Ecstacy last Tuesday. Assistant Manager Jane Thorn maintained that
their moratorium on sales was unrelated to the FDA’s warning
statement.

"We (Aahs) pulled off Herbal Ecstacy for other reasons ," Thorn
said. "It’s not something we carried in great excess, but it wasn’t
something that we didn’t have."

Vior explained that the FDA has not issued anything more than an
alert and warning to the general public, but the organization is
still collecting data. Vior also commented that industry
manufacturers were aware of her organization’s concerns.

"We are depending on people to bring these things to our
attention. Ultimately, our mission is to protect the public
health," Vior said. "We do need significant information to do
anything else though."

Consumers experiencing any side effects from ephedrine
supplements should inform the FDA and call 1-800-FDA-4010.