Booming Dietary Supplements Industry Fears It Won't Get A Fair Shake

THE FDA GETS TOUGH WITH THE HERBAL CROWD

By Joanne Jacobs

BUTCHER'S Broom, Devil's Claw, Dong Quai, Eyebright, Ma Huang, Marsh
Mallow, Nettle. DHEA, Melatonin, Herbal Phen Fuel, Diet Phen, Thermo Phen,
NutriZac Mood Food.

The last time I was in a healthfood store I was wearing bellbottoms and
beads. The only thing I know to do with Marsh Mallow is roast it over the
campfire, and add chocolate and graham crackers.

But these days, ``natural'' remedies aren't just for earnest, catowning
women. More than 100 million Americans have made dietary supplements
herbs, vitamins, minerals and amino acids into a multibilliondollar
industry.

It's an industry ``in limbo,'' says Michael Ellis, president of Metabolife
of San Diego.

Under a 1994 law, the Dietary Supplement Health and Education Act,
supplements aren't regulated like drugs, which must be proven safe and
effective in controlled studies before reaching the market. Supplement
manufacturers may make general health claims (``stimulates immune
system''), as long as they don't claim to cure disease (``treats AIDS'').
The FDA can remove products if it can show an unreasonable risk.

The Food and Drug Administration sees herbal products as Mother Nature's
patent medicine oversold and undertested.

The current fight is over ephedra, also called ma huang, a popular
stimulant used to speed metabolism, depress the appetite, boost energy and
build muscles. In large doses, it's been sold as the equivalent of the
illegal drug ecstasy.

Now that dieters can't get prescription diet drugs such as fenfluramine or
Redux, they're turning to products using ephedra and St. John's wort, which
is prescribed as an antidepressant in Germany.

The FDA has moved against Nutri/System diet clinics' ``Herbal PhenFen,''
saying the name falsely implies it's a drug.

However, safety is the big issue: The FDA says the ephedrine alkaloids in
ephedra are linked to headaches, nervousness, insomnia, high blood
pressure, irregular heart beat, seizures, heart attacks, strokes and death
in more than 900 ``adverse reports'' over four years.

Dieters take 25 mg pills four times a day. Proposed FDA rules would limit
the dose to 8 mg three times a day for no more than one week, making it
worthless as a diet aid.

But is ephedra dangerous at more than 8 mg a dose?

My cold pills contain a synthetic version, pseudoephedrine, at 30 mg a
dose. An asthmatic who uses bronchodilators like Primatene may take 150 mg
of ephedrine a day.

``If it's truly unsafe, remove the product,'' Ellis says. ``And remove
Sudafed too: A child can take 15 cold pills and get high.''

The ``adverse reaction reports'' are hooey, says Theodore Farber, a former
FDA toxicologist who's now an industry consultant. The industry's panel of
scientists found 83 percent lacked crucial data, such as medical records,
dosage information and proof of ephedra use. They found no deaths or
serious injuries at 100 mg a day.

The 42 deaths in the reports include a man who shot a store clerk, a woman
who shot herself and several crashes, including a woman who drove 90 mph
the wrong way on a oneway street, ran a stop sign and hit a tree. The
autopsy found ephedrine and a blood alcohol level of .212, more than
double the legal limit.

The FDA advisory committee relied on 50 reports with a good medical
history, according to Elizabeth Yetley, the FDA's director of Special
Nutritionals. That included two deaths attributed to ephedra by coroners:
One young man used a bodybuilding product; the other doubledosed on
``herbal ecstasy.''

The committee also used knowledge of ephedrine's characteristics, Yetley
said. The clinical studies available were ``not helpful for dietary
supplements'' because they dealt with different products, and screened out
highrisk patients, she said. ``Experience in the real world'' shows the
ephedra in supplements is dangerous at a lower dose than the ephedrine in
overthecounter medications.

The FDA is especially concerned about longterm use: Unlike users of cold
pills and bronchodilators, dieters and bodybuilders use supplements daily
for months or years.

The industry doesn't trust the FDA to give supplements a fair hearing.
``This is backdoor regulation,'' says Peter Mirijanian, spokesman for the
Dietary Supplement Safety and Science Coalition.

Skeptical as I am of the idea that ``natural'' means ``safe,'' I have to
wonder why the FDA talks about 900plus reports, when only 50 have enough
data to be used. Why use anecdotal reports from a selfselected population
but not clinical studies? And why not wait for data from two safety studies
that will be concluded in late spring?