Banning Herbal Supplements

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Interviewer:  You're very active in defending people's rights to have
access to herbal medicine. Is that access getting more restrictive?

Dr. Upton:  No. There was a time in the '70s and '80s where there were some
restrictions that would go around like that, mostly herbs that FDA said
should not be used for internal consumption. Sassafras because it contains
safrole, for example, or black pepper and basil contains safrole, but
they're not telling us not to eat pesto and stuff like that, or black

So there was a (inaudible 00:00:38) period when things like that were
happening. Most recently ephedra was banned and it should not have been
banned as a traditional herbal medicine in my opinion, or a traditional
herbal supplement. But there's a place where the industry really abused it.
They were using it for the wrong things the wrong way, in the wrong

For example, they were using it in energy products, weight loss products,
fat products that both categories are subject to a high level of abuse.

Interviewer:  Sure.

Dr. Upton:  If a little bit is good, more is better. Plus, they were using
very highly concentrated, purified ephedrine, synthetic or naturally
derived ephedrine to spike these ephedra products so people would feel a
zing from it, and then they would go back to it. Because of that, that
causes problems.

Now, the problems that were associated with the ephedra products were
predominantly because of weight loss or energy, highly concentrated
ephedrine products, not traditional ephedra products. At first, FDA
differentiated between the two and said, "No, we're not really going to go
after these traditional products. We don't think they're a problem. We
really want to go after this abuse category."

Then when the rubber met the road, they went after the whole category and
ephedra was banned. I chalk that up to a mistake of the responsible part of
the industry of supporting the use of the ephedra in weight loss and energy
products. It's an inappropriate use for the herb, and now literally one of
the most effective herbs of Chinese medicine is lost, both to consumers and
to traditional Chinese medicine practitioners who relied on it for the last
3000, 3500 years.

As far as now, I had a (inaudible 00:02:42) conversation with somebody here
on the floor, in one of the lectures yesterday. We were talking about how
kava also disappeared, and kava disappeared for much of the same reason.
There were a few case reports that were documented of potential

Very little evidence of true causality except in a very minor few cases
compared to the millions of daily doses that are sold and used in Europe as
the number one anti-anxiety herb throughout the European Union. Even though
FDA didn't officially ban it, because of the potential problem, most
companies, they don't want to take on the liability, so that disappeared.

So there are different reasons why we might lose access to an herb. One
might be like the FDA banning ephedra, and another might be that the
insurance companies won't provide product liability insurance for something
like kava that has a risk or you have to have $110,000 a year (inaudible
00:03:43) extra supplementary policy if you're going to sell kava.

The gentleman that I was talking to is a toxicologist. He said, "Yeah.
There's no reason why kava should have ever been taken off of the market
based on the evidence that was there." It was predominantly by innuendo.
When you extrapolate that out, if they can take ephedra or we can lose
access to an herb like kava, both of which have great safety records...

Actually, on the ephedra side, they maintained the ephedrine products, the
Sudafed products that were on the OTC market, they're not yielding anymore
or any less ephedrine than a traditional Chinese product. But they took the
traditional products and said, "You can't use them, but we're going to keep
our drugs." They specifically said, "Because we know they're safe."

So even though the same amount in OTC is safe, it's not safe for you to use
in a traditional Chinese herbal product. That's a problem, and if the herbs
can be taken away on such flimsy evidence either by FDA ruling or by
insurance not covering or physician or consumer fear, there are a lot of
herbs that are at risk.

Black Cohosh came up recently as a potential hepatotoxin. Again, huge herb
but the Canadian government actually was very smart and they said, "Okay,
let's look at the reports and let's test the products." They found that
those products weren't associated with (inaudible 00:05:26) which is really
North American Black Cohosh, but were other herbs from China.

So it wasn't Black Cohosh, but Black Cohosh gets implicated by inference.
This goes to the quality control because of poor quality control on the
part of the companies making the products.
Why are some herbal supplements banned? Some might be after misreading clinical studies. That takes important products off the shelves. Roy Upton is the executive director of the American Herbal Pharmacopoeia. He discusses some recent products that were taken off the market and why.

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