Botanical debate on FDA rules infuses herb industry
By Nanci Hellmich, USA TODAY
For years, botanical experts have said echinacea
might shorten the duration of your cold, ginkgo
biloba may help keep your mind sharp as you age
and garlic may do your heart a favor.
But new research on many dietary
supplements is conflicting. And even if some of the
health benefits are true, it is difficult for the
consumer to determine the right dosage or to figure out
the differences between brands on the market. (Related
item: Research on hot-selling herbs)
Part of that problem may be
solved if new rules proposed by the Food and Drug
Administration take effect in a year or so. The rules
would set standards for making and labeling dietary
supplements so consumers can make more informed choices.
Herbal remedies have been widely
used in other countries for centuries, and the products
enjoyed a surge in popularity in the USA during the late
'90s. Sales of herbal supplements tallied $4.18 billion
in 2001, up from $4.12 billion in 2000, according to the
Nutrition Business Journal, an industry
newsletter.
Still, herbs have been surrounded
by controversy recently. Some studies have shown that
the products aren't effective. And ephedra, promoted as
a weight-loss aid, has been linked to health problems,
including heart attacks and strokes. It also has been
linked to a number of deaths.
So are herbal products safe and
effective?
"In general, the record clearly
shows that herbal products are relatively safe," says
Mark Blumenthal, founder of the American Botanical
Council, a research and education group that supports
responsible use of supplements.
A lot of research has been done
that has shown the herbs are effective for various
conditions, he says. For instance, he says, there is
good evidence that saw palmetto helps symptoms of benign
enlarged prostates, a condition called benign prostatic
hyperplasia, which causes urination difficulties.
But others say the answers on the
safety and effectiveness of herbs aren't in yet. "We're
still trying to figure out what these herbs do and what
they don't do," says David Schardt, senior nutritionist
with the Center for Science in the Public Interest, a
consumer group based in Washington, D.C. "It's clear
they have some biological effect, but we really don't
have a handle how significant that effect is."
Herbs under the microscope
Many studies have raised
questions about the effectiveness of herbs. For
instance, St. John's wort is said to ward off
depression, but one large study in the USA found that it
was not effective in treating moderate to severe
depression. Botanical experts say the product is
intended for mild depression. A government-funded study
on mild depression is in the works.
Garlic is supposed to lower
cholesterol. One government agency reviewed the
literature and concluded that garlic may lower
cholesterol levels in the short term, but there's no
evidence that it lowers cholesterol in the long term,
Schardt says. Still, there are indications garlic may
have other benefits for heart health, he says.
"We need good research," Schardt
says. "It's good that the government is getting into it,
because they have the resources to do these studies
properly."
Maintaining the purity
Physician Tod Cooperman,
president of
Consumerlab.com, knows how much the quality of
products can vary. His company has tested more than 700
products since 1999. Many products failed to meet the
standards the company established after reviewing the
scientific data on the herb. (Names of products that
have passed are available to subscribers on the Web
site.)
"I see a place for herbals, but
people have to be careful because the quality is
variable from one brand to another," Cooperman says.
Some herbal products didn't contain enough of the active
ingredients to be effective, and some products were
contaminated with pesticides, he says.
Compared with vitamin and mineral
supplements, herbals are the most ripe for problems
because of the complexity of manufacturing them, he
says. They need to have the right active ingredients
that have been shown to be effective in clinical trials.
They have to be made from the right species of plants
and the right parts of the plants. And they have to be
dried properly. Plus, they shouldn't be contaminated
with metals from the soil or pesticides used on the
herbs, Cooperman says.
"For the sake of the consumers
and the manufacturers themselves, the quality of these
products has to be consistently higher," he says.
Blumenthal says when the FDA
eventually issues final manufacturing rules, "consumers
and health professionals will have a higher level of
confidence in all of these supplement products." |