But the FDA's Effort to Ban the Supplement Is
Derided as a PR Ploy
http://washingtonpost.com/wp-dyn/articles/A6364-2001Jul16.html
Tuesday, July 17, 2001; Page HE04
If you believe Internet advertising,
the medicinal herb comfrey is good for much of what ails you, from aiding
digestion to treating asthma. One Web site even proclaims that placing
comfrey leaf in your shoes and luggage will result in a safe journey. But
two federal agencies, worried that comfrey contains chemicals harmful to
the liver, have taken steps in recent days to stop its marketing as a dietary
supplement.
That's fine with major players in
the herbals industry, who support the Federal Trade Commission's move to
prohibit a Utah company from touting oral comfrey products for such serious
ills as multiple sclerosis and spinal cancer. But they view the related
demand from the Food and Drug Administration (FDA) that companies withdraw
comfrey supplements -- and alert their customers to immediately stop using
them -- more as a belated public relations ploy than as a reaction to a
serious and urgent public health problem.
In the 1980s scientists discovered
that comfrey, used for centuries externally to heal wounds and internally
to soothe inflamed mucous membranes, contains chemicals called pyrrolizidine
alkaloids, which can cause serious liver damage -- a finding noted by the
FDA in 1993. By the mid-1990s many herbalists were recommending comfrey
for external use only; the American Herbal Products Association (AHPA),
which represents about 220 major manufacturers, distributors, importers
and retailers, put such a recommendation into its code of ethics as a condition
of membership.
"We say it's about time," says AHPA
vice president Joseph Betz. "The most annoying part of the [FDA's] letter
is they've essentially adopted our trade recommendation -- but haven't
given us credit."
Yet the FDA's Christine Lewis, who
wrote the letter, says it's not clear there is a consensus against internal
use of the herb, noting that AHPA represents only a portion of a large
industry. While the FDA has had concerns about comfrey for a long time,
she explains, documenting that a product is unsafe and meeting the agency's
burden of proof that there's a "significant or unreasonable risk" is a
labor-intensive and time-consuming process. The FDA did not cite any new
proof about comfrey in its letter, nor did it mention recent cases of comfrey-related
poisoning.
Mark Blumenthal, president of the
American Botanical Council, one of eight groups that received the FDA letter,
says there are flaws in it: The agency failed to distinguish Russian and
prickly comfrey, which contain liver-toxic chemicals, from common comfrey,
which lacks them. The agency failed to point out that comfrey's root has
about 10 times the alkaloids as its leaf, and didn't acknowledge that alkaloid-free
comfrey extracts are available.
"Our concern is the unsafe ingredients
out there," Lewis replies. There are, she adds, "probably quite a few details
here, but generally, the products are not safe."
James Duke, former chief of the U.S.
Department of Agriculture's medicinal plants research laboratory, thinks
otherwise. Duke, who grows comfrey in his garden, says it is "an excellent
herb externally and very unlikely to cause problems internally. It does
contain traces of pyrrolizidine alkaloids, and anyone eating it like spinach
three times a day for 10 years might have a problem, but nobody in their
right mind is going to do that."
© 2001 The Washington Post Company
Judy Packer-Tursman