The US Food and Drug Administration
once had the power to force manufacturers of over-the-counter
dietary supplements, including herbal remedies, to prove those
products were safe, if the agency felt such a pre-market review was
warranted.That changed in 1994, when
Congress passed the Dietary Supplement Health and Education Act,
which gives sellers of vitamins and herbs the freedom to tout the
alleged benefits of their products without much FDA intervention.
Since DSHEA, it's been possible to put a
supplement on the market and keep it there until the FDA finds clear
evidence that the product is harmful. Unlike drugs regulated by the
FDA, dietary supplements and herbs do not have to be proven to be
safe or effective to be sold.
Before DSHEA, all health claims on supplements -
as on food - had to have FDA approval before marketing. Since DSHEA,
manufacturers have been able to make "structure/function" claims
without prior approval. That means they haven't been able to say a
product prevents a particular disease, like depression, but they can
say something vague like the product is a "mood enhancer."
But the vagueness of struc ture/ function claims
has caused considerable confusion among consumers. In response to
that, last week, the FDA issued a new ruling on disease claims,
which takes effect in 29 days.
It states that a number of common conditions such
as aging and pregnancy are normal life stages, not diseases, and
therefore manufacturers can make structure/function claims for
products aimed at them, says Peggy Dotzel, acting associate
commissioner for policy at the FDA.
But some consumer advocates say the ruling is a
blow to consumer protection. The change is a "huge weakening" of the
previous FDA proposal, says Dr. Sidney M. Wolfe, director of Public
Health Citizen Research Group in Washington, D.C. It is "a snake-oil
exemption" and a "complete cave-in to the industry."
On the other hand, industry representatives were
delighted.
"The FDA has backed down from its previous,
ill-considered proposal to redefine the word `disease' by broadening
it. . .to include nonpathological states that are a normal function
of aging or the body," said Mark Blumenthal, executive director of
the American Botanical Council in Austin, Texas, a nonprofit
research and education organization funded in part by the herbal
industry.
Under the FDA's original proposal, "menopause
would be considered a disease. Even balding and graying of a beard
would have been considered a disease," he said.
In essence, he added, the final rule now "allows
herbal products to continue making certain kinds of claims that
might not have been able to be made had that definition of disease
gone into final status."
With manufacturing of herbal products, DSHEA
requires only that manufacturers produce them in accordance with
"good manufacturing practices" of the food industry. But there is a
wide range of standards within the food regulations, which are often
less stringent than those in the pharmaceutical industry.
The FDA is now writing more stringent
manufacturing regulations for supplements and has sought comments
from supplement makers and the public.
While the United States continues to struggle with
ways to regulate the herbal industry, other countries have long had
a better grip on things.
In Germany, herbal products are regulated largely
as pharmaceuticals - both as prescription and over-the-counter
drugs, notes John Cardellina of the Council for Responsible
Nutrition, a Washington-based group representing the supplement
industry. But, he adds, the German "approval process for drugs is
not as stringent as the FDA approval process."
Judy Foreman’s column runs every other week. Past
columns are available on
www.myhealthsense.com.
Listen to her live
call-in webcast radio show every Wednesday night
from 8:30 to 9:30 EST on
http://www.healthtalk.com.
