FDA Loses Supplements Fight
March 1999 Issue of Natural Foods
Court rules that health claims are OK, information helps, not
hurts, on labels
The FDA lost a key legal battle recently, and now the agency must
define just what it means by "significant scientific agreement" for health
claims on supplements labels.
The U.S. Court of Appeals ruling
validated what many in the supplements industry have been saying for years: more
information on supplements' labels translates into better educated consumers.
The natural products industry
has served as the voice of the dietary supplements consumers in this matter,
according to Susan Haeger, president and CEO of Boulder, Colo.-based Citizens
for Health, a plaintiff in the five-year lawsuit. "[We are] extremely pleased
that the appellate court has told FDA to define significant scientific
agreement," she said. "This landmark decision is absolutely essential to allow
consumers to make informed choices about their health care and is likely to have
The ruling overturned a lower
court decision that had ruled that the FDA could continue to operate the way it
had in the past. Lawyers for the FDA have not yet announced if they will appeal
the latest decision to the Supreme Court.
Some of the implications of the
appeal court's intent are apparent in the sharply worded comments in the ruling
directed at the FDA. The court criticized the agency's argument that health
claims lacking significant agreement are inherently misleading: "...It would be
as if the consumers were asked to buy something while hypnotized, and therefore
they are bound to be misled," according to the judges of the District of
Columbia Appeals Court. "We think this contention is frivolous."
The ruling also included the
right for dietary supplements manufacturers to put more information on labels
than is currently acceptable. This includes disclaimers as well as health
The ruling went on: "Although
the government may have more leeway in choosing suppression over disclosure as a
response to the problem of consumer confusion where the product affects health,
it must still meet its burden of justifying a restriction on speech--here the
FDA's conclusory assertion falls far short."
Retailers said they were excited
about the ruling. "From where we are sitting, we see it as a good decision,"
said Jim Lee, president of Boulder, Colo.-based Wild Oats. "To define
significant scientific agreement--simply put, it means that more information
will be provided to our customers. And we know our customers want that."
The January decision came in a
case originally filed by a group that included the American Preventative Medical
Association, Citizens for Health, People Against Cancer and others. In 1994
those groups filed a lawsuit against the FDA, asking the agency to define
"significant scientific agreement"--the standard FDA phrase for regulating
health claims allowed on supplements' labels.
"I am absolutely thrilled that
the court has recognized the validity of our position and instructed the FDA,
finally, to define significant scientific agreement," said Ralph Miranda, M.D.,
president of the preventative medicine association. "Now, the FDA will no longer
be able to get away with continually raising the bar for supplements
manufacturers in an effort to prohibit the dissemination of truthful, scientific
In addition to defining
"significant scientific agreement," the court ordered the FDA to reconsider the
following four claims made in the 1994 lawsuit:
* Consumption of antioxidant
vitamins may reduce the risk of certain kinds of cancers.
* Consumption of fiber may
reduce the risk of colorectal cancer.
* Consumption of omega-3 fatty
acids may reduce the risk of coronary heart disease.
* A supplement with 0.8
milligrams of folic acid is more effective in reducing the risk of neural tube
defects than a lower amount in foods in common form.
Watch for more work on this
issue in the courts later this year, said Tony Martinez, New Jersey- and
Washington D.C.-based attorney and lobbyist who worked for the natural products
industry on the Dietary Supplement Health and Education Act of 1994. "This
decision represents an important and significant victory for the attorneys
involved. They deserve the thanks and congratulations from the industry," he
said. "It will be interesting and significant to see what objective criteria the
FDA develops for significant scientific agreement."
-- Substitute for a drug, through a name such as "Herbal Prozac" or claims
that they contain aspirin or another well-known drug.
But supplement claims clearly targeted to help a well person stay well would
be OK. The FDA said naming a supplement "Cardiohealth," for instance, is legal,
as is saying it "supports the immune system," "reduces stress" or "helps
maintain cardiovascular function."