State Journal-Register
                           10/9/94

        Law will ban unproven diet supplement claims

THE ASSOCIATED PRESS

  WASHINGTON--Congress decided a bitter fight between
dietary supplement makers and their critics Friday, passing
legislation that allows any supplement to be sold once it
has been shown to be safe, but banning most claims to cure
or prevent illness.
  The Senate passed the bill early Saturday and sent it to
President Clinton for his expected signature. The House
passed the bill Friday.
  "This bill resolves an extremely contentious issue," Rep.
Henry Waxman, D-Calif., said before the House passed the
bill by voice vote at 3 a.m. Saturday and sent it to the
Senate.
  The measure would require manufacturers of vitamins,
minerals, herbal products and amino acids to follow for four
years very strict government rules on product health claims
--rules companies say constitute a ban.
  The bill would set the first safety standard for dietary
supplements: They must not pose a "significant or
unreasonable risk" of injury if used as directed.
  And makers of new products would have to show the Food and
Drug Administration proof that they are safe 75 days before
they go on the market, so FDA has a chance to fight any sup
plements it fears are dangerous.
  Those provisions were the most fiercely fought in the
two-year battle over the $4 billion industry. Companies
contended FDA unfairly treated their mostly natural products
as drugs, and spent S2.5 million lobbying Congress to change
that. Critics charged the industry with selling snake-oil
therapy.
  Half of all Americans are estimated to consume dietary
supplements, and about 2 million wrote Congress asking for
legislation ensuring their access to the products.
But Friday, both sides were happy.
  The bill "will help to keep our industry alive," said
Gerald Kessler of the Nutritional Health Alliance.
  "Now dietary supplements will be regulated within a
rational framework," said Michael Ford of the National
Nutritional Foods Association.
  "We are delighted," said Bruce Silverglade of the consumer
group Center for Science in the Public Interest. "The bill
preserves access to supplement ingredients while protecting
consumers from misleading health claims and unsafe
products."
  The bill amends a Senate version, adding the safety
provisions to beef up FDA oversight. The new version is
expected to easily pass the Senate before Congress adjourns
this weekend.
  The other major change is that supplements comply with
strict health-claim rules for four years, instead of the two
years the Senate had mandated.
  At issue are FDA standards that require significant
scientific agreement on the disease benefits of supplements
before a product can make a claim. Only calcium to prevent
osteoporosis and folic acid to fight birth defects have
passed FDA muster.
  Manufacturers say significant agreement is almost never
found in science, and that FDA-rejected claims such as
"anti-oxidant vitamins prevent cancer" should be allowed.
  Under the compromise bill, a presidential commission
composed of supplement experts would study the issue for two
years and decide how health claims should be treated. Then,
the secretary of health and human services would have two
adjust FDA rules. If the secretary did not, Congress could
reopen the issue.
  But manufacturers did win some leeway--the right to label
how a substance affects bodily function.  They could say,
for example, that Vitamin A is necessary for good vision.
  That does not mean people need extra supplements of
Vitamin A, which is easily found in the U.S. diet, to
maintain normal vision, Silverglade said. "Consumers will
have to . . . be on guard against such dubious promotional
tactics," he said.
  FDA will be looking carefully at such claims to ensure
they're not deceptive, said spokesman Jim O'Hara.