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Lactation Information and Discussion <[log in to unmask]>
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Sun, 2 Apr 2000 00:17:36 EST
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Dear Friends:
    I thought this article was timely to our discussion about prescribing.
While many of the comments are related to pregnancy, they certainly could
apply to lactation. What do you all think?

Want to send this story to another AOL member? Click on the heart at the top
of this window.

Dietary Supplement Claims Debated

By RANDOLPH E. SCHMID
.c The Associated Press


GAITHERSBURG, Md. (AP) - From strong modern vitamins to the traditional
comfort of herbal teas, health experts are debating whether dietary
supplements should be allowed to claim benefits for pregnant women.

Some worry about another thalidomide tragedy, a repeat of the deformed babies
of four decades ago whose mothers took the anti-nausea drug.

But others fear that too many warnings could frighten mothers-to-be away from
supplements of proven value such as vitamins and folic acid.

The Food and Drug Administration, which must decide what the supplements can
claim on their labels, hosted a jammed hotel ballroom here Thursday to hear
conflicting evidence.

Some speakers warned of possible hidden dangers in products that do not have
to face government regulation or the extensive testing of drugs.

``The notion that dietary supplements are safe may be debated, but when it
comes to the fetus we do not know,'' Allen A. Mitchell of Boston University
told the panel, urging a ban on all claims relating to pregnancy.

Jan M. Friedman of the University of British Columbia added that just because
something is natural or has been used for many years doesn't necessarily mean
it's safe.

Ranging from exotic herbs like cat's claw and blessed thistle to better known
vitamins and minerals, dietary supplements have become among the nation's
biggest sellers in recent years. Sales nearly doubled from $3.3 billion in
1990 to $6.5 billion in 1996.

At one time medical students were taught there was no evidence that alcohol
was hazardous for a fetus, since it had been used for thousands of years, he
said. ``We didn't know about fetal alcohol syndrome because it hadn't been
studied,'' he said.

Dr. Donald R. Mattison of the March of Dimes Birth Defects Foundation opposed
allowing supplements to be promoted for such things as morning sickness and
leg swelling.

He warned that it may be hard for an expectant mother to tell the difference
between ordinary nausea and swelling that are part of pregnancy and more
severe forms that can be a sign of serious illness.

But makers of herbal and chemical supplements argued that their products are
safe and carefully labeled.

``Products that have a centuries-long tradition of providing comfort to women
should be allowed to continue providing that comfort,'' said Michael McGuffin
of the American Herbal Products Association, citing peppermint tea and ginger
products as examples.

Of more than 640 herbal products listed by his association, more than 200
already carry cautions against use by pregnant or nursing women, he pointed
out.

Dr. R. William Soller of the Consumer Healthcare Products Association said
his organization this week adopted a voluntary program of labeling most
supplements with a warning that pregnant or nursing women should check with a
health professional.

The exceptions, he said, include such things as multivitamins and folic acid
which are of proven value in pregnancy.

Rules announced in January by FDA would have permitted supplements to claim
usefulness for such things as morning sickness and swelling of the legs,
considered a normal part of pregnancy.

But the agency backed off after receiving complaints that some supplements
could be harmful to pregnant women and their unborn children. It directed the
manufacturers not to make any claims until it could restudy the issue.

Congress banned the FDA from regulating the manufacture or sale of
supplements, but it can insist that labels be truthful. Health claims can be
made only if they meet criteria set by the FDA.

In the rules for supplements announced in January, the agency said it would
allow claims related to the normal ``structure-function'' of the body without
prior review. These include such claims as ``calcium builds strong bones,''
and ``fiber maintains bowel regularity.''

On the other hand, a statement that a supplement can treat, cure or ease a
specific disease would mean it is claiming to be a drug and would not be
allowed without approval.

On the Net:

FDA Center for Food Safety and Applied Nutrition: http://vm.cfsan.fda.gov

FDA Center for Drug Evaluation and Research: http://www.fda.gov/cder and
click on calendar for supplements meeting information

Council for Responsible Nutrition: http://www.crnusa.org

Consumer Healthcare Products Association: http://www.ndmainfo.org/

Center for Science in the Public Interest: http://www.cspinet.org

Warmly,
Nikki Lee RN, MSN, Mother of 2, IBCLC, CIMI, CSTP
Elkins Park (a suburb of Philadelphia, Pennsylvania; northeastern USA)
supporter of the WHO Code and the Mother Friendly Childbirth Initiative

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