Fwd: Panel: FDA Can Move Against Supplements (AP News Article)

[Guest guest]

3 Apr 2004 05:20:09 -0000

" IAHF.COM "

Panel: FDA Can Move Against Supplements (AP News Article)

 

IAHF Website: Breaking News, Whats New, What to Do, All Countries, EU FSD,

Codex, DSHEA

 

IAHF List: The Associated Press published the article below in the aftermath of

the National Academy of Sciences unleashing their report " Dietary Supplements: A

Framework for Establishing Safety " http://books.nap.edu/books/0309091101/html/

 

This AP article will undoubtedly be picked up by major newspapers world wide and

used to fuel the rabid global attack against dietary supplements.

 

Additionally, Consumer Reports has generated an article which calls for a dozen

supplements to be yanked from the shelves.

See

http://www.consumerreports.org/main/content/display_report.jsp?FOLDER%3C%3Efolde\

r_id=419337 & bmUID=1080967795242

 

I checked the Thomas legislative database to see if S.722 The (so called)

Dietary Supplement Safety Act of 2003 had picked up any cosponsors as a result

of these announcements. (It hasn't, but I'll keep monitoring it.)

 

The best way consumers world wide can continue to defend their access to

supplements remains to contribute to the Alliance for Natural Health's lawsuit

to overturn the EU Food Supplements Directive- see

http://www.alliance-natural-health.org

 

Please forward this information widely, we have our work cut out for us to

offset this Associated Press article:

 

 

http://customwire.ap.org/dynamic/stories/F/FIT_DIET_SUPPLEMENTS?SITE=APWEB & SECTI\

ON=HOME & TEMPLATE=DEFAULT

 

Panel: FDA Can Move Against Supplements

 

By LAURAN NEERGAARD

AP Medical Writer

 

WASHINGTON (AP) -- The Food and Drug Administration doesn't need direct evidence

of human harm before taking steps to curb sales of a dietary supplement, an

advisory panel reported Thursday.

 

Data from animals, test-tube studies, even similar products can suffice, the

panel said.

 

Still, Congress should require manufacturers to report customers' side effects,

thus easing constraints lawmakers have placed on the FDA's ability to protect

the public from dangerous supplements, the Institute of Medicine concluded

Thursday.

 

The report promises to bolster new FDA efforts to crack down on risky

supplements - and challenges long-held assumptions that the agency must prove an

ingredient unsafe before pulling it off the market.

 

Not true, concluded a panel of well-known scientists from the institute and its

sister agency, the National Research Council.

 

 

 

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" You don't have to have proof of harm, " stressed Barbara Schneeman, vice provost

and a nutritionist at the University of California, Davis, who headed the panel.

 

The law requires the FDA to demonstrate significant or unreasonable risk from a

supplement, something the panel insisted can be done with less strict evidence.

The report provides FDA with step-by-step instructions on how to evaluate

supplement safety when there isn't clear-cut human data.

 

By setting a scientific framework for the FDA's work, " it's certainly our hope

this is going to allow them to be more effective in identifying substances that

could pose a risk for harm to human health, " Schneeman explained.

 

Contrary to frequent claims by supplement proponents, neither an absence of

reports of side effects nor a product's long history of use automatically mean

it's safe, the report cautioned.

 

Indeed, legal " constraints imposed on the FDA make it difficult for the health

of the American public to be adequately protected, " the report concluded,

calling on Congress to better fund the FDA's oversight of supplement safety -

and to mandate manufacturers' reporting of customers' side effects, just like

medication makers must.

 

Sen. Richard Durbin, D-Ill., has introduced legislation for side-effect

reporting; support is uncertain.

 

The $19 billion dietary supplement industry - with products ranging from

mainstream vitamins to controversial hormones and stimulants - is loosely

regulated. A 1994 law sought by the industry means that, unlike most

medications, most supplements sold today never had to be proven safe, much less

proven to bring any health benefit.

 

The burden is on the FDA's $10 million dietary supplements office, with a staff

of 25, to uncover enough evidence to push risky ones off the market. Later this

month, the heart attack- and stroke-causing herb ephedra is slated to become the

first supplement formally banned under the law's provisions.

 

That ban comes after 155 deaths that were linked to the herbal stimulant and a

pitched eight-year battle with ephedra supporters. The FDA at first said it

lacked enough proof of harm for a major crackdown but later reversed that

position. In December the agency set a legal precedent by making ephedra's

actions inside the body key to its risk analysis, rather than simply trying to

prove it caused individual deaths.

 

The Institute of Medicine report " appears to be consistent " with the ephedra

approach, said Dr. Susan Walker, the FDA's dietary supplement chief. " We

anticipate this will be a very useful document. "

 

But even with clearer instructions, providing enough evidence to ban a risky

supplement " may take a considerable period of time, " she cautioned.

 

The industry stressed that the report did say most supplements probably are

safe.

 

" I see this report as an attempt to establish a framework that addresses, in a

predetermined manner that everybody understands - the regulator, the regulated

industry - how we can address safety issues, " said Michael McGuffin of the

American Herbal Products Association.

 

His group supports mandatory reporting of serious side effects.

For Health Freedom,

John C. Hammell, President

International Advocates for Health Freedom

556 Boundary Bay Road

Point Roberts, WA 98281-8702 USA

http://www.iahf.com

jham

800-333-2553 N.America

360-945-0352 World

 

 

 

 

 

 

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