FDA Claims Food Supplement Deaths; Hides Details from the Public

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Orthomolecular Medicine News Service, October 9, 2008

 

FDA Claims " Food Supplement " Deaths; Hides Details from the Public

 

(OMNS, October 9, 2008) " Dietary supplements cause 600 'adverse events' " ,

reported USA Today on 22 Sept, 2008. In an article that looks much like an

official US Food and Drug Administration press release, it said that " Serious

side effects from the use of food supplements resulted in 604 " adverse-event "

reports - a list that includes at least five deaths - through the first six

months that such accounts have been required by law. " (1)

 

Good grief! Looks like all those supplement-popping health nuts really are nuts

after all. Food supplements simply must be dangerous!

 

Or are they?

 

Later on in the article, far from the headline, USA Today conceded that " An

adverse event can be anything from a concern that a supplement isn't working to

a serious illness that follows consumption. " And, FDA spokesman Michael Herndon

admitted that of the five deaths and 85 hospitalizations reported, " Some of

these deaths were likely due to underlying medical conditions. "

 

FDA's method of gaining data is suspect at best and biased at worst. Their

" Dietary Supplement Adverse Event Reporting " webpage,

http://www.cfsan.fda.gov/~DMS/ds-rept.html, states: " FDA would like to know when

a product causes a problem even if you are unsure the product caused the problem

or even if you do not visit a doctor or clinic. " The measure of uncertainty

involved in publicly soliciting adverse reports " even if you are unsure that the

product caused the problem " is noteworthy.

 

But most significant of all is that FDA refused to disclose exactly which

supplements allegedly were causing problems. Doesn't the public have a right to

know? In the absence of FDA disclosure to the contrary, it is likely that the

five or fewer deaths attributed to " food supplements " were in fact due to

medicinal substances marketed as dietary supplements. FDA acknowledges this in a

round-about way at their website (http://vm.cfsan.fda.gov/~dms/mwgblghb.html).

There you will find an " Important Message " which asks health professionals to

" Report Serious Adverse Events Associated with Dietary Supplements Containing

GBL, GHB, or BD . . . a group of products sold as dietary supplements for

bodybuilding, weight loss and sleep inducement which have been determined to

pose a significant public health hazard. These products are chemically related

to gamma butyrolactone (GBL), gamma hydroxybutyric acid (GHB), and 1,4

butanediol (BD), and can cause dangerously

low respiratory rates (intubation may be required), unconciousness/coma,

vomiting, seizures, bradycardia and death. GBL, GHB and BD have been linked to

at least 122 serious illnesses reported to FDA, including three deaths. "

 

But these substances are not foods. They are not vitamins, and they are not

minerals, and they are not amino acids. They should not be considered with or as

food supplements. Over half of all Americans safely take nutritional supplements

every day. If each of those persons took only one tablet per day, that would be

some 145,000,000 individual doses daily, for a total of over 53 billion doses

annually. Many healthy people take more. And yet, according to national

statistics compiled by the authoritative American Association of Poison Control

Centers, there is not even one death per year from vitamins. (2) Look at the

reports, which detail each individual vitamin, mineral, amino acid and herb, and

see for yourself at

http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx.

 

By comparison, FDA acknowledges that prescription drugs resulted in 482,154

adverse-event reports in the year 2007. That is nearly 400 times as many adverse

events from prescription drugs per six-month period. And this much higher number

does not include over-the-counter drugs, a striking omission. Many

non-prescription drugs, such as Tylenol (acetaminophen), are a long way from

safe. Liver toxicity from acetaminophen poisoning is by far the most common

cause of acute liver failure in the United States. Acetaminophen accounted for

51% of all acute liver failure cases in 2003. (3) Indeed, the Associated Press

previously reported that common drug dangers are so bad that " Harmful reactions

to some of the most widely used medicines - from insulin to a common antibiotic

- sent more than 700,000 Americans to emergency rooms each year. " (4)

 

Vitamin supplements compete with FDA-sponsored drugs. FDA has been trying to

eliminate availability of vitamin supplements for over 45 years. As early as

1962, writes constitutional attorney Jonathan W. Emord, " FDA perceived a

competitive threat emerging to drug regulation from the sale of dietary

ingredients at above RDA doses. " In 1966, " FDA published a rule that any dietary

supplement exceeding 150% of the RDA for a vitamin or mineral would

automatically be regulated as a drug. " In 1976, after a " public outcry, " the

Proxmire Amendment prohibited FDA from deeming a vitamin or mineral a drug

solely because of potency.

 

" Undaunted, " continues Emord, " FDA tried yet again to rid the market of vitamins

in the 1970s by claiming on a case by case basis that they were adulterated

based on their potency. " FDA also tried to have supplements declared to be

unapproved food additives. " FDA's position was a logical absurdity: Single

ingredient dietary supplements were food additives because the ingredients were

added to a gelatin capsule which was, FDA said with a wink and a smirk, a food.

.. . The United States Court of Appeals for the Seventh Circuit described FDA's

position as an " Alice in Wonderland " approach. " In 1980, FDA tried to get

vitamins classified as over-the-counter drugs. . . FDA has repeatedly exceeded

the limits of its statutory authority to bring about changes designed to protect

drug companies from competition. " (5)

 

Additional evidence comes directly from FDA, whose own Dietary Task Force

Report, released June 15, 1993, said: " The task force considered many issues in

its deliberations including to ensure that the existence of dietary supplements

on the market does not act as a disincentive for drug development. " There is

also this statement was made by FDA Deputy Commissioner for Policy David Adams,

at the Drug Information Association Annual Meeting, July 12, 1993: " Pay careful

attention to what is happening with dietary supplements in the legislative arena

.. . . If these efforts are successful, there could be created a class of

products to compete with approved drugs. The establishment of a separate

regulatory category for supplements could undercut exclusivity rights enjoyed by

the holders of approved drug applications. "

 

FDA wants control of vitamins. Their latest ploy is to frighten the public into

thinking vitamin supplements are dangerous, without proof, and without even

naming the supplements they accuse. Don't fall for what Abram Hoffer, M.D.,

calls " the FDA's grand lie that, if told over and over again, is accepted as

somehow true. "

 

Vitamin supplements are not the problem. Poor eating habits, and too many

medicines, are the problem. Food supplements are a solution. They are effective,

and vastly safer than drugs. The US Food and Drug Administration knows this full

well.

 

References:

 

(1) Perez AJ. Dietary supplements cause 600 'adverse events'. USA Today, Sept

22, 2008:

http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm

or

http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm?\

POE=click-refer

 

(2) Annual Reports of the American Association of Poison Control Centers'

National Poisoning and Exposure Database, 3201 New Mexico Avenue, Ste. 330,

Washington, DC 20016. Download any report from 1983-2006 at

http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx free of

charge. The " Vitamin " category is usually near the end of the report. Summary

and commentary at: http://www.doctoryourself.com/vitsafety.html

 

(3) Larson AM et al Acetaminophen-induced acute liver failure: results from a

United States multicenter, prospective study. Hepatology 2005;42:1364-1372. See

also: http://www.medpagetoday.com/Psychiatry/Depression/tb/2233

 

(4) Associated Press, Oct 17, 2006. http://www.msnbc.msn.com/id/15305033/

 

(5) Emord JW. FDA violation of the rule of law. Speech from the Health Freedom

Exposition in Richmond, Virginia September 23, 2006.

http://www.emord.com/events/speeches/fda_violation.htm

 

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Editorial Review Board:

Damien Downing, M.D.

Harold D. Foster, Ph.D.

Steve Hickey, Ph.D.

Abram Hoffer, M.D., Ph.D.

James A. Jackson, PhD

Bo H. Jonsson, MD, Ph.D

Thomas Levy, M.D., J.D.

Erik Paterson, M.D.

Gert E. Shuitemaker, Ph.D.

Andrew W. Saul, Ph.D., Editor and contact person. Email: omns

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