FDA WRONG, ONCE AGAIN
FDA and Vitamins
Orthomolecular Medicine News Service, October 9, 2008 (Updated June 20, 2011)
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.fda.gov/food/dietarysupplements/alerts/ucm111110.htm 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
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 "
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.
(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
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