Saturday, January 27, 2007

01/27/07 - New attacks on vitamins... and AER - DEATH by Medicine

Vitamin Lawyer on HealthRadio; Vitamin Shoppe under attack; DEATH by medicine

Vitamins are under major media attack -- again. A new Adverse Event Reporting Law has been signed by the President. These issues are so important for Dietary Supplement Purveyors, that I reproduce below most of the report from Nutraingredients-USA and devote this entire issue of my Update eMemo to the attack:

The Vitamin Shoppe calls for independent testing procedures - By Clarisse Dou

1/26/2007- Following the withdrawal of its women’s multivitamin product - as a result of allegations of high lead content by - the Vitamin Shoppe has expressed both its desire to get to the truth of the matter and for industry to devise new testing methods.

NutraIngredients-USA ran an article Wednesday on the Vitamin Shoppe's decision to withdraw its "Especially for Women" multivitamin. The decision was sparked by the highly publicized results of a study conducted by industry watchdog that pinpointed 11 products - out of 21 tested - as not meeting their labeled contents and standards.

The Vitamin Shoppe… said… “Our industry badly needs an independent testing procedure that truly has the best interests of the consumer at heart…”

ConsumerLab said the Vitamin Shoppe’s multivitamin was contaminated with 15.3 micrograms of lead per daily serving. This is more than ten times the amount of lead permitted without a warning label in California – the only state to regulate lead in supplements – and several times the normal daily exposure to lead…

The Vitamin Shoppe has also stood by its assertion that its products are manufactured according to Good Manufacturing Practices (GMPs). “We have strict checks and record keeping requirements that follow "Good Manufacturing Practices" for food and all products delivered to our distribution facility.”

Draft current GMPs were published in 2003, but the final version of the guidelines are reported to still be going through a law-making process at the Office of Management and Budget.

“There is a proposed regulation for GMPs that are specific for dietary supplements that have been in discussion since 1995… “We regularly audit our contract labs to assure that they are complying with our educated best guess as to what these proposed regulations will entail and for the legally required compliance with food GMPs.”

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So, what does this mean to the average vitamin company? These are the points to consider –

First: cGMPs are about to become a center of the attack on the industry.

Second: the attack continues, in different ways and places. Just a week ago Tuesday, the New York Times carried a major article attacking vitamins as potential poisons – my comments and those of Maury Silverman – prepared for my appearance last Saturday on HealthRadio - Dr. Alan Pressman, - are below:

Date: Thu, 18 Jan 2007 03:26:45 PM EST
From: "Ralph Fucetola JD"

Subject: The Safety of Dietary Supplements

Well, Dr. Pressman, I looked at the NY Times propaganda piece.

I'd be happy to appear on your show this Saturday. What strikes me is the extraordinary SAFETY of supplements -- one death in 60,000 complaints, for example, with many ten millions of users - 230 deaths in 23 years. Compare that to aspirin - 1,500 deaths per year, every year. Etc.

With the new Adverse Event Reporting law, we may get better statistics over the next few years. See: .

Among other failures, the Poison Control people are not collecting the right information. It has been suggested by some critics of such studies that often the adverse reaction is caused by the interaction with drugs and it is the drug that is to blame, not the food substance.

Maury Silverman recently wrote me (about implementing the new AER law):

"Implementing 'objectively' has been stated many times here, meaning to first identify concurrent use of foods and dietary supplements with drugs of any kind, be they prescription, OTC, or illegal/illicit/counterfeit.

"Once that is done on the MedWatch form your company now must fill out once a complaint comes to you that must be reported to FDA, the FDA should screen out drug-drug interactions & drug-nutrient interactions, (which are inherently drug problems). The current MedWatch form is very inadequate to gather this

"This is important so that:

" (1) the dietary supplement ought not be blamed for a serious adverse event prompting a lawsuit against your company, or yourself since you are so
numerous on the record as disbelieving and/or being delusional on this matter.

" (2) The FDA can require labeling of the drug, for contra-indications, known drug-drug and/or drug-nutrient interactions. As drugs are so inherently
more dangerous than foods and dietary supplements, better labeling of drugs, first, is vital importance to the nutrition industry and the public health.

" (3) Drugs can be labeled for the nutritional deficiencies they cause. That goes also for alcohol, caffeine, and nicotine when poor nutrition is concurrent.

" (4) More 'E' can be put into the full implementation of DSHEA. This means more quality information from the nutrition community on how to avoid
adverse events, when there is concurrent usage with drugs.

"The problem is too often that the medical establishment does not educate or train its practitioners on nutrition and the healing qualities of natural products. They are more likely than not, drug salespeople. From when I was a youngster, I do remember that people grew up on food and good nutrition, not DRUGS.

"I suggest here that you look at the article in the October 9, 2006 issue of Archives of Internet Medicine titled: "Factors Associated with Dietary Supplement Use among Prescription Medication Users". (166: 1968-74, 2006)"

Allen, Thanks for the opportunity to respond to obvious BS.

Third: The current attack on vitamins needs to be seen in light of AER – Adverse Event Reporting. AER implementation will be directly tied to these developments. And, a word to the wise: The new AER law is not concerned with the general propaganda that nutrients are not safe, as a class of food. Nutrients are generally recognized as foods, and foods are generally recognized as safe when ingested as directed. AER is concerned with specific batches of specific products and whether they are contaminated or otherwise unwholesome. AER may provide the ammunition to yet again prove nutrients safe.

Please review what we have to say about AER developments on the AER Consultants web page, – we will post information on developments there. AER Consultants will engage with the FDA on the issues that need to be covered by the AER regulations to protect the industry as well as the consumer. Your thoughts on that would be appreciated, so please let me know what you think needs to be included.

What can concerned citizens, health freedom activists, alternative practitioners and dietary supplement purveyors do to protect their access to wholesome, high potency nutrients? Stay informed! Be ready to make your views known. Support health freedom groups like - if you are in the industry, realistically analyze the situation and remember, “Management manages…”

And now for the counter-punch... DEATH by medicine:

Previously published by the Life Extension Foundation, Gary Null and several other healthcare professionals lay it out: government-approved, standard medicine is the single greatest CAUSE of preventable death in the USA. While we've known this for a while, it's useful to see the statistics all brought together in one article, especially now that Dietary Supplements and natural alternatives seem under heavy media attack.

Well, that’s all for now.

Ralph Fucetola JD

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