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Bill Sardi
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Posted July 27, 2011: by Bill Sardi
San Dimas, CA (July 26, 2011)- Idebenone gets the headlines today for restoring vision to patients with an otherwise incurable inherited eye disease — Leber’s heredity optic neuropathy. And this discovery suggests idebenone may be helpful for patients with glaucoma, another optic nerve disease.
You may not be familiar with idebenone, produced by a pharmaceutical company in Japan. But you may have heard about idebenone under another name – coenzyme Q10. Idebenone is known as synthetic analog of coenzyme Q10, a natural antioxidant produced in the body. To be sold as a patentable drug in Japan the molecule had to be re-arranged molecularly.
Posted in Dietary Supplements ; No Comments »
Posted : by Bill Sardi
SAN DIMAS, CA (July 26, 2011) -Saying the newly proposed safety guidelines for dietary supplements would likely eliminate most children’s vitamins from store shelves, the first official comment regarding the FDA’s New Dietary Ingredient guidelines has been submitted, and it also calls for dietary supplements to be removed from oversight by the FDA altogether. The newly proposed guidelines were published on July 1 and are subject to a 90-day comment period.
Bill Sardi, long-time dietary supplement advocate, health writer and dietary supplement formulator, speaking from his office in San Dimas, California, says dietary supplements are safer than tap water, table salt, aspirin and even food and it is unlikely the newly proposed guidelines will make them any safer. His 16-page critique of the FDA’s newly proposed safety tests, available for viewing at www.knowledgeofhealth.com ,demands that an economic impact report be commissioned before any further action is taken by FDA.
Posted in Dietary Supplements, Health Care System, Vitamins ; No Comments »
Posted : by Bill Sardi
The predicted power grab of herbal and dietary supplements, many which have the same biological action as prescription drugs, is now underway. Drug patents face expiration (see article below) and profits will crash at pharmaceutical companies. Stock prices will fold for Big Pharma. The pipeline for new drugs is bare.
The New Dietary Ingredient guideline proposed by FDA would cost billions of dollars, result in many supplements being withdrawn from store shelves not because they are unsafe but because they can’t afford the onerous testing requirements to prove they are safe, and will wipe out most small business entities in the supplement business. One consequence, under the FDA guideline, children’s vitamins would virtually disappear, as they must undergo costly 1-3 year tests to prove they don’t cause birth defects. New Dietary Ingredient testing will cost tens of billions of dollars. The retail price for supplements will have to rise to that of drugs, and being unaffordable, consumers won’t be able to buy them.
Posted in Dietary Supplements, Health Care System ; No Comments »
Posted July 22, 2011: by Bill Sardi
New Dietary Ingredient Notifications and Related Issues; Availability
Docket No. FDA-2011-D-0376
Comment Tracking Number: 80ec9da3
Date: July 22, 2011
To:
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
From:
Bill Sardi
Knowledge of Health, Inc.
457 West Allen Avenue, Suite 117
San Dimas, CA 91773
This comment is submitted to the FDA under 21 CFR 10.115(g)(5)).
Outline
Posted in Dietary Supplements, Health Care System ; No Comments »
Posted July 11, 2011: by Bill Sardi
It’s the middle of summer on a holiday weekend, late on Friday afternoon, and the American public is readying themselves for another 4th of July celebration. It’s the typical point in time, when the populace is distracted, that government agencies often pick to release a bombshell that won’t likely be popular with the public. And it was some bombshell.
The Food & Drug Administration (FDA) had secretively, albeit belatedly, drafted a 47-page guideline pointed at dietary supplement companies, with a demand they prove their newly introduced products are safe. It was written without input from industry. The rub is that the guideline extends back 16 years to any new dietary ingredient introduced after the Dietary Supplement Health & Education Act (DSHEA) was passed in 1994. This includes popular dietary supplements such as resveratrol curcumin, hyaluronic acid, acai berry, and many others. Thousands of new dietary ingredients have been introduced over that time, and only a few hundred of them actually had safety data filed with the FDA. Shame, shame.
Posted in Dietary Supplements, Health Care System ; No Comments »
Posted July 7, 2011: by Bill Sardi
The dietary supplement industry has only 90 days to comment on the FDA’s new dietary ingredient guidelines, which would require many supplements currently on the market (since 1994 when the Dietary Supplement Health & Education Act was passed) to undergo onerous and expensive safety testing.
Some of the animal testing would requires 3 years to complete. It is difficult to ascertain the cost of meeting these new requirements but it appears to be in the millions of dollars for each ingredient. It would take 3 years before any new dietary ingredient could be introduced as well. Essentially, the only way these natural medicines would remain on the market is to make them expensive prescription drugs. You are talking about many well known supplements such as resveratrol, hyaluronic acid, piperine, curcumin, etc.
Posted in Dietary Supplements ; No Comments »
Posted July 1, 2011: by Bill Sardi
Autoimmune disorders affect an estimated 8% of the population, 78% of whom are women, says a Centers of Disease Control report. Many would dispute 8% is a low figure. One reason may be that not only is autoimmune disease, like many other broadly defined maladies, under-reported, but women with autoimmune problems may also be the most vocal in their cry for help.
The most well-known autoimmune disorders are rheumatoid arthritis, lupus, MS. Type I (childhood) diabetes and Hashimoto’s. For a list of diseases defined as autoimmune in origin, click here.
The reasons for the high prevalence in women are unknown, but may have to do with women’s proclivity to drinking cow’s milk (more about this in a moment) to replace lost calcium during pregnancies and during menopause.
Posted in Dietary Supplements ; No Comments »
Posted June 20, 2011: by Bill Sardi
June 16, 2011 The New York Times
By JOHN TAGLIABUE, COPENHAGEN
For the last seven years, Marianne Orum has owned a narrow store in a charming street in the heart of this Danish capital.
But in January Ms. Orum got a phone call from government food inspectors. Tipped off by a competitor, they told her she was selling products that were fortified with vitamins or minerals, and such products require government approval, which she did not have, so she would have to take them off the shelves.
Posted in Dietary Supplements ; No Comments »
Posted June 9, 2011: by Bill Sardi
I’m writing in a less hopeful mood today. The optimism that the masses would get wind of the ruse being played upon them by the pharmaceutical companies and the excessive testing and treatment prescribed by doctors is all but a fading dream.
The Internet was the medium that was predicted to lead a patient-driven health revolution. While the Internet has expanded and penetrated into most American homes over the past decade, no bona fide health revolution is on the horizon. In fact, the greatest online traffic for health related issues emanates from spammers and online hucksters, not from Paul Revere-like pioneers who want to overthrow the reigning disease-care system.
Posted in Health Care System, Modern Medicine ; No Comments »
Posted June 5, 2011: by Bill Sardi
Why does modern medicine refuse to consider the many drawbacks of statin drugs?
Posted in Dietary Supplements, Modern Medicine ; No Comments »
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