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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 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 »
Posted May 19, 2011: by Bill Sardi
While cardiologists cast a blind eye at potential liver and muscle side effects induced by statin cholesterol-lowering drugs, natural health advocates suggest coenzyme Q10 supplementation to avoid the potential side effects of muscle degeneration (myopathy) associated with these drugs. In fact, coenzyme Q10 supplementation (100 mg/day) has been shown to reduce the severity of muscle pain among statin drug users by 40%. However, there is more to this story than C0-Q10.
For some time now it has been noted in the medical literature that the pattern of side effects associated with statin drugs resembles selenium deficiency. Statin drugs have a negative effect upon selenium proteins which does seem to explain many of the enigmatic effects of statin drugs. The underlying biochemical mechanisms for this are now well described.
Posted in Dietary Supplements, Minerals, Modern Medicine ; No Comments »
Posted April 29, 2011: by Bill Sardi
A question arises: would American adults be better off using their out-of-pocket medical expense money to buy dietary supplements rather than drugs?
Before the dollars-and-cents of this issue is addressed, a major misdirection by American medicine needs to be confronted. The prevailing practice of modern medicine is to consider every malady a drug deficiency. Yet we know so many health problems emanate from overloads or deficiencies of essential nutrients. Examples would be: for a nutrient deficiency — mental depression from a lack of folic acid, and for nutrient excess — high cholesterol, fatty liver and arterial disease from iron overload.
So many drugs that are prescribed are inappropriate because the condition they are prescribed for has a nutritional origin. The drug never addresses the true cause of disease, it only masks its symptoms. Furthermore, the biological action of most prescription drugs can be duplicated with dietary supplements, with fewer side effects and lower cost.
There is good reason to search for alternatives to prescription drugs beyond just cost. Inappropriate prescribing is a widespread problem in modern medicine, despite the many checkpoints (doctor, nurse, pharmacist) prior to patient use. Oftentimes, “drug therapy can do more harm than good.” One recent study found 69% of elderly patients were prescribed inappropriate medications. This study did not include factoring for underlying nutritional deficiencies caused by drugs themselves.
Posted in Dietary Supplements, Health Care System, Modern Medicine ; No Comments »
Posted April 22, 2011: by Bill Sardi
Commercially available foods are supposed to be tested for bacteria and fungi. While the foods we eat at not sterile (devoid of germs) they are supposed to be have low bacteria and fungal counts, leaving our stomach acid to kill off the remaining microbes in the stomach. However, the overseers of the US food supply, the US Department of Agriculture and the US Food & Drug Administration, are permitting unclean food to reach consumer markets, and this time it isn’t just ordinary bacteria, it is life-threatening antibiotic-resistant bacteria like Staphylococcus aureus and E. Coli! And these treatment-resistant germs are killing thousands of Americans. You can read the whole sordid story here.
This problem has been spawned by the use of low-dose antibiotics in animal feeding. Instead of animals being raised and their meat processed in clean environments, the animals are fed grain (mainly in the feeding pen for fattening) rather than grass, and this increases the bacterial count 100-fold. Public health authorities then shift the blame for any foodborne infections on the consumer for not cooking their meat sufficiently to kill bacteria.
Posted in Dietary Supplements, Germs ; No Comments »
Posted April 18, 2011: by Bill Sardi
According to a recent government report, which pharmaceutical companies will surely use to develop counter strategies, the use of dietary supplements is at an all-time high and rising. About 50% of the American public now uses dietary supplements.
One doesn’t know whether to declare this achievement a failure in the midst of widespread nutrient deficiencies, or a meaningful sign that the doctors and patients are adopting nutrient-based therapies.
That people are taking vitamin pills is one thing, that they are taking the right doses and forms of nutrients is another. Most supplement users have been herded into taking no more than 100% of the Recommended Daily Allowance, which is the level to avoid a frank nutrient deficiency for perfectly healthy adults, not the level for optimal health. The RDA does not apply to growing children, pregnant females, smokers, diabetics, the hospitalized, or people taking many drugs, which comprises a strong percentage of supplement users.
Posted in Dietary Supplements, Modern Medicine, Vitamins ; No Comments »
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