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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.
Yet, during the decade-and-a-half long time gap in implementing this safety provision in the DSHEA, no birth defects were reported for newly introduced dietary supplements like there were for drugs such as diethylstilbestrol and thalidomide. With a couple of exceptions (discussed below), there were no deaths or significant side reactions attributed to dietary supplements over this same time period. New dietary ingredients had entered the marketplace for what was to be the largest uncontrolled human experiment. There would be no placebos, no eliminating criteria (stacking the deck) as with controlled studies. The young, old, infirm and sturdy partook of dietary supplements in presumed faith they were relatively safe. They weren’t wrong in their choice.
Over this same time American Poison Control Centers tabulated deaths and side reactions caused by vitamin, mineral and herbal products, and there was nary a death attributed to these self-prescribed remedies.
Oh, the weight-loss stimulant Ephedra (Ma Huang) was banned due to a few associated deaths, but those were largely attributed to overdosing on this herbal-based molecule. Oddly, the FDA continued to allow a synthetic version, pseudoephedrine, to be marketed in various over-the-counter cold and cough remedies, even though it exhibited similar biological activity.
One can overdose on aspirin, no problem. Aspirin in standard doses kills an estimated 6000 Americans every year, largely due to bleeding gastric ulcers, but remains on store shelves. It’s those dratted dietary supplements like Ephedra that have to be weeded away.
Ephedra was the only effective product to produce lean body mass in an era of growing obesity in America, and it was yanked off the shelves via irresponsible overuse by crash dieters whose families were looking to sue. The news media publicized the deaths to create public doubt over the safety of all dietary supplements. There were cries for more regulation at the time.
Then there was tryptophan, an amino acid supplement that was rapidly replacing various antidepressant drugs and sleeping pills. It was found to be a better antidepressant than placebo pills, which cannot be said for most of antidepressant drugs.
Somehow, a pharmaceutical company in Japan that made tryptophan altered their manufacturing process, which resulted in a few reported deaths. The FDA banned tryptophan in 1989 and lifted the ban in 2005, but by then consumers had been frightened away from the product.
Oddly, the US Food & Drugged Administration chose to ban all tryptophan supplements regardless of their origin. After all, America was about to enter the Prozac era of psychopharmacology. This was a tip off that the whole tryptophan fiasco was orchestrated to protect sales of prescription pharmaceuticals, which appears to be a hidden agenda at the FDA.
The problem is that during this time period many FDA-approved drugs had been recalled after they had entered into broad use and were found to be ineffective, or even worse, result in premature death. This included big-name drugs like Meridia, Bextra, Vioxx, and others. A long list of FDA-approved drugs that were eventually withdrawn from the market place can be viewed here.
Such was the case for Vioxx and Celebrex, both approved by the FDA based upon data from small groups of a few hundred subjects, and were allowed to be advertised before large-group safety data had been tabulated. This led to the premature death of thousands. Data showing an increased mortality rate among users of Vioxx were available 3.5 years prior to the date the drug was withdrawn by its manufacturer. The FDA wasn’t forthcoming about all this and a whistleblower had to reveal the problem by flying to Britain to make the announcement.
For comparison, the dietary supplement industry doesn’t have such leeway. If a few people are harmed or die from supplements, news headlines blare across the front page of newspapers as well as on network TV news. Network evening TV news programs are largely sponsored by pharmaceutical advertising, so don’t anticipate a fair hearing for dietary supplements from the news media.
In effect, there is a distorted drug safety review process where attainment of FDA approval is essentially a license to kill. If there were no FDA and these products had to stand naked to public scrutiny and legal liability without the imprimatur of a government agency, the private legal system would pounce upon these drugs in rapid manner and eliminate them via a flood of liability suits.
This writer tracked the way the news media spun the FDA announcement of new safety reporting guidelines for dietary supplements.
Susan Brady, a HealthNews.com reporter said: “rigorous testing providing safety and effectiveness data, which is required of all drugs, is not conducted in the same way for dietary supplements. And therein lies the problem.”
But just how did dietary supplements, without pre-market safety reporting guidelines, not only end up being safer than FDA-approved prescription drugs, but also comparatively safer than aspirin, tap water, table salt and even food itself?
HealthNews.com reporter Brady penned her report with the headline “FDA Attempting To Regulate Dietary Supplements,” as if a begrudging supplement industry was dragging its feet over the issue. Yet it was the FDA itself that was 16-years late in drafting the safety guidelines for new dietary ingredients. Was the FDA hoping another thalidomide-like flurry of birth defects would doom the dietary supplement industry?
Such a news report as Brady’s, which essentially posed the unstated question of “why don’t you want to be regulated?,” was like asking a man “when was the last time you beat your wife?” Any answer to that type of baited question would be defensive and self-incriminating and would not be allowed in a court of law. But there is no judge in the court of public opinion.. The dietary supplement industry is going to sound half-guilty any way it responds.
The supplement industry didn’t help itself. Reuters News reporter Emily Stephenson, in her article entitled “FDA Seeks To Ease Confusion On Supplements,” quoted dietary supplement executives who literally stuck their foot in their mouth.
One attorney, whose legal group represents dietary supplement clients, said: “Once everyone understands what it means to comply with it, you’ll see compliance increasing.”
But that made it sound like supplement companies were remiss in filing. Without written guidelines in place, supplement companies were left to guess what the FDA wanted and many New Dietary Ingredient (NDI) applications were rejected. It also made it sound like the supplement industry has no objection to the FDA guideline itself, when it is a doomsday document for many small and large companies.
The newly released guidelines spell out a long list of safety tests that may take years to complete at great expense. Some companies may be able to skirt around costly toxicity and birth defect studies if they can show years of safe use, but the FDA is talking about no less than 25 years of safe use.
The FDA surely must know that the cost of complying with the new guidelines is beyond the capability of many small companies, and larger supplement companies which offer hundreds of items on store shelves will have to spend millions to prove their products are safe on paper despite the fact they have been in common use for years without reported problems.
A spokesperson for an association of retail store owners and manufacturers in the supplement industry said her group “plans to ask the FDA to ease up on some guidelines,” again making it sound like the supplement industry wants to water-down safety requirements.
With an ear to the ground, this writer hears the public talking about a black market if popular dietary supplements are eventually pulled from store shelves. But the FDA is one step ahead of this anticipated public response.
Within days of the FDA announcement over guidelines for new dietary supplement ingredients, the FDA also issued an anti-smuggling strategy. An FDA press release says: “The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.”
It appears the FDA knew that talk of a black market would arise and they took pre-emptive action by involving a more formidable policing agency – the Department of Homeland Security.
Most of the involved parties in the dietary supplement industry still don’t know what hit them. Some believe they will dutifully comply with newly penned FDA guidelines, not recognizing this document will doom a growing industry in a dying economy.
The dietary supplement industry holds the greatest promise for reducing the high cost of medical care. Once existing drug patents expire and newly introduced synthetic molecules are no better than older generic drugs, the pharmaceutical industry may attempt to turn so-called nutriceuticals into prescription drugs as they are in Europe.
Americans enjoy the freedom to purchase, at least for now, natural remedies without a doctor’s prescription and at far less cost than in other countries. For example, herbal remedies such as bilberry and Ginkgo biloba are prescription-only remedies throughout Europe.
Big Pharma is closing in on a big power grab – and it must to save itself. That is because modern designed drugs represent a single man-made (patentable) molecule that narrowly targets single genes or cell receptor sites in an attempt to quell symptoms of a sole disease. Whereas, by definition, nutriceuticals are single natural molecules that target hundreds of genes and therefore prevent, treat or cure many diseases.
For example, resveratrol (rez-vair-ah-trol), known as a red wine molecule, exhibits broad biological action that could potentially address many diseases. Resveratrol manifests biological action that counters pain, inflammation, cholesterol, germs (bacteria, viruses and fungi), mental depression, elevated blood sugar, the initiation, growth and spread of cancer (something no cancer drug does), and dissipates beta amyloid brain plaque. Resveratrol is a game changer.
Modern pharmacology must counter this threat from natural medicine if it is to survive. It must capture nutriceuticals and make them prescription-only substances. It must demonize dietary supplements in the short run and convince the American public they are potentially hazardous and need to be controlled by prescription.
Dietary supplements are not a trivial issue in America. The most letters sent to Congress over any issue in the past two decades involved the public’s support for the passage of the Dietary Supplement Health & Education Act of 1994. It has been said that there are three issues politicians dare not tamper with in America: the right to bear arms, the privacy of the American home, and the right to directly purchase dietary supplements unfettered by government.
Many Europeans travel to America to purchase a year’s supply of dietary supplements that are far more expensive in their native country. These foreign consumers come to America because this is a land known for free markets and freedom to use dietary supplements. It would be an embarrassing irony, in “the land of the free,” that under the guise of consumer protection, health freedom and the right to self-care would be discarded.
© 2011 Bill Sardi, Knowledge of Health, Inc.,
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