The FDA Escalates Its Long War on Dietary Supplements

by Bill Sardi

Recently by Bill Sardi: FDA May Be Getting Ready To Water-Down Your Vitamin Pills

FIVE UNBELIEVABLE NEWS HEADLINES

Human life found on another planet in Milky Way galaxy. Jesus returns to east gate in old Jerusalem, signs autographs Federal government admits it seeds atmosphere with chemtrails in population control measure Bankers admit their wrongs and voluntarily go to police stations to surrender and be punished. FDA relents from its long-standing battle with dietary supplement companies and allows disease-treatment/cure claims and removal of label disclaimer that supplements do not cure disease.

NUMBER FIVE IS THE LEAST LIKELY TO EVER OCCUR

The U.S. Food & Drug Administration has a long-standing anti-dietary supplement stance that dates back to the 1940s, an era when the first miracle drugs like penicillin and cortisone were commercially introduced. .

Believing the public was being oversold on the value of vitamin supplements, the FDA pursued one so-called huckster, Adolphus Hohensee, who promoted a line of health foods and vitamins in the 1940s. Hohensee had falsely portrayed himself as a doctor, acquired some questionable diplomas, and paraded a bevy of products that included lecithin, B-complex vitamins, wheat germ oil, mineral capsules and herb laxatives. Hohensee's lectures would generate up to $50,000 in daily sales of his products.

The FDA took issue with Hohensee, claiming his educational materials were part of the labeling for his products. He incurred heavy fines. He was assailed for "a gospel that condemned the normal American food supply and made purchase of special supplements necessary for physical and mental salvation."

The FDA responded that dietary deficiency diseases did exist, but these had been eradicated in America with fortified foods and an adequate food supply. Hohensee accurately stated that eggs, processed grains, milk and meats of the day were not what they were decades earlier. Crops were depleted of nutrients. Foods were over-processed.

Critics claimed Hohensee's statements were false. The soil's quality has little influence on the quality of the crop grown, they said, or otherwise the crop wouldn't grow. Hohensee claimed that garlic was good for lowering blood pressure. Though Hohensee's own diet was not a very good example for others (he was caught drinking beer, fried food and white bread by news reporters), his message rang of truth. He and others were harassed, fined, jailed, and branded as food faddists who peddled "nutritional nonsense." The Federal Trade Commission and the American Medical Association also took action. The AMA published articles of "pseudo-nutritional doctrines."

Today we know that:

A significant percentage of the American public is deficient in essential vitamins. Without dietary supplements many Americans are deficient in essential nutrients.

Garlic does reduce blood pressure in some cases. Studies conducted in the 1920's, and more than 16 modern studies conducted in the 1980's and 1990's confirm that garlic can significantly reduce blood pressure. A more recent analysis of ten studies involving garlic and its primary active ingredient allicin reveals that garlic reduces systolic blood pressure by an average of 16 points and diastolic blood pressure by 9 point compared to a placebo tablet. That is as good as any blood pressure medication. Recognize that maybe 1 in 5 patients with high-blood pressure who take medications achieve 140/90 blood pressure. Anti-hypertensive drugs are fraught with side effects, including the potential for inducing an excessive drop in blood pressure during sleep that can impair circulation to the optic nerve and result in blindness. Garlic has none of these side effects.

The Recommended Daily Allowances are woefully inadequate and out-dated and do not address the individual nutritional requirements of 50 percent of the population (the hospitalized, smokers, pregnant females, those taking medicines, growing children, those individuals who exercise, anyone under emotional stress, have greater nutritional needs).

Adolphus Hohensee, for all of his shortcomings, was just another of the ridiculed advocates for self-care and the nutritional approach to health maintenance.

Skeptics will scrutinize the relatively weak scientific citations quoted herein in support of the claim that dietary supplements prevent, treat or cure disease. It must be recognized the dietary supplement industry does not generate sufficient profits to conduct long-term, placebo-controlled human studies involving thousands of patients. The criticism that is continually heard about dietary supplements is that they represent unproven therapy. But in most instances drugs have already been disproven. For example, statin cholesterol-lowering drugs and anti-cancer drugs do not significantly reduce mortality rates, yet they are held in high esteem as approved by the FDA. The National Institutes of Health, which controls billions of dollars of research funds, is remiss in sponsoring well-designed studies involving nutriceuticals. Furthermore, the supplement industry cannot be blamed that its products don't prevent or cure disease. If supplements did that, they would be declared drugs by the FDA! With the exception of deficiency disease (rickets, scurvy, beri beri, pellagra, etc.) it is categorically impossible for a dietary supplement to claim it prevents, treats or cures any disease without facing sanctions from the FDA. This is silly. Supplements DO prevent, treat and cure many diseases. A muzzle has been placed over the dietary supplement industry.

FDA Attempts To Restrict Vitamins In The 1970s

The FDA, in league with the National Academy of Sciences Food & Nutrition Board and other health authorities has worked to limit the intake of essential nutrients so as to restrict their use to frank deficiency diseases only.

Richard S. Colman, Ph.D., President and Director of Scientific Research at Biomed Inc. in Concord, California, a first-person observer of events at the time, calls attention to the FDA's effort in 1973 to make vitamin dosages over 1.5 times the Recommended Daily Allowance available by prescription only. Government received more mail against the proposed 1973 vitamin regulations than it received on the Vietnam War, says Colman.

Dr. Colman goes on to say: "In 1973, thousands of people rallied at the Cow Palace, a convention hall a few miles south of San Francisco, to protest the proposed FDA regulations. I was present as an observer. People were carrying signs saying: u2018GO TO HEALTH, FDA.' By a vote of something like 408 to 3, the House of Representatives voted to take the power to regulate vitamin dosage away from the FDA." The FDA soon dropped its plan. A subsequent effort by FDA also failed.

FDA Refuses To Implement Law

Peter Barton Hutt, former chief counsel for FDA (1971-75) and senior counsel with the Washington, D.C., law firm of Covington & Burling LLP, provides us with a more detailed history of the FDA's long war against dietary supplements. According to Hutt, the primary thrust of the FDA's anti-supplement efforts has been to maintain that dietary supplements are unnecessary for any person who eats properly, "a feeling that has continued to persist within the agency up to this very day," says Hutt. This is in the face of the fact that the government's 5-A-Day program to eat fruits and vegetables has miserably failed to reduce mortality rates for heart disease and cancer.

For decades the FDA applied pressure and attempted to gain greater authority to regulate the supplement industry. This led to Congressional hearings that finally landed in the US Court of Appeals in 1974, who overruled parts of the regulations. Then Senator William Proxmire (D-Wis.) pushed through Congress the Vitamin-Mineral Amendments of 1976 which further reduced FDA flexibility in regulating dietary supplements, says Hutt. Frustrated and bending to the will of the people, in 1979 FDA revoked all of the regulations it had propagated in 1972.

According to Hutt, the freedoms gained in the 1994 Dietary Supplement Health & Education Act have FDA Commissioner David Kessler MD to thank for them. Dr. Kessler's arrogance prompted the supplement industry and the public to fight back.

A year prior to the passage of DSHEA Dr. Kessler announced he would resist approval of any proposed disease prevention claims for dietary supplements and would attack dietary ingredients other than essential vitamins and minerals on the ground that they are illegal food additives that must be removed from the market.

Eventually the Dietary Supplement Health & Education Act of 1994 was passed, but, as Hutt explains: "Kessler was so infuriated by the enactment of DSHEA that he ordered FDA not to enforce the new law. FDA took virtually no enforcement action because Kessler was convinced if the law was not enforced and the worst elements of the dietary supplement industry were allowed to run wild, Congress would repeal the law. Of course, that did not occur. For a full decade, however, Kessler sacrificed protection of the public health to his own personal animosity toward DSHEA."

Then the FDA drug its feet for more than a decade before outlining Good Manufacturing Practices for dietary supplements, all the while demeaning supplements for not exhibiting the quality of drugs. Was the FDA again hoping that some poorly made dietary supplement would kill or seriously harm consumers so it could then re-launch its vendetta against the supplement industry?

What happened was, after years of allegations that the supplement industry was hiding serious side effects from regulators, an Adverse Events Reporting rule went into effect where supplement manufacturers had to report any adverse reactions that caused a consumer to see a doctor or be hospitalized. However, even with this reporting requirement, dietary supplements have proven to be comparably safer than aspirin, tap water and table salt. Again, the FDA's war against supplements fizzled.

The Current FDA Challenge Facing Dietary Supplements

The current challenge dietary supplements face is worse than any before. The FDA now seeks to implement a new guideline that would force all supplements dating back to the passage of the 1994 DSHEA to undergo toxicity and birth defect studies, a requirement that would so expensive it would quash the entire industry, require more than $50 billion of testing which represents the entire estimated profits produced by the industry for 20 years, a guideline that would be impossible to administrate (56,000 supplements would have to undergo an approval process in a short time), a guideline that would surely eliminate thousands of products from retail store shelves and place hundreds of thousands of Americans workers into unemployment lines. The FDA has aimed a death blow at the industry. To find out how to oppose this new FDA guideline, visit www.operationpushback.com

This tyranny against dietary supplements by the FDA will never end till it is relieved of its duty to oversee the supplement industry. Oversight may be better accomplished by turning supplement regulation over to the US Department of Agriculture. Otherwise the American public will continue paying a steep price for the FDA's bias of drugs over supplements.

Evidence That Vitamins Cure Disease Pre-Dates Most Drugs

The idea that vitamins  food factors that are essential for life  could cure disease was first described in the very early 1900s and pre-dated most drugs. Subsequently various specific vitamins were discovered and then later synthetically produced and commercialized.

Because of a focus on profitability and patent protection, drug companies ignored un-patentable molecules from nature such as vitamins, minerals and amino acids to the point where only now, because of gene analyses, are vitamins like vitamin D, folic acid (vitamin B9), thiamin (vitamin B1) and vitamin C, along with various herbal extracts such as resveratrol and quercetin from red wine, curcumin from turmeric and allicin from garlic, being rediscovered as having broader biological activity than synthetic drugs.

Because of political and industry pressure, as patents for older drugs expired, the FDA has been forced into approving new drugs that are even less effective than older drugs at an much higher consumer price. This has been documented for diabetes drugs, drugs to treat Parkinson's disease and epilepsy. All the while, dietary supplements have been considered step-children to drugs.

Remarkably, it may be dietary supplements that break the mold of designing individual drugs for every disease. Instead, so-called nutraceuticals would address many diseases, particularly chronic diseases of aging. But trying to get these revolutionary natural molecules past the FDA is going to be some challenge.

The mapping of the human genome and the discovery that genes are dynamic rather than fixed in nature (genes can be switched on and off in what is called epigenetics) now for the first time reveals natural medicines may be superior to patent drugs. In fact, natural medicines like ginger root, garlic, ginseng, curcumin and many others have a safety advantage over prescription drugs. The safety of drugs is not fully known till years after FDA approval and many thousands of patients have taken the drug whereas natural molecules have been in use for centuries and are in common use in the population.

Researchers now propose that epigenetic side-effects of pharmaceuticals may be involved in the etiology of many diseases including heart disease, cancer, nerve and mental disorders, obesity, diabetes, leukemia, bipolar disorder, schizophrenia, infertility, and sexual dysfunction. Pharmaceuticals wreak havoc over human genes. Researchers are calling for epigenetic screening of all existing and future pharmaceutical drugs. The FDA actually approves drugs that worsen disease.

At some indefinite point in time pharmacologists began to re-arrange natural molecules into synthetics that could garner patent protection and be used to hike up the price and profitability of medicines. Pharmacology today largely based upon the design synthetically produced molecules that address a particular cell receptor site or gene target.

Eventually the US Food & Drug Administration took on the role of protector for the interests of US Drug Manufacturers and their number one position globally in the $880 billion pharmaceutical industry. This got to the point where, in one instance, the FDA totally relied upon a manufacturer's false claim that its anti-inflammatory drug was safer (caused less gastric upset and bleeding ulcers) than other drugs, allowed that drug to be widely promoted on television, and the drug led to thousands of premature deaths.

Blood on its hands

At the height of the Vioxx scandal, where an FDA regulator-turned-whistleblower had to actually leave the country and break the news about the increased risk for death when taking this drug, the FDA had the gall to send tart cherry growers in Michigan a warning letter that their products were being advertised as drugs. All that the tart cherry growers were doing is linking their websites to a US Department of Agriculture report showing tart cherry is as effective an anti-inflammatory agent as ibuprofen. Tart cherry doesn't cause gastric ulcers as does Vioxx and the many other COX-2 inhibitor drugs that are still on the market. In fact, there is still no safe prescription or non-prescription pain reliever on the market to day.

Sins Of Omission

The FDA does not consider it has the assigned duty to notify and educate the public that the biological action of many drugs, like tart cherry, can be duplicated with dietary supplements at far less cost and fewer side effects. The FDA's job has morphed into protecting the pharmaceutical industry rather than public health. FDA employees might as well wear hats and T-shirts emblazoned with the names of major pharmaceutical companies on them like race car drivers and their crews wear Pennzoil caps and shirts.

For example, it has been documented for decades that vitamin C acts as a potent statin drug that can eliminate cholesterol from the arteries via increased bile flow. It was authoritatively documented that chondroitin sulfate, a molecule naturally made in the body, when consumed orally can eliminate angina chest pain and reduce mortality from heart disease, working in a superior manner to an array of prescription drugs.

The FDA also chooses not to compare new drugs against existing medicines, but gives pharmaceutical companies an easy passage to approval by only having to show new drugs are better than an inactive placebo tablet. Whereas the first drugs like penicillin and insulin worked in most patients, today medicines like statin drugs are approved by the FDA when they only work in 1 in 71 subjects (3%) over a 5-year period in averting a non-mortal heart attack. Essentially the FDA has given license to pharmaceutical companies to treat all chronic diseases as if they are drug deficiencies when in fact many are rooted in nutrient overloads or deficiencies. In this scenario, patients will never get well.

Yet another dereliction of duty is the FDA does not require drugs to be labeled that they deplete essential nutrients. For example, statin cholesterol-lowering drugs deplete coenzyme-Q10 and selenium and cannot work if vitamin D levels are low. The FDA doesn't even want the public discovering dietary supplements help prevent drug side effects!

How Bad Is The FDA?

There is a litany of anti-dietary supplement policies and practices attributed to the FDA over the years. Here are some of the most atrocious fiascos the FDA has been responsible for:

After over a decade of wrangling over whether to fortify foods with folic acid to prevent birth defects (spina bifida, anencephaly), the FDA finalized a ruling on this subject in 1996. Many thousands of birth defects could have been prevented, but the FDA was reluctant to take action despite science that obviously pointed to this B vitamin as a preventive nutrient. The reason why the FDA was so slow in approving food fortification to prevent birth defects is because, as one government scientific expert indicates, this "would destroy the scientific basis for RDA's in this country." The FDA didn't want even one nutrient to be used and allowed to claim it prevented a disease. The FDA has the shame of all those birth defects on its hands. The folic acid food fortification program went into effect and silenced its critics.

In the mid-1990s the FDA took a multi-herbal dietary supplement out of the hands of dying prostate cancer patients because it was mislabeled, even though it was saving their lives. True, it was spiked with two drug molecules (a blood thinner and a hormone), but men were living in extended remission from their disease. Over 100 studies were published showing this herbal product was extending terminal prostate cancer patients' lives indefinitely. Instead of allowing this herbal drug to continue to be used on a compassionate life-saving basis, it chose to literally take these pills out of the hands of otherwise hopeless patients.

The FDA has become a shill for pharmaceutical manufacturers, even going so far as to hide a startling downturn in the life expectancy of Americans in 1993 that was caused by a toxic flu vaccine. Since the Spanish Flu in 1918 the life expectancy of Americans progressively rose, year after year. This investigator tracked down the cause of this sudden drop in life expectancy and found it was linked to a late flu season vaccination program in nursing homes that year. The FDA and other public health agencies said nothing about this. Had a news report reached the public that a killer flu vaccine  a vaccine that was FDA-approved  was responsible for the greatest downturn in American life expectancy in eight decades, it would have caused the nation's annual flu vaccination program to implode and who knows what would have happened to the FDA.

In 2002 the Food & Drug Administration (FDA) issued a warning, asking physicians to report adverse reactions associated with kava kava supplements, an anti-anxiety herbal product. Based upon reports from European pharmaceutical companies, the public was also warned to report any side effects and the FDA warning was published in newspapers and on TV news reports. Later, published studies cleared kava kava from any suspicion, but the damage had been done. The public backed away from kava supplements based upon the bulletin issued by the FDA, and this forced kava farmers in the South Pacific to plow over their fields. A $25 million crop-based industry was destroyed by FDA rumor spreading.

Does the FDA Have Another Vioxx In-The-Making?

The largest pharmaceutical company in the world faces expiration of many of its blockbuster multi-billion dollar drugs. Make it an unstated assignment for the FDA to do what it can to help out a pharmaceutical company that faces such a falloff in revenues.

Just such an example is the recently approved blood-thinning drug ticagrelor (Brilinta), which an FDA panel initially declined in December, 2010 by a 7-to-1 vote. Keep in mind that the patent for the reigning blockbuster anti-clotting drug clopidogrel (Plavix) expires next year.

The maker of ticagrelor (Brilinta) appealed and re-submitted data from European trials to gain FDA approval on July 20, 2011. But comparative studies in the US showed that clopidogrel (Plavix) produced fewer deaths (3.2% death rate for clopidogrel versus 3.8% for ticagrelor). Larger studies confirm the lower 3.2% death rate for Plavix. So how did Brilinta suddenly exhibit a 16% lower death rate than Plavix? Simple: the drug manufacturer monitored its own trials in Europe, but not in the US.

Skeptical researchers said: "Since the u2018play of chance' cannot explain these discrepancies due to excess death rates, and considering that study sponsor self-monitored sites in most countries, but not in the USA, the mortality data are questionable, and should be independently verified…. The future practice of self monitoring in pivotal indication-seeking clinical trials should be completely banned."

Do we have another Vioxx in the making here? Similarly, the FDA relied upon drug manufacturer data for Vioxx, a drug that was later recalled. Meanwhile, dietary supplements safely thin the blood, such as fish oil, magnesium, garlic and resveratrol, and can be taken in combination without side effect or over-thinning of the blood as occurs with drugs. You will never learn about this from the FDA.

Supplements DO prevent and treat disease

Despite what the FDA says dietary supplements DO effectively prevent, treat and even cure diseases, though every dietary supplement must include the following disclaimer statement on its label: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Imagine an FDA that wasn't anti-dietary supplement. The FDA disclaimer might say something like this:

Dietary supplements make a significant contribution to daily nutrient needs. Consumers are urged to carefully examine the level of scientific evidence (lab dish, animal, human studies) that substantiates whether a supplement prevents, treats or cures disease, and whether that science pertains to a particular product or its ingredients in general and provides the same dosage and form of nutrient used in a published study.

Summary: Here is the FDA's legacy:

Avoidable deaths from use of Vioxx while tart cherry growers were muzzled;

Babies with preventable birth defects in their spinal cord and backbone as a result of foot-dragging over inclusion of folic acid into fortified foods;

Men prematurely dying of prostate cancer for lack of an herbal product forced off the market;

At-risk heart disease patients mistakenly relying upon cholesterol-lowering statin drugs to save their lives and spare them from a mortal heart attack while other natural remedies that may actually avert sudden-death heart attacks go overlooked.

All this is part of the legacy of the FDA in the aftermath of its tyranny against nutritional therapy and dietary supplements. If needless deaths haven't reformed the FDA, what will?

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