• Why You Never Hear Of An FDA-Approved Nutriceutical

    Posted March 19, 2011: by Bill Sardi

    Or How The FDA Forces Promising Natural Molecules To Become A Drug

    This week a striking report issued by university-based researchers convincingly reported that not only had they discovered a major cause of breast and prostate cancer, but that two natural molecules, a sulfur-based molecule (N-acetyl cysteine) and a red wine molecule (resveratrol, pronounced rez-vair-ah-trawl), commonly found in red wine, almost completely abolish DNA mutations that precede these cancers.

    However, there was no special announcement from the National Institutes of Health for these two lowly molecules like there was for tamoxifen in 1998, a drug that also purports to do the same thing, with disappointing results. Tamoxifen inhibits an enzyme (aromatase) that is required for the production of estrogen. At the height of its sales before its patent expired in 2002, tamoxifen was generating over $1 billion in sales. Early on, the National Institutes of Health (NIH) was criticized for its premature approval of a tamoxifen that had not been thoroughly studied. Tamoxifen actually increases the chance of more aggressive and difficult to treat forms of recurrent breast cancer.

    The FDA approved anti-cholesterol statin drugs even though there has never been evidence that any statin drugs lowers mortality for coronary artery disease.

    So much for FDA approval as criteria for safety and effectiveness of any drug.
    Notwithstanding the fact that the biological action of most prescription drugs can be duplicated with vitamins, minerals, amino acids and herbal molecules, this fact is kept hidden from public view and the public often keeps taking ineffective, problematic and expensive drugs based upon the misleading FDA imprimatur. Meanwhile, promising natural molecules, like those mentioned above, are caught in a circuitous web of deceit by the Food & Drug Administration.

    Here’s how the obfuscation game is played. So-called nutriceuticals, a term first coined by Stephen DeFelice MD in 1989 which combined the words “nutrition” and “pharmaceutical,” are loosely defined as any foodstuff that provides health benefits and has no actual legal definition.

    The regulatory status of a nutriceutical is in limbo and the pro-pharmaceutical Food & Drug Administration (FDA) probably wants to keep it that way. Universities and other research centers opt to submit protocols for their government-sponsored studies to the FDA review board, which applies rules for drugs to these molecules even though the Dietary Supplement Health & Education Act of 1994 (DSHEA) makes provision for natural medicines.

    There are regulations within the Federal law which prohibit the use of an ingredient in food if the ingredient has already been the subject of substantial clinical investigation as a drug and those clinical trials have been made public. So this becomes a circuitous process. Approval for human studies of a nutriceutical must meet requirements outlined in Investigational New Drug applications, and when results of the nutriceutical study are published, it is then declared a drug.

    Most nutriceutical companies can’t bear the cost of a drug study. Even if a nutriceutical study is successfully completed, by definition, if a nutriceutical molecule prevents, treats or cures a disease, then it must be classified as a drug.

    With digitalis* and aspirin* as exceptions, in effect there are no FDA-approved natural medicines. There is no such thing as a nutriceutical. This drives up the cost of medical care and direct public access to natural medicines that could be used for self care and prevention.

    It is excessively burdensome for natural medicines to have to comply with regulations for drugs just to make what are called structure and function claims on their labels and advertising. For example, a structure and function claim might be that a nutriceutical promotes a “healthy heart” or “healthy blood pressure within the normal range.” Structure and function claims are something that are permitted by DSHEA.

    The public frequently hears that dietary supplements are not FDA approved. But the FDA has no real provision for approval of anything less than a drug. This is why there are few if any medicines for prevention and self care.

    This is despite the fact that many natural molecules are far safer and more effective than prescription drugs. Vitamin D (bone building, anti-cancer, immune boosting), folic acid (natural antidepressant), magnesium (calcium blocker), are some examples.

    Why dietary supplement manufacturers are fearful of even saying the obvious, that vitamin C prevents symptoms of scurvy (bleeding gums, skin bruising), or vitamin D prevents symptoms of rickets (bone softening, poor immunity), or that vitamin B1 prevents symptoms of beri beri (heart failure, pain, hair graying). #### Copyright 2011 Bill Sardi, Knowledge of Health, Inc. Not for posting on other websites. Free to use for personal health.

    * Digitalis is an extract of the herb foxglove and aspirin was originally derived from white willow bark.

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