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  • FDA’s Caveat For Dietary Supplements, “This Product Is Not Intended To Treat, Cure Or Prevent Any Disease,” Is Costing Americans Their Lives And Their Eyesight

    March 8, 2012: by Bill Sardi

    (March 8, 2012)- Millions of Americans are paying with their lives and their eyesight for the US Food & Drug Administration’s denial that nutriceuticals prevent, treat or cure disease says Bill Sardi, dietary supplement industry executive and health writer, speaking at the annual Nutracon meeting in Anaheim, CA this week.

    “Nutriceuticals, a more sophisticated name for dietary supplements, do in fact prevent, treat and cure essential nutrient deficiency diseases such as vitamin D for rickets, vitamin C for scurvy, vitamin B1 for beri beri, as well as many chronic diseases, yet the FDA bans (censors) statements of fact, keeping the public in the dark over the obvious health benefits and cost effectiveness of nutriceuticals,” says Sardi.

    “The US FDA maintains a narrow pharmaceutical model for chronic diseases, which are basically treated as drug deficiencies. The FDA maintains dietary supplements must become expensive drugs before statements can be made they cure or treat disease, which is absurd,” says Sardi.

    Example of sudden-death heart attack

    Sardi points to sudden-death heart attacks as an example. There is evidence that resveratrol (pronounced rez-vair-ah-troll), a red wine molecule available as a dietary supplement, can potentially turn mortal heart attacks into non-mortal events.

    Sardi says recent studies reveal aspirin and statin drugs do not reduce the risk for sudden-death heart attacks, only non-mortal events. So millions are dying without any proven technology to prevent these deaths, he says.

    The evidence that a modest dose of resveratrol prevents mortal heart attacks is largely derived from animal studies but it would be unethical to proceed to human studies where high-risk patients would be forced to take inactive placebo pills and allowed to die to determine if resveratrol does in fact prevent these sudden unexpected deaths, says Sardi.

    “It would take at least 5 years and cost more than $50 million to determine whether resveratrol pills prevent mortal heart attacks in humans like they do in the animal lab,” says Sardi. During that time millions of Americans will needlessly die.

    If resveratrol pills are relatively safe (they have been sold as non-prescription pills to hundreds of thousands of Americans over the past eight years without report of significant side effects), why don’t public health officials allow resveratrol pills to come into common use with the provisional approval their health benefits remain to be demonstrated in humans but are based upon solid animal and human epidemiological data? Waiting means millions more will die prematurely.

    In fact, some heart researchers are wondering why there is not even one human clinical study involving resveratrol and heart disease in the past 8 years since resveratrol pills became widely available and scientific studies linked resveratrol to the French Paradox, the fact the wine-drinking French exhibit far fewer heart attacks despite their high-fat, high-calorie diet.

    A New Jersey cardiologist, Nate Lebowitz MD, a rare breed of physician who recommends resveratrol pills to his patients, says he has observed some of his patients experience blockage of their coronary arteries without experiencing symptoms or tissue damage, which is consistent with published animal studies.

    Ed Skonenzy, a 70-year old Palm Desert, California man who has been taking a resveratrol pill for over five years, claims in a CNN report that he was found to have five partially or totally blocked coronary arteries but experienced no angina chest pain or heart muscle damage, and when surgeons opened his chest they surprisingly found a new blood vessel had formed to deliver oxygenated blood to his heart muscle tissue which is precisely what resveratrol was found to do in animal studies.

    Repeat scenario: vision loss

    The same is true for nutriceuticals in rescuing patients from permanent irreversible vision loss due to a condition called wet macular degeneration. While there is effective medicine for this condition, an injectable drug that inhibits the formation of abnormal blood vessels that invade the visual center (macula) of the eye, these drugs don’t work in 1 of 6 cases and some patients refuse to have a needle stuck directly into the white of their eyes.

    In animal studies, resveratrol causes abnormal blood vessels to recede. Even more convincingly, a soon-to-be-published series of case presentations shows a resveratrol-based pill rescues aged patients from threatened permanent vision loss. Their treatment options had been exhausted and patients either failed drug treatment or refused injection of medicine into their eyes.

    “However, we are unsure we can find eye physicians willing to launch such a study given their financial conflict of interest in administering injectable medications into the eye,” says Sardi.

    “We actually became aware in 2007 that a resveratrol pill I had formulated was reversing this disease. Photographic evidence was provided. But then the eye doctors who made us aware of this suddenly claimed the treatment didn’t last and they backed away. Since then about 150,000 older adults have permanently lost their vision due to this eye malady that could have been saved had off-label use of this nutriceutical been allowed,” says Sardi.

    An inpatient at a government hospital threatened with permanent vision loss refused injected drug treatment but was prohibited from using a resveratrol pill as an alternative because it was not FDA approved. The patient acquired the resveratrol pill on her own and experienced major visual improvement within four days.

    “It is clear that the FDA and physicians are not working in the best interest of patients and are using the drug approval process to maintain the status quo and thwarting safer and more economical alternatives from being used,” says Sardi.

    Nutracon is the premier conference for ingredient and technology innovation within the health and nutrition industry. For more information about resveratrol and health, visit #####

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