As an integrative medicine practitioner, I have been treating patients for over 25 years using allopathic medicine in combination with a wide range of health-promoting botanicals and nutrients. I am also an expert researcher and product formulator, and base each of my nutritional supplement formulas on scientific substantiation combined with traditional botanical wisdom. As such, I have direct, in-depth experience regarding the safety, efficacy and true therapeutic value of countless dietary supplements, both alone and in combination with conventional drugs. That is why the FDA’s Proposed Guidance on New Dietary Ingredients for dietary supplements is deeply concerning to me, my colleagues, my patients and everyone who seeks to support their health using safe, effective and cost-efficient nutritional supplements.
B-6 Already Banned
The FDA’s New Dietary Ingredient regulations are estimated to remove tens of thousands of safe and effective dietary supplements from the market. In fact, the process has already begun. In January 2009, the FDA announced that the active form of vitamin B6, or pyridoxamine dihydrochloride, was a “new drug,” meaning any substance containing pyridoxamine could not be marketed as a dietary supplement. While pyridoxamine dihydrochloride is naturally present in foods such as fish, chicken, whole grain products, vegetables, nuts and bananas, among others, any supplements containing the active form of this nutrient are considered adulterated and illegal by the FDA.
These new FDA guidelines clearly highlight the collusion between the FDA and the heavy-handed pharmaceutical industry to which dietary supplements are in direct competition with. The extreme emphasis on profit by the pharmaceutical industry is evident in their direct attack on the natural product industry, especially now that hundreds of name brand drugs have expired patents, thus allowing them to be sold generically at the expense of Big Pharma’s previously excessive profits. In fact, the main reason for the ban on B-6 is that it is now the active ingredient in a pharmaceutical drug, and thus protected by their patents.
Pharmaceutical industry leaders have driven the FDA to challenge the dietary supplement industry numerous times in the past, and in response to this ongoing threat, Congress enacted the 1994 Dietary Supplement Heath and Education Act (DSHEA). DSHEA was created specifically to prevent the FDA’s over-reach of regulatory power over dietary supplements and protect consumers’ access to nutrients and botanicals. Under DSHEA, dietary supplements are legally classified as foods, not food additives or drugs, and thus not subject the stringent safety laws that are indeed necessary for new chemical compounds.
However, as whistleblowers within the FDA and Big Pharma have repeatedly demonstrated over the last decade, the FDA has allowed numerous pharmaceutical drugs to enter into the marketplace without adequate safety, much less efficacy, data. Drug companies have had to recall numerous common drugs from the marketplace, because they were literally claiming thousands of innocent lives due to inadequate or downright adulterated safety information.
It doesn’t make sense that the FDA would need to create such burdensome safety requirements for dietary supplements, for which proven fatalities are basically non-existent, that are more stringent than those for synthetic drug compounds. No other industry has faced such unnecessary bureaucratic challenges in having to retroactively prove the safety of products for which there are no proven adverse reactions. Quality control of dietary supplements is already established and achieved following the DESHA act and GMP requirements. There are always rare cases where companies and individuals will unlawfully introduce inferior and/or adulterated products. This unfortunate reality can’t be eliminated by the FDA’s proposed excessive regulations, because such entities will continue to manufacture lesser quality products, regardless. Instead of implementing actions to allow for the prosecution of these violations, the new FDA regulations are imposing unreasonable and restrictive regulations that will hurt the health of the American public by allowing Big Pharma to turn inexpensive and important health-promoting nutrients and botanicals into expensive pharmaceutical drugs.
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