New FDA Draft Guidance Threatens Supplements

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.

Economic Impact in the Billions

The economic impact is believed to be in the tens of billions of dollars. Under the new proposed regulations, smaller supplement companies will be forced out of business due to the insurmountable testing requirements and doubtful FDA approval for each new formulation, preparation or dosage recommendation of even a traditionally used common herb or nutrient such as vitamin C or chamomile. With small companies out of business and with the upcoming revised patent law, pharmaceutical leaders can patent and sell these common products at enormous price increases, preventing most Americans from affording critical health-promoting nutrients that are not available in our current food supply due to over-processing. Economic impact aside, the public health impact of these new requirements is grave and should be considered in all enormities by congressional leaders and decision makers.

These proposed regulations will also result in the loss of jobs for tens of thousands of hard-working Americans. The dietary supplement industry is fundamentally different in that it is a multi-billion dollar industry, but those in executive and management positions are upper-middle class workers, not the multi millionaires generated by the combination of Wall Street and Big Pharma. It’s an industry that truly supports the struggling middle class and offers affordable health support to all Americans. The dietary supplement industry plays an important role in educating the public and disseminating vital information on how to improve our health and overall quality of life. This service goes side-by-side with the development and distribution of dietary supplements, as supplements are a central part of health-promoting philosophy, rather than disease-fighting philosophy, which is the underlying mechanism driving Big Pharma. As an expert on dietary supplement safety and effectiveness, I urge America and Congress to take action and stop the FDA and Big Pharma’s power grab to monopolize America’s access to safe, effective and cost-efficient health solutions. Please visit http://tinyurl.com/protect-supplements to send a letter to Congress telling them enough is enough. For more information about various all-natural health solutions, botanicals and nutrients, visit www.dreliaz.org.