FDA To Regulate Supplements as Drugs
as of April 30, 2007

NOTE: The Deadline for comment has been extended to May 29.

Numerous scientific studies show that certain foods provide health benefits for both prevention and treatment of disease. This proposed ban will make it illegal to convey information about which foods offer health benefits. The following is a review of what the FDA proposes to do and what we each need to do to help stop this foolishness.

You can read the actual copy of the proposal here: "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" (FDA Summary). Docket No. 2006D-0480

It can be difficult and confusing to understand what a bill such as this would ultimately mean to you. Here is a simple summary of the possibilities:

For example, this document attempts to define how vegetable juice might be defined as a drug: "This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for food in the Act and FDA regulations...If the juice therapy is intended for use as part of a disease treatment regimen instead of for general wellness, the vegetable juice would be subject to regulation as a drug under the Act."

The FDA defines a drug as "...(B) articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Dr. Myatt's Note: Since when do pharmaceutical drugs actually prevent disease? They are really all "treatment after the fact."

Life Extension Foundation explains that "The FDA is stating that it believes that any person (or product) who states 'drink some vegetable juice to prevent [insert disease]' is actually making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or manufacturer) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.

Who is going to fund a $50,000 investigational new drug application to get carrot juice approved as a drug, or the follow-on millions in research dollars to conduct a study on the toxicity ($200,000) and efficacy of carrot juice ($3 million and up)? Keep in mind that this would have to be done separately for any disease process upon which carrot juice might have an impact."

The FDA's public comment period expires on April 30, 2007, a time period that is too short for anyone to really understand the complexities of this proposal. Many people, myself included, feel that public comments to the FDA fall on deaf ears and have little impact on their decision-making. Remember, these are not elected officials and they have nothing at stake by ignoring public comments.

The action most likely to influence FDA actions concerning this issue to contact your Congressmen and let them know you want the FDA to leave your supplements, herbs, vegetable juice and other alternative medicines alone.

Marilyn B., an enthusiastic HealthBeat subscriber and professional writer, summarized the problem eloquently. "For many years now, the FDA has been playing with the health of the average person, using us as pharmaceutical company guinea pigs on which to test their drugs. If you are unaware of this fact, get aware because this organization is going completely off the charts with its madness. You are about to lose access to natural alternatives (herbs, vitamins, etc.) because the World Health Organization (under CAFTA -- which supersedes prior protective legislation that prevented this from happening) says you should have a prescription to have access to them.