FDA To Regulate Supplements as Drugs
as of April 30, 2007
NOTE: The Deadline
for comment has been extended to May 29.
by Dr. Dana Myatt
Is there no end to the assault on our health freedom?
The FDA is trying to ban the sale of natural foods if the food is intended to
prevent or treat a disease. Hello? Now we need an Rx. to buy vegetables if we
are doing so to preserve our health?
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"Draft Guidance for Industry on Complementary and Alternative Medicine Products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
What Would This Bill Really Mean to YOU?
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
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
What You Can and Should Do Right Now
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.
Your Political Action Summary:
1. Lodge a complaint with the FDA by
clicking here. Be SURE to
include the docket number 2006D-0480. Remember, however, that this is unlikely
to make much impact on the FDA. So in addition to your complaint, take action
step number 2.
2.) Fax your senators and representatives
ASAP. Be SURE to include the docket number 2006D-0480. If you don't have a fax
http://www.faxzero.com lets you send out 2 free faxes per day. A fax really
is that much more important and worth your time than an email, and a
typed or legibly hand-written letter carries a LOT of weight!
3.) Pass this note on to friends, family, anyone who gives a darn about
health freedom. (You know, all those people you forward e-mail jokes to). If you
have friends who aren't on e-mail, snail-mail them this information. Encourage
them to pass it along to as many people as they can.
(Please modify this into your own words,
but this is the gist of it):
Dear Senator BaffleGab:
I support open access to vitamins, herbs, and
supplements, and DO NOT want CAM to be regulated by the FDA.
I am therefore opposed to the "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.
Your Voting Constituent,
How to locate your representatives:
Locate your representatives by state
Locate your senators by state
The Bottom Line
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.
We all know how much MDs know about natural alternatives
-- and it is very little. Additionally, the cost of vitamins in countries (yes,
like Germany and Canada -- I'm not talking about Communist nations here) has
rocketed sky high where this has already been done. Have you written your
Congressman or Senator? I don't think very many people do, or this foolishness
would stop. As the old saying goes, the people get the government they deserve."