CAM Practices, Products and FDA Regulation: Updated Threat Assessment


Commentary by Ralph Fucetola JD - www.vitaminlawyer.com

04/24/07



The US Food and Drug Administration is a confusing and confused agency,
charged with administering federal controls over foods, drugs and
medical devices under a patchwork of laws and regulations that have
drastically increased costs to American consumers and slowed health care
progress, without demonstrable safety benefits. It is therefore inevitable
that many actions taken by the agency are likely to do more harm than
good. Such is the case with the proposed Complementary and Alternative
'Medicine' (CAM) guideline that the agency proposed at the end of
December, public comment period to extend through April 30th. You can go to
www.healthfreedomusa.org to make your comments by clicking on the link that says
'Take Action Now!'



It is true the FDA anti-CAM guidance merely restates the existing law
[as FDA sees it] -- that, if you intend to 'treat disease' with a CAM
product, that product (for example, says FDA, a 'juice') is a 'drug.' By
codifying this in a guidance document, FDA is setting the stage for
another push to control and restrict CAM practices. The FDA uses the term
'CAM product' in the guidance, although Congress has never defined such
a term. The agency seeks to create a 'status' of being a certain type
of product when all Congress has authorized is that the FDA can regulate
certain products 'intended' to 'treat disease.' Of course, the
responsible FDA Senior Science Advisor did say, in a very recent interview,
this is not FDA's 'intent' and using 'CAM Products' is just a matter of
convenience. Of course, as good Americans, we should all believe exactly
what the FDA tells us; trust the agency's intent; shut up and take all
our prescriptions.


In addition to telling us that a juice intended to 'treat disease'
would be a drug, a careful reading suggests even items used in religious
healing ceremonies could now be subject to regulation as drugs or medical
devices. Holy water, anointing oils, prayer beads, rosaries, sweat
lodges and even religious paintings or icons could be classified as drugs
or medical devices and essentially outlawed by the FDA. Does this sound
absurd? Well, it is absurd!


Certainly, all this appears a bit less absurd if we are considering
using an herb or dietary supplement to stay healthy. Says the FDA, if any
supplement is used to treat a symptom, then it is a drug and will be
regulated by the FDA, just like any prescription drug.

The FDA does give us a little hope -- the supplement will be exempted
if it is 'generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling.' This is essentially the same
standard used for substantiating drug claims. In 2004 the FDA gave us the
standard for making claims about foods and dietary supplements: 'FDA
intends to apply a standard for substantiating claims for dietary
supplements that is consistent with the Federal Trade Commission's (FTC's)
standard for dietary supplements and other health related products of
'competent and reliable scientific evidence'.' Quite a difference! This is
just one difference the anti-CAM guidance will codify. And after
codification comes enforcement. All alternative practitioners should take
note!


In other words, your freedom to use a dietary ingredient as therapy
that may benefit a condition will be at the discretion of FDA 'experts'
who will determine whether to regulate it as 'medicine.' Given the
abysmal track record of FDA experts, this could be really bad news.

With so much latitude, I cannot predict just how far the FDA might go
to restrict access to herbs, minerals and supplements, as well as other
CAM the two biggest [problems with the guidance] are broadening the
definition of 'health claim' and the desire to pre-empt the states in the
regulation of some health care issues'

The health freedom movement began to take notice of the pending
anti-CAM guidance in late March. At the start of April, I assisted one group,
Natural Solutions Foundation, to write its commentary to submit to the
FDA, with emphasis on what we see as the important distinction between
'treatment of disease' and its non-medical alternative, under AMA
Ethics Code Opinion 3.04, 'therapies that may benefit.' The comments raised
three demands: products. Many pro-health freedom groups are offering
their concerns too. For instance, one commentator, Jenny Thompson of the
HSI Newsletter suggested, '...[FDA] could take a widely used supplement
off the market if the label states a benefit; such as using lutein to
reduce the damage from age-related macular degeneration, or using
chondroitin and glucosamine to reduce joint pain, or using probiotics to
address digestive problems - the list goes on and on...' The AAHF (American
Association for Health Freedom is concerned that '


1. A public hearing by the FDA before the finalization of the guidance.

2. Changing the title of the guidance to use the phrase 'Complementary
and Alternative Modalities' and not the prejudicial 'Complementary and
Alternative Medicine' as in the draft.

3. FDA recognize that 'therapies that may benefit' are not the same as
'treatment of disease' and do not have to be regulated as 'medicine.'


The organization then alerted its elist and asked its supporters to
also file comments with the FDA, supporting the group's requests. We
apparently touched a hot button issue; over the following week the buzz
spread on the Internet


Propelled by this strong public support, I believe we now have an
opportunity to turn this FDA 'end run' around and use it to protect CAM
practices. We are now seeking support from members of the US Congress to
demand that FDA hold public hearings before making the guidance final. If
FDA fails to hold such hearings, it would be time for Congress to step
in, hold hearings, and propose legislation to protect CAM practices
from FDA action that would deny Americans access to alternatives. With
John Galt, we want to say, 'Get out of my way!'


It has been settled law in this Country for over a century that medical
regulations exist to protect the public, not to entrench licensed
allopathic medicine to the detriment of all the evolving healing arts, which
would refer to as 'CAM practices' - though Traditional and Advanced
Health Care might be a more appropriate term.


'The state has not restricted the cure of the body to the practice of
medicine and surgery -- allopathy, as it is termed, -- nor required
that, before anyone can be treated for any bodily ill, the physician must
have acquired a competent knowledge of allopathy and be licensed by
those skilled therein. To do that would be to limit progress by
establishing allopathy as the state system of healing, and forbidding all others.
This would be as foreign to ours ystem as a state church for the cure
of souls. All the state has done has been to enact that, when one wished
to practice medicine or surgery, he must, as a protection to the public
[not to the doctor], be examined and licensed by those skilled in
surgery and medicine. To restrict all healing to that one kind -- to
allopathy, excluding homeopathy, osteopathy, and all other treatments -- might
be a protection to doctors in surgery and medicine; but that is not the
object of the act, and might make it unconstitutional, because
creating a monopoly.' North Carolina's Supreme Court in State v
MacKnight, 42 S.E. 580, 1902 at p 582.


As NSF's medical director, Rima Laibow, MD, has noted,


'Throughout the world today people are looking to traditional
methodologies and leading-edge CAM techniques because they offer alternatives to
toxic, expensive drugs with their dangerous side effects, other
invasive technologies of modern medicine, and un-manageable and unreasonable
costs. This search for alternatives is protected by the fundamental
right of individuals to communicate and learn; to heal and be healed.'


You can read more about this issue and add your comments to the FDA
through the Natural Solutions Foundation, a non profit NGO at
http://www.healthfreedomusa.org and submit your comments from the home
page. Since the FDA Dockets Supervisor tells us her 9 member staff is
overwhelmed -- apparently the system crashed and only about 128,695 of
the over 315,000 people who have tried to post comments have succeeded
so far - we have now made arrangements to email directly to the FDA and
expect all future comments to get through, so if you did not succeed
last week, please try again.


This Monday morning, April 23rd, the Foundation formally filed a
written request with FDA for an extension of time to file comments. Due (1)
to the confusion between the April 30th deadline stated in the Federal
Register and the 90 day comment period, from the date of publication in
the Register, as stated on the FDA CBER web page,
http://www.fda.gov/cber/gdlns/altmed.htm (which would put the deadline
off until May 28th) and (2) the large number of people who want to
comment. On Tuesday afternoon, we received a letter from FDA denying the
extension, failing to clarify whether April 30th or May 28th is the
deadline, and letting us know, per the statute, the guidance, 'does not
create or confer rights for or on any persons...' the FDA representative
did not say that it would not be used as the basis for actions against
persons, or to justify the agency's expansive view of its authority.


The last time Americans got this mad about health freedom, Congress
unanimously passed the Dietary Supplement Health and Education Act of 1994
(DSHEA) protecting our access to supplements. This time, we will
protect our complementary and alternative practices; our vitamins, herbs,
minerals and healing arts. We are 'mad as hell' and 'we aren't going to
take it any more!'


Ralph Fucetola JD

Trustee - NSF
www.vitaminlawyer.com

If you have not done so, please join the 128,695 people who have
already submitted their comment through the Natural Solutions Foundation
website (http://www.HealthFreedomUSA.org) by clicking on the link that says
'Take Action Now!'

http://www.democracyinaction.org/dia/organ izationsORG/healthfreedomusa/campaign.jsp? campaign_KEY=7185

Thank you for taking the time to read this important message.