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If you are on any alternative health mailing lists you have probably
seen a fairly urgent appeal for people's submissions to the FDA
to help correct their apparent wish to turn natural supplementation
into medicine, which would severely limit your ability to buy nutritional
supplements.
This type of regulation has come into effect in Canada and Australia
already, so we have a direct experience in dealing with the new
regimes. On the surface it looks very benign and supportive of safety
and quality, but in its implementation it puts most small producers
out of business. In Canada for example, before you can sell your
home made herbal remedy with a claim such as "helps you sleep
better", you need to first apply for your site licence, and
for product licence. You must demonstrate that each claim you make
is supported by scientifically validated studies (you can't rely
on traditional or anecdotal information). You must maintain Good
Manufacturing Practices and keep evidence of your activities. You
must maintain a database of all ingredients, and product batch numbers
in case you are asked to recall a specific product containing a
specific ingredient. Try and imagine adding this overhead to a small
manufacturer or distributor ...
Ralph Fucetola, JD from the Vitamin Lawyer.com Consultancy http://www.vitaminlawyer.com
sent out this newsletter asking us to help by spreading the news
and writing to FDA and to our representatives ...
FDA Anti-CAM Guidance Update:
For those of you who have been trying to reach me with less success
than usual, I apologize. I’ve been “riding a tiger”
with the FDA’s proposed new controls on Complementary and Alternative
Practices – over 90,000 comments have been generated to FDA
in a bit over a week! This has been very controversial, with some
observers suggesting the new “Guidance” does not represent
a new power grab by FDA. Naive, Naive! Here is my latest commentary
on the issue:
CAM Practices, Products and FDA Regulation: A Threat Assessment
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.
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.”
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 when 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 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 “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, after an email from The Vitamin
Lawyer. 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:
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.
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 system 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
90,000 of the over 222,000 people who have tried to post comments
have succeeded so far – NSF has 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.
Ralph's website: http://www.vitaminlawyer.com
»
FDA website: http://www.fda.gov/ohrms/dockets/
»
FDA comment page: http://tinyurl.com/2u7ghc
»
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