The FDA has put out a document for comments titled "Guidance for
Industry on Complementary and Alternative Medicine Products and Their
Regulation by the Food and Drug Administration: DRAFT GUIDANCE"
Here is the link to the pdf of the draft comments:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
This has caused an alert to be issued by the health freedom
organizations, concerned that the wording in the draft is an attempt
by the FDA to erode the freedom of access to holistic health products
currently governed by the FDA under DSHEA. The draft uses terms such
as treat and medicine, which imply the practice of medicine, and as
such, may erode the ability of unlicensed complementary and
alternative health care providers, such as nutritionists, herbalists,
aromatherapists, and holistic health practitioners, to recommend their
use.
The draft would not affect the structure function claim allowed for
dietary supplements under the current regulations and does not change
the current law. Rather it is guidance on the interpretation of the
existing law, and that is the concern, as it is being interpreted in a
very allopathic way that could pave the way for inroads into holistic
health access.
One area that is of particular concern is where the draft leaves
essential oils, particularly when used in massage or bath formulas, or
otherwise applied to the skin. According to the draft, adding a
cosmetic to affect even the structure and function of the body would
make it a drug. Under this interpretation, an essential oil blend for
massage for relaxation would be considered a drug!
Would this stop the practice of holistic health practitioners in the
US? In most cases, no. Most of the concern is how this affects the
sale of CAM products and devices. Most of it is already followed by
the responsible markers, for instance, not making disease claims for
dietary supplements or juices. But it is a slippery slope, and we
must all act to avoid any erosion of consumers rights to freedom of
access to the health care of their choice.
Please visit the website for the Natural Solutions Foundation
http://www.healthfreedomusa.org - click on FDA Trying to Kill Natural
Medicine, Supplements Again. Comment Period Ends April 30, 2007 <>Take
Action NOW!
We strongly recommend you send your comments to the FDA URGENTLY
before the comment period ends. The health freedom website contanis an
automated form that you can use, or send your own comments. The
comments that are included reiterate the role of CAM as a non
allopathic model, focused on wellness, and its importance to consumers.
You may want to forward this information to colleagues, friends,
family - Anyone that enjoys being able to access holistic health
modalities. A strong response from consumers and industry members of
the holistic health community will make a difference - it has stopped
prior attempts by the FDA, which many see as an attempt by
pharmaceutical industry to capture the income being lost when
consumers choose holistic options to get and stay well.
rate
email
print
link to this page
Comments: 11
Essential oils are a whole other thing. I almost wish they'd regulate them for safety so that all the companies and there are many out there, that people think are selling safe oils, are not, and regulation might make them take responsibility for what they're selling us. I only buy therapeutic grade essential oils - that's all I use, if they're not GC/MS tested and the company isn't willing to provide a copy of the tests, "batch specific", how would I know what I'm getting? It's not hard at all to fake a scent, it's the properties of the oils that disappear when unreputable companies do that. Unfortunately, I have very few suppliers due to that.
Though I don't want to see the government involved in something that they really don't know enough about, as aromatherapy isn't even recognised in the USA - I wish the companys that sold essential oils would be much more responsible in what they're offering the public.
Take for example a Young Living (company/franchise) practicioner and I know that they've had their oils tested ONCE, by a reputable chemist who not only found out they used inferior oils, but also the the entire company is giving the aromatherapy community a bad name - due to two things, other than their oils - the fact that the founder/owner, Mr. Gary Young, who used to and might still call himself Dr. Gary Young, bought his ND Diploma from the web and had no training at all. They're also the ones who use a very dangerous practice called Raindrop Therapy on their clients - many of whom have been literally burned by it. I have the article on the Aromatherapy, Herbs and More, group - called The White Papers - free to distribute. It's companys like those who give it all a bad name.
For those who think this regulation is a good idea
Wake up!
People need to think for themselves, not trust in some bureaucratic parent to baby their choices and keep them asleep, stupid, and addicted to buying things so the company can make money off of them.
If a business sells harmful ingredients that business won't last very long. It will get a bad name. It's up to the consumer to make wise choices about what he or she buys. Not trust in somebody else to tell him or her what to do.
Leaving everything up to an authority figure is equal to being a baby that needs to be taken care of because you can't think or do the research yourself about whether a medicine/practice is harmful or not.
Legalizing highly addictive and dangerous products (which the FDA already does) isn't any better. If there are many practitioners who don't deliver what they preach, that's their loss. The defamation will spread about the lack of quality or value in their product.
And it's the clients fault for buying into it and not taking the time to do the research and learn for themselves before they believed everything the seller tells them.
Right now the USDA puts an ORGANIC stamps on almost anything that has enough ingredients because it sees it has a market value to do so. The whole product doesn't have to be organic. Don't think this is any different.
They'd probably do better to come up with an approved alternative label for market value if they want to make a cheap buck, rather than regulate stuff off the market in order to sell the next best thing, like the Ma Huang (ephedra) deal.
Teach people to think and do research and learn about the products they are buying and what happens if they drink or use highly concentrated portions of it on their own. Don't let an authority tell you what to do as if they are doing it for your own good.
Be smart. Be alive. Be healthy. Be happy.
Blessings!
My attitude is that it is all bull-flop--dietary suppliments, pharmecutical drugs, alternative and conventional therapies-- until it has been proven to work on _me_. Requires a lot of trial and error, hit and miss. Although, in my experience, the allopathic therapies are more miss then hit, mostly do to the obnoxious side effects. At least the alternative therapies have fewer side-effects, even tho they may be just as ineffective.
Remember, people arent preverse, it isnt the _successes_ of allopathic medicine that are leading them astray, but the_failures_.
Of which there can only be progressively more since medicine seems to be committed to holding dogma over empirical evidence, even though the entire science of stamp coll--er... biology is based _solely_ on empirical evidence. (Until they manage to describe the behavior of more complex molecules then a hydrogen atom with quantum chemistry that is.)
..
U
What if the information the consumer is getting is skewed and miss-represented like with most products out there. Everyone is having the wool pulled over their eyes with marketing loopholes and whatnot. What do I mean?
Here is the latest example:
Centrum's latest product proudly says:
"The trial showed however that patients who took the lutein supplements experienced improvements in several symptoms, including glare recovery, contrast sensitivity and visual acuity, compared with patients taking the placebo. Patients also experienced a 50 per cent increase in macular pigment density relative to those on placebo."
Now our product has lutein so you can expect the same results!
No you can't!
They have about 1/100th of what the study was based on. It's marketing and taking advantage of loopholes that exist in the pharmaceutical industry. They are allowed to take advantage of these miss-representations, I'm not taking the time to go to pubmed.gov - look up the study of every claim that is made.... gimmie a break. There has to be monitoring of such marketing crap.