FDA Threatens Your Freedom?
|
Users viewing this topic:
none
|
|
Logged in as: Guest
|
Login  | |
|
FDA Threatens Your Freedom? - 4/24/2007 9:01:52 AM
|
|
|
Marc David
Posts: 6742
Joined: 4/6/2003
From: Bay Area -CA
Status: offline
|
Have you seen this? 
quote:
Share this with everyone you know.
You have seven days of freedom left.
Potentially, that is, if the FDA and Big Pharma has their way.
The latest move by the FDA is designed to once and for all destroy the 1994 DSHEA law that has made supplements “legal” while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA.
Don't Believe Everything You Read... Here's A Side Of The Story They Aren't Telling You About
Here's what Elissa said over at Bodybuilding Revealed
quote:
Uhhh...I'm not quite sure what all the hysteria is about.
The document that is the source of all the kerfluffle is here: http://www.fda.gov/cber/gdlns/altmed.pdf...I've flipped through it and all it appears to be is an advisory to CAM health care providers to let them know where the FDA stands on various CAM therapies, which may include nutrients, foods, etc. How things are regulated will depend on the claims made...as in the FDA's own example:
Second, neither the Act nor the PHS Act exempts CAM products from regulation. 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 foods in the Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.
While classifying veg juice as a drug might seem like regulatory overreach, as you can see, it depends upon the claim that's being made. They don't have an issue with veg. juice used as a food to promote health. They do have an issue with veg. juice being prescribed as a cure for a disease. But the FDA has always been strict when it comes to making medical claims for foods/nutrients: oats are one of the few food products where specific claims are permitted. So this doesn't strike me as unusual or remarkable. The FDA isn't proposing any new regs here, they're clarifying existing ones as they potentially apply to alternative and complementary medicine.
In other words, they're not doing some wholesale reclassification of vitamins, etc. as medicines. But they are putting CAM practioners on notice that, if these things are claimed as treatments for diseases, then they may fall under different regulatory guidelines.
Anyway...
A lot of people thought this hysteria was being pushed by supplement companies.
Let me say this...
One (1) man reads the FDA document and translates it thru his own bias. Now it's FACT being spread site over site, newsletter over newsletter.
Re-read that again.
1 person's interpretation of the document does not make it a fact.
We're all biased in some way included ME!
Which is why I would urge you to read the full document yourself. It's not that bad really. And make up your own mind.
The people really scared about this aren't legit supplement companies who follow the current FDA regulations.
It's the ones who would like to make some claims about herbs and such that it might cure or lessen a disease.
I'm not for repealing the DSHEA act. But I am also not in favor of total open, unregulated industries.
Big Pharama that these guys keep pointing out are HEAVILY regulated.
Why should the supplements that claim to cure a disease not be regulated in some manner? With tests, studies to back up the claims?
Answer: They should.
Solution: A happy medium. And I do believe it's getting better.
Don't be fooled that the FDA has so much power they just step in a snatch stuff shelves.
Again, bad information by people who don't know.
< Message edited by Marc David -- 4/24/2007 11:12:23 AM >
_____________________________
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/24/2007 10:34:16 AM
|
|
|
JonBensonDotCom
Posts: 3
Joined: 4/24/2007
Status: offline
|
Marc;
Since I am the one being quoted from the original thread, it's only fair I toss my $.02 worth into this.
First, you are absolutely correct: one of the FDA's point of concerns is the statements made by supplements regarding disease. The problem with this lies in the sentence "...promotion of general wellness and health."
Think about it: how can you promote a supplement for "general wellness and health" without comparing it to the ABSENCE of health, i.e. a state of disease?
For example: cherry extract currently (and rightfully) claims to aid in joint health. The 'opposite' of joint health is joint DISEASE, is it not? If not, what is it? Joint "sort-of okay"? Since cherries have been proven to relieve gout (just one example), why should the FDA care of someone takes cherry extract, or if cherry extract puts "for the relief of gout" on the label?
And what of fish oil? For years medical researchers claimed that fish oil had no benefit in the prevention of heart disease. Now we know this is not the case. Yet Carlson cannot put "helps in the prevention of heart disease" on their label...and the consequence is an uninformed consumer.
This all comes down to personal responsibility...which, btw, was the intention of my post. A call to responsibility. The FDA has a role, for sure, but let's face it: they're hardly the last bastion of responsibility. Should I list the drugs they approved under...shall we say, 'monetary pressure'?
Now, on to your "gurus" statement.
I do not claim to be a guru. I'm a fitness writer with a big mouth and a good heart. But I don't know everything...in fact, far from it. However, I'm also a bright fellow who realizes that education is also "personal responsibility" -- and that means I'm not one to listen to someone because they have consonants behind their name. Education is not a matter of consonants. Some of the least intelligent folks I know have "Ph.D." behind their name.
And, might I add, this sentence was in my original post:
<strong>(Special thanks to Mike Adams and NewsTarget.com for providing these excerpts…)</strong>
So, I do not appreciate the fact that you misrepresented me and my authorship integrity. Perhaps you can alter your comment about how "no one quoted Mike". Obviously I did. I would appreciate this Marc.
On to your other comments:
1. Mike did not start this. If anyone started this publicly it was Bill Sardi. I'd love to see you take this up with Bill. He's done more research on the topic than all of us put together.
2. "Bias" is not proven. Prove Mike was bias by presenting a case for his bias, not by stating "one man's bias" and claiming it as fact. Bias toward what? Does Mike own stock in TwinLab? Honestly, I don't know Mike. Perhaps he IS bias, but it's bad reporting to assume this.
3. I am not bias toward supplements as I do not sell them currently, nor have I ever. I'm not a fan of the FDA, although they do some good along with the bad. Perhaps you should read up on some of the FDA's history and make your own judgement. In so doing, look at how aspartame found its way on to every restaurant table in America. Then tell me the FDA always has our best interests at heart.
4. Herbs CAN cure and lessen disease. What we do with this 'fact' is where the contention begins.
Finally, I would suggest that the FDA can indeed "snatch" supplements from our shelves. Would you like a list of supplements once found over-the-counter that are now either regulated or banned?
Some of these appear to have just reasons...but they are 'always' associated with "risk of death." Yet aspirin kills thousands of people every year. Prescription drugs, tens of thousands.
Care to find the rationale in this?
I believe you have some good points. Perhaps there is more "hysteria" than needs to be. However, when it comes to proactive health care, our country is a the bottom of the food chain. This is hardly debatable. Just read QuackWatch.com and get a laugh. Barrett slams everything that isn't sealed with the White House Stamp of Approval. Anything "Eastern" is absurd and unscientific.
How oh HOW did these poor devils survive all these centuries without Big Pharma to take care of them?
And, one might ask, how on earth did we become the most obese and ILL first-world nation on the planet?
(in reply to Marc David)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/24/2007 11:56:05 AM
|
|
|
Marc David
Posts: 6742
Joined: 4/6/2003
From: Bay Area -CA
Status: offline
|
quote:
However, when it comes to proactive health care, our country is a the bottom of the food chain. This is hardly debatable.
Absolutely not debating that in any shape or form.
I'd like to see more people get invovled with good nutrition, exercise and only use medication or herbal remedies when totally necessary.
That's why I promote such books like Burn the Fat, FitOver40, my own book...
People who inspire you to lean clean lives and that you can look up to model after for successful healthy lives.
_____________________________
(in reply to JonBensonDotCom)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/24/2007 1:14:07 PM
|
|
|
JonBensonDotCom
Posts: 3
Joined: 4/24/2007
Status: offline
|
To all who are interested:
http://www.healthfreedomusa.org/index.php
This is a medical doctor speaking on Codex. If you want the 'history' behind what's going on, you should at least check this out.
Marc, thanks for your thoughtful reply and for the edits. : ) I will respond to your post shortly. You rock!
Jon
(in reply to Marc David)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/24/2007 4:57:20 PM
|
|
|
JonBensonDotCom
Posts: 3
Joined: 4/24/2007
Status: offline
|
quote:
Yet asprin helps thousands of people every year. Prescription drugs, tens of thousands cured.
Of course...and the same is true of natural supplements like trytophane. A bad batch killed a few people, ironically right before an Ambian-type drug was released...hmmm...and it's been on the banned list ever since. Ephedra is another banned supplement. There are others of course.
Can we compare this to aspirin? Hardly.
How about...oh, Advil?
Google "TENS" and "Stevens Johnson" and see what you find. You'll find a disease that will make you lose your lunch. This is caused by only a few drugs. One of them happens to be a popular over-the-counter NSAID. I personally know the attorneys who are responsible for TENS victims and going after a certain big-name NSAID.
It's taken YEARS to even get a warning label approval, and that will be years more in the making.
quote:
It's part of being human. Everybody is different. Asprin can be deadly to some and a blessing to others. People go in for routine surgery and die! There's been claims that laser eye surgery killed people! Yet thousands love it and it's saved them.
The point is not that aspirin is bad. The point is that aspirin is regulated and still kills thousands of people every year. No natural supplement has EVER done this, and they are NOT regulated.
quote:
Tell me why many major supplement companies are NOT at all worried about this at all?
On my website you'll find the truth to this. They are 'very' concerned. In fact, I have had contact with two attorneys, one of which represents a very large supplement company who shall go unnamed.
Jon
(in reply to Marc David)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/26/2007 4:37:24 PM
|
|
|
Marc David
Posts: 6742
Joined: 4/6/2003
From: Bay Area -CA
Status: offline
|
quote:
One of them happens to be a popular over-the-counter NSAID. I personally know the attorneys who are responsible for TENS victims and going after a certain big-name NSAID.
It's taken YEARS to even get a warning label approval, and that will be years more in the making.
This only proves the point that if the industry cannot self-regulate, then we need an organization to provide some safety guidelines for quality control and validity testing.
Maybe not the FDA. Maybe the Counsil for Responsible Nutrition. Or maybe another middle of the road organization.
Without some controls in place, this liberal thinking of "let me make whatever choices I want to make" clearly is not safe as proven by your NASID comment.
In fact, there were so many problems with it, the FDA was petitioned so much it moved slowly to change the labels. Slowly becuase it's a big ass government organization that has to look at things very carefully. Under-funded and under-staffed, it's not like they can do much "overnight."
Anyway, in the case of NASID's, here's a group of drugs that passed all the self-imposed and other governmental regulations in place. Yet there WERE numerous problems.
And the FDA had to get involved.
Without the FDA or somebody getting involved, the poor consumer is screwed.
I wonder if there was some middle organization that was able to self-regulate this and impose warnings, safety levels or quality controls if this incident might be different?
Such is the case with supplements.
While creatine isn't in the same category as inflamatory drugs, there still needs to be some self-imposed, self-regulation within the industry to ensure safe is meet, quality control is assured and valid testing is done for the supplement in question.
Self-Regulation with a partnership with the FDA would be ideal.
Not the FDA stepping in and making hasty, misinformed judgements to ruin the industry but not supplement companies lying and misleading consumers.
I think the dietary industry IS capable of self-regulation and the responsible companies are working towards it. They dislike the little guys who cheat, lie, and steal to make a profit while making the entire industry look bad.
Today marked the end of the DCAT 2007 conference.
When an FDA spokesperson was asked directly what level of involvement they saw themselves having in the dietary industry as ideal the answer was...
"A partnership between the FDA and the dietary supplement industry."
They clearly knew the dietary industry was better versed in the supplement at hand and they saw themselves having a partnership vs. having to step in and make quick, wrong decisions that could ruin a profit potential and leave companies in the lurch without any way out.
Take that statement with a grain of salt if you want but...
The mass hysteria from the liberal left is unwaraned and does nothing to ensure this industry is self-regulated.
There's SEVERAL responsible companies who are pushing for valid testing practices, quality control, label guidlines within the industry. All who have employees who are qualified to make such decisions.
The last few days of hysteria have been not much more than a computer virus hoax.
And by that I mean that there is some truth to it but it's hard to get to it beyond the smoke and gas being pour to start a massive fire!
The FDA writes a document and then we hear from the far left and all the lawyers about how it's over. Freedom is being taken away! Your creatine is next and if this continues, you'll have the DSHEA repealed without a congressional act. Then it's your right to vote and your guns.
What we DON'T hear much (except in my small attemps) is somebody in the middle trying to say..
"Hey... While I don't want the FDA who's not qualified to tell me about my creatine, I also don't want this industry to just do whatever the hell it wants without any accountability."
I want a little self-reguation within the industry to ensure me, as the consumer, is somewhat protected from misleading claims and at the same time, I don't want a misinformed big governement agency making decisions based on wrong facts without a way to appeal that ruling.
At the moment, all I keep seeing is the left side screaming how horrible this is and we all need to sign petitions and act quickly.
Mass hysteria is usually ALWAYS incorrect and uses facts and emotionally charged words to make their point.
I know the truth to be somewhere in the middle between the FDA and a responsible self-regulated industry.
Let's end with this...
quote:
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.
And that opened the door in the opposite direction. Many companies, unregulated, made all kinds of crazy ass claims and screwed consumers out of their money based on false hope. Becuase they could. There was little to no regulation. It was nearly impossible to make an informed choice based on an unregulated industry.
Just as too much regulation (before DSHEA) was BAD... so is too little. 
The answer lies somewhere in the middle and from what I can see, the groups with the dietary supplement industry are working towards that and the FDA isn't as closed minded about that as you might be lead to believe.
_____________________________
(in reply to JonBensonDotCom)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 4/26/2007 4:40:28 PM
|
|
|
Marc David
Posts: 6742
Joined: 4/6/2003
From: Bay Area -CA
Status: offline
|
The DSHEA Explained
Probably one of the better explanations from a really good group of qualified people.
_____________________________
(in reply to Marc David)
|
|
|
|
|
RE: FDA Threatens Your Freedom? - 5/15/2007 11:26:50 AM
|
|
|
Marc David
Posts: 6742
Joined: 4/6/2003
From: Bay Area -CA
Status: offline
|
quote:
U.S. Senate bill S.1082 passed today with a vote of 93-1.
FDA drug safety bill passes in the U.S. Senate
- I'm not surprised
- I'm not a believer in this "is a sad day"
- Consumers need some protection from the mass snake oil salesman who would love nothing more than to have an open door policy in which to sell their wares for profit
As there is more of a global economy, people need something more than just the promise and goodwill of supplement companies who:
- don't have to prove jack with any studies
- can make wild ass claims without accountabiliy
_____________________________
(in reply to Marc David)
|
|
|
|
|
|
Advertisement
|
|
|
|
|
 New Messages |
 No New Messages |
 Hot Topic w/ New Messages |
 Hot Topic w/o New Messages |
 Locked w/ New Messages |
 Locked w/o New Messages |
|
 Post New Thread
Reply to Message
Post New Poll
Submit Vote
Delete My Own Post
Delete My Own Thread
Rate Posts |
|
|
Printable Version
