FDA Labeling & Dietary Supplements | Natural Health Blog

Date: 04/11/2007    Written by: Jon Barron

FDA Supplement Labeling Guidelines

On April 30, 2007 the FDA will close the public comment period on a "Guidance" which will effectively classify many alternative health practices and supplements as drugs. www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

These proposed guidelines are, of course, total nonsense. The key point in the guidelines is that any herb or supplement that actually has any beneficial effect should be regulated by the FDA as if it were a drug if it actually helps with any medical condition unless 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 nonsense for two different reasons.

  • First, who are these experts? Are these the same experts that approved Vioxx even though it caused heart attacks? Are they the same experts who approved angioplasty -- now proven to be a waste of $48 billion a year? Are they the same experts who condemned hundreds of thousands of children to birth defects because they took forever to acknowledge the importance of folic acid -- whose benefits were long promoted in the alternative health community? Are these the same experts who refuse to accept the safety of stevia even though billions of servings have been safely used in countries throughout Asia and South America? When the failures of these so called experts are so apparent, time after time, it is nonsense to propose that they be the gatekeepers for herbs and supplements that have been used safely for decades, if not hundreds, or in some cases even thousands of years. And if the safety of these alternative remedies is long established (certainly far longer than for any pharmaceutical drug) why deny people access to their possible benefits -- even if the proof of those benefits is merely anecdotal?
  • Second, the regulations are so poorly written that they are guaranteed to lead to absurdity and self contradiction. For example, if you were to claim on a label that drinking bottled water helped relieve a medical condition such as…severe dehydration (not just a medical condition, but a medical emergency), the new guidelines would mandate that water now be regulated as a drug.

These are badly written guidelines that will lead to:

  • More confusion.
  • More cost.
  • Less access to health.
  • Denial of freedom of access.
  • And ultimately, an increase in civil disobedience, a further diminution of FDA authority as people look for ever more creative ways to flaunt the guidelines in order to maintain access to those herbs and supplements they want.

You might want to contact the FDA and let them know what you think of the proposed guidelines. Make sure to include the docket # (No. 2006D-0480) with your comments. You can write to them at:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Or you can shorten the process and comment online.

An if you have any questions or just want to chat live with them to let them know how you feel, the contact numbers listed on the document are:

Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739

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Comments

  •  
    Submitted by andrea on
    April 15, 2007 - 11:10am

    This proposed regulation of CAM is an outrage. I bet if the FDA held a public forum in DC to hear our views (both expert and layman) it would be the world's largest public forum attended by people whose health continues to be good because they empowered themselves to learn about CAM and how effective its use can be in their lives without consumers needing to be being slaves to the pharmaceutical industry. Freedom of Choice! Take that away, and you jeopardize the health of millions of Americans who value being treated holistically. Shame on you, FDA!

  •  
    Submitted by Andreyna on
    April 23, 2007 - 8:32pm

    I agree: "Nothing has changed. Focus on health, not disease." Don't mention anything about disease; maybe just say - this product will make you a sexy and orgasmic human being. Maybe the FDA people are sexually deprived; they need some kind of booster shot; they change laws for their sexual satisfaction; what do you think? Actually I will enter the CAM industry and I will really label my product as stated above.

  •  
    Submitted by Beth on
    April 14, 2007 - 11:37am

    I think we are about to have a repeat of the clampdown on energy devices that we saw earlier in the century -- when the likes of Royal Rife, Wilhelm Reich and Ruth Drown were destroyed. Computer sophistication and electronics have advanced to the point that these things can be mass produced and are getting into the hands of the lay population where they can 1)use them themselves and not require anything of the medical establishment anymore and 2) use them (with discretion or not) on others and be in competition with the establishment. I am talking about things like the EPFX system, the Scenar device, light and sound therapy machines, magnetic devices, perhaps even Hulda Clark's simple zapper. For all practical purposes, we've already lost ozone. Even oxygen (medical grade) itself requires a prescription.
    From the opening paragraphs on ""Why Are We Issuing This Guidance?"" I pick these two phrases: ""....visits to CAM providers each year exceed those to primary care physicians."" (note the word provider vs physician) and ""We have also seen an increase in the number of CAM products imported into the United States."" Probably they are mainly talking about the EPFX system, whose developer, William Nelson, is in Hungary after the FDA showed no interest in approving a ""drugless"" therapy and rejected approval of the system with no explanation.
    In my semi-rural county, suburban to a large metropolitan city with plenty of hospitals, we now have two monsterous cathedral-like hospitals. Same thing going on everywhere. Those won't be paid for with healthy people, and they can't afford to have their formerly captive population wander off and spend their money elsewhere. And they won't adopt any of these devices for their own because they are too efficient and inexpensive to use. They NEED endless inefficient ""therapy"" (drugs) and hugely expensive overkill type ""therapy"" (surgery, MRIs etc) that can't be afforded by the small guy.
    The danger I see is that while everyone gets riled up and focuses their attention on the outrageous (vegetable juice as a regulated drug), the real noose tightens elsewhere. The FDA will only look like its backing down when it says it realizes that regulating vegetable juice is kind of ridiculous and certainly not practical. Watch out then.
    Life is energy. Life stops when the electrons quit flowing. You can see it on the ECG. It's the energy medicine they're really after.

  •  
    Submitted by Bob Stubblebine on
    April 12, 2007 - 9:15am

    Mike Adams is not a fear mongering zealot. There has been several web sites knocked down lately and I wonder who is doing it? These guys are for playing keeps and with millions of dollars at stake who knows what they will do? If this is just a simple regulation then why are these guys being so agressive? Check the web and see what they have done in other areas. They want to see how much feed back is around and what they can get away with before the big guns come out. I trully wish it were just tighter guidelines but it appears like more than that. They don't have anything else to do besides vitamins and alternative health?

  •  
    Submitted by charles faris on
    April 18, 2007 - 11:47am

    anything that leads to "an increase in civil disobedience, [and] a further diminution of FDA authority" sounds pretty good in my book...give 'em enough rope i say...the fda does not have the resources or the teeth to actually enforce this, and they will crack under the strain...

  •  
    Submitted by Charles Transue on
    April 11, 2007 - 9:45pm

    I'm confused about the level of gravity of this issue. The first article I read about it was by Mike Adams, on News Target. He claims that the legislation would literally strip the country of alternative therapies, foods and dietary supplements, making virtually all of them illegal.
    Jon, if the tone of YOUR article about the FDA's proposed legislation accurately represents the actual impact it might have if it passes, then Mike Adams is nothing but a fear-mongering zealot.
    Could the proposed legislation be little more than somewhat stiffer regulation of product labeling? If so, we have little, if anything, to worry about.
    I am open to any and all comments about this!

  •  
    Submitted by Colleen Peters on
    April 15, 2007 - 6:48am

    I think this is nuts. It is another step in attempting to control what we put into our bodies, taking care of ourselves.

  •  
    Submitted by Deb Perzo on
    April 19, 2007 - 11:53pm

    Please excuse my grammar..."IF IT AIN'T BROKE, DON'T TRY TO FIX IT". Freedom of choice-Focus on health. Thank you for your consideration.

  •  
    Submitted by Dona Wheeler on
    April 22, 2007 - 10:39pm

    In most instances, prescription medication has more NEGITIVE aftermaths than positive. I witness that every day, as for myself I am quiting RX, for the harm they do. My life has been impacted in too many ways, and I will not be a human guni pig. I have healed of many health issues, doing ""natural"". Doctors get their pay from drug companies, so infact are no more than leaglized ""pushers"". Having been self diagnosed with Bipolar depression in 1993, starting medication,[Lithium] was Toxic. I was out of it, for 5 years, my ex walked out, never got involved, and I lost all. In 2004 at 325 lbs, my ex shrink, put me on Topomax, and I lost weight, but it threw me into ""mania"". And again life altering changes took place.
    Natural, Alternitived wins hands down

  •  
    Submitted by gilli mimi on
    April 14, 2007 - 5:34am

    Here in the UK we have the same legislation going through though we are battling against it. The chinese medicine berries goji berries are now apparently under threat - despite being used for thousands of years in chinese medicine. Funny how they don't stop selling red wine when people say that it can help make you live longer... oh gosh - I forgot the government makes all that money from tax on alcohol - I wonder if that's why they don't ban it.
    There was a cynical comment in one of the main UK newspapers some time ago pointing out that if the government supports poor health for the population (and denies people the ability to improve their health) - they'll get sick and die earlier and there goes your pension deficit problem.
    The world isn't run by governments - it's run by the major multinational corporations - and the largest corporations are the drug companies - and they want to keep their shareholders happy. They want us all to keep on eating pizza and burgers and then we need their cholesterol reducing drugs, weight loss products, and eventually diabetes treatments, heart problem drugs and lots of medical intervention. The sicker your population - the more money spent on medical costs. A healthy population doesn't need drugs - so what's going to happen to GlaxoSmithKleinPharmaJohnson&johnson then?
    This may seem fairly harmless now - but could ultimately lead to the end of any alternative to pharmaceutical based medicine.
    With elections looming soon - please lobby your representatives and vote for your health.

  •  
    Submitted by HKohler on
    April 16, 2007 - 7:14am

    Everyone just needs to do their part and make sure their voice is heard.
    Go here and post your comment:
    http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA
    My comment to the FDA:
    I cannot properly express my disgust at this proposal. How you people, buried so deeply within the pockets of big business and the greedy pharmaceutical manufacturers, find the audacity to even attempt to slip this through is beyond me. What's even more of a mystery is how you sleep at night. You, who serve the corrupt cartels that push Vioxx and sell HIV infected ""medicine"" to innocent and unsuspecting children, think you have ANY authority to decide what free citizens put into their bodies? Do you honestly think we will stand for this? Think again!
    I don't need ANYONE to regulate what I decide is to my nutritional benefit. Most especially an organization that allows all manner of toxic and cancer-causing CHEMICALS, processed junk foods, virtually untested pharmaceuticals and genetically modified foods, and horrible nutrient depleting practices, such as irradiating and bleaching, to be forced onto the unsuspecting populace by whom they are employed and supposedly serving. Again, how do you sleep at night? Do you pump your belly full of the lovely sleep-driving inducing pharmaceuticals? Oh, by the way, how did that ""slip"" past your ""expert"" eyes?
    Where were you when smoking cigarettes was considered A-OK? Where are you in spreading awareness or banning partially hydrogenated oils which cause so many health problems in our country? Where are you in protecting the public from water poisoned with fluoride and pharmaceutical toxins? You do not do the job your are meant to, and therefore are not qualified nor respected enough to dictate what juices I can drink for my own health.
    Deprive your own families of proper nutrition. Leave the rest of us alone.

  •  
    Submitted by James Anderson on
    April 19, 2007 - 4:35pm

    I would like to add to the many great comments made here.
    Where was the FDA investigation and scrutinty when they approved the many harmful artificial sweetners on the market? Where is the investigation on the harmful effects of Canola oil? Where were they or what were they doing when they approved drugs like Vioxx and Thalidimide?
    What about DDT? It was on and in many foods for a very long time and is still found on herbs from China and other nations with lax regulation.
    I believe we should all be petitioning for a total overhaul and house cleaning of the FDA to rid it of the corruption and incompetence that has cost so many lives and caused so much hardship.
    There are far too many games being played with what can and cannot be sold and used in this country and very little of it has to do with any real science, only politics and corruption.

  •  
    Submitted by Jennifer on
    April 21, 2009 - 5:26am

    This is what happens when the FDA and pharmaceutical get their way. I can't get the natural product that worked for me but I can get it by prescription from my doctor at a ridiculous cost..oh wait I need insurance too. I am in my 40's and have seen no less than 12-15 natural remedies I regularly used taken away. They are sold back to me in the same or a synthetic form by the drug company.
    Please see article on http://heartdisease.about.com/cs/cholesterol/a/Nrxcol_rry.htm.

  •  
    Submitted by Jessie Njer on
    April 30, 2007 - 3:32pm

    This is the letter I wrote today to the FDA
    April 30, 2007
    TO: Federal food and Drug Administration
    Dear Sir:
    With great horror and disappointment I found out that the FDA is trying to sneak a regulation banning the use of natural herbs without Americans being well informed or having a say on this issue. I have asked a lot of people and nobody knows about it, how is that possible??
    I don't understand, it appears that you are trying to ban natural alternative treatments, but tobacco is ok? Why? Is it because tobacco generates multi billion dollars in taxes?
    Now, you are trying to ban natural alternatives so that drug companies can have the full pie? Do you have to give it all to the drug companies and doctors? What is going to happen to all those people that can't afford medical insurance or pay the large doctor bills? You have to realize that many depend on natural alternatives to stay healthy. Are you going to give every American paid health insurance and drug coverage?
    Since you do not seem to care about people, why should they not be allowed to make a personal choice? People need to have the right to choose what they put in their bodies. This is not an issue that the FDA needs or should decide. This is a matter of personal freedom. Natural alternative plays a large part in many cultures, including mine. Throughout my life I have taken very little medicine and I intend to keep it that way.
    After all, in the opinion of many people including myself the FDA has not shown to have good judgment. It appears that you approve of drugs and treatments because the drug companies tell you to approve them. After many people die because the product is defective, like Viox, then your remove it but not before the drug companies already made their billion dollars profits in the process. Why don't you go and concentrate your efforts on something else, and leave people that like to use alternative treatments alone? After all this is the right of every American.
    Just remember, that everything that grows was God's gift to humanity to take care of all our illnesses and well being and should not be regulated by the FDA. Even my dog, when she does not feel well, goes to the garden and finds the grass she wants to eat, then she throws up and everything is fine.
    I saw a documentary last night of how dogs are being trained to smell cancer and diabetes in people. Are you going to prosecute dogs for practicing medicine without a license?
    As I said before this is a matter of freedom of choice. Everyone has the right to choose what to put in their body, their Doctor or what kind of alternative treatment to use. If the FDA approves poisons (medicines) to please drug companies, a person should have the ability to choose something different if they desire, anything less should constitute a violation of human rights.
    Maurice & Jessie Najer

  •  
    Submitted by John on
    April 13, 2007 - 1:46pm

    I've been reading the FDA's CAM Guidelines at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf and under the "Device" and immediately following sections and I can't help but to wonder if they will outlaw the use of common rocking chairs that a mother uses to rock, soothe, and calm her baby? Are they going to raid our homes and arrest our "easy chairs" that vibrate and generate heat? Will they take away our TV, phones and other appliances because they emit radiation? Will they take my bed because I rest and sleep in it and rest and sleep helps to cure many ailments? Will they outlaw toys, games, sports, Disney World, entertainment, and other recreation that is known relieve stress? What has this world of America come to? God have mercy!

  •  
    Submitted by John Hammell on
    April 16, 2007 - 9:20pm

    Michael Donaldson is 110% CORRECT in his assertion that this FDA Guidance Document is just empty FDA sabre rattling. He is CORRECT in his assertion that FDA is not saying anything NEW in their guidance document- that this is merely a call to ""watch your labeling."" There is something ELSE going on here, however, and since no one else has picked it up, I will call it to your attention: Mike Adams has ZERO credability right now with IAHF, National Health Federation, Alliance for Natural Health, or allied health freedom groups all over the world because he disseminated the OUTRAGEOUSLY HYPED DISINFO on this that was distributed by the (so called) ""Natural Solutions Foundation"" in what can only be truthfully characterized as yet another ""RIMA/BERT DISINFO ERUPTION"". NSF has a long history of DISTRACTING the grass roots from the REAL ISSUES on the health freedom front in an obvious effort to create COGNITIVE DISONANCE and INACTION re the things that matter the MOST, and this FDA Guidance document has been no exception! See My Petition calling for Congressional Oversight on FDA's Trilateral Cooperation Charter- its been signed by more than 10,340 people but we need at least 100,000 or congress will sit on their hands and won't give us oversight: http://www.thepetitionsite.com/takeaction/373269232#body IAHF and Allied groups conduct a TRIAGE ASSESSMENT of ANY and ALL threats or potential threats arrayed against dietary supplement consumers in the USA and the WORLD, assigning a specific VALUE to the threat so that we don't waste ENERGY or TIME on things like this which don't measure high enough to warrant action. Under the FDA's Trilateral Cooperation Charter with Canada and Mexico:http://www.fda.gov/oia/charter.html FDA has engaged in more than 730 Compliance Actions against weight loss dietary supplements, acting as though a North American Union were ALREADY IN PLACE despite the fact that NO IMPLEMENTING LEGISLATION has EVER been passed in the USA allowing them to DO what they're DOING!! THIS represents a FAR greater threat than FDA's Guidance Document which NSF has HYPED to the NTH DEGREE as part of a PHISHING expedition to build their mailing list! NSF and allied Controlled opposition groups including so called ""Citizens for Health"" in the USA and so called ""Friends of Freedom"" in Canada are attempting to DIVERT public attention from IAHF's efforts to get CONGRESSIONAL OVERSIGHT on FDA's Trilateral Cooperation Charter and from the FACT that the FDA is in violation of the LAW for ignoring IAHF's Freedom of Information Act Request regarding this. NSF has a LONG HISTORY of engaging in this EXACT SAME sort of DISINFO. When CAFTA was moving through CONGRESS, IAHF and allied groups attempted to KILL IT recognizing that the SPS (Sanitary Phytosanitary Measures) language it contains dovetails with IDENTICAL SPS language contained in NAFTA, WTO, and CODEX to rope us more into CODEX's draconian restrictions vis a vis dietary supplements. NSF generated no less than SEVEN SPIN PIECES against the mssg of IAHF and allied groups during our campaign to kill CAFTA, and simultaneously they made the GRANDIOSE announcement that a ""MIRACLE"" had occurred at Codex (due to their actions, naturally). National Health Federation and allied groups exposed this claim of a supposed ""miracle"" as totally FALSE, (See Paul Taylor's Article ""A Modern Major General Exposed?"" http://www4.dr-rath-foundation.org/THE_FOUNDATION/Events/codex-moderngeneral.html What NSF was clearly attempting to do back then was to create COGNITIVE DISSONANCE so that the grass roots would read OUR pleas for action against CAFTA/CODEX, and THEIR assertion that a ""MIRACLE"" had occurred at CODEX so that the public would SIT ON THEIR HANDS AND DO NOTHING! EVERY TIME they send out a supposed ""ALERT"" they do some variation on this same theme, only right NOW their goal is to DIVERT public attention from the very REAL mssg of IAHF and allied groups because they, and their CIA handlers don't WANT congressional oversight on the FDA's Trilateral Cooperation Charter, or any OTHER aspect of the planned North American Union. People keep forgetting who Laibow/Stubblebine are. Stubblebine was the Director of Army Intelligence. His reports went directly to the White House and the CIA. Stubblebine and his wife SUED film maker Kevin Miller because he REFUSED to edit his anti Codex documentary film the way they wanted it editted. They didn't want ANY MENTION of CAFTA made in the film. Their goal is to DIVERT public attention from ANY ASPECT of REGIONAL HARMONIZATION. THAT is how CODEX is being ushered into the USA, our country is being DECONSTRUCTED and forced into a NORTH AMERICAN UNION with Canada and Mexico where dietary supplements are regulated as DRUGS. See National Problematique- The North American Nightmare: Then see ""The Real Face of the European Union"" which discusses its Nazi Origins and fully delineates whats coming at us here: http://www.stopthenorthamericanunion.com/videos/EuropeanUnion.html People don't grasp whats happening right under our noses. They don't grasp that the planned NAU is being modelled after the EU, and they don't know the HISTORY of the EU which was originally conceived by the Nazi High Command(and the ruling elite who put Hitler into power) in the waning hours of WW2 as a LONG RANGE means for Germany to achieve via POLITICAL means what they were UNABLE to attain militarily via WW2. THIS is a REAL threat, a VERY real threat, but Jon Barron is too undiscerning, apparently, to grasp this. So he has UNWITTINGLY climbed aboard the bandwagon created by Laibow/Stubblebine, with Mike Adams ignorant complicity. I urge Jon Barron, Mike Adams, and OTHERS who have been DUPED by this NSF Disinfo Campaign to start seeing the BIG PICTURE and to STOP assisting controlled opposition groups who are working on behalf of globalist interests. Learn the TRUTH about whats going on on the health freedom front: Sign on to the IAHF email distribution list at http://www.iahf.com and see our TAKE ACTION section at http://www.nocodexgenocide.com IAHF were the first to call the Codex vitamin issue to global attention (1996- Life Extension Magazine) and we've been walking POINT on health freedom issues since that time. I first started doing my health freedom work in 1989- 18 years ago. NSF aren't respected by any legitimate health freedom organization in the world, and its high time the public grasped this.

  •  
    Submitted by Jon Barron on
    April 13, 2007 - 10:59am

    I actually know Mike Adams personally. Yes, he is extremely passionate, and he definitely speaks his mind, but he is not a zealot. You may agree or disagree with him on any given point, but rest assured, Mike is the genuine article -- one of the real class acts in the world of alternative health.
    Jon Barron

  •  
    Submitted by jonbarron on
    April 11, 2007 - 11:12pm

    Fundamentally, I don't disagree with Michael Donaldson. I never said it was a law or a regulation. I referred to it only as a ""Guidance,"" an internal FDA document that clarifies how they intend to interpret DSHEA. That said, there are three important points worth considering: 1. In its specificity, the document tightens the restrictions on alternative health labeling found in DSHEA. 2. Its very specificity makes manifest fundamental inconsistencies and absurdities in the DSHEA law. If you substitute ""water"" for ""cranberry tablets"" and ""severe dehydration"" for ""urinary tract infection,"" as found on Page 12, then you've turned water into a drug according to these guidelines. Obviously, the FDA would never turn water into a drug, but the guidelines allow them the option to do so. That ""flexibility"" alone makes the guidelines dangerous. In reality, what the guidelines do is extend the FDAs authority to arbitrarily decide when to enforce their will. 3. And the FDA absolutely does ask for public comment, allowing people a chance to address points one and two above. Obviously no responsible person wants total license for any and every marketer to claim that herb X cures cancer, but to not be able to mention the possible cancer fighting benefits of herbs like graviola or pomegranate, protocols such as detoxing or energy work, or supplements such as curcumin and green tea is equally wrong. It denies people the chance to make informed decisions. And as for waiting for the ""so called"" experts, these people can’t even decide whether or not vitamin E provides any benefits or in fact puts you at risk. (And notice when it comes to these experts how non-specific the FDA is in their guidelines as to who they actually are; and how conveniently that allows them to reject any opinion they don’t like.) Is this all a big deal? Probably not. Far more dangerous is the work of the FDA in killing herbs and supplements sub rosa (/natural-health/newsletter-dietary-supplements-herbs-remedies). Kava kava is a great example: * It was trashed by the FDA based on erroneous reports that it might cause liver damage after hundreds of studies prove that it doesn’t. (/natural-health/alternative-kava-kava-dietary-supplements) * If you sell Kava kava, it is denied coverage by most of the major insurers because of their fear of lawsuits that might be triggered by the FDA’s statements of possible liver damage. So, many are fearful to even sell the product. * And right on cue, the class action lawsuit that was settled last year based on the liver damage kava kava does not cause. (http://www.lawyersandsettlements.com/settlements/05514/kava_kava_settlement.html) Ultimately, the danger is not in big legislation, but in the slow and steady erosion of our rights to choose our own health care options that goes on under the table, out of sight and out of mind. And once again, it's worth restating, the FDA did ask for comments. If no one says anything, then we can't complain tomorrow if we wake up in the morning with that much less access to alternative therapies.

  •  
    Submitted by Jon Barron on
    October 19, 2007 - 12:51pm

    Wow, Sean. That's a bit harsh -- and also more than a bit disconnected from reality. You seem to think that anecdotal evidence is bad and that clinical studies are good. That alternative health is based on anecdotal evidence and that medicine is based on rock solid clinical studies. And that trying to move around perfectly reasonable FDA guidelines is unethical and untrustworthy. Unfortunately, the reality does not match your expectations. You might want to check out my recent blog on Blood Transfusions. I posted it just for you. You might be quite surprised with what you learn.

  •  
    Submitted by Judy on
    April 12, 2007 - 10:28am

    I agree with both Mike Adams and Jon Barron. Simply put, the FDA is trying to control what we do and what we think. Every little inch they claim of our Health Freedom is one step closer to removing our rights to choose what we put into our bodies. I hope everyone who posts here takes the time to comment via email or letter on this draft.
    P.S. I love Mike Adams and the people at NewsTarget.com. Please don't dis him or his opinions. We all have a right to say what we feel, but can we at least try to be nice to one another?

  •  
    Submitted by julie on
    April 28, 2007 - 8:31pm

    THE FDA, BIG PHARMA, AND CHEMICAL COMPANIES ARE ALL IN BED TOGETHER. I WOULD LIKE TO KNOW HOW THEY SLEEP AT NIGHT WITH ALL THAT BLOOD ON THEIR HANDS. THERE ARE TWO GREAT BOOKS I READ THE HUNDRED YEAR LIE BY RANDALL FITZGERALD AND CANCER STEP OUTSIDE THE BOX BY TY BOLLINGER. WE NEED MEDICAL AND FDA REFORM NOW MORE THEN EVER BEFORE HUMANS ARE EXTINCT. WE ARE WORRIED ABOUT ANIMALS GOING EXTINCT, THEY WILL BE AROUND LONG AFTER US BECAUSE THE FDA CAN'T FULLY CONTROL THEM. AFTER I READ THESE BOOKS I COULDN'T BELIEVE THAT ASPARTAME, MSG, CHLORINE, FLUORIDE, VACCINATIONS AND A HOST OF OTHER THINGS WERE SO BAD AND HOW OUR GOVERNMENT CAN JUST SIT THERE AND LET THIS HAPPEN. THEY ARE SO CLOSE TO A CURE FOR CANCER, YEA RIGHT THEY HAVE HAD PROOF THAT ALTERNATIVE METHODS REVERSED MANY CANCERS BUT THEY WERE SURPRESSED BECAUSE THEY (FDA AND CRONIES) WOULDN'T MAKE A BUNCH OF MONEY. WHERE'S THE JUSTICE? WHAT CAN US LITTLE PEOPLE DO TO CHANGE THIS? DO WE HAVE LEGAL RIGHTS TO CHANGE THIS MESS? GOD HELP US!

  •  
    Submitted by Leanna on
    April 12, 2007 - 8:59pm

    I can personally and professionally speak for Mike Adams' integrity, groundedness, genuine good heart and much more, and where he comes from is not the energy of a fear mongering zealot by any stretch. Looking at history and present day events as objectively as one can, one can see that there are forces at work here that clearly demonstrate that they are money and power mongers. We should do all we can to support people like Mike and Jon for putting themselves at very real risk in standing up for our freedom.
    If this item in question was not deliberately created and meant to be deceiving, malleable, etc., then why is it written the way it is, presented the way it was *(or was not)? We have a lot at stake here, and so do they. They have more, though, and have shown they also have more guns and used them for less gain. We definitely need to stick together, like never before, or just like before, who's to say? I just know that there is power in knowledge put into action, so spread the knowledge far and wide. The required action will become evident, I believe.

  •  
    Submitted by Linda Nedderman-Eaton on
    April 12, 2007 - 4:15am

    Try to understand that FDA Guidance Documents are NOT law. I agree with Mike Donaldson. This guidance document doesn't change anything. You already cannot make disease claims for any food or dietary supplement, or it will be regulated as a drug. That is basically all that is being re-said. If you are selling a juice for treating a disease, then you have a drug, but if you sell it to promote optimal health, then you have a food. The intended purpose or use is the key. The document to which they are referring is simply a ""Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration"" clarifying their already draconian position on CAM. Is is NOT legislation NOR is it PENDING legislation. Our ability to purchase and use herbs and supplements are presently not in any danger by this Draft. By PRESENT LAW you ALREADY cannot state that water can cure dehydration or an apple can ""cure"" hunger, nor can anyone right now claim that vegetable juice can ""treat, cure, ""mitiate"" or in anyway alter any disease process or BY PRESENT LAW it will be treated as a drug and the person making the claim can be prosecuted for practicing medicine without a license. The FDA can call CAM products anything they want, it still can't change an act of congress. I agree with Jon Barron that a far more dangerous situation is the work of the FDA in killing herbs and supplements sub rosa (/natural-health/newsletter-dietary-supplements-herbs-remedies). By law the FDA can do this and has had the power to do this for sometime. AND as Jon points out in his link we just don't know how to stop this. And my suspicion is that that might be the real way that the FDA will finally strip us of all supplements and herbs and such, by picking them off one by one. The National Health Federation http://www.thenhf.com/ has nothing to say about this because it is NOT a bill. However there are other serious bills being introduced and reintroduced that we definitely need to be taking a look at. One of these is H.R. 1148/S.654 Safe Food Act of 2007 Both are identical to last session's Food Safety Admin bills, sponsored by Durbin and Rep. DeLauro. Sen. Richard Durbin (Asst. Minority Leader for the Democrats) has reintroduced S.654 under the pretext of the need for food safety protection, thereby creating a new federal food safety agency. This is very dangerous legislation for consumers of dietary supplements as it would repeal the DSHEA Act of 1994, and if signed into law, as currently proposed, dietary supplements would be reclassified and regulated like drugs. The companion bill, H.R. 1148, was introduced by Congresswoman Rosa DeLauro. Both introduced similar legislation at the end of the last Congress. This ""Food Czar"" legislation needs your opposition. Please use the petitions on the National Health Federation website to contact your Senators and Congresspeople now. I did, however, send comments in via the government site but truly my comments mean nothing to the FDA and they will ignore them because the Guidance that they are providing to Industry is, in fact, already law so they don't give a hoot what we have to say about it. What we also need to do is to continue to try and get bills introduced and passed in Congress that give us Health Freedom. One was introduced sometime back but apparently never got off the ground. Linda E. Nedderman-Eaton

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    Submitted by liveinyourbody on
    April 15, 2007 - 1:18am

    Codex is for real. Some of the comments have been saying that the requirements are not binding. I encourage you to view the video about Codes on this site. http://www.healthfreedomusa.com/
    Find out what Codex is really about.
    Sign the Citizen's Petition.
    Stop Codex.

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    Submitted by Michael Donaldson on
    April 11, 2007 - 8:07pm

    This guidance document doesn't change anything. You cannot make disease claims for any food or dietary supplement, or it will be regulated as a drug. That is basically all that is being said. If you are selling a juice for treating a disease, then you have a drug, but if you sell it to promote optimal health, then you have a food. The intended purpose or use is the key.
    So, we don't treat diseases, we help people achieve optimal health.
    The FDA is in a sense saying, ""Watch your language."" Its a game of words, but also a game of ideology. Many CAM practitioners don't treat ""diseases"" anyways, but they do help people achieve optimal health, and dis-ease happens to go away.
    The definition of what is a dietary supplement is pulled exactly from the 1994 DSHEA law. See http://www.fda.gov/opacom/laws/dshea.html#sec3
    Nothing has changed. Focus on health, not disease.

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    Submitted by Michael Kennedy on
    April 21, 2007 - 6:28pm

    Why would the FDA go to the trouble of restating its guidelines if nothing has changed? The answer comes from the Natural Solutions Foundation: First, the term "CAM" has been redefined and is used in the Guidance to mean "Complementary and Alternative MEDICINE" rather than the more generic "Complementary and Alternative MODALITIES". The difference is significant, as we have written before, because the redefinition of these practices and the products as MEDICINE may be interpreted by an agency hostile to all competitors to drug based medicine to mean that only licensed physicians may carry out these practices. The products which support these practices, vitamins, minerals, amino acids, herbs, juices, berries, holy water, organic foods, nuts, grapes, coconut oil, or whatever, which are used to support the procedures and intended to bring about healthy states become, under this guidance, "CAM products". As CAM products, if they are being used with the intent to bring about health impacts or benefits, they are classified as untested drugs. In the US and elsewhere, untested drugs are illegal and people or organizations selling, recommending or making claims for them are committing a crime. The "Guidance" makes it clear that "CAM products" will be classified as untested drugs if the intent behind their use is to heal, cure, treat or mitigate illness or to create health. The standard for regulation has been changed from use to INTENT! The FDA now gives itself the right to determine WHY you used, bought, recommended, provided or produced this substance.

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    Submitted by Mike Self on
    April 23, 2007 - 4:30pm

    For Linda Nedderman-Eaton | April 12, 2007 10:15 AM
    We already cannot say that water cures dehydration and you think there is nothing wrong with those government agencies putting out further garbage?????????

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    Submitted by Mirto Capeder on
    April 14, 2007 - 12:31pm

    Being a person of action, I share the following with you.
    MASS E-MAIL: Tyranny on our Health Freedom in the USA.
    I do extensive research on items related to health. One of the major reasons that the people of the USA are so unhealthy, given all our resources, is the FDA. While the FDA has done some good, overall they have been a failure and done more harm than good in many cases. It's obvious to even someone like me that they have sold their soul to the Pharmaceutical Industry, money, and power.
    With that in mind I introduce the following:
    It's been a whirlwind week of disturbing developments about the Food and Drug Administration. For those of you who are concerned, you should be, read on. I have included a site for your review, just one of the better ones of many that cover this issue. Before we go there, here is some action I have taken and I don't waste my time on issues that are not important. Nothing is more important than our health and I include physical, spiritual and mental. In this case physical but that also effects the mental and spiritual. Take away physical health and life starts to crumble, like breaking a leg on a 3 legged stool.
    ACTION I'VE TAKEN:
    I have spent a bit of time reviewing the information and have also taken action. I have sent the FDA 3 responses on this issue in the docket format available by e-mail. I will be sending more.
    Below is 1 of items I already sent via their online format. Share with your e-mail contacts if you want. Tell them to spread the word on this police action against our freedoms.
    Or you can shorten the process and comment online (Select comment online) from the site below when you get to:
    Dockets Management Branch (HFA-305)
    5630 Fishers Lane, Rm. 1061
    Rockville, MD 20852
    http://www.jonbarron.org/blog_published/2007/04/fda_labeling_guidelines.html#more
    Here is one of my letters I sent under selection comment online as I indicated above. Docket: 2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability.
    Please keep your hands off of my vitamins, minerals, amino acids and all other forms of supplements I use.
    At one time I was taking medication (toxins in the body) approved by the FDA. Eating foods that you guys should have been warning us about, but you didn't. I came to a point of being close to death. Though I was not physically dead, it was life without living. I felt lousy most of the time. Then I started on a road to doing my own research and found out how incompetent and corrupt organizations like yours are. I started eating the correct foods, taking supplements and stopped taking toxic medications that you approved. Today I feel great and have clarity of mind and vitality most of the time. I take no prescription or non-prescription drugs not even aspirins of any type. That is one of the major reasons for my great health along with proper diet and quality supplements. So stay out of my life. I'm not a 5 year old child.
    ? Focus on doing your job instead of being a DICTATOR on my supplements. Focus on cleaning up your mess with prescription drugs such as VIOXX. Statin drugs are even a fraud based on what is advertised on television and you and the FTC do nothing about it. Prescription drugs kill over 100,000 every year. Vitamins 0 in 16 of 23 years and between 1-2 in 7 years due to gross iron overdose. Best you think of items like this on toxic prescription drugs. ""The desire to take medicine is perhaps the greatest failure which distinguishes man from animals"". Sir William Osler, one of the most brilliant physicians of recent times. He also said, ""The greater the ignorance, the greater the dogmatism."" In the early 19th century a quote was attributed to Oliver Wendell Holmes ""If all the drugs were thrown into the ocean, it would be all the worse for the fishes and all the better for mankind.""
    While the FDA has done some good, overall you have been a failure and it's obvious to even someone like me that you have sold you soul to the Pharmaceutical Industry, money, and power. You are one of my 10 Major Evils of Modern Day Health + Six.
    Feel free to use this letter and e-mail or share anything else I state with anyone you want.
    Suggest we all hit the FDA Docket Multiple times and tell your associates to do likewise. Lets' bring these criminals down. They are worst than most criminals as they hide behind the guise of doing good for society. We had many dictators that did the same such as Adolf Hitler the Nazis in Germany
    NOTE: No less than 9 Nobel Prizes having been awarded for the discovery of the importance of role of vitamins and micronutrients in human health.
    Now the Rest of the Story:
    It's been a whirlwind week of disturbing developments about the Food and Drug Administration. Following yesterday's breathtaking revelations that the FDA plans to regulate virtually all herbs, vitamins, functional foods and even massage oils as ""drugs,"" I received skeptical questions from FDA defenders who insisted that the FDA had never done anything to harm the American people.
    Oh really? Apparently they aren't familiar with factual history. So to help educate those FDA defenders about how this rogue agency is destroying the very freedoms upon which this nation was founded, I have posted the true history of FDA raids on natural healers, vitamin shops and even a church!
    Click the headline below to read the full story... and after you read it, ask yourself this question: If the FDA would use armed agents to raid a church and confiscate its ""healing devices,"" is there anything the FDA *wouldn't* do to protect the profits of Big Pharma?
    http://www.newstarget.com/021791.html

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    Submitted by Mitch on
    April 14, 2007 - 2:34am

    Valerie, you stated: ""How can we stop these nuts, control freaks, money hungry nuts?...""
    Answer: They cannot and will not be stopped because the masses here in the US are not desperate enough (nor are the masses even aware that there really is a problem)yet to exercise their Constitutional 2nd amendment rights. By the time the middle class is completely wiped out here (and we're getting closer, faster, with US Dollar hegemony coming towards a likely end), our 2nd amendment rights will be gone or surpressed with martial law, and the capability for a successful revolution will be almost impossible. It's the bottom of the ninth inning, we're down 5 runs, with 2 outs and nobody on base.

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    Submitted by Rob Cooke on
    April 18, 2007 - 10:10am

    Global Warming...bees dieing, the true medicinal healers of the planet..it's plant based world going extinct...all that will be left is non-biogradeable synthetic drugs and toxins to work with?
    Why does the FDA even bother in regulating the nutrional foods industries, or creating this current power play?
    They (the FDA/Chemical companies & the Repuglicans) are allowing climate change to do their dirty deeds.
    I fear that the people of this planet has too much malaise, chronic fatigue to fight caused by pharmaceuticals,car exhaust (lead in our brains) and the other thousands of self, & involuntary forced to consume poisonous compounds.
    We've come to a point in this country (USA) especially where...ONLY a revolution can stop these criminals.
    WHERE'S all the young people today,to take these life & more likely death matters into their own hands???
    Watching the brilliant new program ""PLANET EARTH"" series, reminds me when I was a teen in 1973 watching the science (non) fiction movie ""SOYLENT GREEN"".
    Where Edward G. Robinson checks into a voluntary suicide clinic. They play old film of how the planet once looked in it's FULL glories.
    Similar to what Charlton Heston screamed in the end..
    ""TELL them!..Tell them that the planet is dying..and the FDA are criminal liars!!!""
    All we have/had is the real medicines and healing therapies of the planet to stay well. Most of us are victims of the pharmaceutical and chemical industries...we've learned the hard way. Remember to write your concerns to one of the VERY few, Republican Senators that were on ""our side"" in 1994. I'm obviously not a lover of the Repubs...but Senator Orin Hatch of Utah,was instrumental in stopping the regulation of vits, herbs etc. back then.
    Plead to him to help us again!

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