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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    Submitted by samatha on
    April 15, 2007 - 11:12pm

    I agree with everything you say, the FDA needs to leave us alone. If they are not trying to kill us, they are not happy. We have no rights as of now already, so if an elderly person has almost lived his life feels that the natural supplements are helping him, let him be in peace. Look what they have done to our food, and I'm sure they had a hand in our pet food too.

    Submitted by sean on
    October 16, 2007 - 1:37am

    ""why deny people access to their possible benefits -- even if the proof of those benefits is merely anecdotal?""
    Answer: Because that's not science or medicine. That's an anecdote which can and should carry absolutely no definitive weight when making a decision regarding people's health.
    If you claim something will produce a certain effect with regards to someone's health, you'd better have solid data to back it up and not just anecdotes.
    Then you've got people like ""Michael Donaldson"" who advocates a political approach as opposed to a straightforward and honest one. You say that you want to treat disease but the big, bad government says that ""you can't say that"". So instead of accepting the laws, you decide that it's best to circumvent the laws, and play a 'game of words' in order to go ahead and do whatever you want anyway.
    That really doesn't give me good reason to trust you at all, when everything you do is fundamentally based on this lie, or if you prefer, difference of words or ideology.

    Submitted by Shari on
    March 7, 2008 - 10:59am

    Wow Sean...where did you go? More importantly, where do you work and for whom?

    Submitted by Simon on
    April 16, 2007 - 8:56pm

    On the one hand, the FDA is recognizing the positive health effects of alternative medicines (ranging from 'Biologically Based Practices' to 'Subtle Energy Medicine'). This is no small feat. It seems to be an indicator that much of the American public (the sheeple) are recognizing and engaging with Complementary and Alternative Medicine (CAM).
    Unfortunately FDA regulation brings with it a great deal of administrative and regulatory clutter which may prove to be frustratingly obtrusive. Creating obstructions to healing and health is obviously counter-productive and uncalled for (unless CAMs were leading to a high rate of mortality, sickness and complications) - especially since the FDA has often failed in its attempts to regulate for public health. Many vantage points suggest that the organization is nothing more than an agency controlled by very large and wealthy pharmaceutical companies.
    It should not come as a surprise that the FDA would want to regulate CAM happenings. And it is upon all of us to bring the FDA and other organizations into alignment with public health rather than corporate donations and profits. I highly recommend that friends, family and other US citizens provide public comment in order to prevent the use of the gov't to serve pharmaceutical comany control and profits.

    Submitted by Steve Kowal on
    April 15, 2007 - 4:15pm

    “Put Your Hands Up and Step Away From the Echinacea!”
    If you believe more in natural herbs, supplements and alternative remedies (massage, acupuncture, homeopathics) than in the mindless ingesting of toxic synthetic chemicals to maintain your health, then you will be outraged at this. The corporate-controlled pawns at the FDA (the same ones that allow cancer-causing additives to be put into food and personal-care products) are planning to deny you your right to choose to use natural (i.e. non-pharmaceutical) alternatives. You have only until April 30th to voice your opposition.
    FDA draft rules (Docket No. 2006D-0480-kept under the radar for us regular people) will allow the FDA to reclassify “botanicals, vitamins, minerals, proteins, probiotics, functional foods…as a drug.” Our access to natural supplements, homeopathic remedies, medicinal herbs, natural juices, therapeutic teas and anything that is not a synthetic, manufactured (i.e. profit-making) drug will be severely restricted. They will be regulated (translated: controlled, removed and/or confiscated) from general use. Any non-doctor “dealing” in these substances (i.e. health food store owners) could be arrested for “practicing medicine” without a license. (details at www.newstarget.com/021789.html)
    Be outraged, but not surprised. It is more of the same of the corporate/regulatory/governmental (CorRegGov) system that systematically denies us the right to decide issues on health, food, transportation, energy and the environment. It allows corporations to recklessly splice viruses into FrankenCropsä, add carcinogenic chemical additives into “food,” legally kill our environment; vacuum out natural resources, drug and torture factory-manufactured animals…..so why be surprised that this same corporate-controlled system is allowing (pharmaceutical) corporations to eliminate natural remedy options and force us to resort to a monopoly of expensive, dangerous, synthetic prescription drugs?
    Yet our response is so Pavlovian it is painful. Even the above mentioned article, after it ends its harangue, describing the FDA as “criminal,” encourages us to lodge our “complaint against the FDA by going to the FDA Docket Comment Form.” We have become so disempowered that we think that our only recourse for the crime is to complain to the criminal! We are told to write letters in huge numbers to regulatory agencies and elected officials. We may “win” but in the end, nothing changes. We gain no control, no rights. Rather, the corrupt system remains intact until the next assault when, once again, we will be encouraged to write still more letters.
    The corporate “vision” of “endless-moreä” will never represent our best interests. And nothing will change unless we assert our democracy-based rights to decide for ourselves. It is time to dismantle, not just tweak, the system that favors the “few” over the “many” and re-write a new vision…one based on “real people” (i.e. not corporate) values, one based on OUR ideals for family, health, vibrant local economies, diversity, toxic-free food, energy and sustainability.
    So express your outrage NOW by writing letters and calling senators but understand it does nothing to challenge the fundamental, underlying illegitimacy of the system. Then gather your neighbors and begin the empowering process of writing YOUR community vision into local law. One that denies the illegitimate usurpation of your democratic rights and instead arrests the corporate few for violating your community vision.
    To learn how visit www.ACEne.org.

    Submitted by Susan Bench on
    April 11, 2007 - 8:37pm

    Jon, you make a very good point here. Although they are just proposed guidelines, it does show the FDA's end game and how far reaching they are willing to go to regulate anything that promotes health, including something as simple as cranberry juice.
    I am going to write a letter right away and let them know that their new strict guidelines are abusive and infringe on our health freedoms.
    Bottomline, if clinical studies show that a certain herb or fruit helps with a certain condition, they should be able to state that without suddenly making that fruit a drug (or massage oil a medical device). Even worse, as companies try to do studies to support known health benefits with a certain food, now that same study could be making the vegetable a drug.
    If people take this lightly, it will be a loss to the entire health industry.

    Submitted by torokilopz on
    August 4, 2007 - 10:29am

    Definitely nice and neat site you got there.

    Submitted by Valerie on
    April 12, 2007 - 5:16pm

    How can we stop these nuts, control freaks, money hungry nuts?...

    Submitted by Will Hof on
    April 23, 2007 - 9:42am

    See John Hammell's comments above.
    It says in short: It takes the attention away from the important and more pressing issue regarding Mexico,US,Canada.The super highway connecting all,Macquarie Bank buying most reginal radio stations to suppress voiced oppression...common folks GET A GRIP!!
    Rob Cooke:""WHERE'S all the young people today,to take these life & more likely death matters into their own hands???""
    They are conveniently sent to fight a war thousands of miles away! No trained guns at home,is the same as applying GUN-CONTROL.
    Very smart indeed. You guys are bled (tax dollar wise) to death with this war mongering.

    Submitted by Will Hof on
    April 12, 2007 - 7:31am

    I would like to draw your attention to an article appearing in the ISIS publication regarding the disregard for human life at the level of WHO by a previous staff member.When this occurs at international level,(ignoring alternative methods) wouldn't it be logical to have it occurring at the local level? Make up your mind, as it is your freedom to do so.Find the link here.

    Submitted by Dynamin on
    January 20, 2017 - 2:20am

    It is in individuals hands, if one is following healthy diet plan for its day. Start with healthy habits like wake up early do some exercise follow strict diet plan. I don't think one will need any medicine.


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