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Is the FDA Planning an Unpleasant Surprise?

fdaWe know that the FDA is discussing new regulatory requirements for supplements.

The Agency has not only discussed this internally. It has also sent out some feelers to see if some support can be generated within the natural products community. Reaching out in this way is often a rewarding strategy for the Agency. The reason is that some major companies actually favor more regulation because it discourages competition from small or new companies. This is another example of the crony capitalism that is so prevalent in the government/industry medical complex.
We have it on good authority that FDA Commissioner Joshua Sharfstein believes he has the regulatory authority to implement additional requirements for supplements without legislation. What might the new regulation look like? Possibly pre-registration, where any supplement must be registered with the FDA. Possibly pre-approval, which the FDA could refuse to grant on any number of grounds. More likely: pre-registration leading in a short time to pre-approval.
With respect to pre-approval, keep in mind that the Agency tends to believe that no supplement is safe, no matter how much science or longstanding dietary use is cited, unless the producer pays up to a billion dollars to take the substance through the full FDA drug approval process. This is why ANH-USA has (successfully) sued to make the Agency allow some partial health claims on supplement products.
ANH-USA is opposed to any such new measures, which are unnecessary, burdensome, and would result in reduced access to supplements. Supplements are more than adequately regulated. Supplements are also already required to register with the FDA under “The Public Health Security and Bioterrorism Preparedness and Response Act of 2002”.  (http://www.nutritionaloutlook.com/article/public-health-security-and-bioterrorism-preparedness-and-response-act-2002; http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081616.htm)
ANH-USA is monitoring these new developments closely and will ask you to take action when and if appropriate.  We are also exploring the possibility that the FDA is deliberately hiding information that should be available under the Freedom of Information Act (FOIA).

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30 thoughts on “Is the FDA Planning an Unpleasant Surprise?

  • william rice

    If the fda has not evaluated supplements, then why would they be of the belief that they are in any position to regulate them?……….Also ,the fda is not the only organization that can evaluate food, and say what is good for us (CHILDREN)! there are a lot of different schools of thought on the subject of supplements and many different diciplines. The fda has evaluated many drugs in the past and I wonder how many of those evaluations were a mistake?

    • I Dr. Anthony Ford
      I am petition to the FDA not to regulate what foods are good for the children and what vitamins they need.
      This is against the constititution to destroy our food and vitamins.
      Thank you,

  • Charlotte Braun

    Please leave the supplements alone and concentrate on the pharmaceutical drugs that kill thousands of people and have so many side effects that more medication is needed.

  • Charles Arnold

    To my mind, at every turn, the FDA declares itself: an “enemy of the people” (and, a captive of Big PhArma). Accordingly, no matter which Administration is/has been occupying the White House, that asleep upline is, also, decidedly, deaf to the interests of the people (i.e., the voter constituency)!
    By such insidious nips and tucks, as those of the FDA Commissioner, the contract with the governed is fastly eroding!

  • cindy

    In my opinion, the FDA is a criminal organization. Somebody needs to take them down a peg or two. They are a danger to this country and its citizens. They should not be allowed to interfere with our freedoms. The FDA commissioner should be somebody in the natural health field that cares about people and nutrition.

  • berry lee

    Restrict only suppliments that have been shown to injure people !! Remember even prescriptions could injure if taken to excess

  • william rice

    If the FDA doesnt evaluate supplements, then why would they want to regulate them and tell us (CHILDREN) what is and is not good for us? there are many

  • Marshall Hornstein

    I just want you to know that I fully support your work with regard to protecting our rights to and access to food supplements. Food supplements – natural vitamins, minerals, amino acids, etc., have been of inestimable value to me over the years in keeping me healthy and clear minded.
    In order to find the supplements that worked for me I had to go through long years of testing on myself to eventually land on a set of supplements that agree with me and promote my health and well being. If I had not had free access to whatever I chose to work with at the time, I would have not achieved the level of good health and freedom from certain kinds of dysfunction, that supplements ultimately helped me to achieve.
    Thank you so much for your good work.
    Marshall Hornstein

  • Norbert Weckstein

    And, according to Dr. Johnathan Wright’s newsletter, Nov 2010, page 4, a report inthe medical journal Clinical Toxology, compiled by the American Association of Poison Control Centers’ National Poison Data System documented that there was not even one death in 2008 that was caused by a dietary supplement!

  • EvelynHobbs

    FDA We Americans are not uneducated Clones. We know a whole lot more than you. We do not have all the money you have. But that doesn’t matter. We are watching. Let us make our own choices. You are not right all the time just because you think you are.

  • Marshall Cussell

    This “smacks” of a government agency being induced to assist private enterprise gains.
    It should require an investigation, by an outsied agency, to really bring this supposed action to light and allow the public to see who is really behind this” rush” to eliminiate further production of supplements, by placing unheard of actions against suppliers of these supplements.
    I, for one, have taken supplements for in excess of fifty years, and enjoy a healthy and active lifestyle at the age of 79 (another two months I shall attain the age of eighty). My doctors are amazed at my annual check-ups and reports that indicate that leave them with no reason to issue medications.


    A law very similar to what thr FDA would like to implement as a new regulation here (in order to bypass the legislative process) has already been passed by the European Union government & is due to be implemented within less that a year.
    It also requires that all companies that make herbal products and/or supplements “register” with the government and register their products along with lengthy forms and a time consuming and expensive approval process.
    The herbs & supplements approval process will make it so expensive for the natural herbal & supplement producing companies to market their products that they will simply be unable to make a profit after going through all the new legal requirements.
    As a result, many of the smaller companies that grow & market herbs and vitamins in Europe will cease to be able to function.That way, people will have many of their sources for herbal products and supplements eliminated.
    Those that remain will be so expensive (due to having to cover the cost of fulfilling all the regulations) that only the wealthy will be able to afford their products.
    Since food nutritional quality has already been seriously compromised due to the Big Agri way of growing food in very unnatural ways, the European people have been using herbs & supplements to make up the difference.
    They will no longer be able to make up for the nutritional lacks in their food by using herbs and supplements since they will either not be available anymore or they will be prohibitively expensive.
    Once people no longer have access to a variety of inexpensive natural herbs and supplements, people’s health will begin to decline as a result of poor nutrition and presto: More people needing to go to doctors, needing hospitals and needing to take drugs to deal with the illness symptoms since they will no longer be able to maintain a healthy body due to inadequate nutrition.
    More money for the drug companies, the doctors and the hospitals. All in the name of “protecting” the public from herbs & supplements. Once this law that has already been passed is implemented in Europe, then the FDA can use it as a precedent to try to implement FDA regulations in the US that would accomplish the same barring of the public’s access to herbs and supplements here.
    Personally, I’d rather be protected from the drug companies, the hospitals and the doctors and still have access to my herbs and supplements!

    • JoAnna Hanna

      I absolutely agree with Vicki and I am very saddened to learn that this same type of bill passed in Europe. This must be stopped from happening in this country. Let’s all send our prayers and positive thoughts out to keep this from passing.

  • Why don’t we all try and get together to SUE the FDA ? There should be plenty of evidence to prove that they have been responding to big bussiness and not for the good of the populace …..

    • Sabastian

      Follow the money, find the crook. It’s no surprise the supplement market will become a feeding frenzy as the Pharma industry looks for new markets. Big Pharma has the resources financially and the network politically to not even involve supplement providers. The supplement industry needs to form a lobbying group much like they have in the diagnostic imaging segment of healthcare.

  • Lydia DiMarcantonio

    It is my beyond my comprehension how the FDA is allowed to continue to dictate the way it does, and no one can do anything about it. This is NOT a democracy. Between the FDA and the government, we are living in a dictatorship. What happened to freedom?

  • deenie

    The FDA is against all supplements but it gladly approves harmful drugs which maim or kill many thousands of people each year. The deck is stacked against the natural medicine field. Our only recourse is educate others and continually bombard our Congress Critters with our hearty protests. Also resist taking any pharmaceuticals and/or vaccines as both are inherently toxic.

  • I truely believe that the evilness of the enimy is in @ hand to destroy the people that is trying to safe the world . It is distroying us thrue the Toxins that is going through food and drug intakes. We need to fight harder by praying together as a unity. No matter what faith you are. The suppliments and food must be saved. We need to pray about the ones that don’t know how bad the toxins are.prayer for the guiidance on the Senates. for wisdom on the Government. This is not about all the figkhting on FDA this is about the distroying the world. And the creation God given Man.!!!

  • Well done, Marshall! And, of course, that’s the whole point of all this ‘business’: the likes of you are bad for business. You, really, should be fined for obstructing commerce, by being so darn healthy that ‘they’ can’t make any money off of you.
    Keep your eyes peeled for us, anh. The gimmick will be for the PTB to try to make food supplements the equivalent of drugs (they are already in that ballpark, for not allowing true information to be made as ‘advertisement’ – for a product, or even for a food itself! The mind boggles). What we really need is a statement in law that “food supplements shall not be considered to be drugs, and therefore subject to the same restrictions and regulations as drugs”.
    Unfortunately, we don’t have a true two-party system in the country, so even the Democrats are not representing the will of the people in this regard, but rather the desire of their monetary masters; or even just their seemingly natural inclination to prefer big government controlling the lives of the people. We need a bipartisan movement in this matter, bypassing both the Democrat and Republican parties, with their allegiances to their masters. Shall we never forget: He who pays the piper calls the tune.

  • So many countries throughout Europe ban toxins that the United States continue to freely use.
    Our country has become so quagmired in money, money, money. This is going to be our downfall.
    How many new mothers out there realize that thimerosal (mercury) is still used to this day as a preservative in vaccinations? 22 countries have banned this poison, but not us! Too much money is involved. The politicians, FDA, AMA, etc. do not care about any of us. They care about getting as much money out of us, lying to us, and treating us like sheep. We are sheeple! Hide your children!!!

  • Les

    How can the public be protected from the likes of FDA Deputy Commissioner Dr. Joshua Sharfstein? BTW, Margaret A. Hamburg is FDA Commisioner since May 2010. Anyway, in this scenario, he/she/they are obviously a tool of Big Pharma and BIg Government, and has/have no interest in a free society where citizens have choices. They are appointees confirmed by the Senate, no?

  • EdD

    Shouldn’t all government agencies become a lot more transparent in their dealings with the people who are forced to pony up with the money to pay for their (sic) research and illegal rulings?

  • EdD

    Industry Capture. The FDA often relies on advisory committees made up of outside experts to offer science-based advice, particularly on approvals of drugs and medical devices. But those panels often include—and are sometimes dominated by—scientists or researchers who have direct financial relationships with the companies whose products are under scrutiny. In recent years, FDA advisory committees evaluating antihypertensives, various diabetes drugs, and the pediatric use of anti-depressants, have all included industry-funded scientists. On one committee, 10 of 32 panelists investigating the controversial painkillers known as COX-2 inhibitors, including Vioxx, had ties to the makers of those drugs.
    Food Safety. Faced with the emergence of dangerous chemicals (such as mercury or acrylamide) in food, the FDA takes years before acting—and even then, its response is typically tepid. Faced with outbreaks of bacterial pathogens in food, FDA is similarly nonresponsive: Salmonella in eggs could be all but eliminated with finalized on-farm regulations to control the hazard, but those have been delayed for years. Shellfish contaminated with deadly Vibrio vulnificus kill 20 or so people every summer, but FDA relies on an industry-funded partnership with state governments to ensure shellfish safety.
    Supplements are also already required to register with the FDA under “The Public Health Security and Bioterrorism Preparedness and Response Act of 2002”. (http://www.nutritionaloutlook.com/article/public-health-security-and-bioterrorism-preparedness-and-response-act-2002; http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081616.htm)
    So by all definitions the FDA should be considered a Government sanctioned Bio-Terrorist organization, and that all the higher-ups should be arrested for conducting willful and harmful acts of Bio-Terrorism against the people of the United States….

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