Government Releases Report to Justify FDA Pre-Approval of Supplement Claims

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supplement labelThey say “stakeholders” have raised concerns about these claims. Could those “stakeholders” possibly be members of the pharmaceutical industry?

The Office of Inspector General (OIG) of the Dept. of Health and Human Services, parent agency of the FDA, has released a report called “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements.” The word in Washington is that it is a naked attempt to support new legislation that would require FDA pre-approval of all structure/function claims—which food and supplement producers are legally allowed to make.

Structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” Under FDA rules, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. The science doesn’t matter to the FDA. Nor does freedom of speech.

The OIG said it reviewed structure/function claims on dietary supplement labels and concluded that:

  • FDA should seek new statutory authority to review structure/function claims to make sure they are truthful and not misleading. This means they think legislation should be introduced to provide FDA with authority to pre-approve structure/function claims before nutritional supplements are marketed.
  • FDA should improve market surveillance for illegal structure/function claims, expanding it to include retail establishments, trade shows, and promotional events, to make sure vitamin stores are not making disease claims and are displaying proper disclaimers on their structure/function claims.

Clearly, FDA pre-approval of structure/function claims would be disastrous given the agency’s longstanding bias against nutritional supplements. Many, perhaps most, claims would never be approved and the process could be very lengthy.

Pre-approval would also create an even greater advantage for pharmaceutical drugs. If supplement makers are prevented from making even these most basic of claims about their products, the public won’t know about their ability to help heal and balance us, and will have only drugs for their health needs.

Who requested the study? OIG says the Government Accountability Office and “public interest groups”—that is, the Center for Science in the Public Interest (CSPI), and Public Citizen—raised concerns, and that “stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support.” CSPI has had an agenda against structure/function claims for a while, even requesting the FDA to abolish structure/function claims altogether, as we reported two years ago. And no one wants FDA to suppress information about the effectiveness of supplements more than the pharmaceutical industry.

The study itself is remarkable for the number of flaws in its methodology and analysis:

  • They sampled only 119 supplements out of 90,000 supplements on the market. Why? Because they chose to sample weight loss supplements and supplements for immune support. The researchers knew that weight loss supplements are usually the worst offenders, are certainly not representative of the nutritional supplement industry as a whole, and this intentionally skews the results.
  • Companies had to voluntarily submit whatever substantiation they had for their claims (66 of 104 companies did so), which again is hardly representative of the substantiation available for all supplement structure/function claims.
  • Not surprisingly, FDA could not readily determine whether manufacturers had submitted the required notification for their claims. FDA could only locate 21 of the 127 notification letters. This points to serious disorganization within the FDA, which calls into question whether FDA even has the capacity for greater enforcement.
  • The report says that 7% of the supplements reviewed lacked the required disclaimer, and 20% included prohibited disease claims on their labels. These instances, the report says, raise questions about “the extent to which these structure/function claims are truthful and not misleading.” We would point out that it was 7% of the 127 they selected, which means that only nine supplements lacked the required disclaimer. And not having a disclaimer doesn’t mean the information provided in the structure/function claims are not truthful or are in any way misleading! Moreover, disease claims for supplements are illegal, and FDA already has authority to enforce against them. If companies are making disease claims, they are certainly violating the law—although they are not necessarily being either misleading or untruthful.

This report is nothing more than a blatant bid for new anti-supplement legislation to be enacted. As always, ask yourself: who would benefit financially from suppressing supplement competition for drugs?

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  • Buck Crosby

    The FDA would kill their own mothers for the ” rewards ” the pharmaceutical companies shower them with , and the pharmaceutical companies themselves would do no less than sell their souls to satan for the bottom line . The very LAST thing on the minds of either one are the welfare of human beings .

  • matt

    This is the biggest load of crap I have ever heard of. So much for land of the free. We are grown people and we can decide for ourselves what we want to take. They have absolutely no right to do this to us!!!!!! I hope everyone bans together to stop these non athletic, never stepped into a gym pansies!!!!!!!!!

  • brian

    why dont we go on the attack against the pharmacuetical industry instead of being on the defense all the time… If we attack them in like ways – they may get the message and step down from attacking us.

    • TOM PAYNE

      The Federal Death Administration must be abolished.

  • It would be wise to begin designing a solid legal strategy to fight the implementation of the disastrous OIG recommendations for FDA usurpation of power over supplements.

  • Diane Harms

    The FDA is obviously trying to do an “end run” around the facts. Am I surprised? Not in the least. They aren’t going to give up because of Big Pharma so they are willing to do anything get around the law. Big surprise!

  • WILLIAM KRUHMIN

    All I can say is these people in the FDA infuriate me.Actually the whole gov’t. I ‘vote’ w/ my $s,online actions and other ways.These issues are so vitally important.Thanks for being there.

  • This is how the new NHP standards started here in Canada too. As a result, we have lost about 1/3 of the supplements we used to have available to us, plus they are more expensive because of all the BS. Don’t let the same happen in the US!

  • Robert Ehlers

    The only disease here is the FDA. How ignorant are the people that work for it. They made a law that said only a drug can prevent, cure or treat a disease. What is the cure for scurvy? Answer: Vitamin C. I guess an orange must be a drug. Do we need a prescription to by oranges. If the Drug companies and FDA had their way it would be required. Or how about proof that broccoli helps prevent. Is broccoli a drug. I guess I should ask my doctor for a prescription for broccoli. Drug companies want people to be sick and unhealthy, it’s big business in treatment with useless drugs that only keep people sick. All drugs have side affects, many very serious and deadly. Unfortunately drug companies have been made immune to responsibility. I thought every “doctor” is supposed to honor and follow the Hippocratic Oath which states that they will do no harm. By prescribing these dangerous drugs, which many are, they are not honoring the oath they took when becoming a doctor. Maybe they don’t take the oath any more. It’s sad that the serious side affects of prescription and none prescription drugs are being kept from the public. I don’t think the people who work for the FDA or the Drug companies have any conscious knowing what serious and deadly side affects these chemicals have.

    • I can only guess that they will rip you off with suletempnps. The only suletempnps a person really needs for fat loss are things that will supplement your diet. Simple things like fish oil capsules, evening primrose oil capsules, coral calcium. maybe whey protein powder. These things are inexpensive. I m sure they will try to sell you some magic pill . . who knows. How much weight do you have to lose?

  • It is time as a whole industry. That we get the people and go after the closing down of the FDA and the other agency’s, that are mere puppets for for big business and some at the top, as the buck stops here should do jail time.

    • TD

      In all fairness, at its inception the FDA provided the public with both a necessary and beneficial service. Since then, however, the unbridled greed and power of BigPharma has both corrupted and weakened the government agency beyond recognition.

      So, rather than abolishing it entirely (which might spell disaster), it would make more sense to root out BigPharma’s corruption and influence within the agency.

      I know, I know. Not very realistic. But one can dream.

      • Healthy Solutions 4U

        What if we abolish the FDA in it’s entirety and just form a brand new regulatory agency that is more accountable to the people? It could be something totally re-worked from the ground up.

  • The government thinks we should trust the FDA. They can’t regulate now because they cower down to big pharma companies.

  • Ed

    Well, it looks like the big money against the little guy. The FDA has a long time reputation of being a patsy for the large drug companies who can afford to support their favorite politician. Given that companies can “give” without restriction to politicians they support this is a logical result. It is all about the money these days.

  • Barb Gilligan

    We need a panel of Naturopathic Drs. to make these decisions. No more FDA rules….as they are to corrupt and accept bribes to make their decisions.

  • Rolf Hefti

    The irony about the government agencies claims that many supplements are stating false health claims is that these same public health authorities also “produce” false statements about the value of supplements by arbitrarily suppressing the expression of factual data on the benefits of supplements (see http://www.supplements-and-health.com/dietary-supplement-regulation-2.html). The authorities want supplement promoters to “come clean”, when they themselves are “not clean” in their mode of operation. It’s indicative of hypocrisy.

  • Deborah Cady

    I find it hard to understand any justification FDA may have for using Stakeholder concern about structure/function claims when the benefits and warnings of any supplement can be got via the internet.

    First, the FDA should define the term ‘stakeholder’, and then explain how existing research on any known supplement is not acceptable while untested, un-researched genetically modified organisms are allowed into our food system, and for that matter allowed to pollute neighboring farmlands with drift, without any kind of public notification or labeling, much less any knowledge of how they benefit the globe and life thereon. Perhaps it’s because GMOs have no use at all, but do have a great deal of money behind them.

    FDA really should review its mission.

    • Yes! Well said Deborah. The FDA needs to look at the lack of safety testing for GMO food crops! Leave supplements alone and start regulating the industries that are hurting the American people. Many eyes are opening across the country but we need to keep alerting everyone and start voting out the crooks that are complaisant in all of this.

  • James Warner

    Obviously the truly dangerous things are drugs not supplements. Great job with informing the public.

  • The pharmacetical companys dont like the competition from the suppliment industry as more americans are using suppliments to forgo the huge profit /cost of rx, less side effects as supporting natural physicological process in the body. No suprise since wwe had naturopath doctors at the turn of the century till John D Rockerfeller didnt want his chemical company interestds (modern pharmeucuaical industry)to be neglected by people using naturophaitic medicine which helped and heals alot better than expensive rx. and gave sweet deals to medical schools to build hopstials provided they stop naturopathic medicine. teaching which happened. Natropathic Doctors were mocked with their cures as witchcraft and mockery at medical schools.
    if this society was based on naturopathic medicine instead of pharmecuitacl companys with their corruption and greed and expensive rx that have major side effect that hurt people instead of healing .. ..we would be a healhy society not one werhe the average person has 5-8 scripts and so many people on medication jsut to function.
    The rest of the world embraces holistic, naturopathic medicine .and that is why some of the supplimetnts are regulated over seas but here its a matter of stifllfing competion.
    It is unfari that when a drug comapny is making a new rx for a suppliment i .e a speicific viitamin , it is taken off the market to no longer be allowed in any suppliments unless fees paid.
    that is abusrd as many suppliments mimic the coupounds found in our bodys i all is good for profit. why america has the most expdnsive health care system in the world yet wwe dont live the longest and our ciitizens have alot of illness in spite of hte high health care per head.
    Wake up people!!

  • Dr. Richard Patten

    Just a continuation of pharma attempts to eliminate competition and take over the market for effective supplements.

    • Lou

      Yep the plan is to COMPLETELY take over all supplements. A bottle of vitamin C that costs one buck will cost 10 bucks PLUS the cost of a doctor’s visit to get the REQUISITE “prescription”.

      All the ground work is in place for this MASSIVE grab. The FDA has RULED that ANYTHING that is used to treat disease is a DRUG. We should KNOW that vitamin C not only can but MUST often be used to treat disease especially conditions that will become fatal without the vitamin C, such a hemorrhagic lung.

      So when will this massive grab go into effect.

  • Is the FDA and OIG paid by the Pharma industry?

    • Lou

      How do you tell where Big Pharma ends and Big Government starts?

  • Richard Contreras

    Please leave supplements alone! Let the ‘concerned’ citizen make his/her own choice about what benefits are obtained by supplements!!

    HANDS OFF!!!

  • Dr. Terry Thoroughman

    If Medicine is great, why all the sick people?

  • Dr. J.J.

    If they take away our supplements, as they already have our quality food and replaced it with poisonous, deadly, GMO food, then we become sick and infertile. This is all an attempt to control population and make a significant profit while doing it. http://explosivereports.com/2012/10/04/leading-world-bank-demographer-vaccination-campaigns-part-of-population-reduction-policy/ Just included a little link on a similar subject which goes hand-in-hand with this. GMO foods, more specifically, Round-Up ready crops, contain a particle which scientists can NOT identify. They know it is not a virus, bacteria, or fungus, but it for sure causes spontaneous abortion. It is found in high concentrations in plants sickened by Round_up and in the livestock that are still born or die early in life. Our quality supplements are one of the best tools in combating these “forced by Monsanto and FDA” environmental toxins. We just need to keep pounding our officials, especially Dick Durban, creepy senator from Illinois who is leading the campaign to remove all natural dietary supplements. Call his office and fax his office until he takes notice. If his phone and fax is swamped, he can’t be using them to make money from crooks/lobbyists. (202) 224-2152

  • Lou

    “FDA should seek new statutory authority to review structure/function claims to make sure they are truthful and not misleading.”

    I do not know whether to laugh or cry.

    How about these claims we have heard thousands if not tens of thousands of times.

    “vaccines are safe and effective”

    “The sun will give you cancer”

    “Fluoride in your water is good for you.”

    “High cholesterol can cause CVD.”

    Please reread Orwell’s 1984. Lies are truth, truth is lies. Big brother decides all.

    If people only understood the extent of the FDAs involvement in the UN Agenda 21 Depopulation Plan, they would tear down the FDA brick for brick.