FDA Accuses Supplement Manufacturers of…Selling Drugs?

May 17, 2011
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supplement-label-150x150Misleading claims vs. legitimate science—getting to the truth can be a minefield! Which is why the Free Speech about Science Act is so important.

The US Food and Drug Administration recently sent warning letters to manufacturers of a number of products—MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak—for making health claims about treating or preventing sexually transmitted diseases, including herpes.

According to the FDA press release, “While some of the companies market these products as dietary supplements, these products are all drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).”

On their websites, the supplement manufacturers make a wide variety of claims. Some of the claims are supported by varying degrees of science; some seem wildly overreaching. But all health- or disease-related claims are currently illegal. And that is precisely the problem: there is no mechanism in place for citing the legitimate science behind a food or supplement’s effectiveness. Many Americans are trying to take charge of their health, and they are desperate for information, so some supplement manufacturers are filling that void by violating current law and making health claims—which makes it even more difficult for consumers to judge a misleading claim from a scientifically valid one.

MedaVir’s website says that research about the product’s ingredients effectiveness has been published in national medical journals, though they don’t link to that research. The website also says MedaVir has been proven effective by an official FDA phase 2 double-blind clinical trial, as well as research at Proctor and Gamble’s laboratories for medical testing and the Cincinnati Children’s Hospital Infectious Diseases Division. Why would FDA warn a manufacturer over health claims when a FDA clinical trial has proven that the product is effective?

Here’s why. The sad truth is, whether the products are effective or not, or whether they have good science to back up their claims or not, is utterly irrelevant to the FDA. Dietary supplements cannot treat or prevent STDs like herpes—only FDA-approved, prescription-only medications can do that. That’s because, as you’ll note above in the FDA’s own words, any product that is offered as a treatment for disease is by definition a “drug product,” and without an NDA, said drug product cannot be sold.

Sadder still, natural substances can be powerful healers, but most of the public will never hear about them. As we have reported in previous newsletters, there are excellent natural treatments for diseases like herpes: vitamin C, selenium, lysine, and especially the powerhouse of the vitamin world, vitamin D. But the FDA says that making a health or disease claim for a supplement instantly and magically transforms it into a drug. It must therefore go through the FDA drug approval process or it cannot be sold. Alternatively, it can be sold, but you can’t tell anyone about its health benefits!

The difficulty, as we have noted many times, is that naturally occurring substances cannot be patented, and without patent protection, few manufacturers will pay the millions—and occasionally billions—of dollars to do the double-blind studies necessary to bring a new product through the FDA new drug approval process.

The long and short of it is this: the current health claim regulation system is broken, and the FDA is exploiting it.

This is why we so desperately need the Free Speech about Science Act of 2011 (FSAS). Passing this bill into law would make a food’s or product’s scientific studies and their implications more transparent and understandable to consumers.

Under FSAS, dietary supplement manufacturers will be able to make well-substantiated disease or health-related claims, based on legitimate scientific research. Because food and supplement manufacturers cannot legally make health claims, it becomes even harder for consumers to make informed and healthy decisions—and consumers are missing out on valuable information. FSAS creates a standard that would weed out junk science and misleading claims, and would provide health-conscious consumers with access to much-needed credible scientific information behind natural products.

We mentioned MedaVir earlier, but some of the other companies targeted by the FDA warning letter also cite scientific evidence to support their claims. The Herpaflor website, for example, cited science behind each of the product’s seventeen different ingredients (or did, before the FDA warning letter made them remove the citations, though we have a PDF of the page in question), supporting the claim that Herpaflor’s ingredients help prevent and treat herpes outbreaks as well as help alleviate some of the side effects such as pain and discomfort. They listed twenty reputable scientific sources for their claims, ranging from NIH studies, The Journal of Dermatology Treatment, The Journal of Medical Sciences Research, and The Journal of Antimicrobial Chemotherapy—though they also listed a number of sources that are not peer-reviewed, like BBC News and Answers.com.

ANH-USA does not, of course, support manufacturers’ misleading or fraudulent claims! We do support, however, the right of consumers to have access to credible, peer-reviewed scientific information about food and dietary supplements. It is difficult for consumers to differentiate what is credible information and what isn’t—because there is no standard in place for citing science for natural products. FSAS would help correct this.

The great irony here is that FDA and FTC absolutely allow egregiously misleading claims—with impunity—so long as they’re made by the major pharmaceutical manufacturers! For example, a full page ad for Astrazenica’s acid blocker drug Prilosec OTC in People magazine says in large type, ZERO HEARTBURN**. If you follow the asterisks down to the bottom of the page, it says in tiny type, “It’s possible while taking Prilosec OTC.” So the actual message is that zero heartburn is possible while taking this drug. Of course, zero heartburn is possible for any other product under the sun! Manufacturers of acid blockers are very careful to avoid saying that their product cures heartburn—because there is no evidence it does. There is abundant evidence, however, that it leads to more infection, pneumonia, bone problems, and a failure to absorb minerals. There is also evidence that it actually makes heartburn worse over time. Yet the FDA and FTC have no trouble with these claims.

Consumers have the right to access this information, and the FDA’s method of barring access to this information in untenable. There must be a system that allows consumers access to credible scientific data, through legislation like FSAS. If you have not already done so, please see our Action Alert and ask Congress to support the Free Speech about Science Act!

99 Responses to “FDA Accuses Supplement Manufacturers of…Selling Drugs?”

  1. Hallie Herrig says:

    DL&Q will be on the Grand OL’ Opry tomorrow night. I am not sure what time they sing, but tune in and listen.

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  2. Yes, censorship is guaranteed by our Constitution and many good men and women lost their lives.
    I personally will put anything I want in my body.

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  3. Bill Sardi says:

    I would dearly desire the FDA to disappear as its actions or inactions have resulted in the deaths of many. Furthermore, it is absurd to think that the FDA prohibits manufacturers from saying vitamin C cures scuvy, vitamin B1 cures beri beri, niacin cures pellagra, B12 prevents and treats permicious anemia, and vitamin D cures rickets. But eliminate the FDA and then the outlaw purveyors of dietary supplements will fleece consumers of their money with unsubstantiated health claims. There must be a referee!

    The problem is that the FTC and FDA, along with Google, are allowing many outlaw companies to spring up on the internet and these agencies take belated action as if to continue to make the dietary supplement industry appear like it is largely outside the law. A simple answer would be to license all supplement makers and demand their executives certify they have read and understand Title 21 of the Federal Register outline FDA regulations for labelling and health claims, and FTC regulations regarding advertising claims. The current model for success in marketing dietary supplements is to skirt around the law, make huge profits, then hire attorneys to fend off the regulators.

    That various published studies indicate a herbal extract or vitamin prevents, treats or cures a disease is one thing, but that published science may not pertain to a particular product. Most of the science cited by supplement manufacturers represents borrowed science. In some instances, competing products were used and they steal that science and claim their product is the same!

    Were the same herbal ingredients extracted in the same manner as those used in the published study? Are the same doses provided in the dietary supplement as used in the controlled study? Many dietary supplement makers offer smaller doses of nutrients than used in studies to fatten their profit margins. In other instances, some dietary supplements overdose consumers claiming their product provides more than competing products. We know that vitamin C and polyphenols (resveratrol, quercetin, curcumin, etc) in low doses are antioxidants but in mega doses are pro-oxidants.

    The above article on the FDA declaring supplements to be drugs is eye catching, but not instructive. Legislation needs to be written to allow non-drugs to be labelled they prevent, treat or cure disease if there is adequate evidence for that particular product. Millions of dollars are not required to prove nutriceuticals are safe and effective. There is an ethical issue for nutrients that avert mortality. The only ethical way to prove this is to conduct animal studies or retrospective studies like were done for aspirin and mortal heart attack.

    The FDA is bought off by the drug industry, but ironically, the patients keep coming back for more because they see and hear the TV ads for drugs on television and they want the most advanced (but expensive) treatment. That Medicare does not pay for dietary supplements is another major problem because many retirees prefer whatever insurance pays for, not what is best for their health.

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  4. Thank You, Thank You, everyone who works to be informed, who works for good natural health, who loves to share a good life with others, and who works to keep our politicians in line. It is a growing awareness and actions that gives me hope for the future. Thanks again.. Grandpa Geoge!

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  5. Pamela says:

    Let me see if I have this right. The FDA says everything about GMO/GE food is safe and we should all eat it and shut up. Out of the same mouth, they say anything that has properties to alter you physically, i.e., kill pain, change the course of disease, repair physical damage, make you feel better at all in any way, is a drug and must be regulated. So we can have supplements as long as no one tells you what they’re good for. And we can have toxic food that will kill us graveyard dead and we’re not allowed to know through labeling if it’s GMO/GE because then we might not eat it. So if it will help you and it’s so labeled, it becomes a drug and if it will kill you and is NOT so labeled, it’s food, shut up and eat.

    Why do I feel like I’ve slipped through the looking glass?

       0 likes

  6. kim w h says:

    Well, on and on it goes….it is time to revoke the FDA and the FTC power.
    I sent my two page letter to the energy and commerce chair people this week.
    I also call lots of people and alternative medicince, wellness clinics, alternative medicine treatment center is America ask ing the to push the bill.
    I am alive today because I treated myself without radiation and chemotherapy, sugery. I was given 3 months to live.
    When is enoug, enough?
    I contact the Presidental hopefuls, this week, too. I sent the a packet of my wants in a health care plan.

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  7. Harv says:

    The corrupted FDA and it’s siblings have bullied Alternative medicines and doctors for many years and it’s time to kick them off their stage and replace them with good honest Alternative people who will pave the way to good health and longevity by being available to help folks get off the toxins and poisons that drugs are known to ingest in the human system…Instead of FDA ..How about AHC (Alternative Health Care) or something like that?

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  8. BJ in PA says:

    SO typical of the FDA. I guess the initial tally of 22,000 heart attack deaths were just not enough to really clamp down on this diabetes ‘medicine’. I suppose it took another 10,000 or so more deaths for the FDA to get serious! Today I got this notice from Drugs.com concerning AVANDIA:

    FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.

    FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.

    DO YOU THINK ANOTHER 10,000 will have to die for them to pull it off the market altogether???

    Good God! I wonder how many people have died from the products whose manufacturers got those threatening letters from the all knowing, all powerful FDA? I would bet many dollars that it’s NONE!

    SICKENING AND DISGUSTING!!!!!! Abolish these death mongers!

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  9. walt says:

    Do away- with the FDA!
    Do away- with the FDA!
    Do away- with the FDA!
    Do away- with the FDA!
    Get rid of these Morons!

       0 likes

  10. Italics Mine says:

    so… what’s the magic way to get government to leave us alone?

       0 likes

  11. sd7 says:

    They just took away supplement freedom in the EU, be careful folks its only a matter of time. BUT, change is on the horizon and this won’t last long.

       0 likes

  12. Heinz Hoeke says:

    The FDA is superfluous! Bombard your congressman with e-mails to introduce legislation to abolish the FDA! These bureaucrats should all be fired and should look for some honest work away from the federal trough!

       0 likes

  13. me says:

    ABOLISH
    the
    FDA!

       0 likes

  14. Ogre says:

    I want NAMES.

    Because of mineral depletion the commercially available herbs etc. tend to be much less effective.

    I don’t gather commercially so I don’t have to provide things to anyone I don’t want to. This includes information. I’ll be damned if I will slog through the swamp for some SOB that wants to tell me what treatments I may or may not use.

       0 likes

  15. Shelah G. says:

    Isn’t it just amusing how advertising can make a claim ‘Zero Heartburn’ for a product like Prilosec or Zantac and put all the negative things about it in the teeny print! The problem isn’t in claims of miracle cures, scientifically based double blind studies or what not! The problem is in Corporate ‘Effin’ America and how many more dollars they can all add to their pockets! Their all too afraid of us knowing the value of natural medicines because the more who know and believe in it take away from organized medicine and their not getting wealthy off of it! Furthermore, they can’t kill us all with the side effects of that synthetic crap!

    Also, what about the food supply? The allow steroids injected into poultry and for it to be sold! They allow the sale of artificial sweeteners! They allow the sale of Monster and Red Bull Drinks…all known for producing ailments in the body that mask symptoms of various dis-ease!

    As far as I am concerned, the FDA should be dismantled and completely done away with!

       0 likes

  16. Smash Cancer says:

    This is very sad, and is the result of huge corporate interests taking over the regulatory and governmental process. They are just trying to maximize corporate profits. I saw a study done by some people a while back that stated that over 80% of all standard medical procedures that MD physicians perform have not been subjected to any ‘randomized double blind studies’. So there is definitely a huge bias against natural products and methods, and for those that make Big Pharma a lot of money. If it makes money for Big Pharma, it’s safe; if it doesn’t, it is subject to ‘regulation’. This is how Vioxx, statins, vaccines and other deadly drugs and treatments are ok, while the time-tested natural ones are under severe scrutiny. It’s also why organic food stores are being raided by gun-toting SWAT teams that are acting like they’re raiding an active drug house. It is institutionalized madness, and government is hell-bent on increasing the madness even more.

       0 likes

  17. Brian Roth says:

    The FDA needs to be shut down.

       0 likes

  18. Emery says:

    The FDA is just an enforcement thug for Big Pharma’s attempt to create monopoly on our health. They are abusing the power of government to force everyone to use their drugs only thereby establishing complete fascist control over our health and lives.

       0 likes

  19. Forgive my typos. The fonts are tiny.
    awl

       0 likes

  20. I totally agree with Sally B. Gifts from God cannot be patetened. Last year, I wrote a parody called, ‘Hot Rocks = Drugs’. When the FDA discovers that rocks heated in a sauna can be beneficial to some, will they try to gain profit?. There is an infinite number of hot rocks in Amrica’s SW.
    awl

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  21. judith says:

    I will certainly call my “representatives” in government and express my concerns. What concerns me more and more is the way the government encroaches into every aspect of our lives.

    I have a question: I take Nexium and Zantac…If these are really harmful, what should I be taking instead?

    Thank you for what you do.
    Judith

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    • Ernie says:

      My sister and I had this problem, here is what we did and it works!!! I researched this and found out you get relux and heartburn because you DO NOT have enough stomach acid. Mix two tablespoons of apple cider vinegar with 6-8 ounces of water and drink before eating and at bedtime for 6-8 weeks then change to taking at your main meal and at bedtime. Also take if you get reflux or heartburn. DO NOT under any circumstances take any type of antacid whether over the counter or prescription, ever. Taking stomach enzymes will speed this process up considerably. Sleep on you left side at night and if you get any heartburn as this will make it go away. if you cannot tolerate the vinegar you can take Hydorcholric Acid (aka Betaine HCI) tablets/capsules with meals and drink the vinegar at bedtime. one side effect of the vinegar at bedtime is its an amazing fat burner.

         0 likes

      • Jason Mead says:

        I was told about and have tried successfully a couple ozs. of pickel juice. That probably verifies the lack of stomach acid therory.
        JM

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    • Nat says:

      Having had severe reflux problems for years and finally bid farewell to it (whew!). I would recommend looking at your diet. For me, it was wheat.

      Stopping wheat helped me loads, changing from cow milk products to goat milk did a bit more, getting rid of *all* processed sugars, especially those included in pre-cooked foods, really slowed it down.

      Finally I was introduced to the Body Ecology Diet, which has got rid of it entirely. It’s basically a diet based round large quantities of easy to digest foods (greens, veg, etc.) with carefully balanced grains or proteins or starch.

      The best part of the diet for reflux is the introduction of cultured vegetables and natural probiotics to help balance the organisms in your intestines and generate a healthy gut. It appears a bit restrictive at first, but when you get into it there are a whole wealth of healthy foods waiting to be discovered!

      Once your gut feels happier, you can ease yourself off the pharmaceuticals, which are probably creating their own problems

         0 likes

  22. Packman says:

    FDA’s attitude begs one question.

    If an organic farmer were to put a label on a bulb of garlic, describing all the known benefits of garlic, would the FDA jump and accuse the farmer of selling a “drug?” I guess the garlic would also magically become a drug if the health benefits were mentioned by the farmer trying to sell it.

    The FDA’s attitude is just ridiculous… and transparent… as we all know they are just pushing special interests of big pharmaceuticals.

       0 likes

    • Ogre says:

      The networks are trying to make Ron Paul look ridiculous but if you want health freedom … he is the only real choice. As a physician, I am sure he holds more disgust for the FDA than all of us put together.

         0 likes

    • wijard says:

      FDA has already done that very thing to cherry growers. Any health claims, regardless of the scientific study done, automatically make food a drug. Guess that’s why it’s the Food and Drug Admin…

         0 likes

    • Rtyree says:

      This already happened with berry growers: http://www.mi-cherries.com/fda1.htm

         0 likes

    • Cathy says:

      A Farmer that that is not registered with the FDA can do what he wants, because Title 21 say their rules apply to registrants. The problem being is most do not go read, They give definitions and tell you who it applies to. The fda is not part of the constitution it is a corporation and you have to contract with them. As long as you don’t hurt someone under the Bill of Rights all is legal, will they threaten you to get you to register? You bet but we must stand, If you have registered withdraw you signature in writing.
      Blessings

         0 likes

  23. Grace Adams says:

    The FDA is to protect the market share of the BIG drug companies. We would be better off without it. The BIG drug companies and their products are bad enough–bad reactions to drugs and medical errors are certainly within the top ten causes of death if not number one–but the products of the BIG drug companies should at least have to compete with non-patent remedies.

       0 likes

    • Jason Mead says:

      Hi Grace:
      Thought you’d be interested to know that JAMA (Journal of American Medical Assn.) listed as the
      # 3 leading cause of death in USA as PROPERLY prescribed prescription drugs.
      JM

         0 likes

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