ANH-USA Files Brief in Free Speech Case


POM-WonderfulThis time it is the Federal Trade Commission (FTC) which is acting lawlessly and trying to censor science about natural health products.

The Alliance for Natural Health USA has filed an amicus brief drafted by famed constitutional lawyer Jonathan Emord in support of POM Wonderful’s suit against the Federal Trade Commission. (An amicus brief is a legal opinion submitted to the court by a third party.) We are participating in the discussion not only because we want to protect free speech rights for natural products, but also to protect consumer access to information about the therapeutic effects of natural products.

You may recall the FTC’s lawsuits against companies such as POM Wonderful for alleged false advertising, even though all POM did was cite legitimate scientific articles and studies. In January, the FTC ruled that 34 of POM’s advertising claims (out of a total of 43) were “implied disease claims,” and issued a cease-and-desist order restraining POM’s future advertising.

In March, POM filed a petition for review of the FTC’s order. Our amicus curiae (or “friend of the court”) brief is in support of that petition.

Our brief offers the legal opinion that in issuing its cease-and-desist order, the FTC violated the First Amendment, as well as the Administrative Procedures Act, the law that governs the way in which agencies of the federal government may propose and establish regulations.

The really egregious part of the FTC’s order prohibits POM (and, by extension, other natural product companies) from advertising any disease-related claims about their product unless it is backed by two random-controlled trials (RCTs). RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two for each product for which they might wish to make a disease claim.

In this case, by the FTC expert’s own estimate, each RCT would cost roughly $600 million, and involve between 10,000 and 30,000 participants. For non-patentable products such as nutritional supplements, the manufacturer could never hope to recoup their outlay in RCTs, even if they could afford them in the first place. This is the “Catch-22” we have talked about that is stifling natural products. Since natural products are not patentable, nobody can afford to run RCTs and get FDA (or now FTC) approval. But without FDA approval, no disease claims may be made. In this way, we arbitrarily banish all natural products from organized medicine. People suffer and die so that patent drug company profits will not be jeopardized.

The Catch-22 as enforced by the FDA is legal—the law is tilted toward drug companies with their huge lobbying presence, campaign contributions, and jobs. But the same Catch-22 is not legal for the FTC to enforce. There is nothing in their statute to support it; they are acting completely outside the law.

The FTC has also totally ignored the $35 million of peer-reviewed scientific research that POM had already compiled. We point out in our brief that the FTC’s new rule suppresses the full range of scientific evidence available— including observational studies, animal studies, ecological studies, etc.—in favor of only one scientific approach, the RCT.

As we further note in our brief:

The FTC’s new rule suppresses the publication in consumer markets of nearly all nutrition science, which science is evident in the totality of scientific evidence (and not in RCTs to the exclusion of other evidence)…. The [agency’s] requirement for at least two RCTs, at a potential cost of perhaps $1.2 billion, effectively rids the market of vital health information through an impractical and unnecessarily high standard and related cost.

The agency also violated the Administrative Procedures Act (APA), because it made the RCT requirement without explaining why RCTs are the only acceptable standard for so-called “truthful disease-related claims.” As we have pointed out before, there is serious scientific criticism of RCTs. They are not necessarily the “gold standard” of proof as often alleged. It is not just the way they are run, which is often flawed. It is also that by their very nature they are more suitable for drugs than for food or supplements, where many co-factors are usually involved.

Moreover, the RCT standard was not made through a formal rulemaking process, where the public is allowed to comment on the rule, but instead was set in place, company by company, via punitive consent decrees. Companies find it difficult to fight these proposed consent decrees because the government has unlimited legal funds and the companies often have few resources. Moreover, if the government wants to be punitive and vindictive, it can just keep raising one charge after another.

This actually happened in the POM Case. When POM publicly challenged the FTC’s new approach, it led the agency to launch charges against POM products. Does this sound like the US, or a fascist country? At the very least it is a case of government bullying, which is all too common these days.

ANH-USA has always championed free speech, and with your support and activism we’ll protect the public’s access to information about natural products—in particular, how they can be used to treat chronic illnesses and imbalances, and even cure diseases. That’s why this petition will, we believe, be so precedent-setting, and so important for people like you and your family.

  • greg dirienzo

    I feel impotent.

    Our crony politicians continue to get re-elected while continuing to line their coats with dirty, or should I say, lobbyist money.

    You are to be commended for your tireless work, for I fear without you we would have no voice at all!

    All of us should be forced to watch the illuminating movie “Soylent Green” better understand what is in store for us.

  • Thank you for what you do and all of your efforts.

  • Sidney Oakes

    If something has a reputation and history for being healthy for a person, the producer of that product should be able to tell potential customers about it. If FTC or FDA want to put some constraint on this, they could require a “black box” statement that this has not been proven via an RCT.

  • sue carole pajak

    People should be free to choose to use natural products and not be limited to using manufactured drugs from the big pharmaceutical corporations.

  • Irma Brandt

    Protect our freedom of speech

  • Irma Brandt

    Protect our freedom of speech

  • Irma Brandt

    Protect our freedom of speech

  • Irma Brandt

    Protect our freedom of speech

  • Irma Brandt

    Protect our freedom of speech

  • Kathy

    Go Baby!!!Don’t let them get away with their evil intent!

  • Gary Pilon

    my only comment is this-No government agency has the right to ban free speed, regardless of the subject matter-That is one of America most important ideals. If this is ever tarnished or revoked we would be no better than any totalitarian government. We need to outlaw PAC’s, jail any politician that takes bribes from these PAC’s- They are not operating in the best interests of the American people only to stay in power and stuff their pockets with illegal gain.

    • Gary Pilon, you are on the right track. However, let me tell you that they are indeed doing it, have been doing it for quite a long time, and will continue to do it unless US citizens get involved in the solution. Meanwhile, their victims are not only US citizens, but people the whole world over. It seems that the whole govenment staff is now somehow controlled by the three giants: Agro-tech companies, Big Pharma, and “Food” companies. Are they working together on this? Is this legal at all? Is there no govenment agency protecting the very lives of the US citizens? Some one had better do something soon. The whole planet is at their hands.

  • Larry A

    This is so typical of the over reach of government. It’s sad to realize the fact that lobbyist money controls the government. And the government controls our lives. And the main stream media only reports what the government allows. Investigative unbiased reporting by our naïve news media is almost non-existent. The people of this great nation needs to stand up and take notice of the politicians that have financial support from the pharmaceutical industry and do not elect them for public office. By the way. The CDC is considering, at the prodding of the American Academy of Dermatologist, to post warning against UV exposure. Most people don’t know this, but regular exposure to UV light has been proven in numerous scientific research publications, by some of the foremost knowledgeable research scientist and university’s in the world to have massive health benefits in preventing an array of deadly diseases including cancers. The AAD is constantly trying to laugh this off and cover it up. The evidence that indoor tanning causes melanoma skin cancer is largely overstated and misleading by the AAD. But it’s all about money. The verification of what I say is out there. All it takes is a little research on natural health web sites. Research that is outside main stream medical web sites and not under the control of big pharmaceutical influence. Do yourself a favor and check it out. Your natural health depends on it.

  • celia mendoza

    How can I help ?

  • Dona

    I believe the people have the right to eat and drink what they want. Government agencies have taken away so many of our rights where food and drink are concerned that to impose further restrictions on what we read regarding natural products is outrageous. They keep products on the market that are injurious to human consumption yet they restrict those things that are natural. I, for one, am angry about the way the agencies allow money to make their decisions rather than common sense.

  • Kim Costanzo

    Something majorly wrong when we have to do a petition for FREEE SPEEEECH !!!

  • Mary Saunders

    Some states now have SLAPP restrictions on government actions that restrain free speech and the rights of citizens. In Washington State, there has been a recovery against strategic lawsuit against public participation. Though it is difficult to sue the U.S. government, it has been done. It also might be more fruitful to go after the agency for discriminatory behavior and for actions in restraint of trade. Sometimes it is useful to find out if the agency is getting funds from particular corporations and to out it if they are. If you find this information out, you can also launch post card campaigns directly against the corporations inolved. In addition to that, there are now retraction-watch sites that out it when there were flaws in clinical trials and when there were conflicts of interest in particular investigators in those trials. Blinds, for instance, are sometimes fairly easily broken. Sometimes many studies were done and only some reported. Sometimes placebo does as well as the drug. There are many ways for farmers to get together and rag back at these agencies.

  • Ruth Hawkins

    I read the book “Stop Alzheimer’s Now! by Bruce Fink, ND. It discusses a lot of things that helped me write a medical history prior to seeing a Neuropsychiatrist for a 3-hour evaluation as to whether I was developing dementia or alzheimer’s. During the month I prepared the history, I was taking coconut oil (as the book suggested), I also put a huge tablespoon of minced garlic in my sandwiches, soups, and casseroles. I also reduced my Prozac antidepressant by 1/2 (40 mg to 20 mg), By the time I saw the doctor, I had decreased my blood pressure medicine from 4 types to 2 types and received approval from my primary care physician. I also had stopped taking both kinds of insulin shots and had stabilized my blood sugars. I was testing 4-6 times per day and was extremely careful in what I was doing. I feel better and look better, even though I am still over 300 pounds. Oh year, I also reintroduced saturated fat and cholesterol into my diet. Can I say that any one of these actions brought about stabilizing blood sugars and reducing blood pressure? No, I can’t; but I have the right to say what all actions I took to bring about this change in my medical condition.

  • It i s interesting that the FDA censors science about natural products yet allows the company that makes prilosec to advertise to advertise that if people take prilosec, they can continue eating the garbage that gives them heartburn.

  • rob rod

    POM (pomegranate) works for me

  • Jodie Santos

    We have the right to know the truth about the products we purchase, what is in them and how they can effect us. We have the right to real information to help us make our own choices of how to take care of our bodies.

    • fallingman

      Says who? Your rulers disagree and they’re the ones with the power. Goos luck trying to take it back.

      BUY POM by the caseload and send the ^*$%#&! FTC and FDA a note that you plan on buying carloads in the future, because anything they oppose must be, well … WONDERFUL. That’s your best revenge.

      • mperez

        to fallingman, well said: it would be funny if it weren’t true!

  • It seems that vwe’re reading two different sets of cases. The FTC stopped POM fomr making implied medicinal claims, because medicinal claims invoke regulation by the FDA, and POM does not have FDA authorisation for these claims. That’s nothing to do with free speech, it’s a part of the perfectly normal regulation of medicinal claims that is designed to protect people form quacks, hucksters and snake oil salesmen.

    You could argue that makign Ponzi schemes illegal infringes the free speech of the fraudster. That might even be technically accurate, but it’s a silly argument.

    You could assert that by slapping a “natural” badge on a product, manufacturers should be exempted from FDA licensing. A moment’s thought will reveal the fatal flaw in that particular idea.

    So, we have a level playing field. Anybody who wants to make therapeutic claims, has to go through the same process. Seems fair to me.

    • Jimbo

      The FDA has too few inspectors. Two doctors have claims that they can use stem cells to created cartilage last after broken hip surgery. However the FDA says this is not permitted because what they are injecting has not been approved. This means I may have crude hip surgery which will not last many years – I think there was 50,000 repeates last year, while the inadequate FDA will make up its’ mind.

  • The FTC ignores anything and everything that doesn’t sit well with its agenda. Its always good to get the word out about garbage like this. Thanks for reporting on it!

    • Where’s the petition. I want to sign it.

    • Exactly,
      Where is the petition I want to sign it too. I have heard this practice going on in other areas, namely the intelligence sector.
      This is totally outrageous. I’ve heard that use of good gut material implanted in another’s ( I didn’t know it had to be a relative.) has been very successful. They just don’t want us to stop taking disgusting drugs that don’t help. Keep up the good work. And give us a petitions to sign.
      Jane Hillhouse

  • Durk Pearson

    Bravo! Thank you for filing your amicus brief. From what I have read here, it sounds right on target.

    Please provide a link where interested parties could download a PDF of your amicus. Publicly available examples of well done arguments can help others from making poor arguments that might result in undesirable precedents. A link to your amicus brief is also likely to encourage donations.

    I have a very personal interest in First Amendment and APA lawsuits against the FDA, since I am the Pearson in the Pearson versus Shalala cases argued brilliantly by Jonathan Emord of .

  • T. Welsh

    “Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship… To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic and have no place in a republic…The Constitution of this republic should make a special privilege for medical freedom…”
    —Benjamin Rush, M.D., signer of the Declaration of Independence and personal physician to President George Washington. Circa 1776 –