“The FTC is trying to regulate supplements as drugs!” says Bayer. Yes, that’s what we’ve been saying for quite some time now. Action Alert!
Global chemical company Bayer AG has a bone to pick with the Federal Trade Commission (FTC) and the Justice Department. Its pharmaceutical and medical products subgroup, Bayer HealthCare, produces a probiotic colon supplement—but the government, they claim, is trying to hold the supplement to the same evidentiary standard as a drug.
The company has provided hundreds of studies which, it argues, support its structure/function claims for the product. The government insists that claims cannot be made without the kind of double-blind random-controlled trial (RCT) used in the drug approval process.
Two weeks ago, the Consumer Protection Branch of the Justice Department, instigated by the FTC, filed a motion requesting an order to show cause why Bayer should not be held in contempt of court for allegedly violating a 2007 settlement order prohibiting Bayer from making “unsubstantiated claims for any dietary supplement it promotes or sells. The government alleges in today’s motion that Bayer promotes one of its products, Phillips’ Colon Health, using claims about the product’s purported benefits without having evidence to substantiate those claims.
Bayer’s 2007 settlement with the FTC had to do with a different supplement, their WeightSmart line of One-A-Day vitamins. Bayer paid a fine and agreed to refrain from making advertising claims concerning the health benefits of nutritional supplements in general unless—and here’s the point of contention between the drug company and the government—Bayer “possesses and relies upon competent and reliable scientific evidence.” Such evidence was defined as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
In the Phillips’ Colon Health case, the government-hired expert, Dr. Loren Laine, a board-certified gastroenterologist and a professor at the Yale University of Medicine, decided that RCTs are needed to distinguish actual efficacy of the supplement from the placebo effect. This is no surprise. The FTC in various other cases has been trying to require a two RCT standard for any claim.
Bayer claims it satisfied the scientific standard by giving the FTC nearly 100 separate scientific papers and studies to back up its claims for Phillips’ Colon Health. Laine reviewed the literature and wasn’t satisfied that Bayer met the “competent and reliable scientific evidence” standard, according to the Justice Department. We are skeptical that this is just Laine speaking. Given the background, it seems likely to us that the FTC staff is as much or more behind this demand.
We would note that the FTC’s proposed standard is supported neither by law nor by science:
- The Federal Trade Commission Act does not require RCTs. As we noted previously, the RCT standard is used under the Food Drug and Cosmetic Act (FD&C) to establish disease claims for drugs. This process is overseen not by the FTC, but by the FDA. And, importantly, there is no such requirement for structure/function claims for supplements.
- When it comes to supplements, RCTs are not necessarily the “gold standard”—a topic we explored in depth two years ago. In this case, Bayer has already provided mountains of scientific evidence, which the FTC’s paid expert simply dismisses out of hand.
- If the FTC wants to change existing law—to change the agency standard for the amount of scientific evidence required—it should go through a formal rulemaking procedure. The public should have the opportunity to comment on such a huge policy change; it certainly should not be done in a back-door approach, through consent orders. It is noteworthy that Congress earlier stripped the FTC of some of its discretion in matters like this, precisely because the agency was abusing it. This is in effect an attempted end run around Congress.
Why then would the FTC, which regulates advertising claims, be attempting to force supplements to use an evidentiary standard that applies only to pharmaceutical drugs? Could it be that the FDA knew it couldn’t get away with such a requirement, so decided to skirt the law by asking the FTC to do the dirty work for them?
Bayer, fortunately, intends to fight back. This is helpful. Too often matters between federal agencies and giant companies are worked out quietly behind closed doors, leaving consumers (and voters) in the dark. The company is protesting the government’s imposition of a drug standard on dietary supplements, and they say they did indeed provide “competent and reliable scientific evidence” as they agreed to do in their 2007 settlement.
One of the underlying issues is whether Bayer’s claims for its product are indeed structure/function (s/f) claims. S/f 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. (In this area, science is completely disregarded by the FDA. So is freedom of speech.)
Most of the health claims Bayer makes—a “probiotic supplement” that “helps defend against” the occasional constipation, diarrhea, and gas and bloating—are indeed s/f claims, according to Bayer and according to the plain meaning of the words. Since s/f claims are specifically protected by DSHEA, the landmark federal Dietary Supplement Health and Education Act of 1994, they should not require an RCT. Requiring RCTs for s/f claims is an alarming and dangerous precedent.
Probiotics, of course, present serious competition to pharmaceutical drugs, and have even been targeted by the FDA’s NDI (new supplement) draft guidance. The guidance contains a vague statement that could stymie the future of probiotics: “Not all bacterial microorganisms are dietary ingredients, and a microorganism that is not a dietary ingredient cannot be a NDI.” We hope the new version of the draft guidance, when it is released, will either strike or clarify this provision.
Action Alert: Tell the FTC to Respond to ANH-USA’s Petition! In 2011, ANH-USA filed a Citizen Petition with the FTC alleging that its arbitrary requirements for food and dietary supplement health claims oversteps its jurisdiction, violates the First Amendment, and chills protected speech. Don’t let the FTC continue to ignore citizens asking for change! Please take action immediately!
20 thoughts on “Big Pharma Giant Takes On the Government”
In this case, I agree with the big pharma company. Supplements are not medication, and should not be treated as such.
In most cases, they are lower profit and lower volume items.
DO NOT REGULATE SUPPLEMENTS AS DRUGS.
Thats because they have more money than govt for selling us all those drugs that are killing us…………..
Way back when the herb, ma huang was being marketed for weight loss and heart health, big pharma realized that they were not making one red cent on this supplement because supplements, like food, are considered nutrients and not drugs. Thus, big pharma was missing out on billions. It didn’t take long for them to align with local corruption and to bring the herb under scrutiny by fabricating stories of death, disease and destruction. Eventually (and unlawfully), the FDA took action against this nutrient, to appease big pharma. Immediately, synthetic ephedra was being marketed by the pharmaceutical giants. The result? Ephedra is the synthetic base of the harmless herb, ma huang and is also the main ingredient in home-lab produced methamphetamine. Big pharma gave us the meth problem as a result of greed. In that end, a harmless and beneficial herb was banned and the FDA got a foothold on regulating vitamins and other nutrients; all while complacent Americans bought the story !!!
Kind of creepy to share a battle with big pHARMa! (keeping the big HARM in drugs)
As a citizen and tax payer of the USA My FTC and FDA works for ME the consumer . I have been using supplements most of my life and have always had terrific healing results . As a consumer I always search out information carefully before taking my supplements . I want the companies who make the supplements to be treated respectfully and with common sense regulations . I want each manufacturer to have the right to say what ever it wants about each product they manufacture . I want as much information as they want to give me. My government must allow freedom of information . Most companies have a bottom line but they usually are started with a passion for what they produce . I have a passion for well being and most of the companies I buy from want to keep their consumers happy and healthy so they will buy more supplements ,,Common sense,.. Do your job government .. The proper way.. The Constitutional way
I’m sorry, but I must disagree with your stance on this issue. I believe that all supplements should be investigated by the FDA, that supplements should be held to the same standards as drugs and that it should have happened decades ago. There are so many false claims being made and so many people wasting their hard earned money on unnecessary supplements that something needs to be done about it. In addition, it’s been proven, over and over and over again, that some ingredients vary widely from one package to the next, at times from the very same manufacturer. Quite frankly, I have no faith or trust in supplements and their manufacturers.
I would sign this petition for sure if the Bayer Company were not to benefit from it. It would be the same as signing a petition that would benefit the Koch Brothers, Wal Mart, or Monsanto. The Bayer corporation are members in good standing of the Evil Empire. They are every bit as evil as the worst of them. Included among their evil deeds are the fact that they supplied Nazi Germany with the poison gas used to exterminate millions of prisoners in the concentration camps. More recently they have sued the European Commission to lift their ban on nicomides. This is the ingredient in some pesticides produced by Bayer that has been scientifically proven to have already killed many millions of honey bees. Of course Bayer cares nothing about doing what is right as long as there is profits to be made. I find myself very disappointed to see that you have started a petition that supports this very terrible company. Are you unaware of the nature of the company you are asking us to support? Or is it that you just don’t care since on this one issue you find yourself aligned with these Bastards.
Doctors need to understand that prescriptions are their business. They already own us medically. Please let us continue to be able to make our own choices as far as supplements go. What are you going to charge for supplements? I’m sure we will not be able to afford them. When we are unable to afford them and start getting our nutrients from our food will you have control over that also. Control yourselves please. Your fathers were more decent. At least they could be happy they helped someone. All you care about is money. It is ruining the person inside of you. Please try to place yourself in the shoes that your fathers wore.
Sen. DURBIN been trying long time t9 have FDA regulate suppliments.
First, all this will profit Big Pharma in a huge, huge way. And of course 100’s of smaller business’ would be out of business. If FDA regulates, then Big Pharma can charge patients
Alot more money for their vitamins & Suppliments that we can now spend less but over the
Counter. 3rd, Insurance would then have to cover them as RX drugs so drug premiums go
Up. This is a lose lose for everyone except Govt. & Pharma.
My regular doctor internist has ordered me on 5 different vit/minerals due to
Very low blood tests. On top I pay otc for Iron for anemia and asprin to support
Rish Mi & stroke. That is 7 seperate doctor ordered supplements I need.does ins. Really want to pay for this? And lot buissness out???
I dont trust any of this for the reason that BAYER is BAYER regardless of the sub division company “Bayer Health Group” which is probably now conveniently being used by the parent company Bayer to appear to be contesting the supplement is a Drug definition. Likely, in truth is just a ruse…they will happily dissolve the company as soon as their agenda of all supplements requiring prescription.
Bayer is still the NAZI chemical plant they were from their beginnings. EVIL seed does not bear healthy fruit.
Why is Bayer afraid to provide reliable scientific evidence re their product claims, if the product truly produces what it claims? Rigorous research woulde prove/sisprove their claims. Obviously Bayer is 8nterested in making as muvh profit with minimum cost and supporting scientific research. Too bwd for Bayer. Mske the testing requirement stronger in my opinion.
Ok, so the FTC, FDA and DOA are all in on this gig. Why not the DOJ, the EPA and maybe even the DOE? Since these products need to be shipped around the country, why not the DOT and DOI? Is there no end to the insanity?
Between the FDA drug money and the FTC, we have allowed government and physicians’ pharmaceutical sales representatives to control the minds or mindlessness of physicians to the benefit of investors. We as citizens are busy with careers, children or aging; who has separate issues that divide us! Taxpayer’s employees and elected must be both dizzy and greedy for the flashing cash that is spread around like ‘butter”; but at the USA and World health expense.
The drug companies don’t want to help us, they want to make money on us. The supplement companies don’t need big pharma help. In fact, if they have anything to do with it, the supplement prices will sky rocket. They’ve hijacked our conventional medical system by charging exorbitant prices for their drugs here in the US. Don’t let them hijack the supplements industry, too!
I have a feeling either the link to ‘Take Action!’ is having issues or is preventing (Big Pharma) this to go through. Each time I click on the “Take Action!’ link for a split second I get the page then I am redirected to either Search engine for ‘Secure3convio site’ or I get page with HTTP/0.90.
You might look into this and get it resolved because I might not be the only one having this issue.
Bayer is another Pharmaceutical Drug Corporation and a Hitler
financier before and during world war II. Bayer does not put our or
anybodies health before profit.
Since you are FOR no regulation on supplements, I don’t believe that you are against GMO. It is well-known and easy to research that supplements use plenty of GMO materials. I have writtten to you before with no reply, so I believe that you may actually be pro-GMO. Who are you actually? Perhaps you are masquerading as anti-GMO?????? I gave you money once, but never again.
See the following – I don’t believe that you don’t know about this:
Thanks to Monsanto, most of the corn grown in the US – up to 95% of it – is genetically modified (GMO). Even worse, some major supplement producers are hiding that GMO corn in vitamins!
Corn is not just used as a filler in dietary supplements, it can be the main source from which Vitamin C, for example, is derived. And of course corn is not the only GMO ingredient used. Rice, soy and sugar are other common GMO ingredients.
To further confuse consumers about what they may be getting in “natural supplements” current regulations allow GMO-containing “food” to be legally labeled as “natural.”
Although some producers now note which, if any, of their supplements are made without GMOs, there’s no clear standard in labeling to certify that those products are truly GMO-free. Some use “GMO-free,“ while others label these products as organic or non-GMO, but those that say nothing about GMO, are likley full of it.
Consumers have a right to know what’s in their vitamins so they can put pressure on all supplement producers go 100% GMO-free. Genetically modifed foods do NOT belong in our vitamins!
Tell top makers of dietary supplements (or the one that makes yours) to disclose all GMOs (including genetically-derived ingredients) in their products.
Dear Member, You raise many valid points here that lead to great discussion, but I would like to clarify ANH’s position on supplements. We believe that the supplement industry is sufficiently regulated by current state guidelines and Good Manufacturing Practice standards. We also believe that there should be strict GMO labeling, with a clear and precise definition of GMO used. Our work protecting supplements keeps corporate pharmaceutical interests out of supplement production, which we firmly believe should remain accessible and affordable, and not regulated like drugs. We would ideally like to see supplements more widely available, and their uses more easily discussed and advertised. Please read more about our work and research on supplements here. Thanks for adding your voice to these important issues. We look forward to continuing our work to protect natural health care.
Wow. For once Bayer is in the right. I seem to remember that a while back Coca-Cola was fighting to be able to use stevia. Maybe these giants will be able to fight some of the Goliaths more effectively than our Davids have been managing.
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