A federal district court has ruled in favor of Bayer in a case where the government tried to regulate supplements as drugs. Here’s what it means for you.
Pharmaceutical giant Bayer AG has won a lawsuit brought by the FTC that accused the company of making unsubstantiated claims about a probiotic colon supplement.
The court ruled, in essence, that Bayer’s claims about its supplement were sufficiently substantiated by the hundreds of studies it supplied to back up its claims—without the double-blind randomized clinical trials (RCTs) that the FTC tried to demand.
In her decision, the judge wrote, “As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the Government cannot try to reinvent this standard.”
In our previous coverage of the Bayer case, we noted that the FTC is completely outside of its jurisdiction in trying to demand RCTs for food and supplement claims—a process that is under the authority of the FDA. The FTC was also acting illegally in attempting to change existing law without going through a formal rulemaking procedure.
This isn’t the first time the FTC has tried to do this. We’ve increasingly suspected that the FTC is working at the behest of the FDA, which knows it couldn’t get away with such a requirement and is asking the FTC to do its dirty work.
Other recent court cases have ruled against government efforts to gag free speech. A district court ruled late this summer that the FDA could not stop Amarin, an Irish pharmaceutical company, from showing doctors the medical studies supporting off-label uses of its fish-oil-derived drug. The FDA’s longstanding position has been that it is unlawful to market a drug for a purpose not approved by the agency, no matter what the science says.
Why does this matter? Consumers are looking for reliable information backed by legitimate scientific research to assist in making informed choices. Access to this information is essential to knowing which foods and food supplements really are healthy and helpful for good health. When government agencies prevent companies from making health claims backed by good science, consumers are denied crucial information.
It should also be noted that there are significant problems with demanding RCTs for food and supplements. First, RCTs are often inappropriate for studying food and nutrients. A new-to-nature drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, D, and magnesium (especially the K2), but isolating it for an RCT would miss that.
RCTs are also incredibly expensive—on average $600 million each and often much more. Pharmaceutical companies can afford to pay this because their drugs have been patented, but this is not the case for natural supplement companies since natural molecules generally cannot be patented and their investment could never be recouped. Supplement companies would likely go out of business if RCTs were required in order to make health claims. This is part of the Catch-22 that we so often refer to.
And what are the statements that Bayer made that are so objectionable? They claimed that their probiotic supplement “helps defend against” the occasional constipation, loose bowels, and gas and bloating—structure/function claims that are protected by DSHEA (the Dietary Supplement Health and Education Act of 1994) and that should not, by law, require an RCT.
(Note: Structure/function claims are statements that describe the role of a nutrient or ingredient as it affects normal structure or function in humans—statements like “calcium builds strong bones” or “vitamin D boosts immune system function.”)
Will these decisions put a stop to further efforts to gag free speech? Probably not, but these court cases provide important precedents to defend against future attacks.
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For whatever reason – this is not allowing me to share on FB. Just letting you know.
I had the same problem and emailed them about it.
Corporate Government Tyrannical Censorship in action (and this type of targeted censoring of important information will most likely only get worse since they feel threatened by the heightened awareness to their corrupt, atrocious ways).
I can’t help but wonder if there would have been a victory to celebrate here if the company were a small nutritional supplement maker as opposed to one of Big Pharma’s giants.
There would have been no victory if it had not been a big company.
Don’t forget that this is one of the same companies that is sourced from germany’s toxic chemical conglomerate that helped them win WW2: truthwiki dot org /ig-farben-pharmaceutical-conglomerate-1916-to-2015/
Their CEO’s are ex-nazi’s who were charged and convicted for mass murder, genocide, crimes against humanity but now run multi-national corporations that have billions of dollars and control over many facets of every-day life. The U.S. protected the conglomerate while germany got bombed and brought it back over to the U.S which explains why the government hates U.S. citizens and has been actively destroying them for the past 70+ years.
They are our enemy from WW2, working from the inside. Saying “We’ll take you without firing a shot” and they certainly have.
Bayer AG is also the company that gave the world *HEROIN*, as a patented, trademarked BRAND NAME, in the 1880’s…. Just sayin’…..
Back in the 1990s a health food store owner told me that they were not allowed to put any information about the supplements anywhere near their supplement shelves. In other words, the books on using supplements of any kind, or any alternative medicine literature had to be on the opposite side of the store, nowhere near their supplement shelves (I forget what the minimum distance had to be). Is that rule now defunct?
I guess the judge must have realized that if doctors can advise their patients based upon studies that draw correlations only, and do not provide RCTs to back up one-sided statements about “risk”, then supplement companies can use observational data as their sole basis for recommendations.
No, that rule is not defunct. I often shop at a small, natural food co-op. The books are up front & to the right as you enter the store while the vitamins & supplements are along the far left wall, just about as far away as you can get them. I am also an independent distributor for Young Living Essential Oils & Supplements. If non members are at a meeting where the Young Living products are being discussed & shared, any books about the products have to be kept in another room away from the products.
The big pharmaceutical companies are using the FDA to try & shut down all companies that manufacture and/or distribute natural products. They don’t want the competition because they know that the natural products really can cure illnesses & diseases. They don’t want people cured of anything because that will cut into their profits.
Thank you for that information. Doesn’t it seem that that ruling can now be thrown out by virtue of this judge’s ruling in this new, but clearly related case, now?
I seriously doubt that will happen. This case was brought by the FTC, not the FDA. The FDA, i.e. the pharmaceutical companies got that rule passed & I don’t see it going away anytime soon. The pharmaceutical companies control the FDA & as we all know, money talks.
The real question is, who is actually going to come and enforce that rule? Is some red tape jockey really going to come with a measuring tape and check to see if the books are “far enough away” from the supplements?
These goons are corrupt and only have authority if you believe they do. Stop allowing them to manipulate you and punish them where they care: Their pocketbooks! Since they only care about selling toxic food, toxic pills and ruining the world it is only a justifiable and honourable thing to do to not support it financially, morally, (meta)physically, via contributions or any other way.
~*Starve this system of the very funds you send them — that they use against you.*~
I know that the FDA has been infiltrating Young Living & other groups by pretending to be members or potential members to see if they are compliant. If we are not compliant, they can shut the company down. The pharmaceutical companies are running scared because people are starting to realize that their poisons can cause more problems & they don’t cure anything. More people have died from prescription drugs than from taking natural supplements & using essential oils. I don’t see things getting any better for natural products until we get the big money out of politics & stop letting major corporations run our government agencies.
All those who support the toxic monopoly should be removed from this world.
F Bayer, F all supporters. F the toxic monopoly and most of all F the U.S. who perpetrates it all and has ruined the entire world and all life on it!