Hundreds of letters have been sent to natural products companies warning them that if they fall afoul of the FTC’s ridiculous rules by sharing information that can benefit your health, there will be hell to pay. Action Alert!
Once again, the government is trying to limit access to the information we have about the benefits of natural products. The FTC sent letters to 670 companies, including those selling dietary supplements, homeopathic products, and functional foods, warning them that if they make claims without proper scientific substantiation, they will face large civil penalties—up to $50,120 per violation. This unprecedented move is a warning shot to the natural health industry signaling that we’re entering a new era of enforcement in which the government will be even more aggressive than it has been in censoring speech about the benefits of natural products. We must push back.
This is a complex issue that is quite technical, but what we’re facing is a government-led campaign to conceal the remarkable truth about the healing and disease-preventing powers of foods and nutrients, ultimately misleading the public so that they spend their money on drugs rather than natural supplements.
The crux of the issue is that the FTC, in conjunction with the FDA, is trying to impose drug standards on supplements, requiring expensive clinical trials in order for supplement companies to make most health claims. Not only are clinical trials often inappropriate for studying nutrients, they are not economically feasible. As we’ve explained many times, clinical trials are incredibly expensive. Drug companies can afford them because drugs are patentable and the costs can be recouped when the drug is approved and sold for exorbitant prices. Nutrients generally cannot be strongly patented, so the costs of clinical trials cannot be recouped. The government knows this, so the attempt to require clinical trials for supplement claims is a backdoor ban on most claims. This makes sense if your goal is to protect the drug industry from competition, but not if you want to promote public health by empowering consumers with information so they can take control of their own health.
The salvo of FTC letters was preceded by a revision to the agency’s Health Products Compliance guidance in December 2022, which includes a crucial change. Companies must have “competent and reliable” scientific evidence in support of health claims in advertising. Previously, this could include all kinds of studies, such as animal, in vitro, or epidemiological studies—though clinical trials were considered “best.” The revised guidance states that,
substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing (RCTs) to meet the competent and reliable scientific standard…Animal and in vitro studies may provide useful supporting or background information, but, without confirmation by human RCTs, they aren’t sufficient to substantiate health-related claims.
This change can be traced to the lawsuit brought by the FTC against Pom Wonderful, the pomegranate juice company, in 2014. Recall that the agency went after Pom Wonderful for advertising the health benefits of its products—even though the company spent $35 million on studies to back up its claims. But this wasn’t enough for the FTC—they wanted two RCTs, a drug standard, to substantiate health advertising claims. The courts rejected the two RCT standard but said one RCT could be required. The FTC is now alerting companies that it plans to enforce this ridiculous standard.
In the FTC’s updated guidance there is even an indication that the agency will, in practice, require two RCTs, not just one—contrary the opinion delivered by the Court in the Pom case:
Although there is no requirement for a specific number of RCTs, the replication of research in an independently conducted study adds to the weight of the evidence. Replication in a second study by independent researchers reduces the chance that the results of a single RCT may be influenced by unanticipated, undetected, systematic biases that may occur despite the best intentions of sponsors and investigators.
Note that the FDA and the FTC work together to regulate health claims, and both apply a similar framework that heavily weights evidence provided by clinical trials when reviewing health claims. FDA rules state that there must be “significant scientific agreement” among qualified experts that health claims are supported by the totality of publicly available science. Like the FTC, the FDA categorically rejects most kinds of evidence other than clinical trials in determining what constitutes “significant scientific agreement.”
Given these agencies’ history, the outlook for free speech isn’t good. The government has a proven track record in egregiously restricting truthful claims about supplement benefits. We’ve reported on the FDA’s attack on cherry and walnut growers for listing the health benefits of those foods on their websites. We’ve told you about the FDA’s restriction of legal structure/function claims because they are “implied disease claims”—an FDA fabrication that isn’t in the law. There was the massive, coordinated censorship campaign launched during COVID by the FDA and the FTC threatening doctors and clinics that told us about the benefits of natural products like vitamin D and zinc for COVID treatment and prevention. We reported on the FTC’s campaign against Xlear, a nasal spray company, for discussing the results of more than a dozen studies demonstrating the plausibility of using its nasal spray to help with COVID. There are many more examples.
This is also another instance of US regulators trying to “harmonize” US law with the European Union’s (EU) draconian system. As our friends at ANH-International have pointed out, most botanicals in the EU aren’t allowed any health claims, and there are only a handful of approved claims for vitamins and minerals. The EU’s FDA equivalent rejected the vast majority of some 44,000 proposed nutrient health claims because they didn’t have what they considered to be the proper substantiation. We cannot allow the US government to follow this model.
ANH-USA supports legislation that would allow the free flow of information about supplements by allowing companies to cite peer-reviewed studies demonstrating health benefits. Help us push back against the government’s censorship campaign and support free speech!
Action Alert! Write to Congress, telling them to stop the FTC’s censorship campaign and to support the free flow of information about supplements. Please send your message immediately.
My personal feelings on this are borne out from my ancient age of 83 & many years of trying to fix my own problems. The base problem is that all vitamins & other supps do not necessarily work just on their own, but influence a lot of processes that go on in our bodies & the truth is that even the medical establishment does not know the real depth of what goes on inside us. SO – for me now the best way to supplement my diet is to take a healthy mix of natural vitamins rather than adding specific ones only. I used to take a variety of different things, then I developed a gut problem which made me stop taking everything for a few days to settle things down, and now I’ve ditched all the separate bottles & take SeaAloe & ‘Greens’ tabs only – both are just made of a mix of veggies & fruits. The only question remaining is will that keep my leg cramps at bay or do I still need the L’Arginine I’ve taken for years for that also?
The problem is clear and it is that the bureaucracies any and all and such as The Federal Trade Commission, Food Drug Administration, Federal Communications Commission or any of the government departments do not have the right to legislate law or by opinion or any other legal means. This is being allowed by the United States Congress through Acts that are not amendments to the United States Constitution and many being unconstitutional in legal construction and engineering. All this can be corrected by re-establishing Constitutional laws making it a violation when constitutional law is not adhered to in constructing the law. By amending the United States Constitution (Convention of the States). Supremacy Clause United States Constitution: Article Six.
Congress is the problem and the people need to make sure that the United States Congress and all legislative bodies, federal, state and local and or municipal and city, township are representing the majority of Citizens and upholding their God given Rights. United States Constitution: Amendment Ten, Declaration of Independence.
This is the Codex Alimentarius which was invented in the USA and then exported to Europe. Where it has been in full effect for years, although we raised a huge protest. Many healthmagazines had to close down. On Internet noone dares to make any healthclaims. The legal amount of substance in supplement is useless too low to have any effect, but very costly. Supplement companies are being bought up by Big Pharma. Animal supplements contain even worse ingredients. F.i. Cyanocobalamin instead of Methylcobalamin which is bioavailable, still being used in the majority of animal supplements. Meanwhile Big Pharma meds are being made of standardized CBD, over the top expensive and coming with names they are unrecognizable for patients. On the other hand growing some plants in your own home still remains illegal in the Netherlands.
I’m in my 70s & have been using Alternatives to Big Pharma’s heinous Drugs for 50 yrs.! My gut told me way back then that Big Pharma just wants customers going back to their doctors for more drugs because otherwise, Big Pharma loses Customers but, more importantly, $$$$$$$! I remember reading an article yrs. ago from the 1st creator of vaccines who said he’d not allow his familiy to have any because Big Pharma’s sole purpose for existence was to make Money! I posted that article toFakebook!
Scientific naturopathy has been in my family professionally since 1959. With knowledge of cause and effect I can tell you that any natural supplement helps, but does not decide. What really cures an organism is the practice of a multilevel daily detoxifying lifestyle that recovers the organism’s self-regulating power and thereby manages to control, reduce and even reverse all human diseases. You want to know more, contact me. Please do not reveal my identity.
Science is the new religion. And as we know, religion stifles free thought, inquiry, and expression. The truth is only what the “experts” and “authorities” deem to be Truth. It’s not just the FDA anymore, but also the FTC and all government agencies in a coordinated attack against OTC supplements. We must restrain Big Government’s collusion with Big Pharma.
I have been sending letters to the Government since the mid 1970s, and recently have been thinking that with the complete insanity in government they will make destroying the alternative health field a priority – apparently this is what they are doing now. How incredibly sad that big government and big pharma are making the push once again, a curse upon their houses!
I don’t see why supplement companies need to publish why someone would buy a supplement. Most people I know who purchase supplements already know what to buy from reading books or articles, talking to others, or taking courses.
I strongly protest the actions of the FDC on imposing such strong regulations on our
supplements while ignoring food which is the best medicine we have. Our food is
loaded with unhealthy ingredients which are making people sick with cancer, diabetes heart disease and obesity,
among other health issues. We can no longer rely on our food to give us all our nutrients that is
why we have to depend on supplements. Perhaps, the FDC wants people to get sick so Big Pharma can continue treating
them with their expensive and dangerous drugs. Please put your focus where it belongs!
I sick of these fascist pigs running my life just because the drug companies donated more to their campaigns.