With chronic diseases on the rise, the FDA’s push to limit access to dietary supplements could further undermine Americans’ health, restricting vital tools for wellness and prevention.
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THE TOPLINE
- Alarming health statistics, such as rising rates of autism, obesity, diabetes, and early death, reflect a failing healthcare system focused on treatment rather than prevention.
- The FDA, along with the FTC, is pushing for stricter regulations on dietary supplements, including requiring expensive clinical trials for health claims, a move that could cripple the industry and limit access to natural health solutions.
- By demanding clinical trials for supplements and censoring claims without them, the government is violating First Amendment rights, restricting the flow of truthful information about the health benefits of supplements.
Consider the following facts:
- Autism rates in kids are 1 in 36 nationally, compared to 1 in 1500 in the early 1990s.
- 74 percent of American adults are currently overweight or obese.
- 1 in 5 children and adolescents have obesity.
- 50 percent of American adults have prediabetes or diabetes.
- 30 percent of teens now have prediabetes.
- Sperm counts are decreasing by 1 percent per year.
- 40 percent of 18–29-year-olds meet criteria for psychiatric disorder.
- Cancers in people under 50 are up 79 percent.
- Americans are dying earlier, driving life expectancy to its lowest point in decades.
These staggering figures tell us a simple truth: we are a profoundly sick country, and it’s only getting worse.
The causes of this decline in our health are many. There’s the standard American diet pushed by Big Food, full of processed carbs, sugar, and ultra-processed foods; there’s our toxic environment, where we’re exposed to pollution and a cocktail of dangerous chemicals and pesticides. But these are also the results of a healthcare system that prioritizes treating sick people rather than preventing chronic diseases that are killing us in record numbers.
Dietary supplements have been shown to have a dramatic impact in keeping us healthy and staving off chronic diseases. They aren’t a silver bullet, but can be instrumental in maintaining wellness. But, as we’ve argued so many times, the federal government has, in large part, mobilized against the wider use of supplements. The FDA, and its allies like Sen. Dick Durbin (D-IL) want to treat them like drugs and require pre-approval—which we’ve argued would be the death knell of the supplement industry as we know it.
Equally as important, the government has been determined to censor truthful speech about the benefits of supplements. The latest attack was launched by the FTC when it 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. What is “proper scientific substantiation”? In the government’s view, it means one thing: clinical trials.
We asked our Executive and Scientific Director, Rob Verkerk, Ph.D., what he thought:
Randomized Controlled Trials or RCTs are often inappropriate for studying food and nutrients. A new-to-nature drug molecule can be better isolated in its effects, because you can omit it completely in your placebo group, standardize your variables across both treatment and placebo groups, and get very high statistical validation. That doesn’t mean you necessarily learn about drug interactions, which is why polypharmacy (the regular use of 5 or more medications at the same time, something that’s common in many elderly people) can reveal such shocking and unexpected results.
When it comes to nutrients, you just can’t remove them from your placebo without disastrous consequences. Foods and supplements often also depend on co-factors. For example, if you’re looking at studies on bone health and look only at studies with supplemental calcium, you’ll see mixed evidence, including evidence of harm. That’s because many people already have adequate calcium in their diet and you only start to see consistent benefits when a range of other cofactors are consumed, notably supplemental K2, vitamin D, magnesium, and trace elements like boron.
RCTs are also prohibitively expensive for most companies. High quality RCTs of the type regulators take note of because they follow standards set for pharmaceuticals cost an average of $600 million, and sometimes much more. Clinical trials of integrative medicine can be even more expensive because effect sizes for each intervention are often small, these need to be studied separately so interactions can be quantified and treatment durations may be long and benefits delayed, necessitating long periods of follow-up.Given that RCTs are the only methodology viewed by regulators as being adequate to determine conclusive proof, you’ll find nearly all nutritional interventions remain tarred with the brush of “inconclusive evidence.”
Then there’s the financial constraints. As nutrients and other integrative therapies generally cannot be patented, there isn’t a way for a commercial interest to recoup the astronomical costs of conducting RCTs. Only pharmaceutical companies making drugs, which can be robustly patented, can afford theses costs.
There are also problems with the FTC’s actions on legal grounds. Jonathan Emord, Esq., ANH’s General Counsel, explained:
The supreme law is the First Amendment. Consequently, any agency act or regulation that deprives the public of speech protected by the First Amendment is unlawful. The blanket RCT requirement effectively imposed by FTC in the health product context is by its very nature unconstitutional.
FTC fails to comprehend a fundamental First Amendment lesson: that speech can be true even if inconclusive. That was the lesson the United States Court of Appeals for the DC Circuit accepted in the case I litigated, Pearson v. Shalala.
In a world where almost all accepted scientific relationships are more probable than not, but rarely—if ever—deemed conclusively proven, when government erects a barrier to speech that is a rigid, costly one, like the demand for RCTs, government necessarily censors truthful speech, violating the First Amendment.
Emord continued to describe how the FTC, by requiring clinical trials, is engaging in prior restraint and thus violating the First Amendment:
The First Amendment places a burden of proof and production on the government to prove in every instance not that speech is potentially false but that it in context is provably false. The FTC cannot shift those burdens to speakers by demanding that they be prohibited from speaking unless and until they have an RCT or two before uttering a peep. That is a classic prior restraint. There is no more central purpose of the First Amendment than to disarm the federal government of any prior restraint over speech and press.
These are the reasons that the FTC’s Health Products Compliance guidance violates the First Amendment.
It’s a shame that it has to come to legal actions and a need for new legislation to get federal agencies to allow the American public to learn about products that can improve their health. We’re fighting for changes that allow the free flow of information about supplements. With our newly-appointed General Counsel, Jonathan Emord, we’re also going to be leveraging the recent Supreme Court decisions to use litigation to open up the marketplace to truthful statements about the benefits of supplements.
We’ve got exciting news we’re going to be able report regarding court filings later this month — make sure you keep abreast of our free weekly newsletter and you’ll find updates on this in a forthcoming issue!
