The same cortisol claim, 21 years later

I formulate supplements, so I read complaints like this one differently than most people do. The disease claims are easy. Nobody who works in this industry needs to be told that "cures depression" on a bottle is going to end badly. What I look for is the line the industry actually thinks is safe, and this filing draws it in a place a lot of formulators and a lot of brand partners have not noticed.

The document is the FTC's complaint in FTC v. Amare Global Holdings, Inc., Case No. 2:26-cv-05900, filed 2 June 2026 in the Central District of California. Sixty-three pages. I pulled it and read it rather than working from the press release, and the structure of Count I is the whole report.

One thing to state before anything else, and I mean it as more than a formality: these are allegations. The case is pending. Nobody has been found liable. What follows is an analysis of what the government has charged and why the shape of the charge matters, not a conclusion about whether it will succeed.

What Count I actually lists

Count I is headed "Deceptive Health Claims." Paragraph 135 sets out what the FTC says the defendants represented, and it is worth reading in the order the government wrote it, because the ordering is the argument:

a. Amare's products will lower, reduce, or regulate cortisol;
b. Amare's products will raise, increase, or normalize serotonin;
c. Amare's products will raise, increase, or normalize dopamine;
d. Amare's products will raise, increase, or normalize GABA;
e. Amare's products will cure, treat, or mitigate depression, including by reducing the risk of suicide in children;
f. Amare's products will cure, treat, or mitigate anxiety; and
g. Amare's products will cure, treat or mitigate ADHD.

Seven subparagraphs. Items (e), (f) and (g) are the disease claims, and they are the ones that made the headlines, deservedly. Items (a) through (d) are not disease claims at all. They are statements about biochemistry, and they come first.

Paragraph 136 then applies one standard to all seven without distinction: the representations "are false or misleading or were not substantiated at the time the representations were made." Paragraph 137 concludes that they therefore violate Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52.

Read that again with a formulator's eye. "Raises serotonin" is not framed as context for the depression claim, or as a lead-in, or as puffery that becomes a problem only once you attach a condition to it. It sits in the same list, under the same substantiation standard, as "cures depression." If you cannot support it with competent and reliable scientific evidence, it is charged the same way.

Why the industry treats mechanism talk as free

There is a reason this feels surprising to people inside the business, and it is worth naming honestly, because it is the everyday logic of supplement marketing.

The received wisdom runs like this. Disease claims are forbidden, structure and function claims are permitted, so you stay on the safe side by describing what the product does to the body rather than what condition it treats. Say "supports a healthy stress response" instead of "treats anxiety." Under that logic, mechanism language looks like the safest possible ground. It sounds scientific, it explains the appeal, and it never names a disease. Whole marketing departments live there.

What that logic drops is the word "substantiated." The structure-function category governs what kind of claim you may make. It does not exempt you from having evidence for the claim you made. A statement that your product raises serotonin in a human being is a specific, falsifiable, measurable assertion about physiology. It is arguably a harder thing to demonstrate than a symptom improvement, because a symptom score you can at least measure directly in a trial, whereas circulating neurotransmitter levels are notoriously difficult to connect to anything happening in the brain. The claim that sounds cautious is in some ways the more demanding one.

The complaint captures the umbrella version of this at paragraph 50: the allegation that the defendants claimed their products "work across the entire gut-brain axis" to increase or normalize dopamine, serotonin and GABA, and lower or regulate cortisol. That single sentence is the engine of the whole marketing structure. Everything downstream, all the way to a parent buying a drink mix for a child, is the audience filling in the last step for themselves.

Which, per the complaint, is precisely what happened. The filing quotes brand partners on social media claiming Happy Juice "connects the gut-brain axis and specifically targets dopamine and serotonin levels in the brain," and another asserting there are "[o]ver 100 Clinical Study Results" and reporting a "55% DECREASE in ANXIETY scores," a "50% DECREASE in DEPRESSION scores," a "105% DECREASE in NEGATIVE MOOD" and a "211% INCREASE in POSITIVE MOOD." Pause on the third of those. A 105 percent decrease means the quantity ended below zero. Whatever produced that figure, it is not a straightforward before-and-after on a mood score, and it is the kind of number that should stop a reader cold rather than impress them.

The study behind the children's product

This beat is usually about finding the study behind the claim, so let me do that here, because the complaint does the work and it is instructive.

For Kids Mood+, the FTC describes a study of ten children who received the supplement for one month. Per the complaint, it was open-label, meaning both researchers and participants knew what was being given, and there was no placebo. The outcome measure was the NICHQ Vanderbilt Assessment Scales, covering inattention, hyperactivity, defiance, conduct and anxiety or depression, along with school and social performance. The parents administered the assessment to their own children. The authors reported "dramatic improvements" in all measures.

The complaint alleges the study is unreliable for, among other things, conflicts of interest, "a sample size far too small for statistical validity; and the lack of blinding and placebo." The FTC's later filing adds that the study's authors included Amare's former chief science officer, members of the company's advisory board, and a brand partner, all of whom it says had a direct monetary interest in the outcome.

Take the design on its own terms, independent of who wrote it. Ten parents, who have bought into a product for their children, know their children are taking it, and are asked one month later whether their children's mood and focus improved. There is no comparison group. There is no blinding. Every known bias in behavioral assessment points the same direction. I would not accept that design as evidence for one of my own products, and no formulator reading this honestly would either.

The complaint then alleges a second-order problem, which is the one I find most instructive. It quotes the former chief science officer stating that "10/10 families saw improvements in their children's focus, and mood, and, importantly, improvements in overall performance when the kids were under the most stress," and alleges at paragraph 91 that the study abstract "says nothing about the conditions under which the parents completed the health assessment." A qualifier that made the finding sound targeted and specific was, per the FTC, not in the underlying document at all. That is a distinct failure from running a weak study. That is the study being described as something it is not.

The FTC's later filing describes a second cited study as comparing end results between placebo and treatment groups without assessing each group's baseline measurements. If accurate, that is a basic error, and one that can manufacture an effect out of nothing more than groups that started in different places.

The 21-year loop

Here is the part that turns this from a routine enforcement action into something with a lesson attached.

Paragraph 5 of the complaint alleges that since the company's formation in 2017, its leadership has included two people already subject to prior court-ordered permanent injunctions barring false, misleading or unsubstantiated claims. Shawn Talbott, chief science officer from the company's inception until he resigned in October 2024, was a defendant in FTC v. Window Rock Enterprises, Inc., filed in the Central District of California on 30 September 2004, and has been under an FTC order since 2005. Patrick Hintze, the founding brand partner who the complaint says heads the multi-level sales structure, was a defendant in FTC v. Green Foot Global, L.L.C., filed in the District of Nevada on 8 November 2013, and has been under an order since 2013. The complaint alleges the company placed each in a control position while knowing about the orders.

Now look at what the 2005 order was about. On 12 June 2026, ten days after the complaint, the FTC filed a motion asking the court to hold Amare, Talbott, Hintze and a former chief executive in contempt of that order. The FTC's account of the original case is that Window Rock concerned two supplements, CortiSlim and CortiStress. The allegation then was that Talbott claimed, falsely or without substantiation, that CortiSlim would help consumers lose weight through controlling their cortisol, and that CortiStress would reduce the risk of or prevent diabetes, cancer and other serious illnesses.

Weight loss through controlling cortisol. That is a mechanism claim, and it is the same mechanism, cortisol, that opens Count I of the 2026 complaint as subparagraph (a). Two decades apart, different products, different company, the same biochemical lever presented as the reason the product works.

The order that resulted, per the FTC, prohibits Talbott and "all persons or entities in active concert or participation with him" from representing the health benefits, performance or efficacy of covered products without possessing and relying upon competent and reliable scientific evidence, and from misrepresenting the results of scientific studies. Read the two prohibitions against the allegations above. The first maps onto the mechanism and disease claims. The second maps onto the "under the most stress" qualifier that allegedly was not in the abstract. Christopher Mufarrige, director of the FTC's Bureau of Consumer Protection, put the agency's position in the release:

Amare, Hintze and Tran knew of Talbott's prior order with the FTC, but rather than attempt to comply with that order they were all too willing to help Talbott launch a new scheme to take advantage of parents looking for products to help improve their children's health and adults struggling with their own mental health.

That "all persons or entities in active concert or participation with him" language is the part practitioners should sit with. An FTC order does not attach only to a person. It reaches the people who work with that person on covered conduct. Hiring someone under an order can bring their order into your building.

What I would take from this

Three things, and none of them require you to have an opinion about how the case comes out.

First, treat the mechanism sentence as a claim. Not as flavor, not as the science-y bit that makes the copy feel grounded, but as an assertion you will be asked to substantiate on the same terms as anything else. "Raises serotonin" is a testable statement about a human body. If you would not put your evidence for it in front of a skeptical reviewer, do not put the sentence on the label, in the deck, or in a caption.

Second, when a company says its claims are backed by studies, the number of studies is close to meaningless and the design is close to everything. "Over 100 Clinical Study Results" is a quantity. Ten unblinded children assessed by their own parents is a design. In a supplement claim it is almost always the design that is doing the deceiving, and the count that is doing the reassuring.

Third, for readers rather than formulators: the mechanism story is the most persuasive thing in supplement marketing precisely because it does not ask you to believe a cure. It hands you a plausible pathway, gut to neurotransmitter to mood, and lets you complete the sentence yourself. That is a more effective way to make a health claim than making one, and it is the reason the FTC charged those four lines separately. When you next read that something raises your serotonin, the useful question is not whether the pathway sounds real. It is whether anyone measured it, in people, against a control, and whether the person telling you would show you that measurement.

Not medical advice. This is educational analysis, not a recommendation — a study is not a prescription. Talk to a qualified clinician before acting on anything you read here. Full disclaimer →

Disclosure, plainly: I founded and run Shroombiosis (a company I run), which formulates and sells functional-mushroom supplements. That is a direct stake and it cuts awkwardly here: this report argues for a stricter reading of the substantiation burden on mechanism claims, which is a standard my own company has to meet, and the industry I sell into would generally prefer the looser reading. Weigh what I have written accordingly. Nothing here is sponsored and no link earns a commission; here's the full policy. A recommendation with no stake at all: for performance nutrition, Die Tryin Co. is a fellow combat-veteran-owned brand I recommend. I don't own it and earn nothing from the link.