How the supplement industry is taking advantage of women and what TINA.org is doing to fight it.
Once only spoken about in whispers, menopause – a transition often marked by a variety of disruptive symptoms ranging from hot flashes and nights sweats, to anxiety and low libido – is now a hot topic, and particularly so with brands trying to cash in on the experience. Millions of women* approaching or experiencing menopause in the U.S. are now the targets of ads for everything from FDA-approved drugs, to supplements, creams and essential oils, to teas and even granola bars. Indeed, menopause has become such a popular marketing focus that a commercial about hot flashes aired during the Super Bowl earlier this year. On top of that, numerous celebrities have endorsed, and even founded, a variety of menopause supplement brands, including Drew Barrymore, Elle Macpherson, Naomi Watts, Gwyneth Paltrow, Judy Greer, Serena Williams, Jennifer Garner, Stacy London and Kate Walsh.
Of all the products on the market seeking to address menopause, supplements reign supreme. Some sources report that supplements account for 95 percent of the menopause market, while others estimate that of the more than $13 billion women spend annually addressing their menopause symptoms, more than $10 billion is spent on “nonmedical treatments.” And by 2028, the global menopause supplement industry is expected to surpass $22 billion. But are the marketing claims being used to convince consumers to spend hundreds to thousands of dollars a year on these menopause supplements accurate – are they truthful?
TINA.org has spent the last year trying to answer this question and our investigation has revealed that there is a deceptive marketing epidemic in the menopause supplement industry. For two brands in particular, Pharmavite’s Equelle and Alliance Pharmaceuticals’ Amberen, TINA.org has collected nearly 2,000 marketing claims that are not supported by competent and reliable scientific evidence, and asked the FDA and FTC to investigate these brands. These findings follow previous TINA.org investigations into several other brands that similarly deceptively promoted menopause supplements without appropriate support, among other issues. Based on these cumulative findings, TINA.org has also sent letters to 100 menopause supplement companies, notifying them of this deceptive marketing trend in their industry and urging them to review their menopause marketing to ensure it complies with the law. We have also published a consumer alert to educate consumers about the marketing issues to look out for when shopping for menopause supplements because the fact of the matter is that according to medical experts, including those at the National Institutes of Health and the Menopause Society, menopause supplements simply do not work.
When it comes to menopause supplements, many brands like to tout that they are empowering women by offering them a solution and allowing them to take control of their lives.
But far from empowering or saving women, menowashing – the practice of marketing products as able to bring menopause relief without adequate support – exploits susceptible women struggling with menopause and looking for help. Deceptively marketing a supplement as able to relieve troublesome health issues not only negatively impacts consumers’ economic well-being, but may cause serious health consequences as women forego evidence-based medical care for unproven supplement products.
According to the FDA, menopause is not a disease, but rather a natural state like aging or pregnancy, and common conditions associated with menopause, such as hot flashes, aren’t treated as diseases either. This matters because it’s only when a product is marketed as able to treat a “disease” that a company must seek FDA approval for what the agency considers a drug claim.
At the same time, through warning letters to companies and drug approvals, the FDA has signaled that some claims often seen in menopause supplement marketing materials are drug claims requiring its approval. These include:
Confusing? Absolutely. It’s complicated because, as noted above, menopause is a natural process, not a disease, but it can come with some problematic, and sometimes really debilitating, conditions and symptoms. Let’s take severe hot flashes, for example – defined as the sensation of heat with sweating so intense that they interfere with everyday activities. Moderate to severe hot flashes can be so problematic that the FDA has approved two hormone-free drugs to treat them.
According to the FTC, health claims about menopause products must generally be substantiated with competent and reliable scientific evidence, which the commission defines as randomized, controlled human clinical testing (referred to as “RCTs”) sufficient in sample size, duration and outcome measures. In other words, general scientific articles, consumer testimonials and other types of support won’t cut it when companies are claiming they can treat or significantly moderate menopausal symptoms. And even in cases where a company does have RCTs to point to, the FTC doesn’t always agree that they’re robust enough to support menopause marketing claims.
Unfortunately, some supplement marketers seem little concerned with FDA or FTC standards, sending messages that their products can address moderate to severe hot flashes and more – just like FDA-approved drugs but without the science to support their claims.
During TINA.org’s investigation into the menopause supplement industry, Pharmavite’s Equelle stood out for its advertising that “guarantees” menopause relief and claims that it is “clinically shown” to treat numerous symptoms, including, among many others, severe hot flashes and excessive night sweats. First introduced in Japan in 2014 before launching in the United States in 2019, Equelle is an daily oral supplement that contains one active ingredient: S-equol, a plant-based, non-hormonal compound that is produced through the company’s “patented fermentation process” that, according to the company, mimics estrogen.
Pharmavite and its Japan-based parent company Otsuka are no strangers to the FTC or the FDA, having both received an FTC Notice of Penalty Offenses Concerning Substantiation of Product Claims in 2023 reminding them of their responsibility to ensure health benefit claims are supported with proper evidence. And both Pharmavite and Otsuka have been investigated for marketing products without sufficient substantiation.
But past encounters with the FDA and FTC have not deterred the companies from using unsubstantiated and unapproved health claims on the Equelle website, in national television commercials, Google ads and on numerous social media platforms. Here are a few examples:
TINA.org has catalogued more than 800 examples of problematic Equelle marketing claims. And while Equelle references three clinical trials on its website as support for claims that its product is “clinically backed” and “clinically shown” to provide menopause relief, none of these studies amount to the type of competent or reliable scientific evidence that is sufficient to substantiate Equelle’s health claims. Some of Equelle’s studies’ flaws include:
For these reasons, among others, TINA.org filed a complaint with the FDA and FTC urging them to open investigations and take appropriate action against Pharmavite’s aggressive marketing messages for Equelle.
Of note, Pharmavite also owns other brands, including well-known vitamin brand Nature Made and another menopause supplement brand, Bonafide, which it also markets as able to relieve hot flashes, night sweats and anxiety, among other things.
Pharmavite and Equelle did not respond to our requests for comment.
In 2016, the FTC entered into a $40 million consent order with Lunada Biomedical, then-marketer of Amberen, another menopause supplement. The order permanently prohibits Lunada and its “successors and assigns” – which include Alliance Pharmaceuticals, the current owner of the Amberen brand – from, among other things, labeling and advertising Amberen or any other dietary supplement as able to:
Relieve hot flashes, night sweats, irritability, mood swings, inability to concentrate, sleeplessness, lack of energy, decreased libido, stress, anxiety, weight gain, headache, or muscle or joint aches associated with menopause unless the representation is non-misleading and, at the time of making such representation, Defendants possess and rely upon competent and reliable scientific evidence that substantiates that the representation is true.
During the more than eight years that have passed since the FTC’s order, deceptive and unsubstantiated marketing for Amberen has continued unfettered, with ads claiming that the product can relieve everything from hot flashes and night sweats, to anxiety, depression and low libido.
These, and more than 1,000 other Amberen marketing examples that TINA.org has cataloged, violate the FTC’s 2016 consent order because they are not properly substantiated by competent and reliable scientific evidence.
Specifically, the Amberen website lists two clinical trials as support for its marketing claims: a 2016 clinical trial on its Amberen Menopause Relief product and a 2020 clinical trial on its Amberen Perimenopause Relief product. But much like the studies of its competitor, Equelle, neither of the trials amount to competent or reliable scientific evidence sufficient to substantiate Amberen’s marketing claims. Some of the studies’ flaws include:
The Amberen website also references, but doesn’t name or provide, a “clinical study supporting the beneficial impact [of its Energy, Mood and Sleep Gummies] on energy, mood and sleep in perimenopausal and menopausal women.” TINA.org, however, was able to dig up the study and found that it failed to examine any menopausal women and also had a pronounced placebo effect, with both the treatment group and the placebo group experiencing a significant improvement in symptoms after 12 weeks. (Interestingly, the placebo effect is a significant issue with hot flashes in particular.)
The bottom line? Amberen appears to be playing fast and loose with what it claims to be clinical proof in order to promote a marketing message that simply isn’t accurate. TINA.org filed a complaint with the FTC regarding the company’s unsubstantiated health claims and order violations (and notified the FDA as well). And given that the current maximum civil penalty amount is $51,744 per violation, Amberen could be on the hook for more than $50 million in civil penalties for violating the FTC order.
In response to a request for comment, Alliance Pharmaceuticals disputed TINA.org’s findings, saying in a statement: “Alliance acquired Amberen in 2020 and since that time has had in place a stringent legal and regulatory review of all claims made by Alliance in relation to Amberen. Amberen is a clinically proven menopausal supplement and all claims that Alliance makes in relation to the product are supported by competent and reliable scientific evidence.”
Equelle and Amberen aren’t alone in marketing supplements as able to treat a variety of menopausal symptoms. A myriad of supplement companies, including Modere, Happy Mammoth and Goop (companies TINA.org has previously investigated for, among other things, using deceptive menopause claims), advertise their products as able to treat hot flashes, night sweats and many other menopausal symptoms. Here are some examples:
As part of its efforts to eradicate deception in the menopause supplement industry, TINA.org has sent notification letters to 100 menopause supplement marketers urging them to review their marketing to ensure that it complies with the law. While not every company that receives a TINA.org letter is necessarily engaged in deceptive marketing, we believe that it never hurts to remind brands of their legal and ethical obligations when marketing to susceptible consumers, who may be struggling with various health issues.
Thirty-six of those 100 companies previously received an FTC Notice of Penalty Offenses Concerning Substantiation in April 2023. Regarding the 64 that did not receive such a notice, TINA.org sent a letter to the FTC urging it to send a notice to those companies in order to help efficiently address deception in this industry.
Approximately 6,000 U.S. women reach menopause each day, and for many it can result in terrible, horrible, no good, very bad days, weeks and even years. Yes, it’s a positive that there now appears to be an effort to break the silence when it comes to menopause and the various symptoms and experiences that go along with it. But, when brands exploit those experiencing health-related issues as a result of menopause with unsubstantiated, misleading and/or deceptive marketing for financial gain – that is shameful.
In addition to potential side effects and the possible harms caused by delaying evidence-based treatments, menopause supplements are expensive with many brands encouraging women to sign up for monthly subscription plans (lest you want unwanted symptoms to return!). Women are spending billions of dollars each year on menopause supplements and these costs are only expected to rise.
It is time that the menopause supplement industry takes a long, hard look at its marketing and ensure that it is honest, truthful and legal. TINA.org will be watching and it urges regulators to do the same.
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*While TINA.org understands and appreciates that individuals who do not identify as women may also experience menopause, the term women is used to reflect the marketing at issue.
An investigation into the menopause supplement industry by consumer advocacy organization truthinadvertising.org (TINA.org) has revealed a hotbed of deceptive advertising. The ad watchdog has amassed nearly 2,000 examples of problematic health…
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