Modere Voluntarily Discontinues Certain Earnings & Health-Related Product Claims; Direct Selling Watchdog Recommends Others be Discontinued

McLean, VA – January 24, 2024 – The Direct Selling Self-Regulatory Council (DSSRC) of BBB National Programs recommended that Modere modify or discontinue certain earnings and health-related product performance claims for its Ova and Ova-m products. 

The advertising claims were made by Modere USA, Inc., a direct selling company that markets health, beauty, and wellness products. The inquiry was brought to DSSRC by a non-governmental advocacy group (NGO).

The challenged product performance claims include, but are not limited to:

• “Cultural and societal views about women have made it difficult to discuss what’s happening with our bodies let alone find solutions. …Whether you’re dealing with unpredictable menstrual cycles, normal symptoms of PMS, occasional hot flashes, night sweats, or a low libido, you know, we often chalk our experiences up to simply being women, you know, but not anymore. Together, we’re going to empower women to reinvent their hormone stories…”.
• “…Project 23 takes a unique approach to hormonal health unlike anything else… If you suffer from PMS, cramps, bloating, low energy, low iron levels, UTI's, low libido, mental clarity, thyroid levels, inflammation, skin issues, hot flashes, night sweats, vaginal dryness, mood... basically all the terrible things our hormones and cycles can do to us women...THIS IS FOR YOU! …”.
• “Now there’s a natural way to treat the cause of all of your PMS symptoms[.] It will help to relieve/ease: -Cramps -Bloating -Support energy levels – Healthy blood flow”.
• “…I’ve been using the menopausal formula and Alyson Layser the period formula for almost 3 weeks. I’ve noticed ✔️ deeper sleep (& I don’t have problems sleeping anyway but this is DEEP sleep) ✔️ improved word retrieval less brain fog ✔️ weight loss Alyson has noticed ✔️ improved skin/less acne ✔️ less bloating ✔️ lighter period ✔️ less cramping …”
• “…Regulate those hormones without hormone therapy??? Count me in!”
• “…What if there was a NATURAL way to treat: ✔️ Heavy flow ✔️ Menstrual cramps ✔️ Irregular cycles ✔️ Skin congestion ✔️ Hot Flashes ✔️ Hormones ✔️ Moodiness ✔️ Brain Fog ✔️ Energy…#EveryWoman #ReinventYourHormoneStory #Project23…”.

Challenged earnings claims include, but are not limited to:

• “…People’s lives are being changed, their finances, their health, and their families…This market will be $48 Billion by 2027 (and up to $58.2B by 2030)!!…#project23”.
• “…I’m also going to help a whole lot of people kick their financial struggles to the curb.”
• “How I went from waiting tables all weekend to working online on my own time from magical Bali. … A friend approached me about working online and creating a freedom lifestyle for ourselves and I thought could this really be true? Do people really get to make an income online and get their time freedom back?? And it turns out it was true. … Gone are the days where I would work double shifts and burn myself out. 6 years later I am working from Bali with my partner and I no longer have to work for my vacations because I have created a passive income online and that has given me my time freedom and choice back. … If you’re looking to create an income online send me a message…#multiplestreamsofincome.”
• “This business has afforded me the opportunity to travel and to live my life, and to design a life that I’ve always wanted … If we learned anything during the lockdown, it’s that working from home and actually being able to generate an income that is versatile, that is residual, that is long lasting, is important, and being able to be with your family is important, but also being able to make money and pay your bills is important too.”

Modere participated in the DSSRC process in good faith and worked quickly to remove all of the earnings claims as well as most of the health-related claims identified by the NGO, more than 200 claims. 

While discontinuing and/or modifying almost all of the social media posts brought to its attention, Modere also reserved its right to disseminate permissible structure-function and general efficacy claims” for Ova and Ova-m in future advertising. Conversely, the NGO alleged that Modere and its salesforce members were communicating inappropriate and unsupported health claims that required FDA approval and that the representations would not be considered permissible structure function claims in context. 

Like the National Advertising Division (NAD), DSSRC does not make FDA regulatory distinctions between structure/function and disease claims, and instead examines the messages reasonably conveyed by the advertising as a whole and determines whether the submitted evidence supports those messages. Modere did not provide testing on the Ova or Ova-m products themselves and instead relied on testing conducted on the products’ ingredients at the same or a similar dosage level to the amount of those ingredients as contained in the two products. 

After a thorough review of the substantiation provided for the remaining health-related claims in question, among other findings, DSSRC determined the following claims are not supported:

• Claims that Ova can reduce bloating or abdominal cramps.
• Claims that the ingredients in Ova support iron metabolism.
• The broad representation that Ova supports the endocannabinoid system and supports libido.
• The claim that the ingredients in Ova support liver health and detoxification.

As a result, DSSRC recommended that Modere refrain from making such assertions in future advertising for Ova.

However, DSSRC also concluded that:

• Certain individual ingredients in Ova can reduce stress, support mental clarity, help improve feelings of well-being, support the absorption of key nutrients, promote clear-looking and healthy skin, and support healthy blood flow. 
• Modere provided a reasonable basis for the statement that the ingredients contained in Ova-m are effective in reducing hot flashes, night sweats, and vaginal dryness.
• Ingredients in Ova-m improve sleep health, provide mood and energy support, and have a positive impact on libido are supported.
• Modere demonstrated a distinct correlation between the dosage of sage extract in Ova-m and cognitive well-being.

DSSRC appreciates Modere for their proactive approach to addressing issues identified by DSSRC as well as their commitment to the self-regulatory process and a continued effort to keep unsupported claims out of the marketplace. 

All BBB National Programs case decision summaries can be found in the case decision library. For full text of DSSRC decisions, visit the DSSRC Cases and Closures webpage.