The Honorable Bernie Sanders
The Honorable Bill Cassidy, M.D.
The Honorable Buddy Carter
The Honorable Diana DeGette
Dear 119th Congress,
Today, the burden heavily falls on women’s shoulders to investigate the ingredient sources, analyze efficacy claims, and check for contaminants in their vitamins and supplements. This is an unfair responsibility, especially during the most vulnerable and nutritionally demanding stages of a woman’s life: preconception, pregnancy, postpartum and beyond.
The incomplete regulatory framework governing the 100,000+ supplements on the market has effectively turned consumers into their own regulatory agencies. (1) Ritual hopes that through key updates to federal law, some of this burden can be removed from consumers’ shoulders.
Oversight Falls Short
The supplement industry is primarily governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has not had meaningful updates since its inception over 30 years ago. (2) Since then, the supplement industry has grown 2275%. (3) Last year, the FDA called for updates to DSHEA, asking Congress to “provide FDA with additional authority to increase oversight of dietary supplements to better protect consumers.(4)
Urgent Need to Continue Funding at NIH/NSF
The foundation for any Ritual formula is strong peer-reviewed science, and we rely heavily on the work that is funded by the National Institutes of Health (NIH) and the National Science Foundation (NSF). Through their research grants, the NIH supports more than 300,000 researchers at more than 2,500 different institutions, and more than 30% of the research grants produced a scientific article later cited in a commercial patent.(5) The National Science Foundation (NSF) also plays a vital role in advancing science, helping us better understand key issues related to women’s health, research on contaminants like heavy metals, and 25% of NSF funding directly benefits America’s colleges and Universities. (6) By funding these universities, not only can we ensure that the US sustains its leadership role in health innovation, but also we can accelerate progress of lab discoveries to real-world applications.
Ultimately, the research from these institutions helps consumers (and brands) understand safety concerns with ingredients, trust science-backed marketing claims, and ensure the efficacy of products through clinical trial results. NIH and NSF funding is critical to protect consumers, and prioritizing research with real public health applications, like dietary supplements and product safety, ensures taxpayer dollars lead to meaningful advancements in public health.
Listen to Safety Warning Signs
The products and supplements pregnant women take during their most vulnerable times (and their babies’) should provide trustworthy nutritional support, not pose a safety risk. Yet scientific research and consumer testing show heavy metals are linked to reproductive harm and are also a common contaminant in supplements. (7)
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In 2023, the International Federation of Gynecology and Obstetrics (FIGO) issued a position stating heavy metals in prenatals are an important public health issue, calling on our government agencies to take action and for brands to third-party test their products, to reduce the risk of heavy metal contamination. (8)
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In 2023, a Government Accountability Office report tested prenatal vitamins for heavy metals and recommended more research and testing be done and “that Congress consider measures for allowing FDA sufficient authority to carry out its oversight of dietary supplements.”(9)
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A June 2022 peer-reviewed study found arsenic in marine-sourced supplements (like omega-3 DHA). (10)
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A 2018 study of 26 prenatal supplements found that more than half tested over Prop 65 limits for heavy metals, specifically lead. (11)
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A 2018 study on 24 herbal supplements found that all supplements tested contained some content of mercury. (12)
Product Efficacy Overstated by Misuse of the term “Clinically Studied”
The lack of regulation around terms like “clinically studied” in the supplement industry leads to consumers spending their money on hopeful health solutions with questionable efficacy. Some brands may add small amounts of clinically studied ingredients to a formula—at levels much lower than those studied in the clinical trial—yet use the term clinically studied when speaking to the ingredient. Brands abuse these terms by implying the entire product has been clinically studied, when only one or some of the ingredients in the formula have undergone such testing. (13) Discrepancies can arise between the specific form of a nutrient studied and the form present in the product, further confusing consumers.
Ritual’s Policy Roadmap
Ritual urges Congress to consider making key updates to federal law that will better safeguard public health, especially women during critical life stages. While our work at Ritual is far from perfect, we are committed to setting a high standard in our industry.
We believe that well-crafted federal legislation can be bipartisan and pivotal in bringing safer and more efficacious products to consumers.
1. Maintain Funding For The FDA, NIH And NSF
We ask Congress to fully fund and unpause spending freezes for the FDA, NIH and NSF. The research from these institutions is vital for understanding the safety and efficacy of dietary supplements and ingredients.
At Ritual, we conduct gold-standard human clinical trials (following the NIH’s definition) in partnership with leading universities and research organizations and we use research from NIH and NSF to inform our product dosing, form, and design. Simply put, keeping the funding for key agencies and research departments helps our business grow.
2. Establish Health-Protective Limits For Heavy Metals
Using the best available science, we ask Congress to empower the FDA to establish health-protective limits for heavy metals in supplements and protein powder. While keeping vulnerable populations, such as pregnant women and children, in mind.
Ritual recognizes and proactively communicates with our customers that no brand can claim to be “heavy metal free.” With that being said, we still know that proper sourcing and testing practices can help reduce heavy metal contamination. We address the risk of higher amounts of heavy metals through the sourcing of high-quality ingredients, third party testing every batch of our finished goods, and we openly share heavy metal test results for customers upon request. Recognizing that plant-based protein powder is a high-risk product, we publicly share the heavy metal test results for one of our latest released lots of Essential Protein on our website.
3. Clearly Define How “Clinically Studied” Is Used
The FDA should establish, or expand upon the FTC’s existing guidelines, a deeper and clear definition for “clinically studied” claims. Greater transparency for consumers will come when stronger standards are established for clinically studied claims.
As a best practice for clinically studied ingredients, Ritual uses the same doses and form included in the clinical trial(s). We also carefully delineate between the ingredients or the finished product being clinically studied. We have committed $5 million to fund university-led human clinical trials on all our formulas by 2030.
In light of growing concerns, we urge Congress to take this legislative session to act and protect the millions of American families who take supplements daily.
Sincerely,
Katerina Schneider
Founder and CEO, Ritual
