The Honorable Bernie Sanders
The Honorable Bill Cassidy, M.D.
The Honorable Brett Guthrie
The Honorable Anna Eshoo
Dear 118th Congress,
Ritual encourages this Congress to take meaningful steps to improve the safety and efficacy of supplements on the market today. A category leader since 2016, Ritual has been making traceable, science-backed products, including daily multivitamins, prenatals, probiotics, and protein powder.
According to market research conducted in 2022, three-quarters of all Americans take at least one supplement. Yet, despite the high consumption of vitamins and supplements, it has been over 30 years since the industry has seen major updates in federal laws overseeing the safety, efficacy, and quality of the $59 billion industry. Regulated by the FDA, the supplements industry oversight is mostly governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which could be stronger when it comes to regulating the safety and efficacy of supplements. (1,2,3,4)
Supplements Consumption Increases Dramatically, While Regulations Stay Stagnant
The growth of the supplements category has been staggering. In 1994, when DSHEA passed, approximately 4,000 different supplement products were available. According to new data shared by the FDA, there are an estimated 95,000 supplement products available to consumers. With more than 20 times the number of products, additional oversights are needed to protect consumers. Due to limited federal oversight, there are key areas of the supplement industry that need to be addressed: products can be mislabeled, marketed with unsubstantiated health claims, and testing shows they can be contaminated with harmful amounts of contaminants like heavy metals. The safety issues are nothing to balk at; there have been 6,307 reports of health problems from dietary supplements, 92 deaths, and more than 1,000 serious injuries (from 2008-2011).(5,6,7,8)
Ritual’s Traceable Wellness Policy Roadmap
Ritual proposes the following updates to federal law to better protect supplement users. While we never claim to be perfect, we work to hold ourselves to higher standards and address many of these common industry concerns. In fact, we see a clear role that federal legislation can play in helping Ritual deliver the best products to our consumers. Our policy roadmap is as follows, we:
1. Urge the FDA to establish separate health-protective limits for heavy metals in supplements and protein powders.
Testing and research show that heavy metals are common contaminants of dietary supplements, and plant-based protein powder testing has shown widespread issues with heavy metal contamination, specifically lead, cadmium, and arsenic. Lead is a known human carcinogen linked to harming the brain permanently, and equally concerning health issues are linked to arsenic, cadmium, and mercury. (9,10,11)
Case in point, in a 2009 study among 6,712 women 20 years and older, those using herbal supplements had lead levels that were 10% higher than non-users. In a study on 70 brands of calcium supplements, about 25% of the products exceeded the FDA's "provisional" total tolerable daily lead intake for children aged six years and under. A 2018 study on 24 herbal supplements made in Poland found that all supplements tested contained some content of mercury. In a 2019 study of echinacea and turmeric, more than one third identified concerns, including elevated lead levels. A June 2022 peer-reviewed study found arsenic in marine-sourced supplements (like omega-3 DHA). (12,13,14,15,16)
Using the best available science, we encourage the FDA to establish health-protective limits for heavy metals in supplements and protein powder. Standardized best practices and detection limits for heavy metal testing will also help increase the safety of supplements and protein powders frequently consumed by American families.
2. Define terms like “clinically studied” to reduce misuse in the marketplace.
A study from 2017 found that over half the supplements tested were mislabeled, which was determined when the chemical analysis did not confirm the ingredients listed on the label. Misusing a term like “clinically studied” for multivitamins and supplements results in questionable and unbacked efficacy of the product. Brands can sprinkle small amounts of clinically studied ingredients into a formula but leverage the terms to imply the whole product has been clinically studied. In the case of plant-based protein powder, mislabeled organic ingredients can increase ones exposure to heavy metals and herbicides glyphosate, deemed a known carcinogen by the World Health Organization’s IARC program. (17,18)
A clear definition for clinically studied should live within FDA or expand upon FTC’s existing guidelines. Creating standards around how brands should speak to clinically studied ingredients and formulas is critical to greater transparency. Ritual encourages best practices, including using the clinically studied ingredients in the same doses included in the studies, formats that maximize absorption in the body, or human clinical trials for finished good claims.
3. Strengthen oversight of adulterated, unregistered, and contaminated products.
Currently, to identify potential safety concerns, the FDA mostly relies on adverse event reports submitted by individuals and inspections of manufacturing facilities. Bacterial and fungal contaminations can occur and are known to degrade active ingredients or lower the stability of products. Vulnerable populations (people over 65, children, and persons with chronic diseases or an impaired immune system) are especially at risk for microbial contamination to cause infection or illness. (19,20,21)
In May of 2022, the FDA sent ten companies warning letters for selling adulterated dietary supplements that contain either new dietary ingredients that did not have the required premarket notifications or unsafe food additives. The ingredients found in some of these products can potentially cause harm, such as the potential adverse effects of higenamine on the cardiovascular system. (22)
Knowing there are documented issues with supplements being adulterated, contaminated or unregistered, we encourage Congress to establish stronger accountability for players introducing dietary supplements to the market.
4. Address mislabeling issues by ensuring supplements contain the ingredients actively marketed on the label.
The FDA does not test dietary supplement products to ensure the ingredients on the label are in the bottle. Testing of supplements purchased at major retailers found that of the 24 herbal supplements tested, 17 were found not to contain the herbs listed on their labels (ginseng, ginkgo biloba and St. John’s wort and more). (23) This can easily happen when companies use a small amount of an ingredient in a formula, simply for the purposes of marketing a product. Ritual believes its best practice to validate the amount of active ingredients specified on the label as there are often discrepancies. (24) We encourage legislation that strengthens existing requirements for companies to back up the claims on their labels and to actively test their products for the intended shelf life.
5. Require ingredient traceability.
As noted in the draft supplement reforms before the Senate HELP committee in June of 2022, many supplement companies know very little about their ingredient suppliers, relying on their manufacturers to procure and formulate their products. Ritual encourages Congress to create provisions that require even basic levels of traceability for ingredients, like knowing the name and final place of manufacturing for ingredients. Traceability is required to understand and reduce supply chain risks linked to environmental harm and human rights abuses hiding along the value chain. By requiring traceability across the whole supplements industry, brands like Ritual could glean more information about country of origin and better understand the full journey raw materials and ingredients take before ending up in our products.
Ritual Proves Traceable Wellness is Possible
As Certified B Corporation, Ritual brings a new level of transparency to the health & wellness industry. We develop vitamins and supplements that are backed by science and are traceable. Ritual publicly shares our supplier names (and where ingredients are manufactured) on our website, along with publishing and leveraging best-in-class scientific research. Our Certificate of Traceability is the first of its kind showcasing ingredient supplier names, final place of manufacturing, tests conducted (including heavy metals) and packaging materials for each Ritual product. We take this transparency a step further, publishing the heavy metal tests for our protein powder on the Certificate of Traceability.
This commitment to traceability has paid off in industry-leading trust. Ritual is the #1 online prenatal vitamin in the U.S. Our vegan protein powder is the first protein to be Informed Protein Certified and is used by elite athletes, featuring heavy metal testing transparency on our website. Our flagship multivitamin (Essential for Women 18+) has USP verification, held by less than 1% of supplement companies, a peer-reviewed and published human clinical study, and a patent on the technology. Ritual never claims to be perfect, but we are proof that there is a better way to make safer, efficacious supplements.
In light of growing safety concerns, the FDA needs greater authority to ensure the safety and efficacy of all vitamins and dietary supplements and consumers need greater ingredient transparency to make informed decisions. Therefore, 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
