“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 letter signed by Ritual Founder and CEO Katerina Schneider reads.
In addition to the call to action, Ritual presents a policy roadmap and itself as a model of traceability for industry to follow.
Growth at a staggering rate
The letter begins by citing data from the Council for Responsible Nutrition showing that three-quarters of the U.S. population takes at least one supplement – supporting a $59 billion industry that has grown twenty-fold since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“The supplement industry has grown at a staggering rate and it’s safe to say it is at a tipping point,” Ritual's Chief Impact Officer Lindsay Dahl told NutraIngredients-USA. “There are over 95,000 supplements on the market, and the federal regulations overseeing the industry have not kept up with its growth. It’s been over 30 years since the industry has seen major updates in federal laws overseeing the safety, efficacy and quality.”
Earlier this month, Food and Drug Administration Commissioner Robert Califf, MD, requested additional funds and authority to increase oversight to modernize DSHEA and protect the health and safety of consumers in a transparent marketplace.
“Specifically, FDA is seeking to amend our authorities to: (1) require all dietary supplements to be listed with FDA, with information to include product label and other basic information; and (2) clarify FDA’s authorities over products marketed as dietary supplements,” Dr. Califf presented as part of the FDA Summary of FY 2024 Legislative Proposals.
The Traceable Wellness Policy Roadmap
As a starting point for increased oversight, Ritual submitted a Traceable Wellness Policy Roadmap in its letter to Congress with five main lines of action:
1. Urge the FDA to establish separate health-protective limits for heavy metals in supplements and protein powders: “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 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.”
3. Strengthen oversight of adulterated, unregistered, and contaminated products: “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: “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: “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 as model
Established in 2016, Ritual entered the market on a mission to make simple, traceable, science-backed vitamins for women and continues to hold itself to high standards with its Made Traceable initiative and partnerships with like-minded companies along the supply chain. It has since expanded its product line with daily multivitamins, prenatals, probiotics and protein powder for different life stages, including formulations for men, children and teens.
“Our Certificate of Traceability is the first of its kind online tool that showcases our ingredient supplier names, final place of manufacturing, tests conducted (including heavy metals) and packaging materials for each Ritual product,” Dahl said. “This is the level of transparency we believe should be table stakes for all players in our category. We never claim to be perfect, but we want to show that traceable wellness is possible.”
Ritual also submitted a letter to the Senate HELP committee and met with committee members ahead of the June 2022 hearing to address basic traceability requirements and says that it will continue to engage Congressional leaders in meaningful conversations around a cleaner supplement industry, which it views as a nonpartisan issue.
“Ritual hopes this letter is a conversation starter for what policy reforms could help empower the FDA to address our rapidly growing category and also deliver on consumer safety desires and expectations,” Dahl added.
