As President Joe Biden and his team rightly focus on the nation’s public health in response to COVID-19, consumers are asking themselves how they can play a more active role in their own health and wellness. The Dietary Supplements Quality Collaborative, or DSQC, a diverse group of national stakeholder organizations across the public health spectrum, is focused on advancing important legislative priorities and regulatory initiatives to ensure consumers have access to quality and safe dietary supplements.
In the last 25 years, the dietary supplement industry grew from $4 billion with roughly 4,000 products to $50 billion with over 50,000 products. Due to the rapid growth of the space, both government and industry stakeholders are examining the Dietary Supplement Health and Education Act, which governs the U.S. supplement industry, to be sure that foundational law keeps up with the rapidly growing industry, the science underlying these products and the explosion of online marketing that didn’t even exist when the law was first enacted.
Government action typically lags behind industry advancement, but considering the 12.1% growth in the dietary supplements category in 2020, driven largely by COVID-19, the limited transparency provided by the current regulatory framework is especially worrisome. This market has seen increases in adulterated products marketed by bad actors. For instance, 965 of the products tested by the Food and Drug Administration from 2007 to 2019 were identified to include potentially hazardous substances or hidden ingredients. This level of adulteration poses significant risks for consumers and is at odds with the practices of industry’s responsible participants.
To better protect consumers and monitor the industry, we must increase transparency measures in the marketplace and clarify the regulatory confusion around the FDA’s ability to regulate products marketed as dietary supplements. DSQC will be looking for legislative clarity from Congress and implementation of regulatory tools by the FDA to achieve these goals — balancing continued access to dietary supplements with additional, effective safeguards.
For example, the FDA previously expressed interest in establishing a mandatory product listing for dietary supplements. This would require products marketed as dietary supplements to be listed in a registry accessible by the agency and the public, along with the product label and information about the manufacturer and/or distributor. Our multi-stakeholder and cross sector collaborative of public health champions believes that implementing a listing will enhance the FDA’s ability to capture trends, identify products containing dangerous ingredients and prioritize investigations of products and/or manufacturers that pose the highest risk to public health.
What’s more, creating a mandatory product listing is a win for both consumers and the dietary supplements industry. If enacted, consumers, pharmacists and retailers will all be able to access information about products and their ingredients, helping us determine which products are safe to consume, recommend or store on shelves.
Congress also should eliminate the loophole in the statutory definition of a dietary supplement to better protect consumers. FDA has opined that products marketed as dietary supplements that contain illegal and sometimes undeclared ingredients do not meet the statutory definition of a dietary supplement, even if they carry a “Supplement Facts” label. FDA said it believes these products fall outside of its jurisdiction for dietary supplements in a “no man’s land”— neither supplement nor drug. Clarifying the definition such that it covers all products marketed as dietary supplements will allow the FDA proper oversight and enforcement capabilities to investigate illegitimate products. If a product claims by its marketing and labeling to be a dietary supplement, FDA should be able to regulate it as a supplement.
As questions remain about the composition of upcoming healthcare legislation and how priorities will be balanced at the start of the Biden administration, it is clear there are tangible opportunities for Congress, the FDA, DSQC and stakeholders to modernize dietary supplement regulations to better protect consumers.