Industries rarely seek out more regulation. But in recent years, a growing number of people in the dietary supplements sector have asked for amendments that would update arguably the most important piece of legislation: the Dietary Supplement Education Act of 1994 (DSHEA). Regulations, many argue, have not kept pace with the pace of the market.
The history of dietary supplement regulations
When Congress passed this act more than 26 years ago, the industry began to break into the mainstream with $4 billion in annual sales of some 4,000 product offerings. In 2020 alone, analysts say between 50,000 and 80,000 different nutritional supplements were on the market, generating more than $170 billion for the year. Since then the dietary supplement industry has continued to grow. By 2032, experts project the annual value of this market will exceed $350 billion.
The pandemic drove countless consumers to dietary supplements to boost their immune systems and protect their health. But the forecast ahead is mixed. Regulators have focused their attention on the supplements industry in recent years. And as Democrats control the White House and House of Representatives, industry insiders expect a heavier hand in regulations in the years ahead.
What most industry insiders anticipate is a sweeping overhaul of DSHEA, but experts differ on what that might—or should—entail. We’ve put together a list of the top five things the dietary supplements industry should expect from DSHEA 2.0. Download our ebook now to make sure your team can prepare.
A Sneak Preview: 1 Thing to Expect from DSHEA 2.0
A Mandatory Product Registry
The FDA has put a mandatory product registry in its annual budget request for each of the last two years. According to that request, “This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency and promote risk-based regulation.”
Building on CRN’s OWL Database
Although a mandatory product registry has long been the third rail of regulation on nutritional supplements, the industry already has a voluntary, self-regulated database, the Supplement Online Wellness Library (OWL), launched by the Council for Responsible Nutrition (CRN) in 2017 and updated in 2021. The Supplement OWL “serves as a resource for consumers, businesses, and regulators to identify products, their ingredients, and the companies who market them, and permit registry users to examine and evaluate labels and other product information.”
“Other enhancements include multi-factor authentication for participants to add more security for participating companies; a multi-version component to help companies efficiently enter product information for multiple versions of the same product in circulation; and a supplier feature for brand owners to designate their contract manufacturers as a business user with administrative capabilities on their behalf,” according to CRN.
Learn more from this resource
Including the latest developments affecting the dietary supplements industry, such as:
- What President Biden’s COVID task force means for the supplements industry.
- How a mandatory product registry can transform the business.
- What regulators plan to do about adverse event reporting.
- How a better-funded FDA can strengthen enforcement.
- How TraceGains helps facilitate DSHEA compliance.