October 25, 2021 marks the 27th anniversary of the Dietary Supplement Health and Education Act (DSHEA) being signed into law, establishing a regulatory framework for dietary supplements where no such system existed before.
To mark this achievement, CHPA is taking a look back at the history of dietary supplements, and the work that went into creating the landmark law.
Pre-DSHEA
Prior to DSHEA, there were decades of legislative debate around the regulation of dietary supplements – or “foods for special dietary uses,” as they were known as back then – that started as early as the 1930s and lasted until passage. The first defining regulatory milestone came in 1938, with the passage of the Food, Drug, and Cosmetic Act to better define food safety, and again in 1968 as regulations started to focus on health risk issues. After the industry exploded in growth through the late 1970s and 1980s, initial discussions began around creating a specific regulatory system for dietary supplements to ensure proper guardrails were in place for this burgeoning industry. But the FDA strongly advocated for dietary supplements to be regulated as food additives, leading to industry backlash and significant constituent interest and advocacy.
In a CHPA Chat podcast episode titled, The History of DSHEA and Its Founding Mothers and Fathers, Loren Israelsen, Founder and President of the United Natural Products Alliance (UNPA) says of the criticism aimed at tighter regulation, “It became one of the greatest populist movements as it relates to legislation that we have seen in modern times.”
Much of this constituent and industry interest was driven by what was seen as an overly restrictive approach by FDA to supplements other than vitamins and minerals.
The Birth of DSHEA
Senator Orrin Hatch, R-Utah, a health enthusiast, became the champion of dietary supplement issues when he led the effort to develop DSHEA legislation. Despite initial opposition across Congress, Senator Hatch worked with other key Senators to draft the bill and solicit co-sponsors until the bill was supported by the majority of both the Senate and the HELP Committee. After years of work to gain immense support, the bill passed by a voice vote in the House and in the Senate in 1994.
“It shocked a whole lot of people. It validated a deeply held belief in millions of Americans that they have a fundamental right to access natural health products,” reflected Israelsen.
DSHEA changed the very nature of the dietary supplements industry over time as an increasing number of companies have transitioned from private, to public, to venture capital. DSHEA also provided clarity for certain classes of dietary ingredients that previously had no protection, such as botanicals, amino acids, and fish oils, - categories that have experienced significant growth since its passage. No doubt, DSHEA changed the trajectory of the dietary supplements category in America.
Looking ahead
Twenty-seven years later, the landscape for the dietary supplements industry has changed drastically, but have the regulations kept up? There are now an estimated 50,000 to 80,000 dietary supplement products on the market, with demand continuing to grow as consumers take control of their healthcare routines.
Today, CHPA is advocating for a modernized dietary supplement regulatory structure to protect public health and reinforce the credibility of the category, ensuring consumers have access to safe, high quality supplements that can play a role in maintaining a healthy lifestyle.
For more information about the history of DSHEA, be sure to listen to the CHPA Chat podcast episode, The History of DSHEA and Its Founding Mothers and Fathers.
