Former U.S. Sen. Orrin Hatch (R-Utah) said a concept proposed by FDA—that products marketed as dietary supplements be listed with the agency—“makes sense” to him.
“If this industry wants to be regarded as the mainstream regulated industry that it is, it seems logical” FDA should be aware of the dietary supplements on the market, Hatch said Tuesday during a podcast interview with Natural Products INSIDER.
In its fiscal year (FY) 2020 budget request to Congress, FDA reported it didn’t have clear authority under the law to require a listing of dietary supplement products on the market. An estimated 50,000 to 80,000 products are on the market, according to FDA.
A proposal submitted to Congress by FDA would mandate “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, and improve transparency and promote risk-based regulation,” the agency explained in its budget document.
Sources in the dietary supplement industry are divided on the pros and cons of a mandatory product registry.
Hatch—who joined the Senate in 1977 and retired in January 2019—said many companies are accustomated to such a product listing system based on requirements in other countries. But the former senator suggested any requirement adopted by Congress must be “fair” and not overly burdensome “with too much reporting of information that FDA does not have the resources to use.”
“In other words, we should not regulate the dietary supplement industry into the ground,” Hatch said, “which some people will try to do, acting like they’re the sole protectors of our health … in this country.”
DSHEA ‘has withstood the test of time’
Hatch was one of the principal authors and champions of the Dietary Supplement Health and Education Act of 1994 (DSHEA). He served in Congress for more than 40 years.
Hatch suggested DSHEA—a 25-year-old law—does not require a significant overhaul.
“I’m pleased that the law has withstood the test of time and that, by and large, there have not been many real problems,” he said.
He added, “There may be issues for clarification, such as when is a dietary ingredient ‘old’ and when it is a new dietary ingredient.”
But he acknowledged different factions are viewing the current time as an opportunity to reform the law, including “some in the anti-supplement ranks.”
Hatch concluded the law has been a success. He cited, for example, the benefits to the economy and tremendous growth in annual revenues since passage of DSHEA. In 2018, U.S. sales of supplements generated an estimated $45.8 billion, reflecting 5.7 percent growth over the previous year, according to Nutrition Business Journal. In 1994, Hatch and his colleagues in Congress estimated annual sales of just $4 billion.
“Most people have become accustomed to taking dietary supplements and feeling really good about it,” said Hatch, who referenced figures from a 2016 survey that more than 170 million Americans take supplements. “And there’s justification for their feelings because the dietary supplement companies are very sophisticated today and they do a terrific job. And it’s not to say there aren’t some people who should not be in the business, but we can weed those out.”