Published 11:10 AM EST Feb 11, 2019
The U.S. Food and Drug Administration is cracking down on the dietary supplements industry to protect the consumers who use these products.
The FDA announced Monday that its overhaul includes new ways to inform the public quicker when there's concern about an illegal and potentially dangerous ingredient, updating how it evaluates new dietary ingredients coming on the market and creating new enforcement strategies.
FDA Commissioner Scott Gottlieb called this effort to take on the business, which includes vitamins, minerals and herbs, "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years."
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On Monday, for example, the FDA mailed 12 warning letters and five online advisory letters to companies selling products they illegally claim prevent, treat or cure Alzheimer’s disease, diabetes and cancer.
"Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions," he said.
Three out of 4 American consumers take a dietary supplement regularly, though that jumps to 4 out of 5 when it comes to older consumers, according to the FDA. For children, the rate is 1 out of 3.
"What was once a $4-billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers," said Gottlieb, who added that he's taken supplements himself.
Globally, supplements are a $128-billion business, according to the Nutrition Business Journal 2017 data. The largest chunk of that, 31.4 percent, is in the U.S.
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The FDA acknowledged that most manufacturers are legitimate, but the problem is the ones not above-board that sell dangerous supplements, like those that are spiked with drug ingredients not declared on their labels or that make misleading claims.
"I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks," Gottlieb said.
Sandra Eskin, food safety project director for the Pew Charitable Trusts, applauded the FDA's plan, but pointed out that it's only the beginning of what needs to be done.
"This is a great first step to improving the safety of dietary supplements," she said. "In recent years, there’s been an explosion of products with risky ingredients and we think it's absolutely critical that the agency address this problem."
The federal Dietary Supplement Health and Education Act, which regulates the manufacture and labeling of dietary supplements, became law in 1994. The FDA created the Office of Dietary Supplement Programs three years ago.
Follow USA TODAY reporter Zlati Meyer on Twitter: @ZlatiMeyer