FDA takes on dietary supplements

Agency updates how it evaluates ingredients.

The 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 the 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.”

On Monday, for example, the FDA mailed 12 warning letters and five online advisory letters to companies selling products they 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,” Gottlieb said.

Three out of 4 American consumers take a dietary supplement regularly, and 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 has taken supplements himself.

Globally, supplements are a $128 billion-a-year business, according to the Nutrition Business Journal 2017 data. The largest chunk of that, 31.4 percent, is in the USA.

The FDA acknowledged that most manufacturers are legitimate, but it said the problem is the ones not above-board that sell dangerous supplements, such as those spiked with drug ingredients that are not declared on their labels or that make misleading claims.

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.”