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Survey: Consumers support mandatory dietary supplement registration

Some groups in favor of a product listing requirement have argued it would help FDA more effectively target potentially dangerous supplements.

The majority of consumers support a requirement that manufacturers of dietary supplements provide FDA a list of their products and ingredients, according to a survey from The Pew Charitable Trusts, an independent nonprofit group.

In response to a question whether consumers support such a requirement, 79% “strongly” and 17% "somewhat" expressed support, Pew found. Only a small minority of respondents were opposed.

Pew’s results were based on a May 2019 survey of 1,000 respondents through an online panel by SSRS, an independent research company.

Pew’s findings suggested many consumers overestimate FDA’s authority over dietary supplements, with 29% believing manufacturers must prove safety to FDA, or FDA tests supplements for safety before they are sold (23%). Thirty-two percent of consumers agreed with the statement that “FDA can primarily take action only after a supplement is on the market and it is shown to be unsafe,” while 16% weren’t certain about FDA’s authority.

This month marks the 25th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

DSHEA generally does not require supplement manufacturers demonstrate to FDA the efficacy or safety of their products before selling them. But they must comply with cGMPs (current Good Manufacturing Practices), and dietary supplement manufacturing facilities are subject to audits by FDA. Also with some exceptions, manufacturers must notify FDA before placing a new dietary ingredient in their products, demonstrating a reasonable expectation of safety.

Among other findings, Pew’s survey revealed 1 in 8 adults (~12%) reported they or an immediate family member suffered a severe side effect, such as a heart or liver problem, from a supplement. The survey specifically asked respondents whether they or their immediate family members "ever experienced any serious side effects (such as increased heart rate, high blood pressure, kidney problems or liver damage)" from taking a supplement.

Supplement manufacturers must report to FDA serious adverse events associated with their products. FDA and experts caution an adverse event report (AER) has several limitations and does not prove a product caused an illness since a preexisting medical condition and other factors could be responsible.

Current law does not require supplement manufacturers register their products with FDA. However, facilities that manufacture food—dietary supplements are a subset of food—must register with FDA. Pew is among the groups that support a requirement that dietary supplement products are listed with FDA.

Some groups in favor of a product listing requirement have argued it would help FDA more effectively target potentially dangerous supplements or products disguised as supplements but tainted with undeclared pharmaceutical drugs.

“These findings illustrate the urgent need to improve FDA’s ability to ensure the safety of supplements,” Liz Richardson, who directs the health care products project for The Pew Charitable Trusts, wrote in an analysis on the survey’s results. “Only Congress can authorize mandatory product listing. Lawmakers should pass legislation soon that gives the agency crucial information to act quickly and effectively when public health risks arise.”

FDA has estimated as many as 80,000 supplement products are on the U.S. market. And in survey results released Monday, the Council for Responsible Nutrition (CRN) disclosed 77% of Americans report taking dietary supplements. That’s the highest usage to date in the CRN Consumer Survey on Dietary Supplements, which is in its 20th year.

CRN’s survey found vitamins and minerals continue to be the most popular supplement category, with 76% of Americans taking such products in the past 12 months. 

“While the industry continues to innovate, there is no denying that these regulated products have become mainstream,” said Nancy Weindruch, CRN’s vice president of communications, in a statement. “More than three quarters of Americans are taking dietary supplements each year—a crystal clear trend that serves as an indicator of the vital role supplementation plays in their overall health and wellness regimens.”

Similarly, Pew’s survey found a majority of respondents—roughly 7 in 10 adults—reported taking at least one supplement in the past two years.

 

TAGS: Regulatory
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