Dietary Supplements: Do Consumers Know the Risks?

Many consumers do not know that the dietary supplements they buy are, by law, not approved by the U.S. Food and Drug Administration (FDA) for safety before they reach the marketplace. To help educate the public about supplements, their potential risks, and how to report adverse side effects, FDA contracted with Westat to conduct 32 focus groups in 2020 and 2021. One of the objectives of the focus groups was for FDA to learn more about consumers’ beliefs and behaviors around dietary supplements. The findings by Westat’s moderators, Cynthia Robins, Ph.D., a Senior Study Director, and Willow Burns, M.A., a Qualitative Researcher/Study Manager, informed the development of education materials for FDA’s Supplement Your Knowledge: Dietary Supplement Education Initiative.

“There are a lot of reasons people take dietary supplements,” says Ms. Burns. “People take them because their iron or calcium levels are low, for example. Then there are people who take them because they don’t think they are getting enough vitamins or minerals through their diet. And then there are people who are trying to hedge their bets—they see dietary supplements as safe and take them for general wellness. This third group was interesting.” “When we asked participants what evidence they had that their supplements were actually working,” notes Dr. Robins, “many said that while they had no proof of efficacy, they believed in them and preferred taking a natural supplement over prescription drugs.”

“Many people think there’s little downside to taking dietary supplements,” says Ms. Burns. “They see them as having the potential for long-term benefits with little risk.” Part of the educational component was to let people know that there can be severe health risks from taking supplements, and FDA can only take action if consumers report problems with the supplements.

“It was concerning that few participants knew they could report adverse side effects to FDA—which includes calling in and reporting through FDA’s safety reporting portal,” says Dr. Robins. “Adverse event/side effect reports to the FDA are one source of information that can help FDA take action on supplements.” In June 2022, Westat began conducting cognitive and usability testing of a redesign of the FDA portal and interface to make it easier for consumers to file a report. Ms. Burns is one of the cognitive interviewers on the project, which is being led by Bethany Tennant, Ph.D., a Westat Senior Study Director.

Were there challenges the moderators faced when the pandemic hit? “We had to quickly pivot from conducting the focus groups in person to conducting them online. This was a steep learning curve,” says Dr. Robins. Ms. Burns concurs: “It should be expected that there will be challenges when something is new to everyone. You won’t get it all right the first time. But we worked well with the client to make adjustments, and those lessons learned are carrying through into our current focus group work with FDA.”

In August 2022, Westat will be conducting in-depth interviews with consumers about labels on dietary supplements. “There are regulations about the health claims dietary supplements can make. For example, they cannot claim to diagnose, treat, cure, or prevent a medical condition—only drugs can make this claim,” says Dr. Robins. The interviews, which will be conducted by Ms. Burns and Westat’s Seth Messinger, Ph.D., a Senior Study Director, will explore how consumers interpret the wording on supplement labels.

These are just some of the many projects Westat is conducting to support FDA to meet its mission to protect the public’s health by providing accurate, science-based information, informing policymakers with data so that they can develop the best strategies to enhance the safety of food products.

For more information on the regulations:

• Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Congress
• CFR – Code of Federal Regulations Title 21