Most Supplement Users Back Enhanced FDA Oversight of These Products

Survey finds 1 in 8 adults say they or a family member have experienced serious side effects

Most Supplement Users Back Enhanced FDA Oversight of These Products

A new survey finds that most American adults believe the Food and Drug Administration (FDA) should do more to ensure the safety of supplements, whose ingredients range from vitamins and plant extracts to probiotics, hormones, and amino acids.

These products, marketed for uses such as improved nutrition, weight loss, and athletic and sexual performance, remain popular: About 7 in 10 adults said they had taken at least one in the past two years. However, after being informed that the FDA does not know specifically what products are on the market, 9 in 10 said they favored requiring that manufacturers inform the agency of all supplements they make and their ingredients.

Currently, the FDA lacks the means to create such a mandatory product listing or obtain such basic details under the law governing regulation of these products, the Dietary Supplement Health and Education Act. The law, which turns 25 this October, generally limits the agency’s ability to act on safety concerns to after a supplement goes on the market—a fact just 1 in 3 knew in the nationally representative survey of 1,000 adults conducted for The Pew Charitable Trusts in May 2019.

Nearly all respondents agreed that the FDA should be responsible for the safety of supplements. But about half overestimated the agency’s authority and thought that manufacturers must either prove a product’s safety to the FDA (29 percent) or that the agency tests supplements for safety before they are sold (23 percent).

The idea of a product listing requirement earned high levels of support, regardless of respondents’ supplement use or views of government regulation. (See Table 1.)

Table 1: Strong Support for Mandatory Supplement Product Listing With FDA

Even those skeptical of government regulation back such a requirement

  Support Oppose
  Strongly Somewhat Total Strongly Somewhat Total
All  79% 17% 95% 2% 3% 5%
Among those who have used supplements 79% 17% 95% 2% 3% 5%
Among those who say most government regulations are ...

Necessary and protect consumers

84% 14% 98% 0% 2% 2%

Unnecessary and harm the economy

63% 25% 87% 6% 7% 13%

Note: Respondents were asked how much they support or oppose this statement: “In order for the FDA to know what supplement products are on the market, manufacturers should be required to give the agency a list of the products they make and their ingredients.” Totals may not equal 100 percent because of rounding.

As many as 80,000 different supplements are sold in the U.S. Ensuring that the FDA has basic information about them would help the agency identify potentially dangerous products and better protect consumers. For instance, if the FDA learned of risks tied to a certain ingredient, it could easily pinpoint other products with the same component and take steps to alert manufacturers and the public.

A growing number of policy leaders have expressed interest in mandatory product listing and its benefits. In February, then-FDA Commissioner Scott Gottlieb said product listing data could complement the agency’s efforts to develop a more modern and efficient oversight system, and President Donald Trump’s fiscal year 2020 budget request included support for supplement listing legislation.

Adverse experiences span supplement types

More than 15,000 health problems linked to supplements were reported to the FDA between 2004 and 2013, but the survey findings suggest that many more negative reactions may have occurred. About 1 in 8 adults—12 percent—said they or an immediate family member had experienced a severe side effect, such as a heart, kidney, or liver problem, from a supplement.

Table 2: Health Problems Associated With All Supplement Categories

Share of adults who said they or a family member had experienced a serious side effect

Experience resulted from taking a supplement for:

Weight loss

7%

Diet

5%

Exercise or athletic performance

4%

Sexual performance

2%
Net percentage with experiences from 1 or more product categories 12%

Note: Respondents were asked: “Have you or has anyone in your immediate family ever experienced any serious side effects (such as increased heart rate, high blood pressure, kidney problems, or liver damage) as a result of taking any _____ supplements?” Respondents could report side effects from more than one type of supplement.

Respondents expressed notable differences in their opinions on the safety of supplements across the four product categories described. Seventy-four percent considered supplements marketed to enhance weight loss as “not too” or “not at all” safe, while 60 percent said the same about those intended to boost sexual performance. Perceptions were more mixed for exercise or athletic performance products, with 58 percent considering them “extremely” or “pretty” safe and 43 percent viewing them as “not too” or “not at all” safe. (The total exceeds 100 percent because of rounding.)

The fourth category of supplements—those for dietary benefits—encompassed vitamins, minerals, herbs or other botanicals, and substances such as fish oil and melatonin. Overall, 85 percent of respondents viewed these products as “extremely” or “pretty” safe; these were also the most widely used type. Still, 1 in 20 said that they or an immediate family member had experienced serious side effects from such a supplement.

These findings illustrate the urgent need to improve FDA’s ability to ensure the safety of supplements. 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.

The survey was conducted for Pew via an online probability panel by SSRS, an independent research company. Interviews were conducted May 17-29, 2019, among a sample of 1,000 total respondents. The margin of error for the total sample is +/-4.6 percentage points at the 95 percent confidence level, including the design effect.

Liz Richardson directs The Pew Charitable Trusts’ health care products project.

Pills
Pills
Take Action
Urge Congress to protect consumers from harmful dietary supplements
Sign Now
Pills in hand
Pills in hand
Article

FDA Lacks Ability to Effectively Safeguard Public From Risky Supplements

Quick View
Article

FDA Lacks Ability to Effectively Safeguard Public From Risky Supplements

The Food and Drug Administration cautioned consumers in January to avoid a product called GoLean Detox. The agency’s laboratory analysis showed that the product contained ingredients from two potentially dangerous drugs, even though it was advertised as an all-natural herbal supplement to help with weight loss.