Katherine O’Malley

Associate Editor

Loyola University Chicago School of Law, 2025

 

How safe are dietary supplements such as your average vitamin pill or gummy? Are they tested like a new drug before they hit the market? Or even tested for effectiveness? We do not know how safe or effective dietary supplements are because regulators like the Food and Drug Administration (FDA) do not test them for either safety or effectiveness.

The FDA treats dietary supplements like food, and the Dietary Supplement Health and Education Act of 1994 (DSHEA) spells out the FDA’s regulatory authority… more like lack thereof. The FDA acknowledges that they do not have the authority to test the safety or effectiveness of dietary supplements. Nor do they have the authority to check the labels before they are sold to the public. And yet, they define dietary supplements as:

“Dietary supplements are intended to add to or supplement the diet and differ from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.”

Why aren’t supplements regulated like drugs, especially when supplements come with many health risks if combined with FDA-approved drugs? Why are supplements treated as a subcategory of food when they come with so many health risks? The FDA has stringent regulations for drugs to ensure that consumers are protected from any adverse health effects, and doctors are given training to advise which medicines can be taken together and which cannot. But the same is not true for supplements. The FDA only has the authority to remove supplements from the market after they have caused enough damage to people’s health, but not before they reach the consumer. The FDA can also simply warn consumers of risks.

Health Risks

Supplements are subject to two standards of safety – a “reasonable expectation of safety” for the “active” ingredients and the higher food standard of a “reasonable certainty” for the inactive ingredients. However, this is not tested by the FDA but rather only guidelines for the producers of dietary supplements.

Despite the intended purpose of supplements to simply add to people's diets, the reality is that producers can place anything in a capsule and label it “mood booster.” This results in hundreds of households obtaining what appears to be a harmless supplement, which may be consumed by anyone, including children, without undergoing any safety or effectiveness testing by a third party. The FDA would respond to this criticism by saying they ensure that producers of dietary supplements follow Good Manufacturing Practices (GMPs) to help ensure the identity, purity, strength, and composition of their dietary supplements. But, in reality, they do not enforce the GMP and rarely check manufacturing facilities to see if these producers have been following the GMP. One study suggests that weak regulations and a boom in social media marketing allow counterfeit drugs and hidden ingredients to slip into these supplements and into the hands of many consumers.

The FDA and FTC’s Shortcomings

Since the enactment of DSHEA in 1994, there has been a rise in the use of new ingredients in supplements, thanks to advancements in science. So, the FDA released an ingredient list directory in March 2023 to help consumers protect themselves from any adverse interactions with their current medicine. The FDA explains that the purpose of this directory is so that the millions of Americans who take supplements can look up every ingredient in every supplement they purchase and ensure they are not putting themselves at risk. This puts the responsibility of protecting the consumer back on to the consumer themselves. Placing the responsibility on the consumer is not only counterintuitive to the FDA’s mission but goes against the fundamental principle of safeguarding public health.

The Federal Trade Commission attempts to govern supplements and the drastic claims the producers try to advertise. In December, the FTC revised its guidelines, but experts say the change will not help because there is no enforcement. Although critics are concerned about an overall lack of oversight, the FTC took action against a supplement brand. However, the FTC’s action against them was not due to faulty supplements but rather for hijacking reviews on Amazon in a deceptive way to make more sales of certain supplements.

As consumers navigate a market flooded with hundreds of different supplements, the onus of ensuring safety and efficacy should not solely rest on their shoulders. Regulatory bodies such as the FTC and FDA must reevaluate and strengthen these limitations in oversight, especially with the increase in social media marketing, in order to uphold their commitment to public safety and well-being.

Katherine O’Malley

Associate Editor

Loyola University Chicago School of Law, 2025

 

How safe are dietary supplements such as your average vitamin pill or gummy? Are they tested like a new drug before they hit the market? Or even tested for effectiveness? We do not know how safe or effective dietary supplements are because regulators like the Food and Drug Administration (FDA) do not test them for either safety or effectiveness.

The FDA treats dietary supplements like food, and the Dietary Supplement Health and Education Act of 1994 (DSHEA) spells out the FDA’s regulatory authority… more like lack thereof. The FDA acknowledges that they do not have the authority to test the safety or effectiveness of dietary supplements. Nor do they have the authority to check the labels before they are sold to the public. And yet, they define dietary supplements as:

“Dietary supplements are intended to add to or supplement the diet and differ from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.”

Why aren’t supplements regulated like drugs, especially when supplements come with many health risks if combined with FDA-approved drugs? Why are supplements treated as a subcategory of food when they come with so many health risks? The FDA has stringent regulations for drugs to ensure that consumers are protected from any adverse health effects, and doctors are given training to advise which medicines can be taken together and which cannot. But the same is not true for supplements. The FDA only has the authority to remove supplements from the market after they have caused enough damage to people’s health, but not before they reach the consumer. The FDA can also simply warn consumers of risks.

Health Risks

Supplements are subject to two standards of safety – a “reasonable expectation of safety” for the “active” ingredients and the higher food standard of a “reasonable certainty” for the inactive ingredients. However, this is not tested by the FDA but rather only guidelines for the producers of dietary supplements.

Despite the intended purpose of supplements to simply add to people's diets, the reality is that producers can place anything in a capsule and label it “mood booster.” This results in hundreds of households obtaining what appears to be a harmless supplement, which may be consumed by anyone, including children, without undergoing any safety or effectiveness testing by a third party. The FDA would respond to this criticism by saying they ensure that producers of dietary supplements follow Good Manufacturing Practices (GMPs) to help ensure the identity, purity, strength, and composition of their dietary supplements. But, in reality, they do not enforce the GMP and rarely check manufacturing facilities to see if these producers have been following the GMP. One study suggests that weak regulations and a boom in social media marketing allow counterfeit drugs and hidden ingredients to slip into these supplements and into the hands of many consumers.

The FDA and FTC’s Shortcomings

Since the enactment of DSHEA in 1994, there has been a rise in the use of new ingredients in supplements, thanks to advancements in science. So, the FDA released an ingredient list directory in March 2023 to help consumers protect themselves from any adverse interactions with their current medicine. The FDA explains that the purpose of this directory is so that the millions of Americans who take supplements can look up every ingredient in every supplement they purchase and ensure they are not putting themselves at risk. This puts the responsibility of protecting the consumer back on to the consumer themselves. Placing the responsibility on the consumer is not only counterintuitive to the FDA’s mission but goes against the fundamental principle of safeguarding public health.

The Federal Trade Commission attempts to govern supplements and the drastic claims the producers try to advertise. In December, the FTC revised its guidelines, but experts say the change will not help because there is no enforcement. Although critics are concerned about an overall lack of oversight, the FTC took action against a supplement brand. However, the FTC’s action against them was not due to faulty supplements but rather for hijacking reviews on Amazon in a deceptive way to make more sales of certain supplements.

As consumers navigate a market flooded with hundreds of different supplements, the onus of ensuring safety and efficacy should not solely rest on their shoulders. Regulatory bodies such as the FTC and FDA must reevaluate and strengthen these limitations in oversight, especially with the increase in social media marketing, in order to uphold their commitment to public safety and well-being.