Sometimes on vitamin or supplement websites you’ll see the disclaimer:
“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” To the untrained eye, this statement might look a little suspect. But it’s actually perfectly normal and required by the FDA in certain instances. So what exactly is the FDA’s role in the supplement industry, and what do those two little sentences even mean? Let’s dive in.
First things first: what is the FDA?
The FDA or the U.S. Food and Drug Administration is a federal agency responsible for regulating products that impact public health, such as food products, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. The FDA plays an important part in ensuring the safety of the products we use every day, but is not a source of approval for every industry that it oversees. More on that later.
What does the FDA have to do with supplements?
In the dietary supplement industry, the FDA acts as an enforcement and regulatory agency. This includes defining and enforcing what supplement companies can claim about their products.
To ensure public safety, the FDA has defined Good Manufacturing Practices (GMPs) that it enforces through inspections, and has the authority to prosecute, seize and remove dangerous products from the marketplace. The FDA can also determine if a product is Generally Recognized As Safe (GRAS) after reviewing evidence.
How were the FDA’s rules and regulations determined?
Up until the late 1930s, the food and drug industry was widely unregulated, except for a piece of legislation from 1906 that prohibited misbranded and adulterated food and drugs.
In the early part of the 20th century, many people died from using consumer products that were not safe for human consumption–sparking public outrage and political pressure. In 1937, the issue reached a fever point when an untested medicine killed hundreds of patients, including many children, shortly after its release onto the market. In response, congress passed the Food, Drug, and Cosmetic Act in 1938.
Under the rules of the FD&C Act, foods are treated separately from drugs. Drugs, which are defined as products used for medical purposes, come under stricter regulation. Foods, defined as products used for nutritional purposes, have fewer restrictions. This line in the sand–medical (drug) vs. nutritional (food)–is important because under the FD&C Act, vitamins and other supplements are treated as a subset of food products rather than drug products.
What’s the difference between a drug and a supplement?
According to the FDA, drugs are for treating, preventing, mitigating, diagnosing or curing diseases. Drugs are heavily regulated. Clinical trials on human subjects must show that a pharmaceutical drug is safe and effective for its intended use. Then, the drug must be manufactured under controlled conditions and packaged to meet strict labeling standards before it’s approved by the FDA for consumer use.
Unlike drugs, the FDA says that supplements are for nutritional purposes only. Because supplements are not considered drugs, they are not monitored in the same way. While the FDA does have some regulations for manufacturing and labeling, nutritional supplements have different guidelines for testing, safety, and efficacy than pharmaceutical drugs. Unlike drugs, supplements do not require pre-approval by the FDA before they are released for sale to the consumer.
How does this affect what supplements are allowed to claim?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined the role of supplements and outlined what vitamin companies can legally say about their products. The act dictates that because supplements are not drugs, supplement companies cannot imply, insinuate or state that their product diagnoses, treats, cures, or prevents disease of any kind.
The FDA has further interpreted some normal conditions as disease precursors or markers. This is why you may see some vague wording about what a supplement does–it’s done to comply with FDA’s guidelines on approved dietary supplement claims.
The disclaimer shown above is mandatory for dietary supplements if they make any claims about affecting the structure and/or function of the human body – and the FDA enforces claims to make sure they are following approved guidelines for dietary supplement allowable claims.
Are any supplements approved by the FDA?
No. The FDA does not “approve” nutritional supplements because it does not approve foods. The FDA only approves pharmaceutical drug products.
The FDA does monitor supplement manufacturing and labeling, and regularly inspects companies to ensure that they are meeting regulations. If a supplement company does not comply with FDA regulations, the FDA can ban them from selling their product within the U.S.