Typically most dietary supplement websites you come across will include 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.
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 does not give pre-approval for every industry that it oversees.
The FDA and supplements?
In the dietary supplement industry, the FDA acts as an enforcement and regulatory agency. This includes defining and enforcing the types of claims supplement companies can make 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 does the FDA’s decide on rules and regulations?
Up until the late 1930s, the food and drug industry was relatively 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 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, follow other regulations. 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.
How do drugs and supplements differ?
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 pre-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 has regulations for manufacturing and labeling, dietary 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.
Does the FDA approve supplements?
No. The FDA does not “approve” dietary 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 complying with all regulations. If a supplement company does not comply with FDA regulations, the FDA can ban them from selling their product.