How were the FDA’s rules and regulations determined?
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.
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 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.
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 dietary supplement 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” 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.
- By law, the FDA does not pre-approve dietary supplements.
- The FDA treats dietary supplements as a subset of food products rather than drugs.
- Because supplements are not treated like drugs, they must follow specific dietary supplement regulations, including the types of allowable claims.