Sometimes on dietary 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 how are supplements regulated in the United States? 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 does not give pre-approval for every industry that it oversees. More on that in a minute.

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 the types of claims supplement companies can make about their products.

The FDA takes a close look at product labels and labeling requirements, including websites. This ensures that products are correctly labeled and they don’t make any health claims that could classify them as drugs (such as promising to treat, diagnose, cure, or prevent diseases). (2)

When you glance at the side panel of any dietary supplements, you'll find an important section labeled "Supplement Facts." Here, supplement companies transparently share key details like serving size, dietary ingredients, and amounts per serving.

It's also important to note that according to FDA regulations, all dietary ingredients should be listed on the product. Just below the "Supplement Facts" label, you'll discover additional information on ingredients such as flavors, colors, and sweeteners.

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 an ingredient 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 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 Dietary 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 and safety 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 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.

How to Be an Informed Consumer

Being an informed consumer is key, given the limited oversight from the FDA in this industry. In light of this, it’s important for consumers to take an active role in understanding and evaluating the quality of supplements they choose to incorporate into their routines.

At Ritual, we're obsessed with quality and adhere to a strict quality control process to ensure the high quality we promise to our customers for all of our products. We aim to make the unaccountable world of dietary supplements, accountable. We try to take the heavy lifting off our customer’s shoulders but we also believe you should be aware of what you’re putting into your body. Here’s our advice:

1. Do Your Research

It's important to do thorough research, read credible sources of information and look for scientific studies and reviews about the dietary supplement you're interested in. ICYMI: Every product at Ritual is grounded in science and research. Here’s the proof: our gold standard clinical study for Essential for Women 18+ Multivitamin has been published in Frontiers in Nutrition for—a leading, internationally recognized, peer-reviewed journal. Being published is the final step to ensuring quality research, and often the most difficult one to achieve.

2. Always Read the Label

Read the label and follow the recommended dosage instructions. Be cautious of any extravagant claims or promises made by the supplement company.

3. Check For Third-Party Testing and Certifications

Checking for third-party testing and certifications can help ensure the quality and safety of a dietary supplement. At Ritual, we conduct safety and quality testing at multiple stages of our product’s journey, and go after some of the most rigorous certification standards available—so you can feel confident about the Ritual you incorporate into your daily routine.

4. Consult With a Healthcare Professional

If you have any concerns, consult with a healthcare professional, such as a doctor or registered dietitian before starting any new dietary supplement routine. They can provide personalized advice based on individual health needs and goals.

References:

1. “Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress.” Nih.gov, 2017.

2. U.S. Food and Drug Administration. “FDA 101: Dietary Supplements.” U.S. Food and Drug Administration, 2 June 2022.

3. Research, Center for Drug Evaluation and. “FDA’s Regulation of Dietary Supplements with Dr. Cara Welch.” FDA, 13 Dec. 2023. Accessed 10 Jan. 2024.