Regulatory Deep Dive: What makes a product a drug?

The FDA oversees more than $2.8 trillion in consumption of food, medical products, and tobacco. A crucial part of this is determining what makes a product a drug, a classification based not on its form but its intended purpose and the claims made by its manufacturer.

Quick Summary

A product becomes a drug based on its intended use. If it's marketed with claims to diagnose, cure, mitigate, treat, or prevent a disease, or to affect the body's structure or function, the FDA classifies it as a drug.

Key Points

• Intended Use is Key: A product is legally defined as a drug based on its manufacturer's intended use, not just its ingredients.

• Disease Claims Define Drugs: If a product claims to diagnose, cure, treat, or prevent a disease, it is regulated as a drug.

• Structure/Function Claims: Dietary supplements can make claims about affecting the body's normal structure or function, but not about treating disease.

• API is the Active Component: The Active Pharmaceutical Ingredient (API) is the substance in a drug that produces the desired biological effect.

• Strict Pre-Market Approval: Unlike cosmetics or dietary supplements, drugs must undergo rigorous FDA pre-market approval to prove safety and effectiveness.

• Evidence of Intent is Broad: The FDA considers labeling, advertising, websites, and even consumer perception to determine a product's intended use.

• Dual-Status Products Exist: Some products, like anti-dandruff shampoo or fluoride toothpaste, are regulated as both a cosmetic and a drug.

The Defining Factor: A Product's Intended Use

Under U.S. law, a product is regulated as a drug primarily based on its "intended use". The Federal Food, Drug, and Cosmetic (FD&C) Act defines drugs as items meant "for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" or those "intended to affect the structure or any function of the body". The FDA determines this intent through various forms of evidence, including explicit and implicit claims made on labeling and in marketing materials, as well as consumer perception and the presence of known therapeutic ingredients.

A product making disease claims, which suggest it can diagnose, cure, treat, or prevent a disease, is regulated as a drug. In contrast, structure/function claims, which describe the role of a substance in maintaining normal body function, are permissible for dietary supplements if they don't mention a specific disease.

The Role of the Active Pharmaceutical Ingredient (API)

The Active Pharmaceutical Ingredient (API) is the core component of a drug responsible for its therapeutic effect. While intended use determines the regulatory classification, the API is what provides the pharmacological action. The remaining components, called excipients, aid in delivery and stability.

Comparison: Drugs vs. Other Regulated Products

Distinguishing drugs from other FDA-regulated products like cosmetics, dietary supplements, and medical devices can be challenging, especially when products have multiple functions. The key differentiator is the intended use and the types of claims made.

Feature	Drug	Cosmetic	Dietary Supplement	Medical Device
Primary Purpose	To diagnose, cure, mitigate, treat, or prevent disease, or affect the body's structure/function.	To cleanse, beautify, promote attractiveness, or alter appearance.	To supplement the diet by providing nutrients like vitamins, minerals, or herbs.	To diagnose, treat, or prevent disease without achieving its effect through chemical action within the body.
Regulation	Requires pre-market approval through a New Drug Application (NDA) or must conform to an OTC monograph.	No pre-market approval required (except for color additives).	No pre-market approval required; manufacturer is responsible for ensuring safety.	Requires pre-market clearance or approval based on its risk classification.
Claims	Can make disease claims.	Limited to appearance-related claims.	Limited to structure/function claims; must carry a disclaimer that it's not intended to treat disease.	Can make medical claims related to its function.
Example	Aspirin, prescription blood pressure medication, fluoride toothpaste.	Lipstick, skin lotion, shampoo.	Vitamin C tablets, protein powder.	Pacemakers, tongue depressors, diagnostic imaging equipment.

The Regulatory Pathway: How a Product Becomes an Approved Drug

Products classified as drugs must obtain FDA approval before being marketed in the U.S. This is typically done through a New Drug Application (NDA), which requires extensive testing to prove safety and effectiveness, often taking many years. Alternatively, for certain established ingredients, an Over-the-Counter (OTC) monograph may exist, outlining acceptable standards and allowing products conforming to it to be marketed without individual pre-market approval.

Conclusion

Determining what makes a product a drug hinges on its intended use as conveyed through marketing and labeling. Any product marketed with claims to treat a disease or alter bodily function is subject to stringent FDA drug regulations to ensure its safety and effectiveness. For further details on product classification, the FDA offers resources such as their page on Is It a Cosmetic, a Drug, or Both?.

Frequently Asked Questions

Who decides if a product is a drug?

The U.S. Food and Drug Administration (FDA) determines if a product is a drug based on its intended use, which is established by the claims and context provided by the manufacturer or distributor.

Can a vitamin or herbal product be considered a drug?

Yes. If a vitamin or herbal product is marketed with claims to treat, prevent, or cure a specific disease, the FDA will regulate it as a drug. If it is marketed to supplement the diet with structure/function claims, it is regulated as a dietary supplement.

What is the difference between a cosmetic and a drug?

A cosmetic is intended to cleanse, beautify, or alter appearance (e.g., lipstick, lotion). A drug is intended to diagnose, cure, treat, prevent disease, or affect the body's structure or function (e.g., aspirin). The classification depends on the product's intended use and claims.

What is an 'intended use' claim?

An 'intended use' claim is any statement made by a manufacturer on labeling, advertising, or online that describes the purpose of their product. These claims are the primary evidence the FDA uses to classify a product.

What is the difference between a medical device and a drug?

Both can be used to treat disease, but a key difference is how they work. A drug typically achieves its purpose through chemical action within or on the body, while a medical device does not.

Does the FDA approve dietary supplements?

No, the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. The manufacturer is responsible for ensuring the product is safe and that any claims are not misleading.

What is a 'cosmeceutical'?

The term 'cosmeceutical' has no legal meaning under the law. A product can be a drug, a cosmetic, or both, but this term is often used in marketing to suggest a product has medicinal properties beyond a standard cosmetic.