How Cosmetics can be Considered Drugs by the FDA
The most crucial distinctions between cosmetics in the United States and other countries is the legal definitions of cosmetics and drugs, limitations on colorants, and registration requirements. In some nations, cosmetics businesses are required to register as such, but it is entirely voluntary in America.
It may sound weird that lawmakers consider cosmetics to be drugs. However, consumer product manufacturers know that the distinction exists for a reason. If your company produces cosmetics, you may want to discuss your options with a business law attorney in California who focuses on the Federal Drug Administration (FDA) regulations.
Cosmetics vs. Drugs: How They Relate and Differ
In order to see the bigger picture, it is critical to understand how the law defines cosmetics and drugs. For manufacturers and producers, this concept means that specific labeling and licensing requirements apply. Here are the legal definitions of both product categories:
Legal Definition of Cosmetics
Cosmetics are known as products that improve the aesthetic appearance of one’s body. However, the government has a specific definition of cosmetic products. The Federal Food, Drug, and Cosmetics Act (FDCA) defines cosmetics as:
"Articles to be sprayed, sprinkled, rubbed, or poured onto the human body as a means of cleaning, beautifying, or modifying one's look."
Cosmetic products include moisturizers, perfumes, make-up, nail polish, shampoos, hair dye, deodorant, and toothpaste. While the preceding list is not exhaustive, the idea is to give you a sense of the relevant product category.
Legal Definition of Drugs
Drug categories may include over-the-counter, prescription, and illegal drugs. However, within the context of cosmetics, the legal definition is precise. The FDCA defines drugs as "Articles used in medical diagnosis, healing, treatment, or illness prevention designed to impact the function or structure of the human body."
Current regulations allow the classification of cosmetics and drugs to blur lines. For instance, shampoo is cosmetic. However, dandruff shampoo acts as a cosmetic as well as a drug. Additional examples of this hybrid classification include hair regrowth products, cellulite mitigation, and cell revitalization.
Assuring Safe Use of Ingredients
Cosmetics imported into the US should fulfill the safety criteria and labeling as those produced nationally. The FDA does not automatically approve cosmetics products or ingredients except for colorants, like food dye and other sources.
Cosmetic companies are accountable for marketing safe and effective labeled items, either as a cosmetic or cosmetic/drug hybrid, that avoids prohibited ingredients and within ingredient restriction guidelines.
Speak with a California Business Law Attorney About Classification
The most effective way to establish compliance with the FDA classification standards is simply by speaking with a California business law attorney. He or she can apply industry-specific knowledge and long-term experience for the best possible result regarding the products your company sells.
At De Cárdenas Law Group, it is our mission to see you succeed in every legal aspect of your business. Please allow us to show you how we can help you stay compliant with our legal services. You can schedule a meeting with one of your business law attorneys in San Francisco or South Pasadena by calling (626) 577-6800.