Understanding the FDA’s Rules on Prohibited and Restricted Ingredients in Cosmetics

Cosmetic safety begins with what goes into the product. The U.S. Food and Drug Administration (FDA) regulates cosmetic ingredients to ensure they are safe for consumer use and properly labeled. While most cosmetic ingredients are legal to use in the United States, some are prohibited or restricted due to known safety concerns or misuse risks.

Prohibited Ingredients: What Cannot Be Used

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), certain ingredients are strictly prohibited in cosmetic products sold in the U.S. These are substances that have been proven unsafe or harmful to human health.

According to the FDA, the following ingredients are banned from use in cosmetics:

• Bithionol – Can cause severe skin sensitivity.
• Chlorofluorocarbon (CFC) propellants – Restricted due to environmental and safety concerns.
• Chloroform – Classified as a potential human carcinogen.
• Halogenated salicylanilides (di-, tri-, metabromsalan, and tribromsalan) – Linked to skin irritation and other health risks.
• Mercury compounds – Banned except in trace amounts for specific eye-area uses, due to toxicity.
• Methylene chloride – A known carcinogen.
• Vinyl chloride – Prohibited as an ingredient or propellant.
• Zirconium-containing complexes – Banned in aerosol cosmetics due to potential lung injury.

The FDA also prohibits color additives that are not specifically approved for cosmetic use.

Restricted Ingredients: Limited for Safety

Some ingredients are not completely banned but are restricted to certain amounts, product types, or conditions of use. For example, mercury compounds are allowed only in trace amounts in eye-area cosmetics where no safer preservative is available. Similarly, color additives may be approved for use on certain parts of the body (such as the lips or skin) but restricted from use near the eyes.

Manufacturers must ensure that ingredients are used within the FDA’s prescribed limits and under safe conditions.

FDA Oversight and Enforcement

Unlike drugs, cosmetics do not require premarket approval by the FDA (with the exception of color additives). However, the FDA monitors safety through product testing, inspections, and consumer complaints. If a product is found to contain a prohibited or unsafe ingredient, the FDA can take action, including:

• Issuing warning letters to the manufacturer
• Requesting a voluntary product recall
• Seizing products that violate federal law

What This Means for Brands

Cosmetic companies are legally responsible for ensuring the safety of their products before they reach the market. Staying informed about the FDA’s list of prohibited and restricted ingredients helps avoid costly recalls, damage to reputation, and regulatory action. Manufacturers should maintain strong quality control systems and verify ingredient compliance with the FDA’s current regulations and international standards.

What Consumers Should Know

For consumers, understanding these restrictions builds confidence that U.S. cosmetic products meet federal safety standards. When buying imported or unregulated products online, it’s especially important to verify that ingredients comply with FDA requirements—some international formulations may include banned or restricted substances in the U.S.

Ultimately, the FDA’s prohibited and restricted ingredient rules protect consumers by ensuring that cosmetic products are safe, well-formulated, and free from harmful chemicals. For manufacturers, these regulations underscore the importance of transparency and responsible formulation. By knowing which ingredients are banned or limited, both brands and consumers can help uphold safety and trust in the beauty industry. (FDA Sources)