Federal Regulations of Warning Labels

Prescription drugs should always be adequately labeled.

The United States federal government will issue warning labels on products for the benefit of the environment, population, transportation and sustaining health standards. Agencies within the federal government will utilize the Codes of Federal Regulations to issue warning labels based on specific needs and/or requirements.

Codes

The Codes of Federal Regulations provides general and permanent rules issued by executive departments and agencies of the federal government. There are 50 titles that are addressed within the CFR. Individual agencies will utilize the CFRs to notify the public of subjects that are pertinent to their individual agency.

Hazardous Material

The U.S. Environmental Protection Agency will issue warning labels on a wide assortment of hazardous materials. The purpose is to assure the protection of the environment by controlling pollution on a systematic basis. The EPA will issue warnings and notifications on toxic substances, asbestos, chemicals and pesticides that may pose unreasonable risks to human health or the environment.

Food and Drugs

The U.S. Food and Drug Administration will issue warning labels on products, foods and prescription drugs. Among other labeling requirements of prescription drugs, at a minimum it will identify the type of drug, purpose, specific warnings on its use and point of contact information.

References

• GPO Access
• V/Lex: 40 CFR 763.95 - Warning labels