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Federal Regulations on Cold Medicine

There are three federal agencies that have regulatory authority over cold medicine that is available to consumers over the counter (OTC) in non-prescription formats.

The Food and Drug Administration (FDA) has authority pursuant to Title 21 CFR § 341. The Federal Trade Commission (FTC) has authority pursuant to Title 16 CFR § 255. The Consumer Product Safety Commission (CPSC) has authority pursuant to Title 16 CFR § 1700.

  1. FDA Regulations

    • The FDA reviews and approves all OTC cold medicine ingredients and labeling before they go to market. For the FDA to approve any OTC cold medicine, it must have been manufactured in compliance with federal Good Manufacturing Practices Regulations; the facility where it was manufactured must be FDA registered; the OTC cold medicine must be FDA listed; and it must be labeled in compliance with Chapter V of the Federal Food, Drug and Cosmetic Act.

      Additionally, it must be labeled with truthful and nonmisleading statements about the uses of the product and with the following general warnings highlighted in bold type lettering: "Keep out of reach of children" and "In case of overdose, get medical help or contact a Poison Control Center right away."

      Depending on the active ingredients in the OTC cold medicine, FDA requires addition general warning and directions to be printed on the label as well.

    FTC Regulations

    • The Federal Trade Commission (FTC) is responsible for setting standards for the advertising claims made about OTC cold medicines.

      According to the "Food and Drug Law Journal," Congress gave authority to the FTC over regulating the advertising of OTC cold medicine after manufacturers lobbied for it because the FTC lacks the criminal enforcement power that the FDA has.

    CPSC Regulations

    • The Consumer Product Safety Commission (CPSC) ensures that all OTC cold medicines are properly contained in child-resistant closures. CPSC aggressively instituted protocols for child-resistant, tamper-proof packaging of all OTC drugs after the Tylenol scare of 1982.

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