Drug Regulation in the United States

FDA regulates all drugs manufactured and distributed in the United States. The definition of “drug” under U.S. law generally depends on the product’s intended use. Drug labeling language includes, for instance, if the product is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or if the product (other than a food, of course) is “intended to affect the structure or any function of the body.” FDA determines intended use by analyzing the label, promotional claims, advertising and marketing materials, and any other relevant sources it can find regarding your product. Did you know that sugar is a “drug” under U.S. law, if the labeling asserts it can cure cancer? A cosmetic cream could also be a drug, if the labeling asserts it can remove wrinkles.

Most of FDA’s regulations for drugs are built upon two key principles: (1) a drug must be safe and effective for its intended use and (2) the drug must be labeled with adequate directions for its intended use (unless exempted). Based on those principles, a legally marketed drug (with a few exceptions) must obtain FDA premarket approval through a new drug approval (NDA) process, or comply with FDA’s over-the-counter (OTC) monographs, or be a homeopathic drug that complies with certain homeopathic monographs (and other regulatory materials). Drugs subject to an FDA OTC monograph are not subject to FDA’s NDA requirements, as long as the drug is formulated and labeled appropriately.

Labeling Requirements.

All drugs must comply with a long list of mandatory drug labeling requirements. Those with experience with other FDA-regulated industries will find some very familiar labeling requirements, such as ingredient declarations, statements of identity, and net quantity declarations. However other requirements will look very different, such as the requirement that the labeling must include adequate directions for use (unless exempted). To further complicate the matter, the drug labeling requirements differ based upon whether the product is a prescription (Rx) drug, an OTC drug, or an active pharmaceutical ingredient (API). Additionally, a drug can also be a combination product – such as cosmetic drugs – and the product must also comply with FDA’s cosmetic labeling and formulation requirements.

Other Facts about Drugs and Drug Imports

• All drugs must be manufactured, processed, and packed according to current Good Manufacturing Practices (cGMPs) and the manufacturing, repackaging, and relabeling facilities must be registered with FDA.
• Some products meet the label definition of “drug” and “cosmetic,” which means they must comply with the legal requirements, including labeling, for both categories.
• FDA regularly examines imported drug shipments for compliance with FDA drug establishment registration and drug listing, and compliance with drug labeling requirements.
• FDA will place a foreign manufacturer on FDA import alert if an FDA inspection determines the facility has failed to comply with cGMPs or the foreign facility has shipped drugs FDA believes are unapproved, misbranded or fraudulent. FDA Import Alerts will cause FDA to automatically detain drugs from that facility, resulting often in an FDA Refusal – thus rejecting entry of the drugs into the United States.

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