During the administration of Theodore Roosevelt, the U.S. federal government established its first laws to regulate drugs: the Pure Food and Drug Act of 1906, and the Opium Exclusion Act of 1909. A progressive reform movement begun in the late 19th century that included “muckraker” journalists, women's organizations, clergy, the business community, scientists, health professionals, state drug officials, and national politicians (including Theodore Roosevelt) influenced the passage of these acts.

Both pieces of legislation were narrow in scope yet led to the passage of further legislation that continued the U.S. government leadership role in domestic consumer health and safety and in international narcotics control.