ABSTRACT
Historical Overview 626
Legislative History of the Cosmetic and Drug Provisions of the 1938 Act 627
Implementation of the FD&C Act 629
Initial FDA Action under the FD&C Act 630
Wrinkle Remover Cases of the 1960s 631
OTC Drug Review 632
Warning Letters of the Late 1980s 633
The Alpha-Hydroxy Acid (AHA) Products of the 1990s 635
Use of Foreign Marketing Experience 635
Rationale of the Tobacco Initiative 637
Labeling and Manufacturing Difficulties for Cosmetic Drugs 638
Budgetary Impact on the FDA 638
Potential Future Approaches 639
Conclusion 640
References 640
The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes substantially
different regulatory requirements in USA for cosmetics and drugs. This chapter
traces the history of US regulatory policy for these two categories of products,
discusses the application of US law to products that fall within both categories at
the same time (i.e., cosmetic drugs), and considers potential strategies for resolving the long-standing concern that the drug provisions of the Act impose overly
stringent requirements on cosmetic drugs.
