FDA regulation of OTC oral health care drug products.
The history of the involvement of the Food and Drug Administration in the regulation of over-the-counter (OTC) drugs is reviewed. The development of monographs containing standards for drugs, the function of the advisory panels, and the classification of dental drug products are explained. Examples of ingredients in each category are given. The current opinion of the FDA concerning antiplaque and antigingivitis claims is also discussed.
Rippere
J L
JL
Food and Drug Administration, Rockville, MD 20855.
D003729:Dental Care; D017277:Drug Approval; D004341:Drug Evaluation; D006801:Humans; D009059:Mouth Diseases / Q000517:prevention & control; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000032:analysis / Q000494:pharmacology; D009910:Oral Hygiene; D012307:Risk Factors; D012449:Safety; D014076:Tooth Diseases / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D004366:Nonprescription Drugs