Volume 14: Issue 1 June 1999

HHS Secretary Donna E. Shalala, announced a final U.S. Food and Drug Administration regulation to provide new, easy-to-understand labeling on nonprescription, over-the- counter (OTC) drugs. The new labeling (see sample below) will be in a "standardized" outline format with distinct sections clearly showing the drugs’ ingredients, dose, and warnings; the new labeling will also make it easier for consumers to understand benefits, risks, and proper use of the drugs.

The labels will be easier to read—uncluttered format, simpler wording, and larger type with adequate spacing between letters, words, and lines of text. Use of uppercase and lowercase letters, and dark type on a light background, will also improve readability. Active ingredients will be listed alphabetically with their quantity per dosage unit, thus enabling consumers to clearly determine the purpose of each ingredient. The new labeling will begin appearing on the shelves within the next 2 years; all OTC drugs will be required to have the new labeling within the next 6 years. For more information call (888) 463-6332 or visit www.hhs.gov/news/press/1999pres/990311a.html.

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