Advertisement

OTCS, Switch, and the Impact of Dietary Supplements

  • Eve E. Bachrach
Article

Abstract

As recently as five years ago, ‘consumer self-care’ was almost exclusively the province of over-the-counter (OTC) medicines. Today, with the advent of the Dietary Supplement Health and Education Act of 1994, dietary supplements provide expanded consumer self-care opportunities. Foods are also claiming health benefits. Sensible health care policy requires that the Food and Drug Administration (FDA) take account of this new self-care product continuum in its prescription (Rx)-to-OTC switch decision making. It is well recognized that consumers want to be and can be educated to care for themselves in a variety of health care situations using foods or dietary supplements. The same principle should be presumed to hold true for an OTC drug in parallel health care situations, where the drug is properly tested and labeled for consumer use through FDA’s comprehensive drug review process.

Key Words

OTC drugs Dietary supplements Structure/function claims Drug claims Rx to OTC switch 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Final Rule, Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for dietary Supplements. 62 Federal Register 49859, at 49860, September 23, 1997.Google Scholar
  2. 2.
    63 Federal Register 23624 (1998).Google Scholar
  3. 3.
    63 Federal Register 23627 (1998).Google Scholar
  4. 4.
    21 U.S.C. § 321 (g)(1).Google Scholar
  5. 5.
    51 Federal Register 16258 (1986); 21 CFR § 330.1 (c).Google Scholar
  6. 6.
    51 Federal Register 16259 (1986).Google Scholar
  7. 7.
    64 Federal Register 13254 (1999).Google Scholar
  8. 8.
    63 Federal Register at 23626 (1998).Google Scholar
  9. 9.
    21 CFR § 330.10(a)(4)(v).Google Scholar
  10. 10.
    21 CFR § 101.75.Google Scholar

Copyright information

© Drug Information Association, Inc 1999

Authors and Affiliations

  • Eve E. Bachrach
    • 1
  1. 1.Consumer Healthcare Products AssociationWashington, D.CUSA

Personalised recommendations