Ignoring the elephant in the room—overregulated isotretinoin and unregulated dietary supplements in the United States

Abstract

Isotretinoin is an acne medication regulated by the Food and Drug Administration (FDA) iPledge Risk Evaluation and Mitigation Strategy program due to its potential for birth defects. This program enforces monthly pregnancy tests and comprehension quizzes, among other requirements, which results in disproportionate medication access barriers. In December 2021, the iPledge system underwent a series of changes, which resulted in systemwide malfunctions and hour-long phone support line waiting times. Due to growing challenges to isotretinoin access, patients may turn to unregulated over-the-counter vitamin A dietary supplements marketed for acne, despite evidence of similar risk of teratogenicity to isotretinoin. While the FDA has understandably focused its attention to isotretinoin regulation, it should increase oversight of the dietary supplement industry, and practitioners should remain informed of risks of vitamin A supplements.

Keywords:

• Dietary supplements
• iPledge
• isotretinoin
• regulation
• teratogenicity
• vitamin A

Acknowledgments

The authors would like to thank Rajani Katta, MD, for her guidance in developing this editorial.