Dietary supplements, vitamin A, and regulation: a call to action
Dietary supplements in the United States are considered foods by the U.S. Food and Drug Administration, and thus they are not subject to the same rigorous safety and quality measures as drugs. They are also extremely accessible: a simple google search for “dietary supplements” yields more than 1 billion results. Consumers can buy supplements for a variety of advertised purposes, including an energy boost, skin concerns and many other health issues.
We conducted a study of dietary supplements sold online in 2020 that were marketed for acne. We found a range of ingredients, many containing large and potentially dangerous doses, without third-party testing. An ingredient we found in particular was vitamin A. This was concerning given the demonstrated ability of high vitamin A doses to cause fetal abnormalities and deformaties.
Isotretinoin, also known as Accutane, is a vitamin A derivative commonly prescribed by dermatologists for severe acne. Due to risk for birth defects from this medication, access to isotretinoin is tightly regulated by the iPledge program, which requires monthly pregnancy tests and commitment to using two forms of birth control by female patients throughout the duration of the treatment.
One of our authors, Dina Zamil, was prescribed Accutane, and it took 3 months for her to be eligible to receive the medication through iPledge. We were shocked at the stark contrast we found with acne supplements that may have comparable teratogenic risk, which may simply be purchased online or over the counter and may not have adequate warning labels. In fact, the Accutane medication guide states that high-dose vitamin A in supplements have similar side effects to isotretinoin.
Due to the discrepancy in regulations, we analyzed the acne supplement with the highest vitamin A content that we found online to determine just how risky this supplement could be for pregnant women. It was unclear how much vitamin A was included in this supplement. We had difficulties ascertaining if the amount of vitamin A contained in this supplement was similar to or exceeded the amount of vitamin A that has been found to be teratogenic in studies, as information required for the calculations was missing.
We reviewed Food and Drug Administration regulations for displaying vitamin A content on supplement facts labels. Although the vitamin A content in this particular product was unclear, we found that the supplement was nonetheless compliant with the current legal standards.
We collected this valuable information in hopes that it reaches several audiences. First, we hope to reach our patients who are considering the use of products that claim to provide “better” or “smoother” skin or a “solution for acne,” especially our female patients of childbearing age who might be unaware of the teratogenic risks of vitamin A-containing supplements. We also wish to highlight that healthcare providers should routinely ask about supplement use and be wary of their hidden risks. We need to continue to advocate for our patients.
Learn more about the ethics of over-the-counter vitamin A supplements and the need to advocate for increased oversight of dietary supplements that have teratogenic potential in our recent article in the American Medical Association Journal of Ethics.
By Dina Zamil, third-year medical student at Baylor College of Medicine, Dr. Ariadna Perez-Sanchez, internal medicine resident at University of Texas Health Science Center at San Antonio, and Dr. Rajani Katta, clinical assistant professor of medicine at Baylor College of Medicine.