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 therefore are not subject to the same strict safety and quality procedures as medications. It’s also easily accessible: a simple Google search for “nutritional supplements” yields over a billion results. Consumers can purchase supplements for a variety of advertised purposes, including increased energy, skin concerns and many other health issues.

we ran Study of Dietary Supplements Sold Online in 2020 marketed as a treatment for acne. We found a range of ingredients, many of which contain large and potentially dangerous doses, without third-party testing. One ingredient that we found in particular was vitamin A. This was worrying due to Shown the ability of high doses of vitamin A to cause fetal abnormalities and malformations.

Isotretinoin, also known as Accutane, is a vitamin A derivative commonly prescribed by dermatologists for severe acne. Due to the risk of birth defects from this drug, access to isotretinoin is strictly regulated by the iPledge programme, which requires monthly pregnancy tests and a commitment to use two forms of birth control by female patients for the duration of treatment.

One of our writers, Dina Zamel, prescribed Accutane, and it took 3 months for her to be eligible to receive the drug through iPledge. We were shocked by the stark contrast we found Acne supplements that may have similar teratogenic risks, which can simply be purchased online or without a prescription and may not have sufficient warning labels. In fact, Accutane Medication Guide It states that high doses of vitamin A in supplements have similar side effects to isotretinoin.

Due to the difference in regulations, we analyzed the acne supplement with the highest vitamin A content we found online to determine how dangerous this supplement might be for pregnant women. It is not clear how much vitamin A is included in this supplement. We had trouble checking if the amount of Vitamin A contained in this supplement was the same or exceeded the amount of vitamin A found in studies to be teratogenic, Because the information required for the accounts was missing.

We reviewed Food and Drug Administration regulations to display vitamin A content on supplement facts labels. Although the vitamin A content in this particular product was not clear, we found that the supplement was nonetheless in compliance with current legal standards.

We have collected this valuable information with the hope that it will reach many audiences. First, we hope to reach out to our patients who are considering using products that claim to provide “better”, “smoother” skin or an “acne solution”, especially patients of childbearing age who may not be aware of the teratogenic risks of nutritional supplements containing Vitamin A. We would also like to highlight that health care 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 with teratogenic potential in our latest publications Article in the Journal of the American Medical Association of Ethics.

Written by Dina Zamel, third-year medical student at Baylor College of Medicine, Dr. Ariadna Perez Sanchez, internal medicine resident at the University of Texas Health Science Center at San Antonio, and Dr. Rajani Kata, clinical assistant professor of medicine at Baylor College of Medicine.