JANUARY 13, 2025 | UNLOCKED
(Yes, a ‘creature was stirring,’ and it wasn’t a mouse)
While many were getting a well-deserved “long winter’s nap” over the holidays, CRN was hard at work to be sure a flawed study alleging unsafe levels of heavy metals in certain prenatal vitamins was being removed from publication.
Since the study was first released in pre-publication just before Thanksgiving, CRN has taken extensive measures to address inaccuracies in the study published in The American Journal of Clinical Nutrition (AJCN), titled “Content of Selected Nutrients and Potential Contaminants in Prenatal Multivitamins and Minerals: an Observational Study.” The study incorrectly claimed that some prenatal multivitamins contained heavy metals—lead, arsenic, and cadmium—at levels exceeding “USP Purity Limits,” a standard that does not exist for the finished products tested.
CRN identified that the study misapplied USP limits, which are intended for raw ingredients, not finished products, and incorrectly calculated the amounts based on a per-gram basis instead of per daily dose. Proper application of USP standards (General Chapter 2232 for dietary supplements) demonstrated that all tested products were below established safety thresholds.
Timeline of CRN’s Actions:
November 22: CRN issued an interim alert to CRN members, notifying them of the study’s publication and that CRN was assessing its accuracy.
November 25: CRN contacted the United States Pharmacopeia (USP) to verify the heavy metal limits cited in the study. USP confirmed the limits were misrepresented.
November 26: CRN issued a second alert to members explaining that the heavy metal limits in the study were inaccurate. CRN contacted the Center for Science in the Public Interest (CSPI), which funded the study, for collaboration on addressing the issue. CSPI referred CRN to the study authors.
December 6–13: CRN maintained consistent outreach to USP, repeatedly requesting updates on their response to the study. Eventually, USP confirmed it was drafting a letter to the editor to address the inaccuracies, and that it had communicated with the study’s authors.
December 18: With that confirmation from USP, CRN emailed Laura Borgelt, the study’s lead author, and Christopher Duggan, Editor-in-Chief of AJCN, demanding immediate corrections to the manuscript and press release, citing the need for transparency for both CRN members and the public.
December 20–21: USP confirmed that the study authors had committed to issuing a correction. Borgelt acknowledged that edits to the manuscript were underway and that a request had been made to withdraw the original press release.
December 23: USP issued a public statement indicating the heavy metal purity limits and units were incorrectly applied and that the values presented in the study were inaccurate. CRN alerted top-tier media outlets who had covered the original study, including The New York Times and New York Post, to inform them of the retraction and inaccuracies.
December 24: CRN issued a public statement highlighting the study’s errors and reaffirming the safety of prenatal multivitamins when proper standards are applied.
December 27: CRN distributed its statement across press lists and amplified its message on social media, tagging reporters to increase visibility. The communications team contacted all major news outlets that had reported on the original findings.
December 29: The New York Post agreed to issue a correction, a significant milestone in ensuring public understanding of the issue.
December 31: After persistent communications from CRN, the University of Colorado removed the press release it issued on November 22nd, which included an inflammatory headline.
January 7: The ACJN withdrew the original study from its website. In a press release, CRN commended the response.
January 9: With the press release and the journal article finally removed, CRN sent an email to over 300 healthcare providers who we made connections with at the 2024 American College of Obstetricians and Gynecologists annual meeting to inform doctors that the original headlines were incorrect and encouraging them to reassure their patients that the products are safe.
Why this matters: The study’s misrepresentation of heavy metal limits could have continued to cause unnecessary anxiety for pregnant women and undermined confidence in prenatal multivitamins. CRN’s swift and strategic actions demonstrate its commitment to scientific accuracy, public trust, and the safety of dietary supplements.
CRN will continue to monitor developments and provide updates as corrections are issued. Members can reach out to Andrea Wong or Haiuyen Nguyen for further information.
Questions? Contact Jeff Ventura.