Folic Acid and Folate in Prenatal Supplements: Labeled Amounts Compared to Recommendations This poster described a study comparing the amounts and forms of folate in prenatal supplements to official public health intake recommendations and new labeling requirements from the U.S. Food and Drug Administration (FDA). Labels on foods and dietary supplements must declare the amount of folate (food and synthetic forms) in micrograms (mcg) of dietary folate equivalents (DFE), while intake recommendations—especially for the prevention of neural tube defects (NTDs)—are expressed as mcg of folic acid.  Using data from the ODS Dietary Supplement Label Database and the National Library of Medicine’s DailyMed, ODS’s Leila Saldanha, Nancy Potischman, and Johanna Dwyer—and U.S. Department of Agriculture’s (USDA) Karen Andrews—reviewed the amounts and forms of folate declared on the labels of 53 prescription and 120 over-the-counter prenatal supplements listed in these databases after August 2015.

Pictured with their Nutrition 2019 poster (from left to right) co-authors Nancy Potischman, Director of the ODS Population Studies Program; Leila Saldanha, ODS Scientific Consultant; and Karen Andrews, consultant from the Agricultural Research Service, USDA. Not in the photo, poster co-author Johanna Dwyer, ODS Scientific Consultant.

The authors found that virtually all prenatal supplements on the market exceed the new Daily Value (DV) of 360 mcg of folic acid—or 600 mcg DFE—and that most product labels declared amounts of 800 mcg folic acid (the old DV) or more. Twenty-seven percent of the prenatal supplements were labeled as containing folate in the form of the synthetic salts of L-5-methyltetrahydrofolate (also known as methylfolate). Due to the lack of clinical trials, neither the U.S. Preventive Services Task Force (USPSTF) nor the Centers for Disease Control and Prevention (CDC) recommendations mention the use of L-5-methylterahydrofolate as an alternative to folic acid for the prevention of NTDs. The authors recommend that conversion factors and units used for expressing folate on labels and in the USPSTF and CDC recommendations be harmonized. The criteria for making health claims for folate and NTD prevention on prenatal supplement labels, which were first allowed in 1996, also need clarification.    Saldanha discussed the study findings in an interview for Nutrition 411 on Q&A: Could Some Prenatal Supplements Contain Too Much Folic Acid? She emphasized that healthcare providers “should become aware of the changes in the labeling of folic acid on supplement labels so they may help pregnant women make informed choices when selecting products.”

Enhancing Natural Product Clinical Trials: Highlights From a Workshop ODS’s Barbara C. Sorkin, Director of the Botanical Research Centers Program, presented a poster on highlights from the workshop, Enhancing Natural Product Clinical Trials, held at the National Institutes of Health (NIH), September 13–14, 2018. Experts and stakeholders from academic institutions, government, and the private sector planned and conducted a broadly attended workshop to discuss good practices to enhance rigor, replicability, and the translational relevance to clinical trials of preclinical natural products research. This workshop was deemed necessary because randomized, controlled clinical trials published to date often failed to demonstrate evidence of benefit. This was the case for recent large, NIH-supported clinical trials of dietary supplements such as vitamin D, selenium, and several botanical extracts. Such results are most useful when the evidence on which the trial is based can rigorously address questions such as, for example, whether a different dose than those tested might have shown benefit. Workshop attendees agreed it would be good practice for investigators who design natural product clinical trials to prioritize research based on its potential impact on public health. Critical issues identified in clinical trial design were product identity, replicability, and need for pharmacological hypotheses; power to test a primary outcome relevant to consumers; and use of appropriate controls. The poster abstract is available in ASN’s Current Developments in Nutrition.