ODS Update - Summer 2019

In Case You Missed It: The Office of Dietary Supplements at Nutrition 2019

Staff from the Office of Dietary Supplements (ODS) participated in scientific sessions and presented posters on a variety of dietary supplement research topics at the American Society for Nutrition (ASN) “Nutrition 2019” annual conference in Baltimore, June 8–11, 2019.

Here are some highlights:

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.

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.

New ODS Dietary Supplement Fact Sheets

ODS continues to expand its library of resources with new heath professional fact sheets on manganese, copper, and probiotics; and new consumer fact sheets on niacin, copper, and probiotics. See our full list of fact sheets, including many available in three versions: health professional, consumer in English, and consumer in Spanish.

My Dietary Supplement and Medicine Record

ODS has developed a new form for consumers to use to keep track of the dietary supplements, prescription drugs, and over-the-counter medicines they take. Designed as a fillable and printed PDF, My Dietary Supplement and Medicine Record (153KB PDF) can serve as a personal record and be shared with healthcare providers.

Funding Opportunities

Learn about ODS’s funding opportunities and research programs.

Throughout the academic year, ODS hosts seminars by scientists who conduct research on dietary supplements and related topics. These are the upcoming seminars for fall 2019.

Contact ODS at ODS@NIH.gov to receive seminar announcements and webinar information.

Wednesday, September 18, 2019, 11:00 a.m. ET
Evaluating Botanical Dietary Supplement Safety: Lessons Learned and Future Directions
Nigel Walker, National Toxicology Program, National Institute for Environmental Health Sciences, NIH, Durham, NC

Wednesday, October 16, 2019, 11:00 a.m. ET
Gene-Diet Interactions in Fatty Acid Metabolism and the Potential for Individualized Dietary Recommendations
Floyd (Ski) Chilton, University of Arizona, Tucson, AZ

Wednesday, November 6, 2019, 11:00 a.m. ET
Coffee Compounds Protect Synergistically in Neurodegenerative Disease Models
M. Maral Mouradian, Rutgers University, New Brunswick, NJ

Wednesday, December 11, 2019, 11:00 a.m. ET
Point-of-Need Assays for Measuring Micronutrient Concentrations in Biological Samples 
Saurabh Mehta,Cornell University, Ithaca, NY

ODS Staff News

Jaime Gahche, Nutritional Epidemiologist in the ODS Population Studies Program, received her Ph.D. in nutrition from the University of Maryland, College Park in May 2019. She presented work related to her dissertation at ASN’s Nutrition 2019 conference. Gahche directs the Mary Frances Picciano Dietary Supplement Research Practicum, an annual 3-day training program at ODS.

ODS Staff Presentations

Visit the Staff Presentations page on the ODS website for a complete list.

Recent ODS Staff Publications

ODS staff members regularly publish papers about dietary supplements and related research. Visit the Staff Publications page on the ODS website for a complete list.

LaVerne L. Brown, ODS Health Scientist Administrator, and retired ODS Director, Paul M. Coates, co-authored the chapter: “Addressing Key Knowledge Gaps in Nutrition Research and the Impact of Funding Priorities in Human Nutrition,” in the book Vitamin E in Human Health. The chapter focuses on challenges in advancing nutrition research. These include: assessing nutritional status and dietary intake; phenotypic variations in nutrition requirements (e.g., life stage, sex, genetics, and epigenetic differences); and interrelationships between nutrient intakes from supplements and food and true nutrient bioavailability.

Bailey RL, Dodd KW, Gahche JJ, Dwyer JT, Cowan AE, Jun S, Eicher-Miller HA, Guenther PM, Bhadra A, Thomas PR, Potischman NP, Carroll RJ, Tooze JA. Best Practices for Dietary Supplement Assessment and Estimation of Total Usual Nutrient Intakes in Population-Level Research and Monitoring. J Nutr. 2019. 149:181–197.

Gahche JJ, Herrick KA, Potischman NP, Bailey RL, Ahluwalia N, Dwyer JT. Dietary Supplement Use among Infants and Toddlers Aged <24 Months in the United States, NHANES 2007-2014. J Nutr. 2019. 149:314–322.

ODS Media Appearances

Paul R. Thomas was interviewed by writer Sara Harrison for her article, “Bringing Clarity to the Murky World of Sports Supplements,” published on Wired.com on July 23, 2019.

Carol J. Haggans was interviewed for articles by several media outlets:

• Newsday by writer David Olson for his article, “Studies on Health Benefits of Vitamins, Supplements Bring Different Conclusions” on May 17, 2019.
• Romper by writer Lindsay Mack for her article, “9 Surprising Things That Can Happen When You Take Vitamins” on June 28, 2019.
• Costco Connection by writer Andrea Downing Peck on April 12, 2019, for her article about potassium’s role in health.

Cindy Davis was interviewed by writer Laura Beil for her article, “Vitamin D Supplements Aren’t Living up to Their Hype,” published in Science News on January 27, 2019.