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NIH, USDA analyses show prenatal multivitamin labels incorrect, unclear

Prescription and over-the-counter prenatal multivitamin labels were often either wrong or confusing, according to two studies presented at Nutrition 2019.

Incorrect labels

In the first study, researchers reviewed tests completed on 24 prenatal multivitamins for their vitamin, mineral and docosahexaenoic acid content.

“Pregnant women are at risk of dietary deficiency for several key nutrients, including calcium, iron, folate and vitamin D,” Karen Andrews, BS, of the U.S. Department of Agricultural Research Service, and colleagues wrote in the abstract. “However, intake studies have used only product label information, which may lead to incorrect estimates of their impact on nutrition status.”

For prenatal multivitamins sold through pharmacies, researchers found mean overages of 20% or more when test results were compared with labels for folic acid, niacin, riboflavin and vitamins A, B-12 and D. Similar comparisons yielded surpluses of 10% to 15% in vitamins B6, C  and E, surpluses of 1% to 11% for minerals and docosahexaenoic acid, but 4% below label results for thiamin.

Unclear labels
In the second study, Leila Saldanha, PhD, RD, of NIH's Office of Dietary Supplements and colleagues cited “unclear labels” as the impetus for their review of the synthetic sources of folic acid indicated on labels of prenatal supplements sold with and without a prescription.

Healio Primary Care checked the CDC, the American Academy of Family Physicians and the U.S. Preventive Services Task Force websites and found illustrations of potential uncertainty.

 
Prescription and over-the-counter prenatal multivitamin labels were often either wrong or confusing, according to two studies presented at Nutrition 2019.
Source:Shutterstock

Though the CDC encourages all women of childbearing age to take 400 µg of folic acid daily and to eat foods with folate, the AAFP and USPSTF recommend that these same women consume a supplement with 400 µg to 800 µg of folic acid daily.

Saldanha and colleagues found that 32% of the prescription and 25% of OTC nonprescription prenatal supplements contained synthetic L-5-methylfolate – a relatively new source of folic acid. They converted the natural and L-5-methylfolate forms to equivalent amounts of folic acid to compare amounts in supplements with recommendations.

They found that 100% of the prescription supplement labels and 80% of the OTC nonprescription prenatal supplement labels indicated 800 µg or more equivalent amounts of folic acid – the OLD daily requirement for folic acid for pregnant women. 100% of the prescription supplement labels and 100% of the OTC nonprescription prenatal supplement labels indicated 360 µg or more equivalent amounts of folic acid – the NEW daily requirement for folic acid for pregnant women.

“The [daily values], [tolerable upper intake level] criterion for making a health claim on prenatal supplement labels, the USPSTF recommendations, and the units used for expressing folate and folic acid recommendations need to be harmonized and clarified,” Saldanha and colleagues concluded.

The CDC has indicated overconsumption of folic acid typically does no harm to a woman or her baby.

A NIH spokesperson told Healio Primary Care that as a result of the new labeling regulations, folic acid and all natural and synthetic sources of folic acid will be stated as mcg DFE (dietary folate equivalents) on food and supplement labels. – by Janel Miller

Editor's note: This story has been updated from a previous version.

Resources:

Andrews K, et al. How accurate is the labeled content of prescription prenatal multivitamin/mineral (MVM)? - an analytical pilot study for the Dietary Supplement Ingredient Database (DSID).

Saldanha L, et al. Folic acid in prenatal supplements: Labeled amounts compared to recommendations.

Both presented at: Nutrition 2019; June 8-11; Baltimore.

Also:

AAFP.org. Clinical preventive service recommendations for neural tube defects. https://www.aafp.org/patient-care/clinical-recommendations/all/neural-tube-defects.html. Accessed June 6, 2019.

uspreventiveservicestaskforce.org. Folic acid for the prevention of neural tube defects.

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication. Accessed June 6, 2019.

Disclosures: Healio Primary Care was unable to confirm the authors’ relevant financial disclosures.

 

 

Prescription and over-the-counter prenatal multivitamin labels were often either wrong or confusing, according to two studies presented at Nutrition 2019.

Incorrect labels

In the first study, researchers reviewed tests completed on 24 prenatal multivitamins for their vitamin, mineral and docosahexaenoic acid content.

“Pregnant women are at risk of dietary deficiency for several key nutrients, including calcium, iron, folate and vitamin D,” Karen Andrews, BS, of the U.S. Department of Agricultural Research Service, and colleagues wrote in the abstract. “However, intake studies have used only product label information, which may lead to incorrect estimates of their impact on nutrition status.”

For prenatal multivitamins sold through pharmacies, researchers found mean overages of 20% or more when test results were compared with labels for folic acid, niacin, riboflavin and vitamins A, B-12 and D. Similar comparisons yielded surpluses of 10% to 15% in vitamins B6, C  and E, surpluses of 1% to 11% for minerals and docosahexaenoic acid, but 4% below label results for thiamin.

Unclear labels
In the second study, Leila Saldanha, PhD, RD, of NIH's Office of Dietary Supplements and colleagues cited “unclear labels” as the impetus for their review of the synthetic sources of folic acid indicated on labels of prenatal supplements sold with and without a prescription.

Healio Primary Care checked the CDC, the American Academy of Family Physicians and the U.S. Preventive Services Task Force websites and found illustrations of potential uncertainty.

 
Prescription and over-the-counter prenatal multivitamin labels were often either wrong or confusing, according to two studies presented at Nutrition 2019.
Source:Shutterstock

Though the CDC encourages all women of childbearing age to take 400 µg of folic acid daily and to eat foods with folate, the AAFP and USPSTF recommend that these same women consume a supplement with 400 µg to 800 µg of folic acid daily.

Saldanha and colleagues found that 32% of the prescription and 25% of OTC nonprescription prenatal supplements contained synthetic L-5-methylfolate – a relatively new source of folic acid. They converted the natural and L-5-methylfolate forms to equivalent amounts of folic acid to compare amounts in supplements with recommendations.

They found that 100% of the prescription supplement labels and 80% of the OTC nonprescription prenatal supplement labels indicated 800 µg or more equivalent amounts of folic acid – the OLD daily requirement for folic acid for pregnant women. 100% of the prescription supplement labels and 100% of the OTC nonprescription prenatal supplement labels indicated 360 µg or more equivalent amounts of folic acid – the NEW daily requirement for folic acid for pregnant women.

“The [daily values], [tolerable upper intake level] criterion for making a health claim on prenatal supplement labels, the USPSTF recommendations, and the units used for expressing folate and folic acid recommendations need to be harmonized and clarified,” Saldanha and colleagues concluded.

The CDC has indicated overconsumption of folic acid typically does no harm to a woman or her baby.

A NIH spokesperson told Healio Primary Care that as a result of the new labeling regulations, folic acid and all natural and synthetic sources of folic acid will be stated as mcg DFE (dietary folate equivalents) on food and supplement labels. – by Janel Miller

Editor's note: This story has been updated from a previous version.

Resources:

Andrews K, et al. How accurate is the labeled content of prescription prenatal multivitamin/mineral (MVM)? - an analytical pilot study for the Dietary Supplement Ingredient Database (DSID).

Saldanha L, et al. Folic acid in prenatal supplements: Labeled amounts compared to recommendations.

Both presented at: Nutrition 2019; June 8-11; Baltimore.

Also:

AAFP.org. Clinical preventive service recommendations for neural tube defects. https://www.aafp.org/patient-care/clinical-recommendations/all/neural-tube-defects.html. Accessed June 6, 2019.

uspreventiveservicestaskforce.org. Folic acid for the prevention of neural tube defects.

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication. Accessed June 6, 2019.

Disclosures: Healio Primary Care was unable to confirm the authors’ relevant financial disclosures.

 

 

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