Dietary Supplements Containing the Upper Tolerable Limit Amount or More of Pyridoxine (P24-034-19)

Abstract

Abstract Objectives To estimate what proportion of pyridoxine containing-dietary supplements available in the USA contain higher than the upper tolerable limit of pyridoxine. Methods The Dietary Supplement Label Database (DSLD) from the National Institutes of Health was chosen as the data source to characterize how many supplements contain an amount of pyridoxine (vitamin B6) that is at the upper tolerable limit (UL) or above. DSLD was searched for all dietary supplement labels that contain pyridoxine. Label data was downloaded into an excel spreadsheet and characterized based on target age group and amount of pyridoxine contained per serving size. Results A total of 5615 pyridoxine-containing dietary supplement label entries were reviewed. Of these labels, 4871 were for patients 4 years and older, 106 were for pregnant or lactating women, 148 were for toddlers ages 1–4 years, 8 were for infants less than 1 year of age, and the rest did not specify a target age group. From the dietary supplements targeting people 4 years and older, 288/4871 (5.9%) contained 100 mg of pyridoxine or more per serving, which is the UL for adults 19 years and older; 330/4871 (6.8%) contained 80 mg of pyridoxine or more, the UL for children 14–18 years; 449/4871 (9.2%) contained 60 mg of pyridoxine or more, the UL for children 9–13 years; 1031/4871 (21.1%) contained 40 mg of pyridoxine or more, the UL for children 4–8 years old. From the dietary supplements targeting pregnant or lactating women, 2/106 (1.8%) contained 100 mg pyridoxine per serving which is the UL for this patient population. From dietary supplements targeting toddlers ages 1–4 years, 1/148 (0.6%) contained 30 mg of pyridoxine which is the UL for this target group. Finally, because there is not an established UL for infants 12 months or less of age, those labels could not be characterized. Conclusions In spite of the ULs set by the Institute of Medicine's Food & Nutrition Board, an alarming number of manufactures produce dietary supplements that contain pyridoxine at the UL level or higher per serving size. This poses a significant safety risk to patients consuming dietary supplements. Funding Sources None.