In an article in The Annals of Pharmacotherapy three Canadian pediatricians reviewed adverse effects and events of vitamins in light of their current prevalence of use and concluded that vitamins should be viewed as OTCs.
“Our recommendation is that vitamins A, E, D, folic acid, and niacin should be categorized as OTC medications. Labeling of vitamins, especially those intended for children and/or vulnerable groups, should include information on possible toxicities, dosing, recommended upper intake limits, and concurrent use with other products,” wrote Alexander Rogovik, Sunita Vohra, and Ran Goldman.
“Vitamin A should be excluded from multivitamin supplementations and food fortificants,” they added.
The findings were dismissed by both the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN).
"This article, though published in a peer-reviewed journal, is a pre-determined conclusion in search of evidence to support it,” said Andrew Shao, senior vice president, scientific and regulatory affairs, CRN. “The authors have clearly cherry-picked literature to support their position and did not assess the totality of evidence in order to develop their unbalanced recommendation.”
Daniel Fabricant, PhD, vice president for scientific and regulatory affairs at NPA told NutraIngredients-USA: “The authors need to understand that what they're asking isn’t data driven, there is an adverse events reporting (AER) system, and if any of these such theoretical issues they bring up were in-fact real, there would be a signal in the post-market surveillance system which the authors should recognize is the same for medical prescriptions, devices, and OTCs.
“Most importantly, they need to understand that the risk needs to be attributed to the riskier product, which all medical scientists, toxicologists, and so on worth their salt would agree is the pharmaceutical,” added Fabricant.
The reviewers focused on collecting data from predominantly randomized controlled clinical trials. Data was also used from surveys on vitamin-drug interactions from a pediatric emergency department.
Vitamin use is extensive, said the reviewers, with data from the National Institutes of Health indicating that over one-third of Americans regularly use multivitamin supplements.
Regarding adverse events, the reviewers quote results from randomized clinical trials of vitamins A, E, D, niacin and folic acid, many of which were performed in diseased populations, and with relatively high doses of vitamins.
“This article focused on vitamin-related adverse effects and interactions, many of which have been shown to be significant in randomized controlled trials and at a population level, in light of very high prevalence of vitamin use and food fortification, rather than on evaluating the impact of recommended policy changes on vitamin manufacturers or the food industry, which is not our expertise,” explained Rogovik, Vohra, and Goldman.
Dr Rogovik is the assistant director of the Pediatric Research in Emergency Therapeutics (PRETx) Program at St. Michael’s Hospital, Toronto. Dr Vohra is the director of the Complementary and Alternative Research and Education (CARE) Program in the Department of Pediatrics at Stollery Children’s Hospital in Edmonton. Dr Goldman is an associate professor in the Department of Pediatrics at the University of British Columbia.
Dr Shao told this website that the authors use outdated and incomplete evidence to support their preconceived conclusions on the safety profile of individual vitamins, while omitting important evidence countering their assertions.
“The authors pay lip service to the Institute of Medicine’s (IOM) safe upper intake level (UL), but ignore the principles on which it is based, namely nutrient risk assessment,” explained Dr Shao. “Risk assessment is a globally accepted scientific methodology for assessing risk of exposure to nutrients and is endorsed or practiced by the IOM, UK EVM and Codex, to name a few. It is based on the well known concept that the dose makes the poison and the process involves examining the totality of the evidence. All nutrients, and in fact anything ingestible can be toxic, even water, at the right dose.
“By mentioning the UL, but merely citing those studies that support their preconceived conclusions rather than assessing all the evidence, the authors present a poorly contrived, unconvincing argument and reflect their ignorance of the subject matter, extreme bias, or both,” added Shao.
Dr Fabricant added that it is well known that very active pharmaceuticals like warfarin will interact with many things, including foods. “But does that mean that because spinach interacts with warfarin, that we should go out and make spinach an OTC? Of course not.”
“These folks fail to understand that supplements with good reason are appropriately and adequately regulated as foods, and provide all the appropriate measures to protect the consumer and just as ridiculous is the notion that spinach would be an OTC is the notion that vitamin D should be one as well,” added Fabricant.
Source: The Annals of Pharmacotherapy
February 2010, Volume 44, doi: 10.1345/aph.1M238
"Safety Considerations and Potential Interactions of Vitamins: Should Vitamins Be Considered Drugs?"
Authors: A.L. Rogovik, S. Vohra, R.D. Goldman