Reuters published today that the, ”Walgreen Co. has been sued by a woman who accused the largest U.S. drugstore chain of deceiving customers into believing its Vitamin E dietary supplement contributes to cardiovascular health.”
“The complaint, filed on Friday in federal court in Chicago, challenges a label on Walgreen’s Vitamin E 400 IU Dietary Supplement that says the product “naturally contributes to cardiovascular health by helping to protect LDL cholesterol from oxidation which may cause cellular damage.” The plaintiff maintains that she purchased several bottles and the product doesn’t work.
The Food and Drug Administration has not completed a review on the case. However, it had a similar case in 2009 requesting the Food and Drug Administration (FDA) to authorize a health claim about the relationship between dietary supplements of vitamin E and reduced risk of heart disease. The FDA responded in a letter addressed to the plaintiff at that time.
The agency said in the letter that they, “did not find a sufficient basis to establish a causal relationship between vitamin E supplements and CVD risk from its evaluation of the results of the clinical intervention trials. The agency noted that, overall, the results of the observational studies were inconsistent; i.e., a clear relationship between vitamin E intake and a reduction of risk of cardiovascular disease could not be discerned. The agency concluded, therefore, that the results from the totality of scientific evidence, considering the limitations of some of the study designs and the inconsistent results obtained, provided an inadequate basis to support a relationship between vitamin E supplements and reduced CVD risk. The conclusion the FDA determined that health claims relating vitamin E supplements and reduced risk of cardiovascular disease are inherently misleading and cannot be made non-misleading with a disclaimer or other qualifying language.
Furthermore, The office of Dietary Supplements – National Institutes of health report, “the Heart Outcomes Prevention Evaluation (HOPE) study, which followed almost 10,000 patients at high risk of heart attack or stroke for 4.5 years found that participants taking 400 IU/day of natural vitamin E experienced no fewer cardiovascular events or hospitalizations for heart failure or chest pain than participants taking a placebo. In the HOPE-TOO follow up study, almost 4,000 of the original participants continued to take vitamin E or placebo for an additional 2.5 years. HOPE-TOO found that vitamin E provided no significant protection against heart attacks, strokes, unstable angina, or deaths from cardiovascular disease or other causes after 7 years of treatment. Participants taking vitamin E, however, were 13% more likely to experience and 21% more likely to be hospitalized for heart failure; a statistically significant but unexpected finding not reported in other large studies.”
However, Reuters does report that, “According to the National Institutes of Health, Vitamin E has an antioxidant function that protects cells from damage caused by so-called free radicals, which can contribute to the development of cardiovascular disease and cancer.”
It will be sometime yet before the Walgreen case is validated or refuted.