Bayer Warned – Pull False Vitamin Claim or We’ll Sue

Bayer Warned – Pull False Vitamin Claim or We’ll Sue

May 8th, 2013 // 5:00 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

A nonprofit organization has threatened Bayer that it will sue them for making unsubstantiated and illegal claims about its One A Day vitamin to stop various types of diseases and provides major health benefits. These include breast cancer, improve immunity response and increase energy.

For example, the Center for Science in the Public Interest notes that a Bayer web page offers tips to not get breast cancer. The page states that taking a One a Day vitamin with a lot of vitamin D can help to  support breast health. But the organization states that there is limited evidence of the role that vitamin D plays in preventing this type of cancer.

The legislative director for CSPI states that Bayer is comparing One a Day vitamins to the efficacy of a mammogram. He says that Bayer is saying if you take these vitamins, you will cut your breast cancer risk.

CSPI also states that Bayer is using the same tactics when it states that the vitamin helps bones, joints or the eyes. Consumers tend to think those words mean that vitamins can help to stop arthritis, osteoporosis or serious eye problems.

This is the second time that CSPI has gotten in a legal struggle with Bayer. In 2009, CSPI filed a suit over a claim that a One a Day men’s vitamin with selenium could cut prostate cancer risk. The organization states that the biggest prostate cancer clinical trial ever had to be stopped when it was shown that selenium did not help to prevent the disease.

Bayer claims that the 2009 lawsuit was rejected in court and Bayer states that it has strong scientific evidence to support any claims made about One a Day. Bayer also denies that it has ever made claims that its vitamins can mitigate, prevent or treat serious diseases. Bayer also disagrees with the argument from CSPI that a randomized and controlled clinical trial is the standard form of evidence to support the claims made by companies that make vitamins.

On a more unusual note, Bayer also stated that CSPI has sued other companies on similar matters and negotiated some sort of resolution before going public with threats of lawsuits. This was regarding Pfizer and its Centrum vitamins. Bayer stated that CSPI should not have gone straight to the media with this issue and should have consulted with Bayer first.

Bayer also in recent months has had issues with cGMP quality agreements that have resulted in FDA 483s in some cases. Learning how to write a cGMP-compliant quality agreement can really help to reduce the risk of 483 and warning letter observations.


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