Misleading health related Vitamin Claims

Product Claims – Saying what you mean, meaning what you say.

Misleading Consumers with false Health Claims can lead to judicial inquiry and facing legal implications thereafter.

The Issue:

German Global Pharmaceutical giant is in the limelight for facing charges levied by The Center for Science in the Public Interest (CSPI), a leading consumer advocacy group. Their product One-A-Day multivitamins has come under rigid scrutiny for false claims with regards to its health benefits. ¹

The group maintains that the Pharmaceutical Company has been releasing misleading information about Selenium, a trace mineral found in their One-A-Day Multivitamin. It widely claimed that Selenium was able to “support prostate health” and “reduce the risk of prostate cancer.” This claim was questioned by the Advocacy Group who claimed that the trace mineral could in fact cause a lot more harm to the consumers than its proclaimed benefits.

Claims Tug of War:

The Pharmaceutical Company had earlier claimed that their One-A-Day mens vitamins could help to prevent prostate cancer because of its ingredient Selenium. They were now revising the verbiage in their advertising material and packaging claims to conclude that the inclusion of Selenium could ward off ‘certain types’ of cancers because of the perceived cancer fighting benefits.

A statement issued by the CSPI executive director, Michael Jacobson to the media brought out a startling discovery. He revealed that the Pharma Giant has been giving American men false hope about Selenium contained in their product, One-A-Day multivitamins. It was also brought to the notice of the Consumers that a trial study found that the so called benefits of Selenium supplements weren’t that accurate to be justified and clinically accepted. It could in fact have serious health complications and may cause more harm. The company still continued to run and display for sometime advertisements containing verbiage of highly disputable nature.

After the incident, The Company spokesperson was quoted saying that the Company indeed had reviewed the section on the U.S. Food and Drug Administration's permitted qualified health claim on Selenium. It was therein that it was mentioned that ‘Selenium may reduce the risk of certain cancers’. The company also confirmed that it was now channeling to adjust the claims in their advertising material and packaging.

The Vedic Way:

A successful product delivers successfully on all fronts. Right from Discovery, Development to Commercialization is a path filled with challenges. Overcoming Regulatory hurdles in the right and certified usage of Health related Claims is more complicated than it appears. Understanding the nuances of product claims and the government regulations surrounding its legal acceptability can be very daunting. A less regulated market can prove to be easy bait to Nutraceutical Divisions to launch product(s) without much research on the ethical and acceptable Health claims associated.

The Vedic way suggests beginning with identifying the nature of claims one wishes the product to be associated with. Knowing that markets and Regulatory bodies have absolute clear demarcation when it comes to soft claims or hard ‘drug’ claims. Ascertaining that the information accrued from Regulatory bodies is adequate and clinically compliant with the nature of claims one wishes to market Conducting trials in compliance with ICH-GCP Guidelines to fully substantiate your product claims is not an option, it’s a must, a necessity to highlight the authenticity of the product and the claims made likewise.

With professional help from Regulatory Clinicians, this incident could have been avoided. Correct data being analyzed for the development of the most relevant and clinically accepted Health Claims. Had the Data borrowed from FDA been checked to ensure its compatibility with the claims developed the result would have been definitely different.

Shefali Roy looks after International Marketing at Vedic Lifesciences Pvt. Ltd. For more information you can reach her at vedic@vediclifesciences.com or on +91 22 42025731

REF:

1) http://www.healthnews.com/natural-health/vitamins-supplements/bayer-one-a-day-men-s-vitamin-claims-lead-lawsuit-3738.html