FDA enforcement: An injunction for disease claims

An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products. 

Claim substantiation is one of the major concerns in the successful clinical development of a nutraceutical/ dietary product. It is a critical component in the process as false or misleading claims made by supplement manufacturers are subjected to judicial action. Often manufacturers find themselves at crossroads due to their lack of knowledge of correct label claims. They prefer to set these claims by relying on information which most of the times may come in from dubious sources and try to avoid consultants who are experts in the field. Result; Product Recall or in the above case a permanent injunction. How do you avoid such a situation? First and foremost one needs to identify the product correctly in accordance to the therapeutic benefits accrued from its ingredients. An overzealous effort to claim what doesn’t exist or relate to certain health conditions can even cause fatalities. Specific Claims need substantiation and cannot be stated without clinical evidence. Consult a right consultant with experience and expertise in the field of Nutra product research. Such consultants will guide you in understanding your product potential and will assist you in drawing up correct and relevant claims and then substantiate the same. Vedic offers a simple and scientific environment to substantiate your claims. Let us help you deliver your promise of good health.

http://www.nutraingredients-usa.com/Regulation/FDA-enforcement-Consent-decree-for-GMP-violations-and-an-injunction-for-disease-claims