Regarding your product labels – are they all they should be?  Has your formula changed recently? Do you have other ideas about what to say about your product on your label? What about the most recent changes in FDA’s evaluation on labeling? How does your label affect your costs for maintaining quality control and overall cGMP compliance? Do you know how to establish the correct label claims for your product? Do you know how to correctly determine the expiration date of your product by conducting sufficient stability or shelf-life testing? Do you know the difference between supplement facts and nutritional facts?

The matters of label revision come about because of any of these questions raised above.  Even the smallest change in the composition of your formula impacts your label and mandates change. Understanding the pitfalls and compliance issues with claims you wish to make is also critical to successful regulatory conformance.  

Label revisions are a requirement not only for the things you wish to change but for those things that mandate change.  Even the adjustment of the level of one excipient in your formula likely means a label revision is required.  Since this is a costly prospect, each revision should be addressed carefully and each revision should take advantage of the opportunity to insure that the copy present, both mandatory and otherwise, is the best it can be.  

Label claims presentation is a key to your marketing success as much as anything, especially with sports performance products who traditional to an nutritionally aware and educated consumer base. When your formula changes, not only the active ingredient levels but also your raw material sources, your label needs to be changed as well unless you have qualified your entire supply chain to demonstrate consistency and reliability.  

Knowing what changes are required and applying these changes to your full advantage makes for the most effective use of this change. If your label is over a year old, the chances are something has changed. Whether it is the formula as a result of manufacturing process change or the supported claims you make coming under closer regulatory scrutiny, these are the opportunities you have to enhance while maintaining conformance with the applicable regulations.  

An annual review at a minimum is key to keeping current and allows for you to maximize the impact of your labels. And if you are using a contract manufacturer to make your product, you need to conduct even more due diligence to ensure they are correctly abiding by cGMP guidelines.

This applies to all forms of copy that can be defined as labeling by FDA. It is not only the information on the package that is considered labeling and especially when you use electronic media for marketing presentation, where change is easier and less costly, those changes can become concerns if they are considered to be labeling as well.  Every change you make to your labels has impact on your conformance to the regulations, even if the information is not directly applied to your product.  

Taking the time up front to insure that you have the right and sufficient protocols in place for your labeling as well as manufacturing and raw material qualification, is required for cGMP compliance and is the surest way to avoid regulatory challenge, which could result in fines, negative press and decreased brand value or even costly product recalls. Furthermore, one should not just be concerned with what the FDA may or may not investigate when it comes to their label claim, but what the FTC might identify or more commonly, a civil or class-action suit that results in expensive litigation for years to come.