Product formulas sometimes stop working.  An ingredient may have to be replaced because they don’t make it anymore.  An ingredient may become unacceptable because of government regulations or because the blogosphere has deemed it unfashionable.  Or maybe production problems just won’t go away.  In any case, sometimes a formula needs to be fixed before you can continue to make it. 

At a certain level you are making a new formula as if it were a new product development project.  Although you have the old formula, the changes you will need to make will require a number of things to be done as if you were making a brand new formula.  From a regulatory compliance standpoint and from a product liability standpoint any changes to your formula make it a new formula.  The relationship to the old formula may help guide understanding the new one, but in terms of ‘proving’ the safety of the new product, most of the time testing needs to be repeated.  Evaluations should be done to determine if any claim substantiation tests need to be repeated as well.   

So like any product development project, write a project profile describing what the product should look like and what needs to be done.  The clearer your plan, the easier it will be to make it happen, and the sooner you will be back in production.

Sometimes fixing a broken formula becomes an opportunity to make changes that improve the product.  Other times, solving the formula problems without changing anything that the consumer experiences is the best way to proceed.  Incorporate your tolerance for changes into your project profile plan.  It is a good idea to outline which ingredients are acceptable in the new formula and which to avoid.  Are you staying with the same ingredient list that is on your current packaging, or will it change?

Once a cosmetic chemist gets your project profile the changes can start to happen.   Your current manufacturer may have laboratory resources available to help with the formula adjustments.  Working with a consulting cosmetic chemist is another option.  This choice gives your company ownership of the new version of the formula, an investment that gives you manufacturing flexibility and more control over your product.

Either way, like any new product development project, you will need to evaluate submission samples of the revised formula to make sure it meets your aesthetic and performance requirements.  Review the specifications for the new formula.  Are any changes necessary?  What does the ingredient list look like?

Once you have approved a new formula for your product there is still work to be done.  Stability and safety testing will need to be done, and claim substantiation testing may also need to be addressed.  Do the formula changes necessitate any changes to the labeling on your packages or copy in your advertising?  Changes to any government registrations or notifications may also need to be addressed.

About the Author:  Cosmetics and personal care technical consulting expert Howard Baker is managing member of Product Integrity Laboratory LLC, which provides product development and quality control/quality assurance services for companies in the fragrance and cosmetic industry that use contract manufacturers.  A cosmetic chemist with more than four decades of experience in the beauty industry, Baker has overseen product development and has provided technical consulting services in the areas of formulation development, product development testing, quality assurance and quality control, and regulatory compliance. Visit: www.prodinteglab.com