Regminds Blog

Working with Suppliers – Are you getting what you pay for?
Published on June 7, 2017
Caden Carter
Quality and Regulatory Professional

“I just figured my supplier/manufacturer knew what they were doing.” I have heard the phrase too many times. Don’t get me wrong, there are plenty of both suppliers and manufacturers out there who are very good at what they do. It just gets difficult when you come to the realization that your formula or marketing plan have to change.

I am specifically speaking of ingredients in this instance. For example, company X hits the drawing board for product development and are looking for natural caffeine sources. They end up choosing green tea, guarana, and green coffee bean. When the project finally gets handed to me, I immediately ask to see spec sheets for the ingredients. It doesn’t take long for me to point out to the client that their caffeine is not “all-natural” at all, but instead mostly synthetic caffeine. That’s when I have to recommend either a change in marketing or a reformulation.

I’ve reviewed thousands of spec sheets and a big problem I see, especially in botanical ingredients, is that you, as the purchaser of ingredients, may not be getting what you request. I’ve seen ingredients passed off as a “Guarana Seed Extract” to be 85% maltodextrin, 10% synthetic caffeine, and a bit of guarana seed extract thrown in at the end. In my previous example, I’ve seen ingredients marketed as “green tea powder” consisting of 85% synthetic caffeine and 15% green tea. This doesn’t just happen with caffeinated ingredients, this can happen with any of your ingredients. This can affect the regulatory status of an ingredient (both domestically and internationally), the types of claims you can make, or even the effectiveness and quality of your product.

It is great to trust manufacturers in areas where maybe you just quite don’t know enough. However, when it comes to YOUR product and YOUR ingredients, take the time to review what is going into your product. It is not only required by regulation, but it could save you some heartache in the future.

Give the Carter Regulatory group a call, send an email or text your questions. Let us help with any FDA compliance questions, 483 Responses, or those dreaded warning letters.