Warning Letter Highlights Importance of Detailed Quality Agreements

The importance of having a detailed quality agreement with your contract manufacturer has been driven home by a recent warning letter issued to a marketer of sports nutrition products.

It’s a common practice within the dietary supplement industry to use contract manufacturers and this is perhaps especially true in the sports nutrition sphere. Handling large volumes of powered ingredients requires special facilities, and many sports nutrition brand holders do not have as part of their business plans a goal to make the investment for dedicated manufacturing facilities. Many of these brands occupy smaller niches with smaller production runs, making it unlikely such an investment could be paid off in a reasonable time without in turn running those same lines in a contract manufacturing mode on the side.

*** 

Denver-based attorney Justin Prochnow, who is a shareholder in the firm Greenberg Traurig, said the letter emphasizes the importance of a having a detailed quality agreement with a contract manufacturer to go along with a general agreement that would cover pricing, delivery and so forth. Just telling FDA that your contract manufacturer handles the quality control on the supplements you sell in insufficient, he said.

Continue Reading.