Designing Meaningful Specifications for Dietary Supplements – A Big Shortcoming
Posted by Jeff Stassi, Eurofins Analytical Services Manager
Do you realize that the FDA requires you to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the product? That certainly seems like a prudent statement. So why do so many supplement companies fall short of setting meaningful specifications? It is difficult to comprehend why so many products are designed and produced without setting appropriate specifications. To highlight the point, a countless number of supplement companies have been called out through FDA warning letters to this very subject. They usually state something like; You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or lead to the adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
So why is it so important?
Well, the obvious reason as described above is that the FDA requires it, but it goes much farther than that. Here are a number of reasons to justify and to place emphasis on setting proper specifications:
- To provide a means to produce a quality product consistently. If you have too much variability designed into your specifications, it will be impossible to produce the same product each time. Consider a high and low limit in order to control the variation.
- To control and prevent adulteration. It will be impossible to control adulteration if you have not addressed unknown components that may be present. Sometimes adulteration happens for economic reasons, by substituting lower-cost components to pass off as the real thing.
- To address safety concerns and contamination. It is important to set specifications that are “likely” to be present in order to address compounds that may be harmful if ingested.
- To ensure label claims are met. The FDA states that the dietary ingredient must be present at 100% through the shelf life of the product. Consider that when designing the specifications adequately.
- To make sure the manufacturer is providing you the product you paid for. It is always a best practice to keep your third part manufacturers honest. It is necessary to qualify the product through independent analytical means where meaningful specifications are needed.
The takeaway is that the best products are always the ones that have taken quality and safety seriously. Much of what it takes to get that that point is to invest in the up-front process by setting meaningful specifications.