Scientifically Valid ID testing for Botanicals
Jeff Stassi, Senior Program Development Manager
From the onset of the dietary supplement GMPs (21 CFR Part 111) back in 2007, a focus has been, and continues to be, on the mandatory requirement to confirm the identity of a dietary ingredient prior to use. This requirement was at or near the top of citations issued by FDA for non-compliance as it became obvious that firms were unable or unwilling to understand the process by which to create identity specifications and to perform the appropriate analysis. Now over a decade later, the industry is getting better but still has issues related to this requirement. One area that continues to be most problematic is using appropriate tests and examinations for herbal/botanical ingredients. As we have discussed in previous webinars on this subject, we remind you of the definition of a scientifically valid method is one that is accurate, precise and specific for its intended use.
The FDA places an emphasis on the use of scientifically valid methods in the GMPs in 111.320, it reads:
- You must verify that the laboratory examination and testing methodologies are appropriate for their intended use
- You must identify and use an appropriately scientifically valid method for each established specification for which testing or examination is required to determine whether he specification is met.
It is also a big part of 111.75:
- Before you use a component you must:
- (i) Conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;
As botanical ingredients continue to increase in popularity and more people begin to rely on them for their health benefits, you can rest assured that the FDA will take a closer look as it is their sole mission to keep the food supply safe for the consumer. So establishing a reliable quality control system for these types of ingredients is extremely important and an emphasis on proper testing is paramount.
So how does a firm establish the appropriate identity testing plan?
First you must understand the tools in the toolbox. There are a number of techniques that when used appropriately can identify, or help identify herbal ingredients. These techniques fall mainly into these categories:
- Macroscopic and microscopic examinations
- Organoleptic (color, odor, appearance, taste, smell)
- Genetic (DNA)
- Chemical analysis
All of these tools serve an important purpose in herbal identity testing, but only when applied in a scientifically valid way. The more processed an ingredient becomes, the more complex it becomes to identify it. So understanding the tools and when to apply them is an important piece of the puzzle, and one tool may not get the job done. You certainly would not pull a screwdriver out of a toolbox to drive a nail in the wall.
Secondly, it is important to understand how and when to use the tools at your disposal. A key step is to establish appropriate specifications on the ingredients you purchase so that the testing process can flow much more easily. Confirming these specifications through appropriate scientifically valid methods will help assure the quality of the finished product. Remember, it may take more than one test to identify the material. In the industry it is known as an orthogonal approach, but it really comes down to performing as many tests or examinations as it takes to confirm 100% identity. If a visual examination can identify an ingredient with 100% certainty, then that is scientifically valid and you will need no further analysis. As ingredients are further processed, the likelihood of using only organoleptic techniques would not be appropriate and will require more sophisticated techniques. This may be the more complicated part for compliance as many firms do not have the proper scientific expertise to completely understand the ingredient and the testing that may go into it. Use a laboratory that has that expertise and will work with you to establish the appropriate program.
In summary, when producing quality products and minimize your risk of non-compliance, here are some key points to consider:
- Create a well-designed identity testing program
- Create identity specification for all incoming ingredients
- Use an orthogonal approach where needed
- Use reputable suppliers for quality ingredients
- Use only scientifically valid methods
Want to discuss scientifically valid testing specific to your product? Contact us at the link below!