Beyond ID Testing
The Need for Additional Testing Beyond ID Verification for Botanicals
Specifications and Verification
There continues to be a focus within the dietary supplement industry on the requirement to confirm the identity of a dietary ingredient prior to use. This has been near the top of FDA issued citations and many warning letters include this as an observation as well. However, the industry has made great strides in this area from the inception of the dietary supplement cGMPS in 2007. More companies have a better understanding for this requirement and the need for using scientifically valid methods for this https://blog.eurofinsfii.com/2019/01/scientifically-valid-id-testing-for-botanicals/.
Even though the industry focus in the area of identity verification has increased, it is also necessary to consider additional testing that is required for ingredients and finished products to fully comply with the regulations.
21 CFR 111.70 specifies that the following specifications must be established and verified for each component used in dietary supplements:
- Purity, strength, and composition
- Limits for contaminants
The above specifications also must be established and verified for each dietary supplement that is manufactured. The best way to ensure specifications are met for ingredients and finished products is to test using an appropriate, scientifically valid method.
Dietary supplement products containing botanicals have increased in popularity and because of this there has been much discussion within industry about how to accurately verify the identity of these dietary ingredients. There are a variety of techniques including DNA barcoding, HPTLC and HPLC that all are appropriate in certain situations. Aside from identity, the industry must be aware that specifications must be made for potential contaminants, and these specifications must be verified, ideally by testing. As botanicals are very complex and diverse, understanding your ingredients is critical to ensure the appropriate specifications are developed. Unfortunately, there is not a single method that will test for all potential contaminants so each potential contaminant must be identified and tested for using an appropriate method. These potential contaminants will vary depending on material, but in general the following are most common for all botanicals and could be used as a starting point:
- Heavy Metals (Arsenic, Lead, Cadmium, Mercury)
- Residual Solvents – if ingredient is an extract
Other potential contaminants could be those from economically motivated adulteration. This may include adding a “filler” to a botanical, replacing some of the target material with a cheaper botanical, or adding a pharmaceutical-type ingredient to improve the efficacy of a product.
As you can see, testing botanicals goes well beyond the id verification. Review your product to understand what additional tests may be needed to ensure quality and safety needed to ensure quality, safety, and compliance with applicable regulations.