However, and despite the best intentions of regulators and others, this document does not offer the security to the marketplace without its sister documents. The C of A presumes the actual manufacturing was done in a GMP environment and that each of the ingredients were approved and suitable for the purpose intended. Assumptions are also made about the stability to the item once it reaches the market and are other critical considerations of the product met to ensure the release to market was done correctly.
The C of A itself is a complex document but has limitations. Many times, the information on the C of A is taken from small samples through a production run, which may give a false sense of security if the manufacturing process itself is not reliable. Additionally, a CMO is not required to test every ingredient on the C of A each time the product is made, leaving it in the hands of the Brand Owner to determine the extent of testing required before the product is released to market. Finally, should the Brand Owner engage a 3rd party laboratory for testing, there might be conflicting information generated when compared to the CMO test results, leading to a potential misunderstanding by the Brand Owner or the retail customer about the viability to the product.
So, what is the Brand Owner to do? The answer is not to send the supplement to a 3rd Party Laboratory and test for “everything” in the product according to the finished product specification. As stated above, the nuances of each product can create headaches without a reasoned, measured approach to analytical testing done in conjunction with the CMO.
What about using an ISO 17025 accredited laboratory, as has been requested by many retailers? Doesn’t this solve the testing problem? An ISO 17025 accredited lab demonstrates that the lab has a documented quality system and that they are proficient in running the assays they are accredited for. However, even an ISO 17025 laboratory will have assay issues with supplements and will encounter matrix interference- so while ISO 17025 accreditation is a gold standard for a testing laboratory, there is still the need for a working relationship between all parties.