Who Builds Finished Product Specifications and Testing Plans for New SKUs?

Every supplement SKU needs a Finished Product Specification (FPS). This document sets the quality standards for the product, including label claims, testing limits, and QC protocols – which are the essential parameters a product gets rejected or accepted for sale into the market.  Without an FPS, you cannot demonstrate compliance to FDA, retailers, or distributors.

FPS is also the foundation for testing plans. It dictates what needs to be tested, how often, and by what methods. For example, a probiotic requires “potency” testing by CFU count, while a protein powder requires heavy metal and allergen testing. Having a professional FPS ensures that your product consistently meets its claims and quality expectations.

While supplement manufacturers are required by regulation to build the finished product specifications, many manufacturers use loose or minimal parameters and testing and rarely share this document with their customers unless requested. What may look to professional and impressive document may actually be a false sense of security. In addition, many times these specifications do not factor a brand’s specific requirements and/or claims.

Blue Ocean Regulatory develops FPS and testing plans for new SKUs. We align them with FDA rules, scientific best practices, manufacturer requirements, retailer standards and your brand’s expectations – it is customized to your specific product and formula.  We also ensure the testing plan is realistic for your manufacturer and labs to execute, avoiding gaps that can delay launches or cause compliance failures.

Almost every week, we see startups with missing or poor finished product specifications which puts their product and brand at risk every single day it’s out in the market.  In one particular case, a brand’s FPS tested no more than a basic microbial test. They did not test for heavy metals, ingredient label claims, weight, allergens or pathogens. We worked closely with the brand and their manufacturer to update the specification and testing parameters, providing peace of mind for the brand and accountability on the manufacturer.  

When building new SKUs, the best partner is one who combines regulatory expertise with practical testing strategies. That’s what ensures your products are safe, compliant, and trusted.