SORA Labs January 2018 Newsletter

Calculating Label Claims

Formulate

You have formulated your product, now what? Take a look at the formula specification sheet to determine what raw materials are needed.

Test Raws

Every raw material going into a formula needs to be tested (CFR Title 21 part 111.75). Once tested, a raw materials certificate of analysis will be received.

Build Label

With the specification sheet and raw material certificate of analysis in hand, the label claims are ready to be made. Download our calculator to assist in building the label.

How To Use The Calculator

Here are the steps to help populate the calculator:

  • Enter the raw materials in column A
  • For columns D & E use the formulation specification sheet to find the correct information
  • Activity claim and activity units for columns B & C can be found on the raw material certificate of analysis or specification sheet
  • Columns G & H are the target specifications for the finished product. This information is used to create the label and is also what you include on the sample submission form for testing the finished product

CRN Member Spotlight

Substantiating label claims can be a daunting process, but testing is always a good place to start. Knowing exactly what is in the supplement bottle is paramount, and recent FDA warning letters confirm this. FDA requires that products have specifications and that those specifications are met. Following 21 CFR part 111 for dietary supplement products, the rules make it clear that testing is required.
Check the article on CRN’s Website

Thorough Testing Equals Safe Products for Consumers

Substantiating label claims can be a daunting process, but testing is always a good place to start. Knowing exactly what is in the supplement bottle is paramount, and recent FDA warning letters confirm this. FDA requires that products have specifications and that those specifications are met. Following 21 CFR part 111 for dietary supplement products, the rules make it clear that testing is required.
Check the article on National Product Insider’s Website