While not possessing statutory authority, a helpful guide for manufacturers of probiotics products is, “Best Practices Guidelines for Probiotics,” created through a partnership between The Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA).

The Guidelines provide a clear outline of measures recommended for manufacturing safe, high-quality probiotics products.  The recommendations also intend to assure consumers that product labels are accurate and backed by robust scientific methods.

The authors state in the introduction of the document, “CRN and IPA have developed scientifically-based voluntary guidelines that address labeling, stability testing, and storage recommendations for probiotic-containing dietary supplements and functional foods. These guidelines are intended to facilitate transparency and consistency.

The Guidelines recommend that product labels contain the following information:

• The quantitative amount(s) of probiotics in a product should be expressed in Colony Forming Units (CFUs).
• The labeled quantity of probiotics should reflect the quantity of live microorganisms at the end of the stated shelf life, not at the time of manufacture.
•  The label should identify the genus, species, and strain for each microorganism in the product.

For products containing only one strain of probiotic, the label should declare the quantity of that strain in CFUs. For a product containing multiple strains, the label should indicate the total count of the blend in CFUs.

To determine the stability of probiotic products CRN and IPA suggest following either ICH Stability Testing of New Drug Substances and Products Q1A or the USP General Chapter <659> Packaging and Storage Requirements, adding, “(s)tability testing should be conducted under real-time conditions to support the stated shelf life of the product. Use of accelerated or other testing in a program to support product release should be scientifically justified and documented.”

The guidelines further advise, “(p)roducts should contain 100% of the quantity of probiotics declared on the product label at the end of shelf life, except for any variability that is attributable to methods. All stability testing methods, including proprietary testing methods, should be scientifically sound, repeatable, and reproducible. The specific testing method used should be documented.”

A typical stability determination following these guidelines may include developing and validating a method for recovering accurate probiotic counts in a particular product. A qualified laboratory such as Q Laboratories can provide the development and validation service along with stability sample storage and time-point analyses for both real-time and accelerated conditions

Access the Guide here.