Article #2 – In the next few weeks, RNI Consulting will discuss different topic around the Probiotic theme. With this series, you will learn about probiotics and the regulatory framework.
Understanding dietary supplement and cosmetic labeling regulations can be a challenge, particularly for probiotics. Probiotics products have unique properties and considerations that are not always explicitly addressed in written regulations, and therefore industry guidance is important to follow.
Some common questions we see are:
- How should a probiotic be identified?
- What label claim should be used?
- What about CFU?
- What if the product has a probiotic blend of several strains?
In this installment of our probiotic series, RNI is here to help you understand the regulatory basics and provide some industry guidelines and best practices for compliant, clear, and transparent probiotic product labels.
Dietary supplement products must list dietary ingredients by their standard common name, and cosmetic products should also list ingredients by their common name – but what does this mean for probiotics? One common mistake seen in commercialized dietary supplements and cosmetic products is that they do not identify the probiotic ingredient adequately and may state just “probiotic” or the genus species name. The best practice for probiotic labeling is to include the full genus, species, and strain designation for each individual microorganism. This is considered industry standard in order to provide complete information to the consumer. Safety information and genetic evaluations are strain specific, and as such, the strain should be included on the product label to clearly and adequately identify the microorganism.
Amount by Weight vs. CFU
Colony forming unit (CFU) is the scientifically accepted method to measure the potency of probiotic microorganisms, but the current dietary supplement regulations require that label claims in supplement facts panel use the quantitative amount by weight (e.g. in mg or g). Recently, however, the FDA has indicated they intend to exercise enforcement discretion for labels that contain the CFU claim, so long as certain requirements are met (for example, the amount in weight must also be included in the supplement facts panel)1. So probiotic dietary supplements should list both the mg amount and CFU amount.
Amount per Serving Claim
Browse any probiotic shelf in a nutrition store and you will likely see many product labels that have an asterisk after the label claim that states: “*CFU = Colony forming units at time of manufacture”. However, the industry standard guidance states that probiotic products should contain 100% of the label claim through the shelf life of the product. Probiotic organisms are sensitive microorganisms and in order to ensure they confer a health benefit, trade associations like the International Probiotic Association (IPA) and Council for Responsible Nutrition (CRN) continue to advocate for this standard of meeting the label claim through the end of shelf life.
- For single strain products the claim should be for the quantity of that strain in CFU
- For multiple strain products the claim should be for the total CFU count of the blend
- Probiotic blends may be listed as proprietary blends
Providing a label claim through the end of shelf life has implications for other aspects of the product and label. The industry guidance for these are as follows:
- Best by Dates: Use a date supported by stability data. The industry standard guidelines state that the product should provide the full label claim through the end of shelf life date on the product label.
- Stability Data: Stability testing should consider the formulation, delivery format, and product packaging. Further, stability testing should have real time data in most cases. Probiotic products should have scientifically valid, adequate, and accurate stability data to ensure the label claim is met through the shelf-life of the product.
- Storage Instructions: Storage and handling instructions should be clear to consumers and should consider the environments that the product may be exposed to throughout the shelf life of the product to ensure that label claim is met through the best by date.
- Product Claims: Another reason that the end of shelf life label claim is important is because the dose of the product when ingested should match the study doses being used as substantiation for product claims.
While FDA has provided guidance on labeling for dietary supplements, no such guidance has been offered for cosmetics…
Is your probiotic label complying with labeling regulations and industry best practices? RNI is here to help! We can support development of compliant labeling and claims for probiotic dietary supplements and cosmetic products that is up to date with the most current best practices and industry guidelines.
1 Available online at: https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-labeling-dietary-supplements-containing-live-microbials