The guidelines, developed by the Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA), are designed to ensure probiotic manufacturers can consistently create high-quality products that consumers can be confident in.
“We believe these guidelines will raise the bar for the probiotic industry,” said George Paraskevakos, executive director, IPA. “In working with CRN to develop this critical list of recommendations, we’ve demonstrated that the dietary supplement and functional food industry is proactive and responsible when it comes to meaningful self-regulation.
“These guidelines reflect the most up-to-date science and industry thinking, and will continue to be updated as best practices evolve. We should always be looking for ways to make our sector and the entire industry better for the benefit of consumers, and adhering to these guidelines is a big step forward.”
“We trust the industry will embrace these guidelines and integrate them into their labeling and manufacturing practices,” said Andrea Wong, PhD, vice president, scientific & regulatory affairs, CRN. “As more and more consumers incorporate probiotic products into their daily health regimen, we felt it was essential to develop a roadmap for companies producing and marketing these products to ensure that they meet consistent, high-quality standards.”
CFUs
The guidelines recommend that the product label should identify the genus, species, and strain for each microorganism in the product, and that the quantitative amount(s) of probiotics in a product should be expressed in colony forming units (CFUs).
Dr David Keller, VP of scientific operations at Ganeden and chair of the committee to develop the guidelines, told us: “As we stand today a number of groups are working on different ways to enumerate bacteria, and they may become the standard one day, but CFUs is the only scientifically sound method that we [the working group] are all comfortable with today.”
Currently, the regulations require the labeling of probiotics by weight per serving (usually in milligrams for probiotics) to give consumers the information they need to evaluate how much “effective” ingredient is in a product. While such an approach may work for vitamins, minerals, fatty acids, botanicals and other dietary ingredients, probiotics are very different.
In addition to the guidelines, IPA has submitted a citizen petition to the FDA to require the labeling of probiotic ingredients in dietary supplements as CFUs instead of by weight. The petition (docket number FDA-2016-P-3968) is open for public comment until May 17, 2017.
Stability, storage & handling
Additionally, the guidelines’ stability testing recommendations are designed to ensure that the stated shelf life of a given probiotic product is scientifically-supported:
- Stability testing should be conducted under the same temperature conditions as the recommended storage conditions on the finished product label.
- Stability testing should be conducted under real-time conditions to support the stated shelf life of the product.
- The product and packaging conditions used in stability testing should be supported by scientifically sound evidence.
- Products should contain 100% of the quantity of probiotics declared on the product label at end of shelf life, except for any variability that is attributable to methods.
Storage and handling recommendations advise manufacturers to consider individual product formulations and packaging, as well as storage and transport environments.
“Manufacturers should provide storage and handling instructions to customers, taking into account individual formulations and packaging,” recommend the guidelines.
The guidelines, which can be read HERE, have been written for the US market, but the general principles behind labeling are applicable to any market in the world, said Ganeden’s Dr Keller.
Working group
The guidelines were developed by a CRN/IPA working group with 60 individuals representing 37 of the top probiotic ingredient and finished product manufacturers, explained IPA’s Paraskevakos. Work on the guidelines started in November 2015 and took a year to develop, he said.
The guidelines are voluntary and adherence will not be a condition of membership for IPA, added Paraskevakos.
FDA appreciates the effort
Commenting on the new best practice guidelines, Marianna Naum, PhD, Strategic Communications and Public Engagement Staff at the FDA told NutraIngredients-USA: "FDA appreciates the effort by CRN and IPA to approach the production and marketing of products containing live microbials in a thoughtful, transparent, and consistent manner and looks forward to learning more about this effort.
"FDA is aware this is a growing area of dietary supplements that could benefit from additional clarity. As our resources allow, we hope to provide guidance on this subject and we intend to continue engaging with stakeholders as we work toward doing so."