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WASHINGTON—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, announced Monday that it had successfully influenced proposed international regulatory guidelines on probiotics at the recent Codex Alimentarius committee meeting.
Following hours of deliberation, during which some countries pushed for the adoption of these new burdensome standards, members of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), held in Dresden, Germany, from September 30 to October 5, 2024, voted to refer the proposal to develop global requirements for probiotics to the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) for a systematic review of the scientific evidence on probiotics.
This action ensures that it will not be returned to the Committee for consideration for at least several years.
The proposal from Argentina, Malaysia and China would have guidelines incorporated like those of the European Food Safety Authority’s (EFSA) into Codex (the collection for international food safety standards), including a definition of probiotics that requires they demonstrate the ability to “confer a health benefit on their host.” Given EFSA’s long history of rejecting almost all evidence of the efficacy of probiotics, this proposal could have led to nations rejecting claims for the beneficial effects of probiotics for better health, and even a prohibition on the use of the term “probiotic” to describe these products.
CRN’s strategic advocacy, working with their colleagues at its member companies and the International Alliance of Dietary/Food Supplements Associations, led to the favorable outcome, blocking the prioritization of new work on the proposal contained in the “Discussion Paper on Harmonized Probiotic Guidelines.”
In a decisive turn during the CCNFSDU proceedings, both the FAO and WHO reiterated that the proposed work on the probiotic standard requirements would fail to address the core concerns of countries seeking to protect their markets from low-quality and adulterated products. While recognizing that quality issues and deceptive marketing exist in some markets, those nations should not look to a global standard to solve enforcement gaps at the national and regional levels. Based on FAO and WHO’s strong statements, the CCNFSDU Chair directed these bodies, WHO and FAO, to reexamine their 2002 guidance document and make updates as necessary. Only after this update will the sponsoring country delegations be allowed to revise and resubmit their proposal for priority setting.
This directive’s conclusion signals that the proposed probiotic guidelines requirements will likely be delayed for years before being reconsidered.
“We are pleased with the outcome of these discussions at CCNFSDU, which validates CRN’s proactive and balanced approach to probiotic regulation,” said CRN’s James Griffiths, Senior Vice President, International & Scientific Affairs. “Our goal is to ensure that high-quality probiotic products remain accessible to consumers, while avoiding regulatory measures that do not enhance product safety or efficacy. All other dietary supplement ingredients are accommodated in current Codex standards, which focus on safety, efficacy, labeling, etc., without the need for a sudden de novo vertical standard just for probiotic ingredients. The unintended consequences could set unneeded and potentially untenable processes that could swallow other dietary ingredients in the future.”
CRN's sustained efforts have emphasized the importance of preserving a science-based, global regulatory environment that recognizes probiotics' proven safety profile and value without layering in impractical requirements that complicate market access and potentially only favor the few companies involved in the details of the new work proposal as it currently stands. This victory at Codex reinforces CRN’s ongoing commitment to advocating for policies that allow companies to bring trusted products to consumers worldwide.
The proposal as presented would echo the EFSA’s model for probiotic regulation, especially concerning health claims, requiring companies to provide robust, evidence-based data that demonstrates a clear and beneficial effect on human health, referred to as a “host-benefit.” This model classifies probiotics as food ingredients rather than supplements, meaning they fall under the strict health claims regulations applicable to foods. Specifically, EFSA mandates that any health claim associated with a probiotic product must be substantiated through rigorous scientific evidence, often in the form of human clinical trials that clearly show a measurable health improvement directly attributable to the probiotic strain(s) in question.
EFSA’s stringent standards have led to challenges for companies in the EU, as many claims do not meet these rigorous requirements, resulting in a high rejection rate for probiotic-related health claims. Consequently, this model has limited the scope of marketing probiotics in the EU, where the label “probiotic” itself is generally not allowed without an approved health claim. Further, both FAO and WHO were quite vocal stating that if this proposal would proceed, it would definitely need outside scientific expertise, especially on safety and efficacy, and that can only be done outside of CCNFSDU as those activities are not in the CODEX mandate or expertise.
As an internationally recognized leader in the field of dietary supplements and functional foods, CRN continues to engage actively at Codex and other regulatory bodies to ensure that global standards reflect the most current science and support a thriving health and wellness industry. CRN was the first non-government organization (NGO) recognized by Codex to advocate on behalf of dietary supplements and continues as the foremost NGO on this topic. CRN annually hosts a scientific symposium in conjunction with the CCNFSDU meeting to educate regulators and other stakeholders on the latest in nutrition science.
