Codex shelves probiotics proposal, exposing industry rift

A recent development at an international regulatory meeting has exposed a rift within the dietary supplement industry relating to the definition of probiotics and the strategy around harmonizing that on a global level.

Labyrinthine committee process

The action took place at a meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (colloquially known as the Nutrition Committee), a subset of the Codex Alimentarius Commission, a joint effort by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), both divisions of the United Nations. The most recent committee meeting took place in Dresden, Germany.

Codex maintains and publishes a collection of internationally recognized standards, codes of practice, guidelines and other recommendations. Those are used by individual countries when writing their own food and supplement regulations.

Committee meetings generally stretch four days and feature attendees from governments around the world, all of whom often weigh in on the matter at hand. It’s a cumbersome process that moves at a slow pace. The meetings are summed up in detailed reports.

Proposals for changes or additions to the guidelines are either then referred to the full commission (much like proposed laws that pass a committee are then sent to a full legislative body for additional debate) or are de-prioritized.

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Outdated probiotics definition

For many years, the International Probiotics Association (IPA) has identified the need for better harmonization of probiotics regulations on the global level. The industry and international regulators are working under a Codex definition implemented in 2001. It defines probiotics as “microorganisms that, when administered in adequate amounts, confer a health benefit on the host.”

Since 2017, IPA has worked with Argentina, China and Malaysia to put forward an alternate proposal. The proposal has several aspects, including clarifying the definition of a probiotic. It would also make labeling recommendations, including the use of the genus, species and strain names. And the proposal would bring more clarity to how probiotics are quantified based on CFUs (colony forming units) and specify the minimum amounts necessary for a microorganism product to produce a health benefit and therefore meet the standard for being called a probiotic.

IPA: Current situation causes confusion, raises costs

George Paraskevakos, executive director of IPA, said the current situation places significant burdens on companies and can lead to higher costs and consumer confusion. Based on the older, broad definition from Codex when crafting their own regulations, countries have come up with classifications for probiotics that can differ greatly from country to country.

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“It could be a food or a food supplement or could even be a drug in another country. The same product. The same 60 capsules,” Paraskevakos said.

“The intended use of the product is to supplement your diet, and you need a drug registration for that?” he added.

However, the proposal for a new, more detailed definition that might help solve some of those problems did not make it through the most recent committee meeting.

CRN raises red flag of unintended consequences

One of the stakeholders at the meeting that advocated against the proposal was the Council for Responsible Nutrition (CRN). Steve Mister, president and CEO of CRN, explained his trade organization’s position.

“The probiotics initiative ... was well intentioned but completely misguided, and it failed to really consider some of the unintended consequences that could have come about if this had moved along as it was,” Mister said.

Mister explained CRN was convinced the proposal would have required companies to prove the benefits they claimed to provide. While developers of probiotic ingredients claim to have a significant amount of research to demonstrate the benefits of probiotics, one highly influential international nutrition body hasn’t seen it that way.

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In 2008, the European Food Safety Authority (EFSA), the governmental body tasked with making recommendations for the harmonization of food standards across the EU, started evaluating dossiers submitted by dietary supplement companies for health claims relating to their products.

From 2008 to 2015, EFSA rejected more than 90% of those claims. And, significantly, it rejected all of the claims for probiotics. There were many harsh criticisms of the process, including an allegation that the standard of evidence required to prove a claim to EFSA’s satisfaction kept creeping up as time went on — finally approaching the standard that applies to pharmaceutical companies seeking drug approval.

Mister expressed apprehension that the industry could be setting itself up for another EFSA-style beatdown by raising questions within an updated probiotics definition.

“What does that mean, to confer a benefit on the host? What level of evidence is necessary to demonstrate that?” Mister asked. “We look at what's going on in other parts of the world where they can't get a health claim for a probiotic because the regulators say that the evidence is not strong enough.”

IPA: CRN’s fears are overblown

Paraskevakos said those fears were overblown. He pointed to the language in the final report.

“This is not about health claims. It says so right in the report,” he remarked. “What we are trying to do is just smooth out the pavement that everyone is driving on.”

Paraskevakos also disagreed with the characterization of committee’s action as a “rejection” of the proposal.  It has been remanded to the WHO and FAO for a systematic review of the scientific evidence on probiotics.

That will delay the proposal for at least a couple of years but won’t necessarily derail it entirely, he said.