Codex shelves probiotics proposal, exposing industry rift

A proposal to clarify the definition of probiotics has been shelved by a Codex committee. The action exposed a disagreement within the industry about whether getting a tighter definition enshrined within these international guidelines is a good idea.

Hank Schultz, Senior Editor

November 18, 2024

4 Min Read

At a Glance

  • Codex Alimentarius is a collection of food standards developed by the United Nations.
  • A nutrition subcommittee recently shelved a proposal for an update of the definition of probiotics.
  • The move exposed a rift within the industry about international probiotics regulations.

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Outdated probiotics definition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.

About the Author

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of SupplySide Supplement Journal (formerly Natural Products Insider) since early 2023. He can be reached at [email protected]

Prior to joining the Informa team, he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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