Navigating Gut Health: Prebiotic, Probiotic, and Postbiotic Claims

Understanding the marketplace and permissibility.

February 9, 2024

In recent years, consumer interest in gut health has skyrocketed, leading to a surge in food and beverage products featuring gut health claims. These claims often center around three key categories of ingredients: probiotics, prebiotics, and postbiotics. 

All three categories have seen their usage grow from niche marketplaces to international recognition and definitions in a matter of decades. Although not defined by the FDA, these terms are generally understood as the following:

  • Probiotics are live microorganisms that may confer health benefits when consumed. The World Health Organization and UN Food and Agriculture Organization jointly filed a report in 2001 defining probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” In simple terms, probiotics are live beneficial bacteria that you eat in hope they survive the acidic environment in the stomach and then colonize your intestinal tract.  
  • Prebiotics are non-digestible food ingredients that promote the growth of beneficial bacteria in the gut. Prebiotics were first discussed in 1995 and were given official guidelines by the World Gastroenterology Organization in 2012, stating prebiotics “lead to health benefits for the individual through a positive influence on native beneficial microbes.” In simple terms, this is the food that you can’t digest (e.g., fiber), and colonies of beneficial bacteria in your intestinal tract can enjoy it instead. 
  • Postbiotics are byproducts of microbial fermentation, such as metabolites and short-chain fatty acids. The most recently coined category, postbiotics have seen major growth since 2010, and in 2019 were collectively described by the NIH as “functional fermentation compounds… that can be used in combination with nutritional components to promote health.” In simple terms, probiotic farts.

Here's a simple chart illustrating the three categories:

Download the resource here

FDA Oversight of Gut Health Claims: 

In the United States, claims are regulated by the Food and Drug Administration (FDA), and the specific requirements depend on whether a product is classified as a conventional food or a dietary supplement.

Commonly Observed Gut Health Claims: 

Commonly observed claims on gut health products span the spectrum of both regulated and unregulated language. Some of the most common include: 

Quantitative Statements of Composition: 

  • 10 billion CFUs
  • Live and active cultures

Nutrient Content Claims: 

  • 10 grams of fiber, an excellent source of prebiotic fiber

Structure Function Claims: 

  • Supports a healthy digestive system
  • Supports normal gut balance

As a starting point to comply, companies should consider the following: 

  • Ensure that their gut health claims are truthful and not misleading. 
  • Any quantitative declaration can be supported through mathematical analysis, testing, or a combination of both considering factors like processing steps, supply chain degradation, and shelf life. 
  • Any nutrient content claim such as "good source of fiber," complies with nutrient content claim regulations for fiber
  • Structure function claim language should focus on normal functions of the digestive system. 
  • Avoid implying that the product can treat, cure, or prevent any disease. 

As the gut health market continues to grow, companies that prioritize compliance and scientific substantiation will be well-positioned to meet consumer demand and build trust in their brands.

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