The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world

Abstract

The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

Probiotics: If It Does Not Help It Does Not Do Any Harm. Really?

“…Moreover, when regulation is enforced, consequences are predicted. Within the European Union, all health claims for probiotics were rejected, except for lactose intolerance improvement [209]. Since 2013, no claims concerning the change or improved gut microbiome composition was approved by the EFSA.…”

“…The American FDA is taking a different approach. Probiotics can be categorized as food, food additive, cosmetics, dietary supplement, or drugs [210], and the responsibility for accuracy and truthfulness of the product is the responsibility of the producer [209,211]. It should be notified that no probiotic was approved for health claims by the FDA in recent years [209].…”

“…Probiotics can be categorized as food, food additive, cosmetics, dietary supplement, or drugs [210], and the responsibility for accuracy and truthfulness of the product is the responsibility of the producer [209,211]. It should be notified that no probiotic was approved for health claims by the FDA in recent years [209]. The tightened regulations impacted the scientific community and the manufacturer’s policies profoundly, as mirrored by the number of publications on the subject in the last two decades.…”

“…The tightened regulations impacted the scientific community and the manufacturer’s policies profoundly, as mirrored by the number of publications on the subject in the last two decades. The number of publications or registered studies increased significantly on microbiota while plateauing on probiotics [209]. The shift to explore the microbiota presents an opportunity to uncover new probiotics and understand their mode of action, and explore relationship with their neighboring prokaryotes, eukaryotes, and their secreted mobilomes [212,213].…”

Data on global analysis of clinical trials with probiotics

“… The data on clinical trials with probiotics are important to gain more insight into registration procedures, the clinical conditions addressed, as well as the major characteristics, including size of the study (number of participants), and duration of the study [ 1 , 2 ]. Both (clinical) researchers as well as producers of probiotics can benefit from these data [ 3 , 4 , 5 ].…”