Clarity concerns: US probiotic product labeling insufficiently clear, researchers find

05 Jun 2019 --- Many probiotic product labels do not give consumers sufficient information to make an informed purchasing decision, according to a research team led by US-based Georgetown University Medical Center. To remedy this, the researchers are urging companies to label products clearly with strain designations, dose at expiration and with proper indication of usage.

Published in the Journal of General Internal Medicine, the study found that of 93 different bottles of probiotics purchased from four large national probiotic retailers in the Washington, DC area, only 33 (35 percent) could be linked to medical efficacy as supported by clinical evidence. 

There has been a more than 40 percent rise in NPD when global launch numbers with a probiotic claim are compared from 2012 to 2017, Innova Market Insights data show. This rapid growth has led to a wide range of different products being available on the market. 

The researchers point out that although the other 65 percent of products in their study might be supported by clinical studies, they were not able to track down the evidence due to “insufficient labeling.”

The researchers considered a product supported by evidence if the product label disclosed the strain of bacteria or yeast designation(s), if these were said to be present at a beneficial dose, and if the product was backed by at least one controlled human study listed on PubMed, a web-based search engine for biomedicine and health studies.

“The higher number of strains, higher dose or greater cost were not associated with evidence,” says the study’s senior investigator, Dan Merenstein, MD, professor of family medicine and Director of research programs for the Department of Family Medicine at Georgetown University School of Medicine.

“It may be counterintuitive to consumers, but we found that products with fewer strains and lower cost were more likely to be supported by evidence we could trace,” he says.

However, “consumers will have to do the legwork themselves to figure out the best product to buy,” Merenstein says. On the basis of labeling, none of the 33 bottles evaluated were linked to evidence that the probiotics inside were clinically beneficial.

“It’s a lot to expect consumers to check the evidence, but trustworthy guides can help them find products backed by evidence,” he says. “Companies could greatly help this process by labeling products with strain designations, dose at expiration, and with proper indication of usage.”

In 2014, a group of experts, two of which are authors on this paper, affirmed the definition of probiotics to be “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.”

The robust use of probiotics has led to a number of studies which found that several strains work as intended. Additional studies, however, have shown that other strains do not work better than a placebo. Manufacturers are required to demonstrate that commercial probiotics are safe for the intended consumer and are labeled in a truthful and non-misleading fashion.

Of the 93 products examined, 67 were judged to be “unique” based on distinct strain composition. Further, any products that did not disclose strains on labels were considered unique, since the precise composition could not be determined. But evidence could not be traced to many of the high-dose, multiple-species and more expensive products, Merenstein says. Some such products listed some strains that are known to be beneficial – but since the dose of the strain was not disclosed, researchers could not determine if such strains were present at an efficacious dose.

Just recently, an expert opinion in Frontiers in Microbiology floated the idea of a global logo or seal to communicate the quality of probiotic products. The paper set out recommendations for the probiotics industry to bring transparency to consumers about what their probiotic products contain. 

In this opinion, the authors stress the importance of  third-party evaluations. Moreover, the researchers urge that labels should communicate genus and species names, strain designations and quantities for all strains present – in addition to a use-by date, storage instructions and company contact information. 

As the probiotic market continues to proliferate, improving transparency – even in the absence of regulatory requirements to do so – is paramount, the researchers note.

“Various published assessments of probiotics have found that some commercial probiotic products fall short of what they declare on the label,” said study co-author and ISAPP Executive Science Officer, Mary Ellen Sanders. “Although regulatory standards exist, enforcement is uneven and is understandably focused on safety concerns rather than accuracy in labeling. But it’s important for consumers and healthcare professionals to have certainty about what’s in a probiotic product that they intend to use for a specific purpose.”

Although in the EU there are strict regulations around using the term “probiotic” on products, these labeling suggestions are in line with them.

“Some of these are high quality and well-labeled. Others are not. This is an opportunity for products that are high quality to get an independent certification of this, and have this communicated on the product label,” Sanders told NutritionInsight at the time.