Over the past decade, consumer advocacy groups have ramped up their efforts to lobby lawmakers and government agencies to hold companies accountable for misleading marketing and labeling practices. While food manufacturers have borne the brunt of these initiatives, businesses in the pharmaceutical industry have also had to contend with the prospect of increased regulatory action. In particular, manufacturers of probiotic products have been criticized for failing to provide consumers with the information they need to make an informed purchase. What's more, a new study from the Georgetown University Medical Center suggests that a vast majority of probiotic retailers include statements on their product labels that are unsupported by clinical evidence. Before diving into the details of the report, let's first recap what probiotics and what they're used for.
What Are Probiotics?
Probiotics are living microorganisms (usually bacteria) that are intended to provide positive health benefits when consumed, per the Mayo Clinic. The ingestion of probiotics has been shown to improve the natural bacteria and flora living in the lower digestive tract, though there is still a lot of debate about the overall effects. Individuals who take probiotic supplements often suffer from bacterial imbalances that can lead to sporadic weight gain, skin conditions and other chronic health issues.
Most people rely on natural sources of these helpful microorganisms, like yogurts, cheeses, sauerkraut and kimchi, but some consumers have turned to dietary supplements to increase their intake. While these supplements are believed to promote a healthy immune system, support weight management programs and prevent diarrhea and constipation, the Food and Drug Administration has not yet formally evaluated these claims. This lack of action partially accounts for why probiotics have come under fire by nonprofit groups and medical experts, as companies often use unsubstantiated claims to market their products. Considering the probiotics market is expected to reach $76.85 billion by 2024, per the research firm Global Probiotics, it makes sense why these supplements are making headlines around the U.S.
Study Reveals Flaws in Probiotic Product Labeling
In early June, a research team from Georgetown University Medical Center released a study that evaluated whether the claims made on probiotic labels were supported by clinical evidence. After reviewing 93 different products purchased from four of the largest national retailers, the research team found that only 35% could be directly linked to medical studies that affirmed their efficacy. While the other 65% may have been verified by clinical studies that were commissioned by the manufacturer, the researchers were unable to locate the findings due to the insufficient information provided on the product labels. In terms of criteria, the study considered a probiotic to be adequately supported by evidence if:
- It disclosed the exact strain of bacteria or yeast used in the manufacturing process.
- The strain was present in the supplement at a beneficial dose.
- One or more controlled human studies that supported its effectiveness was available on PubMed.
It's important to note that none of the 33 probiotic products that were found to the "medically beneficial" and adequately supported by evidence mentioned the relevant studies on their labels. This lack of information forces consumers to do their own research and come to an informed decision on their own, which seems to be the common practice within the probiotic retail industry.
"I think it's a lot to expect consumers to check the evidence, but trustworthy guides can help them find products backed by evidence," said Dan Merenstein, director of research programs for the Department of Family Medicine at Georgetown University, in a public statement on the university's website. "Companies could greatly help this process by labeling products with strain designations, dose at expiration, and with proper indication of usage."
Current FDA Regulations Are Not Legally Binding
While the FDA has not released any legally binding standards for probiotic labeling, manufacturers are required to demonstrate their products are safe and label them in a manner that does not mislead consumers. One of the complexities of the agency's existing draft guidance is that probiotics often fall under different categories based on their intended use and can be considered dietary supplements, food ingredients or pharmaceuticals. Additionally, the FDA has recognized that manufacturers are using several different units of measurement on their labels to inform consumers about the quantity of live microbial in colony forming units, which can be confusing when comparing different probiotic products.
Although there doesn't seem to be any immediate plans to release new standards and guidelines for probiotic labeling, mounting pressure from consumer advocacy groups could put pressure on government officials to revisit the issue.