Washington, D.C., July 16, 2018—In response to a review, “Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota,” published today in the Annals of Internal Medicine, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, CRN:
“This critique of the scientific literature examines the type of data researchers choose to include—or not to include—in published randomized control trials (RCTs), and it raises some legitimate observations about the importance of including safety data in the published results of RCTs. However, drawing any conclusions about the safety of probiotics, prebiotics, or synbiotics, based on this review, is misguided. As the authors themselves state, the only conclusion that can be drawn from the review is that reporting of harms-related information in clinical trials of these products is lacking.
An absence of harms data does not signify the presence of safety concerns; it simply means we need to be better at reporting this crucial information.
As the authors note, clinical trials cited in this review generally do not report harms adequately, and CRN encourages researchers to publish all relevant safety data to better inform the medical community when using probiotics for clinical conditions. While a significant number of clinical trials on probiotics have not yielded any evidence of safety issues, the current literature is not well-equipped to confidently answer specific safety questions about using these products therapeutically in different patient populations.
Probiotics and prebiotics are ubiquitous in the food supply, and the safety of these ingredients is well-supported through their extensive history of use. Further, new probiotic and prebiotic dietary supplement ingredients are subject to pre-market evaluation of safety by FDA. Under the law, dietary supplements containing these ingredients are accountable for manufacturing standards that include testing procedures, labeling and storage requirements, and other practices examined and enforced by regulatory agencies at both the federal and state levels.
We agree with the authors’ premise that members of the research community must commit to fully evaluating and reporting the safety of any intervention to ensure clinicians can confidently understand the safety of probiotics in the clinical setting. As we continue to digest the growing body of evidence supporting probiotic supplementation, researchers can positively contribute to scientific innovation and improve public comprehension of product use by rigorously detailing in their publications all pertinent safety data.”
Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.