The Viewpoint’s authors stated: “Given that numerous meta-analyses and review articles and marketing are supportive of probiotics, it is easy to understand why medical professionals adopt “can’t hurt, might help” attitudes toward these substances.
“However, the paucity of high-quality data supporting the value of probiotics, concerns about potentially biased reviews of their efficacy, the complex framework in which probiotics are regulated and sold, and the limited but increasingly concerning safety information suggest that this approach may not be appropriate.”
The article goes on to explain that, probiotics are regulated in the United States as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994, and adds – without a citation for this statement – that “… many consumers erroneously believe that supplements such as probiotics have had their contents analyzed for purity, have been tested for safety and effectiveness, and are approved by the FDA for use as claimed.”
The International Probiotics Association called the article problematic because, while it correctly points out that probiotics are not drugs, the authors only highlight cases where probiotics have been used as drugs to prevent C difficile–associated diarrhea (CDAD) or been given to patients with severe underlying diseases to prevent pancreatitis or undefined diseases.
“It is somewhat ludicrous to expect the same level of evidence for (mostly) food supplements that naturally incur significant spending on R&D and manufacturing quality measures with globally limited options (if any) for health claims and indication of use related to their body of research,” added the IPA.
“Probiotic scientists would certainly love to be able to cite rigorous evidence that justifies all claims and each step of the product development pathway, but it makes for a challenging business case if no regulatory category will allow claims and there is no reimbursement kickback from insurance/government subsidies.
“When you administer a drug (whether a probiotic or any other drug) you expect adverse events and make a risk-benefit evaluation. In that perspective probiotics perform well with very low adverse events.”
The IPA experts also said that regulatory changes would be necessary as the science deepens around probiotics.
“We are in different times than since the emergence of commercial probiotics a few decades ago and as the science evolves and matures, so must the regulations.”
What does FDA say about probiotics?
George Paraskevakos, executive director of the IPA, notes that under DSHEA, firms are responsible for determining that the dietary supplements they manufacture or distribute are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.
In addition, Current Good Manufacturing Practices (cGMPs) were published in June 2007, and focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.
Paraskevakos added that, unlike drug products, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label.
2020, Volume 323, Number 9, Pages 823-824. doi:10.1001/jama.2019.22268
“The Probiotic Conundrum - Regulatory Confusion, Conflicting Studies, and Safety Concerns”
Authors: S.B. Freedman, D. Schnadower, P.I. Tarr