Probiotics: CRN VP says increased scrutiny is 'not unexpected'; CFU issue needs to be resolved to satisfy scientists, consumers
The probiotics sector has taken some hits in recent months, including a recent viewpoint by Harvard’s Dr Pieter Cohen, a prominent critic of dietary supplements, published in JAMA Internal Medicine entitled, Probiotic Safety—No Guarantees.
Dr Wong, who is vice president, scientific & regulatory affairs at the Council for Responsible Nutrition (CRN), told us that Dr Cohen makes some good points in his paper. “We do agree that live microorganisms should be labeled [as CFUs or colony forming units],” she said. “We’ve supported this for many years, and this has continued through our best practice guidelines [co-authored with the International Probiotics Association]. We believe this is scientifically accurate.”
“We also agree that manufacturers should provide the specific strain or strains on their labels. It’s what the responsible industry wants,” she added.
However, Dr Wong said it was frustrating that Dr Cohen “only briefly” recognized the scientific support that exists for probiotics, which includes meta-analyses and Cochrane reviews.
“Dr Cohen, we think, is inconsistent with his messaging,” she said. “For example, he says the science supports a role against antibiotic-associated diarrhea, but says there are no long terms benefits for healthy people. Antibiotics are used by people who are otherwise healthy, and so that’s inconsistent.”
Draft guidance on labeling with CFUs
Getting back to CFUs, Dr Wong noted that CRN supported the citizen’s petition to amend 21 CFR 101.36 to allow probiotic ingredients to be labeled by CFUs instead of by weight.
The agency recently released a draft guidance that would allow for labeling of live microbial ingredients as colony forming units (CFUs) in addition to weight. “We appreciate it is difficult to change the regulations,” said Dr Wong, “and we are encouraged by the announcement that that the agency was willing to look at this. However, FDA’s guidance missed the mark.
"We have talked to several members who are concerned about the draft guidance because having both weight and CFUs on the label is problematic. They do not correlate with each other.
“This [dual labeling in CFUs and mg] is not really practical and you cannot consistently and accurately label both. This puts the industry in a difficult position,” she said.
The solution, she said, would be allow in CFUs only, and for blends to be listed in descending order by CFUs.
Microorganisms vs Probiotics
As of this morning (Oct 9, 2018), only two meaningful comments have been submitted to the FDA regarding its draft guidance on Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials. One is from Dr Pieter Cohen, MD, Harvard Medical School, Cambridge Health Alliance, who states:
“To: Office of Dietary Supplements, FDA
“I appreciate that the agency is trying to improve the information that consumers have available to them on probiotic bottle labels. I also agree with leading industry lobbyists that an accurate count of the number of live organisms in a serving is much more relevant and useful than the weight.
“I do not oppose permitting firms to place CFUs inside the Supplement Facts label, but I do not think it materially moves the needle forward in respect to ensuring consumers have access to accurate information about high-quality supplements containing live microorganisms [...]
“I have one additional point to add that is not included in my Viewpoint [from JAMA Internal Medicine]: The word probiotic should be used only when referring to a microorganism that has proven benefit for human health as per the WHOs widely accepted definition of 'probiotic'. Therefore, I believe that the agency should find the great majority of products currently labeled as probiotics to be mislabeled as they falsely make a health claim. These dietary supplements containing bacteria and yeast should be accurately labeled as live microorganisms.”
Stakeholders have until November 6, 2018 to submit comment to the FDA via http://www.regulations.gov to docket folder FDA-2011-D-0376.
Negative media
Probiotics were also the subject of some negative headlines last month, based on two studies conducted by scientists from the Weizmann Institute of Science in Israel published in Cell (Zmora et al., Vol. 174, No. 6, pp. 1388-1405.E21 and Suez et al., Vol. 174, No. 6, pp. 1406-1423.E16).
The mainstream media coverage brought stinging responses from numerous stakeholders, including the International Scientific Association of Probiotics and Prebiotics, the International Probiotics Association, and the Natural Products Association. To read our response to those studies, please click HERE.
“You cannot just take these two studies and extrapolate to a whole category,” said Dr Wong. “They also didn’t look at clinical endpoint. What these studies do tell us is that these microorganisms work in different ways.”
This kind of media coverage was not unexpected, said Dr Wong: “Probiotics are a very popular category with consumers so people will take a closer look.”
CRN Workshop focus
Probiotics, prebiotics and the microbiome will take center stage at the CRN Workshop next week (October 16) in Dana Point, CA.
The event will feature three presentations on the microbiome’s impact on human health and disease, including:
Metabolomics: Shedding light on the impact of the gut microbiome metabolism on whole-body health
Sean Adams, PhD, Director, Arkansas Children’s Nutrition Center, Professor and Section Chief, Developmental Nutrition, Department of Pediatrics, University of Arkansas for Medical Sciences
Foods for bugs in your gut: It’s not just dietary fiber!
Oliver Chen, PhD, Principal Scientist, Biofortis, Mérieux NutriSciences
Probiotics and the Microbiome: What We Know and Don’t Know
Donald Brown, N.D., Managing Director, Natural Product Research Consultants
