Metric Weights For Probiotics Mislead But CFUs Inform, Say Industry Groups

Council for Responsible Nutrition, Consumer Healthcare Products Association and Natural Products Association urge FDA to allow colony forming units on probiotic product labels while nixing current labeling regulation’s allowance of metric weight, as the measurement does not reflect live microbials.

Stating probiotic ingredients' weight in metric amounts on product labels as indicated in an FDA draft guidance communicates false and misleading information, say dietary supplement industry groups.

But in separate comments submitted to the agency, the Consumer Healthcare Products Association, Council for Responsible Nutrition and the Natural Products Association all say the agency's decision to exercise enforcement discretion and allow using colony forming units (CFUs) to indicate probiotic ingredients' weight is a “good start” to updating the labels.

CRN and NAP say the scientific community, industry and even FDA already quantify microbials by live CFUs – a measurement of viable microbial cells capable of replicating on agar plates and forming colonies – as the measurement provides the most accurate information on microorganisms present in a product through shelf life.

Weight declarations, on the other hand, do not supply “useful” information to the consumer and “allow unscrupulous companies to fly under the radar” and sell probiotics with “no viable microbial ingredients in the product,” says the NPA in comments signed by President and CEO Daniel Fabricant.

FDA’s draft guidance, “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials,” states the agency will exercise enforcement discretion for using CFUs on labels while it decides whether to conduct a rulemaking to amend its supplement labeling regulation that is part of a 2016 final rule amending labeling regulations for conventional foods and supplements; comment deadline was Nov. 6. Compliance dates are January 2020 for manufacturers with $10m or more in annual sales and 2021 for others. (Also see "FDA OK With Probiotic Weight CFUs In Supplement Facts Labels, For Now" - HBW Insight, 6 Sep, 2018.)

While allowing indicating weights in CFUs, the guidance published Sept. 6 requires that labels state the metric weight of microbials, as already required by FDA supplement labeling regulations.

The agency also requires listing metric weight on Supplement Facts labels if CFUs also are included. CFU quantities must not be misleading, measuring live microbial ingredients only and not including inactive, dead or nonviable organisms; and be declared clearly separate and readily distinguishable from metric weights in a format that does not render misleading other aspects of the Supplement Facts or product labels.

'Dead Cells' Count In Metric Weight

In its comments, CRN contends weight is not an appropriate unit of measure for live microbial ingredients because it represents total cellular mass, including live and dead microorganisms. Quantities labeled in weight would include live and dead microorganisms and not provide information on the amount of the “relevant, beneficial” ingredient, stated Andrea Wong, CRN's vice president for scientific and regulatory affairs.

Further, a CFU's weight may vary from batch to batch. “As such, it is not practical to label the weight of each batch individually or to list individual live microbial ingredients within a blend in descending order by weight for each batch,” Wong stated.

CRN points out FDA has previously stated certain nutrients' amounts should be expressed in units most helpful to consumers and not necessarily match the weight of the source ingredient. For example, vitamin E claims are based on the equivalent amount of alpha tocopherol and different conversion factors are used to determine the vitamin's weight claim that corresponds to the type used in the product.

Similarly, a mineral claim does not reflect total weight of the mineral salt “but only the active elemental mineral component,” Wong says. “In the case of probiotics, live microorganisms are the beneficial and relevant portion of the ingredient. As such, only live microorganism quantity should be declared.”

Metric Opens Door For 'No Probiotic Activity'

NPA contends that a microbial ingredient's labeled weight “may not accurately reflect the number of live microorganisms throughout the range of times a product is expected to be consumed because live microorganisms are susceptible to cell death throughout the shelf life of a product."

Additionally, because the US allows sales of products labeled as probiotic but containing "no probiotic activity (dead cells)," requiring metric weights on labels would allow firms to be complaint with the regulation while selling products with only dead microbials, Fabricant states in NPA's comments.

"FDA's current labeling laws therefore allow for unscrupulous companies to 'fly under the radar' and sell probiotics with no viable microbial ingredients in the product," according to NPA.

Since the “vast majority” of firms selling probiotics already label the products with CFUs to convey the information, FDA should “follow through with the modification of the regulation in retrospective,” NPA says. Modifying "the regulation would "to create a stronger, safer food supply and provide greater clarity and nutrition information to consumers,” the association contends.

NPA also suggests FDA target the regulation for regulatory modification and reform on the update to Department of Health and Human Services agencies' regulatory agendas and to meet President Trump’s “two-for-one-rule” from an executive order requiring federal agencies to remove two regulations for every regulation they implement. NPA made the same request of FDA in 2017.

In its comments, CHPA suggests that as specified in labeling rules, FDA recommend listing live microbial dietary ingredients “in descending order of predominance” by metric weight.

“Stability profiles for various strains differ, such that the order of predominance may change from the time of manufacture compared to the end of shelf life. By adopting a regulation stipulating that the order of predominance for microbial ingredients within a blend be based upon CFUs at the time of shelf life expiry, FDA would ensure a more consistent representation of the active microbial ingredients with a blend and provide more useful information to consumers,” CHPA says.

CHPA encourages FDA to amend labeling rules to express the quantitative amount of probiotic ingredients in CFUs instead of weight and also asks for some flexibility to account for innovation in the science moving forward. “We also encourage the agency to propose a pathway for the inclusion of alternative standards for measurement of viable microorganisms, as the field of probiotics science is rapidly advancing.”

CRN asks FDA to revise its draft guidance without any declaration of the quantitative amount by metric weight. It submitted comments to FDA in March 2017 in support of a 2016 citizen petition from the International Probiotics Association asking the agency to allow firms to declare probiotic ingredients in CFUs instead of by weight, a request that was denied.

CRN developed probiotic best practices guidelines with the IPA in early 2017, which recommended expressing the quantitative amounts of probiotics in a product in CFUs. (Also see "NPA, Retailers Tackle Accountability: Health & Wellness Industry News Roundup" - HBW Insight, 12 Jan, 2017.)