“A search of https://clinicaltrials.gov for active, recruiting and registered but not-yet-recruiting studies results in 273 entries,” said Mirjana Curic-Bawden, Ph.D., principal scientist and application manager fermented milk and probiotics, Chr. Hansen.

Dairy formulators also must decide whether they will opt for a single strain or multiple strains. Then they must deliver the appropriate probiotic count to support the health benefit. Fermented milk products, as well as plant-based yogurt alternatives, can contain a single probiotic strain — for example, Bifidobacterium BB-12 — or combinations of documented strains such as Bifidobacterium BB-12 and L. acidophilus LA-5 or Bifidobacterium BB-12 and L. rhamnosus LGG, Curic-Bawden noted.

“However, blending random probiotic strains, even when they are well documented as single strains, does not necessarily result in a beneficial health effect,” she said. “Whether it is two or three (or more) strains, the most important factor is still effective cell count and clinical documentation for the specific blend of probiotics. It is important that the documented dose, e.g., 1 or 10 billion CFU/serving, is present in the product at the end of shelf life.”

Probiotic claims

Once the appropriate strain has been selected and delivered, dairy companies must navigate a challenging FDA regulatory framework to inform consumers of the documented health benefit(s).

“Regulations require probiotic claims to be science-based, truthful and not misleading,” said Jen Houchins, Ph.D., RD, who is director of regulatory affairs for the National Dairy Council.

She pointed out that the Federal Trade Commission (FTC) states that “the evidence needed depends on the nature of the claim. A guiding principle is what experts in the relevant area of study would generally consider to be adequate.’’¹

“It is also important to consider if any implied claims might need scientific support,” Houchins added. “Structure/function claims may be made for dietary supplements, but caution is warranted to avoid claims that indicate improvement, protection, or treatment of disease — claims that are only allowed for approved drugs or as approved health claims.”²

In a recent manuscript, https://tinyurl.com/yakl83mv, researchers at Washington University School of Medicine in St Louis coined a new term, “Microbiotia-directed foods,” or MDFs. MDFs could potentially alter the structural and functional configuration of consumer’s gut microbial community, allowing the gut microbes to produce nutrients essential to health. This new term promises to expand our view of “essential nutrient” and provides yet another wrinkle in the challenge to adequately explain the role of probiotics and health.

Formulation challenges

“Probiotics are typically fermented together with a yogurt culture, Curic-Bawden said. “If more probiotic strains are inoculated, it does not necessarily mean they will grow well together and survive over shelf life. Some well documented probiotic strains are very sensitive to air and do not readily survive fermentation and processing, or they result in development of off-flavor.”

Unfortunately, some new probiotic strains might not be appropriate or feasible for use in fermented milk products and will be available only as supplements. The challenge for the dairy industry is to keep consumer focus on “real fermented dairy foods” as their primary source of probiotics.

1.
FTC. “Dietary Supplements: An Advertising Guide for Industry,” https://tinyurl.com/jrepw6q.

2.
FDA. ”Guidance for Industry: Structure/Function Claims; Small Entity Compliance Guide,” https://tinyurl.com/llabmqw.