DuPont Sees Immune Health Probiotic Sales Opening Window On More Microbial Use In Nutrition

DuPont Nutrition & Biosciences was providing the industry’s largest variety of probiotic strains for food and dietary supplements before the coronavirus pandemic spiked consumer interest in boosting immune health. With more consumers turning to probiotics to strengthen resistance to the virus, it looks for demand to increase from its customers for strains across its microbial portfolio.

“A large portion of the people out there who are taking probiotics were taking them for immune health already,” said Vanessa Bailey, global marketing leader for the  DuPont de Nemours Inc. division’s probiotics business.

Probiotic foods and supplements made with microbial ingredients based on bacteria from the microbiome – the trillions of microbes living in and on the human body – are intended to provide benefits including improving gut function, nutritional status and immune status metabolic properties.

In a recent interview, Bailey noted Nielsen US market data indicating immune supplement sales, including probiotic-containing products, since March had increased 250% from a year ago. “It’s a significant jump,” she told HBW Insight.

DuPont Nutrition also received Nielsen data showing more than half of 12,000 consumers surveyed said they’d begun using dietary products for immune health, with 20% using supplements with probiotics and 17% probiotic-fortified foods. Probiotic use for immune health among the surveyed consumers exceeded uses of zinc and elderberry, a mineral and a botanical with tremendous sales growth during the COVID-19 pandemic.

Among probiotic consumers, immune health is the No. 3 reason for using the products, behind digestive benefits and general health.

“It’s nice to see that consumers are starting to recognize the value of probiotics,” said Bailey, who works from DuPont Nutrition’s Madison, WI, office and manufacturing facility.

While stockpiling for immune health support drove early sales growth in response to the pandemic, probiotic sales likely will continue increasing, she added. “My gut tells me I think we could see some sustained increase. … There’s going to be some difference in how we behave.”

Regulatory Pathway Challenging For Health Claims ...

Manufacturers using DuPont Nutrition’s strains marketed under its HOWARU brand and other firms microbials already recognize probiotics’ value, but they and consumers as well as microbiologists and other researchers still know relatively little about the benefits that can be developed from bacteria from the microbiome.

The US Food and Drug Administration and the National Institutes of Health acknowledge the potential for probiotic strains to be used for preventing or treating specific conditions or diseases. The agencies also, however, say that current research is far from generating data needed to allow health claims much less therapeutic indications for any microbial.

In its announcement for a public workshop it conducted in 2018 with the NIH’s National Institute of Allergy and Infectious Diseases, the FDA Center for Biologics Evaluation and Research noted that interest is increasing about probiotics’ use for treatment and/or prevention of conditions such as necrotizing enterocolitis and diarrhea. "Historically, these products have presented with unique scientific and regulatory challenges," the center said. (Also see "Microbiome Approval Pathway Workshop Could Help Sort Out Probiotic Path" - HBW Insight, 27 Aug, 2018.)

The International Scientific Association for Probiotics and Prebiotics at that time didn’t agree with the status of the FDA's microbiome oversight. The agency's regulatory pathway for probiotic drugs “is reasonably clear,” but “the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so," ISAPP said.

The association’s perspective aligns with the prevailing view of the nutritional products sector that convincing the FDA to accept live probiotic ingredients as safe and effective in their products is challenging even as research in the area burgeons. (Also see "Probiotics Industry Says FDA Regulatory Bar Is Set Too High" - Pink Sheet, 28 May, 2012.)

The American Gastroenterological Association, however, isn’t in the industry’s camp on probiotics’ use. The association on 10 June updated its clinical guidelines to state that for most digestive conditions there is not enough evidence to support the use of probiotics (see sidebar article).

DuPont Nutrition recognizes probiotic supplements and food are limited to using structure/function claims, but also that health claims are wanted by manufacturers using its ingredients.

“I’m sure there is interest to make something like a health claim, but as you know we’re not quite there yet,” Bailey said.

DuPont Nutrition and other firms aren't shying away from research into potential health claims or therapeutic indications for microbials, though. In January, it announced it was partnering with British startup BioMe Oxford Ltd. in the early stages of developing an orally delivered capsule that can sample gut health to assess the impact of probiotics and other ingredients that effect the microbiome. (Also see "DuPont Venture With Microbiome Startup Analyzing Probiotic Impact On Gut Health " - HBW Insight, 9 Jun, 2019.)

Also in January, Bayer AG teamed up with medical dermatology company Azitra Inc. to develop consumer health products that harness the skin microbiome to treat conditions such as atopic dermatitis.  (Also see "Bayer Harnessing Skin Microbiome In New Product Development" - HBW Insight, 13 Jan, 2020.)

Nestle Health Science SA in November 2019 bega a collaboration with Caelus Health to develop microbiome-based food supplements for the prevention and early treatment of cardio-metabolic diseases. (Also see "Nestlé Developing Microbiome-Based Supplements with Dutch Partner" - HBW Insight, 25 Nov, 2019.)

... Working With Probiotics Can Be Challenging

Working with probiotic ingredients also isn’t understood by many. “Probiotics can be a bit challenging to keep stable [in food]. You really have to be capable with the formulation,” Bailey said.

DuPont Nutrition does more than distribute probiotics to its customers. It will work with them to make sure their plans will lead to making products that deliver probiotic ingredients as they’re intended to be consumed.

“Unless you’re working with probiotics, you likely don’t understand the level of sensitivity. It isn’t an ingredient where you can just dump it into the hopper and it will be just fine,” Bailey said.

The business has general guidelines for its probiotic customers. One is keeping “water activity,” the amount of moisture in an ingredient, as low as possible for good survivability of a lactic acid-based probiotics,” she said.

Another is keeping probiotic-containing products refrigerated. “Some products will be OK in an ambient temperature … but really it’s ideal to have a refrigerated condition for a product. If it gets too warm, that could be really bad for probiotic survivability.”

Additionally, when introducing probiotics to juices that can be highly acidic, such as juices and tea, keep the acid levels as low as possible. High acid levels “also can be not conducive to probiotic survivability,” Bailey said.

“It’s always best to actually do the full formulation with a probiotic and do a shelf-life study to see that it’s actually reaching its target [colony forming units] level through the end of the shelf life,” she added.