FDA warning over infant's death shouldn't call safety of probiotics into question, experts say

By Hank Schultz contact

- Last updated on GMT

FDA warning over infant's death shouldn't call safety of probiotics into question, experts say

Related tags: Probiotics, Probiotic, Dietary supplement

The recall last last year of a probiotic product found to be contaminated with a fungus should not cast a pall over the entire sector, experts say.  Though they are products consisting of cultured microorganisms, probiotic ingredients are no more at risk of this type of contamination than any other ingredient category, they say.

The product in question, Solgar’s ABC Dophilus Powder, was implicated in the death of a unidentified preterm newborn in October.  Probiotics have been used in critical care settings with preterm infants because of their demonstrated benefits in combating necrotizing enterocolitis​, one of the main causes of mortality in these children.

In this case, however, three lots of Solgar’s product were found to have been contaminated with Rhizopus oryzae ​and some of these found their way into the infant’s system.In some cases (especially with preterm infants whose immune systems are not yet fully developed), the fungus can cause infections of the sinus, lungs, intestines, and skin, called mucormycosis.  The fungal infection in this case led to a fatal case of NEC, according to the Centers for Disease Control.  FDA announced that Solgar had issued a recall​ for the lots in question in mid November. The incident led FDA on Dec. 9, 2014 to issue a warning​ on the risk of using probiotics with immunocompromised persons.  

Risk shouldn’t be generalized

As stated previously, for the lay person it might seem that probiotics, being made in a way that encourages microbial growth, would be at heightened risk for the inclusion of unwanted microbial fellow travelers. The fungal species in question is endemic in the environment; yeast and fungal spores are everywhere. But with proper process controls, the risk should be no greater than with the manufacture of botanicals, lipids or other ingredients, experts say.

“With proper quality control you would think that these microorganisms should not appear in supplements.  One should not generalize from this story that probiotics could kill someone,”​ Armin Salmen PhD, vice president of R&D and quality assurance for NextFoods (makers of the GoodBelly line of probiotic juice drinks), told NutraIngredients-USA.

“I kind of look at it that contamination is contamination,” ​said Mike Bush, senior vice president of Ganeden Biotech, makers of the Ganeden BC30 functional food probiotic ingredient. “It’s unfortunate but it’s a fact of the mass production of food and other supplement products that there is a risk of contamination. In this case a lot of contaminated product went out. It’s very frustrating from the viewpoint of a responsible participant in the industry to have the whole industry demonized because a bad batch went out.”

Researchers agree

Research on the subject confirms the opinions of executives within the sector. In a review of the overall safety of probiotic supplement​s, Dr David Snydman of Tufts University concluded: “Although there are rare cases of bacteremia or fungemia related to the use of probiotics, epidemiologic evidence suggests no population increase in risk on the basis of usage data. There have been many controlled clinical trials on the use of probiotics that demonstrate safe use.”

And just as would be the case with any form of dietary intervention in an immunocompromised population, caution is called for when using probiotics with preterm infants​, said another researcher: “In the interests of safety, the use of probiotics in such a population should be indicated with caution and requires further investigation.”

Probiotics for healthy users

The use of a probiotic product for an immunocompromised patient is a key facet of this case, said Lauren Cohen, vice president of communication for the Natural Products Association. In a letter send to FDA just before Christmas, Cohen took the agency to task for seeming to generalize an overall risk posed by probiotics for healthy users from the outcome of a selected case: “The overall matter at hand appears to be an issue related to the Good Manufacturing Practices (GMP) of a single lot from a single product. The safety alert seems to castigate the entire probiotic industry that labels their products as “dietary supplements.” The finding of ​Rhizopus oryzae mold is a GMP concern that should be brought up with the manufacturer of the lot and line of product. It does not and should not affect the rest of the industry and other products sold as live bacteria or yeast.

“Additionally, dietary supplements are not designed to be taken by immunocompromised persons or any other patient population. Federal regulations require dietary supplement manufacturers to expressly state in the products’ disclaimer that they are not to diagnose, treat, cure or prevent any disease. Dietary supplements are to be taken by healthy individuals to supplement their diet and enhance their health. While certain hospitals have dietary supplements on their formularies, they are administered at the discretion and direction of a patient’s health care provider.”

To read the full text of NPA's letter, click here​.

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