Delaney Szwed
Associate Editor
Loyola University Chicago School of Law, JD 2024
On September 29, 2023, following the death of a baby that was killed by bacteria linked to a probiotic drug, the Food and Drug Administration (FDA) released a warning letter regarding the use and risks of probiotics to treat preterm infants. In addition, more than two dozen adverse events in infants linked to probiotics have been reported since 2018. While the FDA’s regulation of probiotics varies drastically and greatly depends on the probiotic’s intended use, this leniency has allowed some probiotic products to slip through regulatory barriers and adversely affect an extremely vulnerable population: preterm infants.
What are probiotics?
Probiotics are most commonly sold in the form of dietary supplements and contain live organisms, such as bacteria or yeast, that can provide various health benefits when ingested. Humans have around 39-300 trillion bacteria living inside of them, and a majority of this bacteria resides in the gut. While most of the bacteria in the gut is harmless and even vital to human health, an improper balance of good and bad bacteria can lead to illness or disease. This is where probiotics come into play. The microorganisms contained in probiotic supplements and products help to feed and add to the good bacteria in the gut which, in turn, reduces the quantity of bad bacteria that may be causing irritation. Specifically, probiotics are widely relied upon to combat irritable bowel syndrome, bloating, constipation, and other gut related ailments. Additionally, probiotics are commonly used to treat preterm infants and prevent necrotizing enterocolitis, a disease affecting the intestines.
Regulation of probiotics
How a probiotic is regulated depends on the product’s intended use. The FDA may choose to regulate a probiotic as a dietary supplement, cosmetic, food ingredient, or drug. However, if a probiotic is going to be used for treatment of a disease or disorder, then there are stricter requirements it has to meet to prove it is safe and effective for its intended use.
In regard to infants, the FDA to date has not approved any probiotic supplement “as a drug or biological product in infants of any age.” For a probiotic to be marketed as a drug or biological product, the FDA requires approval of a Biologics License Application to ensure the product’s compliance with industry standards. If a probiotic is not approved and it is used by healthcare providers for the purpose of treating or preventing a condition, an Investigational New Drug Application must be submitted to ensure compliance with appropriate safeguards.
Risks to preterm infants
As with every drug and supplement, there is always a possibility of adverse side effects. This is especially true for preterm infants who are extremely vulnerable and susceptible to illnesses and reactions. In regard to probiotics used to aid preterm infants, common risks include sepsis and infections that can be caused by the bacterial strain within the probiotic supplement or from the probiotic’s contamination with a pathogen during the manufacturing process.
The FDA was recently informed of one instance where a preterm infant was given Evivo with MCT Oil, a probiotic. The infant ultimately developed sepsis which proved fatal. This one instance, along with other various related adverse events, has drawn the attention of the FDA. Through continued investigation, the FDA discovered that drug manufacturing companies have been distributing probiotic products intended to treat preterm infants in violation of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. While regulation of probiotics is fairly flexible, stricter regulations are required for probiotics functioning as a treatment. Since preterm infants are especially vulnerable, the FDA urges the industry, clinical and research funding communities to conduct high quality, in depth clinical trials with products meeting quality criteria to ensure the product’s reliability in healthcare.
What is being done?
In an attempt to bring awareness to this issue, the FDA released the warning letter to the public, explaining the risk probiotics pose to preterm infants and advising the public to use these products with caution. The FDA also issued a warning letter to Abbott Laboratories, noting the company’s sale of an unapproved probiotic product, Similac Probiotic Tri-Blend, that is intended to treat premature infants in hospital settings. Another warning letter was issued to Infinant Health, Inc. regarding their unapproved probiotic product, Evivo with MTC Oil, also used for treating preterm infants. Both probiotics have since been either recalled or discontinued for sale.
Ultimately, drug companies must comply with FDA regulations regarding probiotics, especially if the intended use is for premature infants in hospital settings. Consistently, the FDA must also monitor and observe distributors and manufacturers to ensure their compliance with the agency’s acts and rules. Nonetheless, when taking into consideration the FDA’s public warning, the letters to non-compliant companies, and the discontinuance of problematic probiotics, it appears progress is being made in the right direction.