FDA Announces Recall of Baby Supplements, Some Could Contain Alcohol

A baby product that was found to contain various forms of alcohol is being recalled.

Pacific Health Sciences is voluntarily recalling a batch of Babies’ Magic Tea brand Baby Sleep Gripe Water, according to a notice posted on the website of the Food and Drug Administration.

The FDA said tests found “ethanol, methanol, and isopropanol that were not declared on the product label.”

“Measured levels were approximately 8.3 percent ethanol, 0.35 percent methanol, and 0.48 percent isopropanol. These substances were not listed on the label. Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product,” the notice said.

The notice added that the organic alcohols ”are known to impair normal functioning of the central nervous system, while infant ethanol exposure has been linked to long-term developmental consequences.”

Exposure to the amounts a baby would ingest when given the recommended dose of the product “can induce drowsiness, incoordination, behavioral changes, nausea, vomiting, and abdominal pain,” the notice said.

Giving a baby even more than is recommended “can increase risk of respiratory depression and other serious adverse health consequences,” the notice continued.

The notice said the company has not received any notices of harm from the product.

The recalled batch has a Lot Number of 25122bw and a “Best Before” date of December 2028.

The recalled product went to a company called Secrets of Tea that sold it online through its website and through Amazon.

Consumers were urged to either return the product for a refund or simply throw it out.

Gripe water in general does not get rave reviews from the Cleveland Clinic.

“Because herbal remedies aren’t subject to the same level of government oversight as food or medicine, there’s no way to be sure that the gripe water you buy for your baby meets basic quality or safety standards,” the site warned, adding that “many brands of gripe water have been recalled over the years because they posed dangers to babies.”

The site noted that gripe water is billed to address colic, gas, and fussiness in babies and generally contains fennel, ginger, baking soda, and flavorings.

The site reported that “there’s little research to suggest it actually works.”

Dr. Christina Vernace told the Cleveland Clinic that “ginger and fennel can relieve stomach discomfort in adults and kids, but babies’ bellies are different.”

“And those ingredients haven’t been proven to work in babies,” she added.

“If your baby has colic, stomach discomfort isn’t necessarily contributing to this complicated diagnosis. So, those ingredients don’t support the claim that gripe water relieves colic symptoms,” she said.

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