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Posted August 16, 2023

FDA Warns Sellers of Homeopathic Products for Infants and Children

On August 9, 2023, the FDA issued a warning letter to ALVA-AMCO Pharmacal Companies, LLC and CalmCo LLC, previously named Ketomi LLC, following a review of the company websites, which found statements about company homeopathic products to be drug claims because they are intended to diagnose, cure, mitigate, treat, or prevent disease, and/or intended to affect the structure or any function of the body.

For example, Colic Calm and Colic Calm + products, sold by CalmCo LLC, were promoted with statements such as, “Colic Calm eases baby’s discomfort often associated with gas, colic, hiccups and teething. Our gentle liquid formula is the #1 selling gripe water for infant gas & colic relief.” and “Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups.”

ALVA-AMCO’s Nauzene Kids products were promoted with statements such as, “For the relief of upset stomach and nausea, including that due to ‘stomach flu,’ ‘car sickness’ or overindulgences in food or drink.”

The companies are required to notify the FDA in writing of the specific steps taken to correct the violations within fifteen working days of receipt of the warning letter.

For more information about related products, see ConsumerLab’s answer to Which supplements help reduce flatulence (gas), and are there any that make it worse?

For more information, use the links below.

Warning: ALVA-AMCO Pharmacal Companies, LLC

Warning: CalmCo LLC previously named Ketomi LLC

See related recalls and warnings:

Children's Liquid Vitamin Supplement Recalled

Nature’s Energy Children’s Colostrum Recalled Due to Undeclared Milk

Similac, Other Infant Formulas Recalled, Linked to Illness and One Death