CalmCo LLC previously named Ketomi LLC
FDA issued a warning letter to CalmCo LLC (formerly Ketomi LLC) in August 2023 regarding its 'Colic Calm' and 'Colic Calm +' homeopathic products marketed for infant colic, gas, and reflux relief. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses and lack an approved NDA. The products are of heightened public health concern because they are directed at infants and were manufactured by a third party (Denison Pharmaceuticals) cited for significant CGMP violations. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (4)
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.
Colic Calm® Plus is a professional strength formulation developed for babies that need extra help. Our Plus formula is enhanced with additional gas absorption properties . . . four more homeopathic remedies for added digestive support . . . amazing healing properties to quickly and safely eliminate the symptoms of infant gas, colic and upset stomach.
Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups
For Symptomatic relief of infant Colic, Gas & Reflux
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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