FDA WARNING_LETTER - CalmCo LLC previously named Ketomi LLC - May 25, 2023

On August 9, 2023, the FDA issued a Warning Letter to Keith Page regarding "Colic Calm" and "Colic Calm +" products, sold via www.coliccalm.com. The FDA reviewed the website in May 2023 and determined these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introducing or delivering these products into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The products are considered drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims on labels and the website indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function. Examples include "Symptomatic relief of infant Colic, Gas & Reflux" and "Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups." "Colic Calm +" is marketed for "professional strength" and "additional gas absorption properties."

These products are not generally recognized as safe and effective (