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

Source: https://www.keypedia.com/records/warning_letter/calmco-llc-previously-named-ketomi-llc/bd3db429-049b-4fe5-8706-53ba742df48b

> FDA WARNING_LETTER for CalmCo LLC previously named Ketomi LLC on May 25, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CalmCo LLC previously named Ketomi LLC
- Inspection Date: 2023-05-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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 (

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/calmco-llc-previously-named-ketomi-llc/c09bc89e-fe0d-4fad-892c-cd47cfe5bc49

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c