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  5. CalmCo LLC previously named Ketomi LLC - 663668 - 08/09/2023
  1. Warning Letters

WARNING LETTER

CalmCo LLC previously named Ketomi LLC MARCS-CMS 663668 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Keith Page
CalmCo LLC previously named Ketomi LLC

1215 Sarasota Center Blvd
Sarasota, FL 34240
United States

Keith@calmco.com
customercare@coliccalm.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

August 9, 2023

RE: 663668

Dear Keith Page:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.coliccalm.com in May 2023. The FDA has observed that your firm offers “Colic Calm,” and “Colic Calm +,” for sale in the United States. Based on our review of your website and product labels, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Please also reference warning letter 654226, issued on July 26, 2023, to Denison Pharmaceuticals, LLC, that summarized significant violations of current good manufacturing practice (CGMP) regulations for its finished pharmaceuticals.

Your “Colic Calm,” and “Colic Calm +” products are particularly concerning from a public health perspective because of these CGMP violations and because they are directed for use in infants.

Unapproved New Drugs

Based on a review of the product labels and your website www.coliccalm.com, your “Colic Calm,” and “Colic Calm +” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

Colic Calm

From the product label:
• “For Symptomatic relief of infant Colic, Gas & Reflux”
• “Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups”

From the website www.coliccalm.com:
• “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 +

From the product label:
• “For Symptomatic relief of infant Colic, Gas & Reflux”
• “Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups”

From the website www.coliccalm.com:
• “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.”

Your “Colic Calm,” and “Colic Calm +,” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that “Colic Calm,” and “Colic Calm +,” are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

CAPT Tina Smith
Acting Director
Office of Unapproved and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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