Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
your “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” 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…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Products are drugs because they are intended to treat or prevent disease based on website claims.
Supporting FDA text
Source excerpt · automated text-match checkyour “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” 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.
Products are unapproved new drugs because they are not generally recognized as safe and effective.
Supporting FDA text
Source excerpt · automated text-match checkthese products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect
No FDA-approved applications are in effect for the products.
Supporting FDA text
Source excerpt · automated text-match checkNo FDA approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide specific steps taken to correct violations
- Explain steps to prevent recurrence of violations
- Provide supporting documentation for corrections
- Provide reasoning if products are not in violation