DesBio/Deseret Biologicals, Inc.
FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. (Sandy, UT) regarding their product 'CHLA:10M,' a homeopathic product marketed for the temporary relief of chlamydia infection symptoms. FDA determined the product is an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act because it is not generally recognized as safe and effective and lacks an approved application. FDA flagged the product as a serious public health concern because consumers relying on it may forgo appropriate medical care for a sexually transmitted infection, risking severe complications including infertility, sepsis, and death.
Flagged claims (4)
chlamydia, series symptom relief
Chlamydia trachomatis 10M . . . Burning Sensation During Urination, Testicular Tenderness or Pain, Vaginal Discharge, Painful Sexual Intercourse
CHLA:10M is for the temporary relief of symptoms related to Chlamydia infection. Male: burning sensation during urination and testicular tenderness or pain. Female: vaginal discharge, burning sensation during urination, and painful sexual intercourse.
Chlamydia 10M
Required actions (2)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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