# FDA WARNING_LETTER - Chlamydia-clinic.com - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/chlamydia-cliniccom/8adc85e7-c74b-4a81-9ddc-65eccf886c01

> FDA WARNING_LETTER for Chlamydia-clinic.com on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Chlamydia-clinic.com
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: On April 28, 2011, the FDA issued a Warning Letter to Chlamydia-Cure, following a December 2010 review of their website, www.chlamydia-clinic.com. The FDA determined that the product C-Cure is promoted for conditions that classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)], due to therapeutic claims for diagnosis, cure, mitigation, treatment, or prevention of disease.

The marketing of C-Cure with these claims violates the Act. Furthermore, the product is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its intended uses, and lacks prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)]. C-Cure is also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because its labeling fails to bear adequate directions for use, as conditions like Chlamydia are not amenable to self-diagnosis and treatment by lay

## Related Officers

- [Director ](https://www.keypedia.com/people/barbara-j-cassens/26dd2da1-417d-4913-9432-3d50fb3c2f40)
- [Associate Director](https://www.keypedia.com/people/mary-k-engle/9426dfba-028c-4d3a-bb62-7bdea653e6bc)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/chlamydia-cliniccom/3e484549-5056-4e64-b514-cbee7778f722

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df