# FDA WARNING_LETTER - Millennium Bioceutics - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/millennium-bioceutics/7202d3f2-fd5b-4a75-9378-f55a0e66d9da

> FDA WARNING_LETTER for Millennium Bioceutics on Unknown Date. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Millennium Bioceutics
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Millennium Bioceutics on February 17, 2011, following a review of their websites, millenniumbioceutics.com and caplexsupplement.com, in October 2010. The FDA determined that "Caplex Supplement" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] due to therapeutic claims for cure, mitigation, treatment, or prevention of disease.

Violations include claims such as "effective in preventing and/or slowing the development of cancer cells," "anti-tumor," and "inhibiting growth of pancreatic cancer." These claims establish Caplex as a drug. Since Caplex is not generally recognized as safe and effective for these uses, it is an unapproved "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)], violating section 505(a) [21 U.S.C. § 355(a)].

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)

Company: https://www.globalkeysolutions.net/companies/millennium-bioceutics/d6a9d997-7e8b-47ec-99cd-c7e3d2809ea0

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861