# FDA WARNING_LETTER - Cellular Rx Inc - April 30, 2011

Source: https://www.keypedia.com/records/warning_letter/cellular-rx-inc/69520e97-2647-43ea-8286-f6cca6b6ebbf

> FDA WARNING_LETTER for Cellular Rx Inc on April 30, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cellular Rx Inc
- Inspection Date: 2011-04-30
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: On April 2011, the FDA reviewed the website www.cellpro7.com and determined that the product Cell Pro 7 is promoted for conditions that cause it to be 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)]. The therapeutic claims on the website, including "Arthritis, joint and muscle pain relief," "Migraine... and Allergy headache relief," and "Asthma, COPD, bronchial infection relief," establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease. The website also features testimonials claiming relief from arthritis, depression, allergies, severe burns, cluster headaches, and a reduction in PSA levels. Additionally, the Facebook account http://www.facebook.com/pages/Cell-Pro7/351345481336 contains testimonials making disease claims, such as controlling osteoarthritis, diabetes, and blood pressure.

The FDA states that Cell Pro 7 is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs require prior FDA approval under section 505(a) [21 U.S

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.keypedia.com/companies/cellular-rx-inc/093d4d82-9131-4dfd-a5c9-4c816bdb7d24

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79