# FDA WARNING_LETTER - Northern Health Products - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/northern-health-products/d199b2b5-5c03-4b40-8321-c4c87ed874e5

> FDA WARNING_LETTER for Northern Health Products on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Northern Health Products
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: The FDA issued a Warning Letter (17-ATL-03) to Northern Health Products regarding the marketing and sale of several unapproved and misbranded drugs for human and animal use, including DCA Cancer Treatment Kit, ALA Alpha Lipoic Acid, N-A-C N-Acetyl L-Cysteine, DMSA Synergy, and Pet DCA. The FDA reviewed the firm's websites, including www.northernhealthproducts.com and www.petdca.com, in September 2016.

The products DCA Cancer Treatment Kit, ALA Alpha Lipoic Acid, and N-A-C N-Acetyl L-Cysteine are deemed unapproved new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] due to claims establishing their intent for disease treatment, cure, mitigation, or prevention. These products lack FDA approval for safety and effectiveness. Furthermore, DCA Cancer Treatment Kit and N-A-C N-Acetyl L-Cysteine are misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] because they address conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use.

DMSA Synergy is cited as an unapproved and misbranded drug because it contains DMSA, an active pharmaceutical ingredient in FDA-approved drugs (

## Related Officers

- [Ingrid A. Zambrana](https://www.keypedia.com/people/ingrid-a-zambrana/122ef711-2d89-489b-a5e9-82893f58dd8f)
- [Consumer Safety Officer](https://www.keypedia.com/people/janice-l-king/af5a2175-c72c-4748-a9ca-c73d708afa3b)

Company: https://www.keypedia.com/companies/northern-health-products/e515da3c-8216-44c8-9fea-7fc53c980a12

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7