FDA WARNING_LETTER - Northern Health Products

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 (