EPH Technologies, Inc. – FDA Warning Letter, Nov 26, 2019

The FDA issued a Warning Letter to Ephbiotech (operating via www.ephbiotech.com) following an August 2019 review of their websites, which market products such as “Detoxoplex,” “Sinoplex,” and “Migrenza.” The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Claims on the website, including "Detoxoplex Withdrawal Relief" for opioid withdrawal, "Sinoplex" for allergy/headache, and "Migrenza" for migraines, establish them as drugs under 201(g)(1) and unapproved new drugs under 201(p) due to lack of general recognition of safety and effectiveness. No FDA-approved applications are in effect for these products. Furthermore, “Detoxoplex” is a misbranded drug under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) because its labeling fails to bear adequate directions for use (21 CFR 201.5). Opioid withdrawal symptoms require professional supervision, making adequate self-use directions impossible, and the product is not exempt from this requirement. The FDA emphasized that marketing unapproved opioid addiction treatments poses a significant public health threat. Ephbiotech must promptly correct these violations, investigate their causes, and prevent recurrence. A written response detailing corrective actions is required within fifteen working days, with potential legal action, including seizure and injunction, for non-compliance.