FDA WARNING_LETTER - goodimmuno.com - November 14, 2022

On November 14, 2022, the FDA issued a Warning Letter to www.goodimmuno.com for unlawfully selling unapproved and misbranded drugs, specifically opioids and benzodiazepines, to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website offers "Tramadol 50mg" and "Diazepam 10mg Loose/Blister," which are unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act, as no approved applications exist for these specific products. These drugs are also misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson and are prescription drugs dispensed without a prescription, violating sections 503(b)(1) and 301(k).

The FDA emphasized the significant public health risks associated with the easy online availability of these drugs, citing the opioid epidemic and the dangers of benzodiazepine co-use with other substances. The letter requires www.goodimmuno.com to cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must respond in writing within