goodimmuno.com

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

www.goodimmuno.com offers tramadol marketed as “Tramadol 50mg” and pictured as “Ol‐tram Tablets 50mg.” Your website states, “**Tramadol** is an **opioid pain relief medication** used for the treatment of moderate to severe pain” (emphasis in original). While there are FDA‐approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Tramadol 50mg” offered by www.goodimmuno.com.

Passage 2

www.goodimmuno.com offers diazepam marketed as “Diazepam 10mg Loose/Blister.” Your website states, “Diazepam 10mg, a medicine that can help you avoid panic attacks, anxiety, and insomnia.” While there are FDA‐approved versions of diazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Diazepam 10mg Loose/Blister” offered by www.goodimmuno.com.

Passage 3

Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.

Passage 4

By offering the aforementioned drugs without requiring a prescription, www.goodimmuno.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].