Suprimo Imports

Selected passages from the FDA letter

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

Passage 1

FDA confirmed through laboratory analysis that a sample of your “AK Forte” contains the undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and methocarbamol.

Passage 2

“AK Forte” and “Bob Marley CannaKing” products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Passage 3

“AK Forte” and “Bob Marley CannaKing” are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 4

The labeling for “AK Forte” does not declare that the product contains the drug ingredients diclofenac, dexamethasone and methocarbamol.

Passage 5

In addition, your “Bob Marley CannaKing” is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use.

Passage 6

Information on the label and/or labeling of “Bob Marley CannaKing” demonstrates that the product is marketed as dietary supplement. For example, the product is labeled as a “Dietary Supplement.” FDA has concluded that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), because, based on available evidence, CBD was not marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized.