Supercore Products Group, Inc.

Selected passages from the FDA letter

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

Passage 1

Your “Hard Steel” and “Gold Hard Steel Plus” products 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 2

The labeling for your “Hard Steel” and “Gold Hard Steel Plus” products do not declare that the products contain a PDE-5 inhibitor or acetaminophen.

Passage 3

Your “Hard Steel” and “Gold Hard Steel Plus” products, which contain undeclared sildenafil, are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), and as such, can be used safely only at the direction, and under the supervision, of a licensed practitioner.

Passage 4

The undeclared active pharmaceutical ingredients in your products also causes these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because its labeling lacks adequate warnings for the protection of users.