Hua Da Trading, 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 “WeFun” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.

Passage 2

Your “WeFun” product is also 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 3

The labeling for your “We Fun” does not declare that the product contains a PDE-5 inhibitor.

Passage 4

The undeclared active pharmaceutical ingredient in your product also causes this product 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.