Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS

Selected passages from the FDA letter

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

Passage 1

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.

Passage 2

The labeling for your “GE Labs Ykarine” product does not declare that the product contains trendione (estra-4,9,11-triene-3,17-dione).

Passage 3

FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act, 21 U.S.C. 321(ff)(3)(B)(i).

Passage 4

FDA has determined that ibutamoren is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(ii).