Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS
FDA issued a warning letter to Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS (Madison, WI) for marketing SARMs products — 'GE Labs Ykarine' and 'GE Labs MK 677' — as dietary supplements on their websites. The products were found to be unapproved new drugs under the FD&C Act, and lab analysis confirmed 'GE Labs Ykarine' contained undeclared trendione, a Schedule III controlled anabolic steroid, rendering it misbranded. FDA cited serious safety concerns including liver toxicity, heart attack, stroke, and kidney damage associated with SARMs and anabolic steroids. The firm was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.
Flagged claims (5)
BOOST STRENGTH & ENDURANCE
MK 677 IBUTAMOREN acts as an orally active GH secretagogue. The selective growth hormone doesn't release cortisol, the stres [sic] hormone, which makes it easier to lose fat and gain muscle at the same time. Other benefits from muscle building include improved sleep quality, increased muscle and connective tissue growth, boosted immune system, and decreased fat.
GE Labs Ykarine Pro . . . [is] a compound that selectively actives androgen receptors. The preparation naturally increases the level of follicles, which affects the body's ability to create new muscle cells. . . . Ykarine binding to androgen receptors affects the growth of bone strength, preventing excessive brittleness. . . . N-acetyl-1-cysteine supports the proper functioning of the liver and increase the level of glutathione – one of the strongest antioxidants.
INCREASE MUSCLE MASS
MYOSTATIN INHIBITOR
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
Due to the serious safety concerns relating to products that contain SARMs and anabolic steroids, it is essential that these violations do not recur.
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