Elite Supplement Center LLC and Elite Training Facility LLC
FDA issued a warning letter to Elite Supplement Center LLC and Elite Training Facility LLC (Wayne/Pompton Lakes, NJ) in July 2022 after reviewing their website and finding they were selling five SARM products — Ostarine MK-2866, Ligandrol LGD-4033, Ibutamoren MK-677, Testolone RAD140, and Cardarine GW501516 — with marketing claims establishing intended human use despite 'Research Only / Not for Human Consumption' labels. FDA determined these products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, citing safety concerns including liver toxicity, heart attack, and stroke risk. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
Cardarine GW501516 GW501516 and Cardarine, has become known as incredible fat loss and endurance agent over the past couple of years. Shred can help stimulate fatty acid oxidation in skeletal muscle tissue.
Ostarine MK-2866 delivers a full dose of premium Ostarine commonly considered the world's most anabolic and popular SARM. Ostarine is known for producing excellent lean muscle gains while helping bone and joint health as well as muscle recovery. This makes it a great choice for body recomposition.
Testolone Rad140 RAD140 has been noted 90:1 anabolic/androgenic ratio. This means serious muscle building power without the possible negative side effects associated with anabolic steroids. Use it as a bulking agent to help put on solid lean muscle mass as well as keep mass in between cycles.
RESEARCH ONLY
Not for Human Consumption
Ligandrol LGD 4033 SARM LGD-4033 also known as Ligandrol. This non-steroidal supplement helps prevent muscle wasting and keeps the you[sic] highly anabolic; that is, it helps you build muscle faster and delivers much of the same benefits of testosterone without the possible negative side effects. Brawn, due to its highly anabolic nature as well as its great aid in recovery, is so versatile that it may be used with excellent results in bulking, recomp, and cutting!
Ibutamoren MK-677 Known as MK-677 and Ibutamoren, is a highly potent growth hormone secretagogue as it mimics ghrelin, the hormone that signals the release of GH. It can also help boost IGF-1 with affecting cortisol levels. Overall, it can help users build lean muscle mass and bone mineral density as well as help you lose fat.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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