Dynamic Health Group dba SARMS AMERICA
FDA issued a warning letter to Dynamic Health Group dba SARMS AMERICA (Cheyenne, WY) in December 2025 for marketing unapproved new drugs — specifically SARMs including Ostarine MK-2866, MK-677 Ibutamoren, Cardarine GW501516, and LGD-4033 Ligandrol — via their website sarmsamerica.co. Despite labeling the products 'for research use only,' the website's health and body-composition claims established intended human drug use, violating FD&C Act sections 301(d) and 505(a). FDA cited safety concerns including liver toxicity, increased risk of heart attack, and stroke. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (13)
By activating AMPK, GW-501516 can significantly boost fat loss and increase overall energy output.
MK677, also recognized as Ibutamoren, Oratrope, or Nutrobal . . . functions as a ghrelin agonist. It acts on the pituitary gland to stimulate the secretion of human growth hormone, making it a human growth hormone secretagogue.
Administered orally, MK677 Ibutamoren mimics the action of the hunger hormone ghrelin, thereby increasing growth hormone (GH) levels in the body. It is notably effective in elevating insulin-like growth factor 1 (IGF-1) levels.
It has shown potential in aiding fat burning and possibly preventing obesity in users. o Increases fatty acid oxidation and promotes fat loss o Lower LDL cholesterol ("bad cholesterol") o Higher HDL cholesterol ("good cholesterol") o Increases endurance o Reduces inflammation o Decreases insulin resistance and improves glucose tolerance
Researchers have found that Ligandrol is effective in creating lean muscle mass and treating bone conditions such as osteoporosis.
Research has shown that MK677 increases bone turnover, bone mineral density, muscle mass, and osteoblast activity in older adults, thereby improving overall body composition.
LGD 4033, also known as Ligandrol, is a selective androgen receptor modulator (SARM) that can provide the benefits of anabolic steroids without the associated negative side effects. It promotes an increase in lean muscle mass, enhances libido, and improves stamina. . . . Taken orally, this tissue-selective SARM can positively impact muscle weakness caused by osteoporosis, cancer, and aging.
It was therefore concluded that GW 501516 has potential as a cardiovascular protection compound.
A randomized controlled trial conducted with health older adults revealed that daily administration of 25 mg of MK-677 improved body composition, bone mineral density, and cholesterol levels over several months, concurrently enhancing appetite.
A 2011 study showed that MK2866 significantly boosted lean body mass, muscle mass, and overall physical functionality in elderly males and postmenopausal females.
MK-2866 has demonstrated a variety of potential benefits in research 1. Increased strength 2. Enhanced protein synthesis 3. Accelerated muscle growth 4. Boosted energy levels 5. Improved bone health 6. Better heart health 7. Weight loss and reduction in body fat 8. Enhanced recovery of connective tissue.
[F]or research use only
MK 677 Benefits in Clinical Research 1. MK-677 has demonstrated various effects in vivo, including: Increased GH levels Enhanced muscle mass and lean body mass Reduction in body fat Increased bone density Accelerated muscle growth Improved immune function Enhanced REM sleep Increased appetite Reversal of growth hormone deficiency Alleviation of pathology associated with beta-amyloid
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.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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