Dynamic Health Group dba SARMS AMERICA

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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

Despite statements on your product labeling marketing your products, “[F]or research use only,” and “[F]or research purposes only,” evidence obtained from your product labeling, including your website establishes that your products are intended to be drugs for human use.

Passage 3

“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.”

Passage 4

“Studies involving Ostarine 1. A 2011 study showed that MK2866 significantly boosted lean body mass, muscle mass, and overall physical functionality in elderly males and postmenopausal females.”

Passage 5

“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.”

Passage 6

“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.”

Passage 7

“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”

Passage 8

“MK 677 and Body Composition 1. Research has shown that MK677 increases bone turnover, bone mineral density, muscle mass, and osteoblast activity in older adults, thereby improving overall body composition. 2. 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.”

Passage 9

“Also known as Cardarine GW 501516 or Endurobol, this compound is a PPARδ receptor agonist. These receptors regulate various biological processes within the body. Research indicates that GW-501516 binds to these receptors, activating AMP-activated protein kinase (AMPK). According to studies, AMPK plays a crucial role in energy regulation and helps the body survive metabolic stress. By activating AMPK, GW-501516 can significantly boost fat loss and increase overall energy output.”

Passage 10

“About Cardarine SARM . . . 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”

Passage 11

“Maintaining Heart Health with Cardarine o In a twelve-week study, participants were administered varying dosages of GW-501516 (Cardarine), including 2.5mg, 5.0mg, and 10mg. . . . Fasting insulin, glucose, lipids, and free fatty acid levels were of the levels taken for said baseline. By the end of this twelve-week study, those involved had experienced a significant change in both cholesterol levels, meaning HDL and LDL. It was therefore concluded that GW 501516 has potential as a cardiovascular protection compound.”

Passage 12

“The popular SARM, LGD-4033, is known by various names in the scientific community, including Ligandrol, VK5211, and Anabolicum. Researchers have found that Ligandrol is effective in creating lean muscle mass and treating bone conditions such as osteoporosis.”

Passage 13

“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.”

Passage 14

“Potential Research Findings 1. Lean Muscle Development:  LGD-4033 has been studied for its ability to promote increases in lean muscle mass by activating androgen receptors in skeletal muscle. 2. Strength Enhancement:  Research suggests LGD-4033 may improve strength and power, supporting muscle performance under experimental conditions. 3. Endurance Support:  Some studies indicate its potential to enhance stamina and physical endurance, aiding in prolonged physical activity during research trials. 4. Fat Mass Reduction:  Findings suggest LGD-4033 may assist in reducing fat mass while preserving lean tissue, making it a focus of studies related to metabolic health.”