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WARNING LETTER

December 12, 2025

RE: 719257

Dynamic Health Group dba SARMS AMERICA:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://sarmsamerica.co/ in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “Ostarine MK-2866,” “MK-677 Ibutamoren,” “Cardarine GW501516,” and “LGD-4033 Ligandrol” (hereinafter products marketed as SARMs) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.¹

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. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

Ostarine MK-2866

On the webpage https://sarmsamerica.co/products/ostarine-mk-2866/:

• “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.”

• “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.”

MK-677 Ibutamoren

On the webpage https://sarmsamerica.co/products/ibutamoren-mk-677/:

• “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.”
• “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”
• “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.”

Cardarine GW501516

On the webpage https://sarmsamerica.co/products/cardarine-gw501516/:

• “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.”
• “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”
• “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.”

LGD-4033 Ligandrol

On the webpage https://sarmsamerica.co/products/lgd4033-ligandrol/:

• “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.”
• “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.”
• “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.”

Your products marketed as SARMs are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719257” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_____________________

1 See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.