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WARNING LETTER

December 12, 2025

TITAN SARMS LLC
Jedediah Bigelow, Legal Counsel
30 N. Gould St., Suite R
Sheridan, WY 82801

RE: 719645

TITAN SARMS LLC:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.titansarms.com/ 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, “LGD-4033” (also referred to on your website as Ligandrol), “RAD-140” (also referred to on your website as Testolone), “S-4” (also referred to on your website as Andarine), and “YK-11” (also referred to on your website as Myostatin Inhibitor) (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 as “Research-grade compound[s]” and “RESEARCH-ONLY PURPOSE,” 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:

LGD-4033 Ligandrol

• On the webpage https://www.titansarms.com/product/ligandrol-capsules:
  “SARMS STATS
  o CARDIAC ENDURANCE
  o PROTEIN SYNTHESIS
  o MUSCULAR BULK
  o MUSCULAR RECOVERY
  o FAT OXIDATION
  o MAXIMAL MASS
  o MUSCULAR ENDURANCE”
• “Ligandrol is a Selective Androgen Receptor Modulator (SARM) — known for its potent anabolic activity in muscle and bone tissue.
  In research settings, it has been shown to:
  o Increase lean body mass even at low doses.
  o Enhance muscle strength and endurance capacity.
  o Aid recovery from musculoskeletal injury.”
• “MUSCLE HYPERTROPHY:
  o Clinical studies have shown Ligandrol to significantly increase lean muscle mass in healthy adults within just weeks of administration.”
• “STRENGTH GAINS:
  o Participants in research trials have demonstrated measurable improvements in lifting strength and muscular endurance.”
• “RECOVERY SUPPORT:
  o By promoting anabolic signaling, Ligandrol can aid in tissue repair following injury or intense training.”

RAD-140 Testolone

On the webpage https://www.titansarms.com/product/rad140-capsules:

• “RAD-140 (Testolone) is a Selective Androgen Receptor Modulator (SARM) — studied for its high anabolic-to-androgenic ratio and potential neuroprotective benefits.
  In research settings, it has been shown to:
  o Stimulate significant muscle growth.
  o Enhance strength and power output.
  o Exhibit neuroprotective effects in research models.”
• “Lean Muscle Retention
  o RAD-140 (Testolone) has been observed to induce robust gains in lean muscle mass, even at low research dosages.”
• “PERFORMANCE ENHANCEMENT:
  o Its anabolic effects contribute to improvements in maximal strength and explosive power.”

S-4 Andarine

On the webpage https://www.titansarms.com/product/s4-capsules:

• “S-4 (Andarine) is a Selective Androgen Receptor Modulator (SARM) — originally developed for muscle wasting and osteoporosis.
  In research settings, it has been shown to:
  o Increase muscle mass while reducing fat.
  o Support bone density improvements.
  o Enhance muscular definition and vascularity.”
• “BODY COMPOSITION:
  o S-4 is often studied for its ability to reduce fat mass while preserving or increasing lean muscle.”
• “BONE HEALTH:
  o Research shows positive effects on bone strength and mineral density.”
• “AESTHETIC BENEFITS:
  o May enhance muscle hardness and vascularity in trained subjects.”

YK-11 Myostatin inhibitor

On the webpage https://www.titansarms.com/product/yk11-capsules:

• “YK-11 is a Selective Androgen Receptor Modulator (SARM) — unique for also acting as a myostatin inhibitor, potentially unlocking greater muscle growth.
  In research settings, it has been shown to:
  o Increase muscle cell differentiation and size.
  o Reduce myostatin activity in muscle tissue.
  o Support rapid strength development.”
• “MYOSTATIN INHIBITION:
  o YK-11’s ability to down regulate myostatin expression may allow for greater muscle hypertrophy than SARMs without this effect.”
• “ACCELERATED STRENGTH:
  o Research models indicate faster increases in muscular strength compared to baseline.”
• “CELLULAR GROWTH:
  o By promoting follistatin expression, YK-11 supports muscle cell development and repair.”

In addition, your website includes images of athletic men and women exercising or lifting weights.

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 “719645” 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.