Atomix LLC

December 12, 2025

RE: 719111

Andrew Pierce:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://atomixresearch.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, “MK-2866” (also referred to on your website as Ostarine or Enobosarm) and “RAD-140” (also referred to on your website as Testolone) (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). We have also reviewed your Instagram and Facebook accounts at https://www.instagram.com/atomix.research/ and https://www.facebook.com/profile.php?id=61565345070286, which direct consumers to your website https://atomixresearch.com/, to purchase your SARMs products. 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 for, “RESEARCH USE ONLY” and “not for human consumption,” 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 websites, 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:

On the webpage https://atomixresearch.com/product/mk-2866-ostarine-25-mg-ml-50-ml/:

“MK-2866, also known as Ostarine or Enobosarm, is a nonsteroidal selective androgen receptor modulator (SARM). It has been widely studied for its anabolic effects on muscle and bone while minimizing androgenic activity in other tissues.”

“MK-2866 enhances lean muscle mass, improves strength, and supports skeletal integrity[.]”

On a March 4, 2025, post on your Instagram account at https://www.instagram.com/p/DGyxya0h2cx/:

“Ostarine (MK-2866) offers potential benefits in muscle growth and bone health, making it a candidate for treating conditions like muscle wasting and osteoporosis.”

On March 4, 2025, Facebook post at https://www.facebook.com/photo/?fbid=122144674874511502&set=a.122112623036511502:

“Muscle Growth and DifferentiationOstarine, also known as MK-2866, is a selective androgen receptor modulator (SARM) that has been shown to stimulate muscle tissue proliferation and differentiation. It enhances muscle cell proliferation and protein synthesis, which can be beneficial for conditions like sarcopenia and cachexia.”

On the webpage https://atomixresearch.com/product/rad-140-10-mg-ml-50-ml/:

“RAD-140, also known as Testolone, is a nonsteroidal selective androgen receptor modulator (SARM) designed to mimic the anabolic effects of testosterone while minimizing androgenic activity in non-muscular tissues.”

“RAD-140 promotes lean muscle growth, enhances strength, and supports bone density, without significant prostate or liver toxicity being observed in traditional anabolic agents. It has also shown potential neuroprotective effects in models of neurodegeneration[.]”

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).

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 “719111” in the subject line of the email.