This is to advise you that your firm's distribution of the product "Super DMZ 4.0" violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), as described below. The Food and Drug Administration has significant safety concerns about your product(s) marketed as dietary supplements that contain synthetic steroids, steroid-like substances, or selective androgen receptor modulators (SARMs). Synthetic steroids have been associated with life threatening reactions such as liver damage, heart attack, pulmonary embolism, and deep vein thrombosis. In addition, 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.
"Super DMZ 4.0" is labeled as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)].
"Super DMZ 4.0" is labeled to contain the SARM, (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide). According to section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321 (ff)(3)(B)(ii)], the definition of a dietary supplement does not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization for investigation as a new drug. (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide), otherwise known as ostarine, has been authorized for investigation and is the subject of substantial clinical investigations, which have been made public, Therefore, "Super DMZ 4.0," which contains ostarine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act. and ostarine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug.
Unapproved New Drug Violations
Under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)], drugs are defined as articles (other than foods) that are intended to affect the structure or function of the body. The intended use of an article may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. 21 C.F.R. § 201.128. Your product labeling includes claims that indicate the intended uses of the product, such as "Anabolic & Androgenic," "Extreme Strength & Power," and "Increases Aggression."
These claims establish that your "Super DMZ 4.0" product is a drug under section 201(g)(1)(C) of FD&C Act because it is intended to affect the structure or function of the body.
Moreover, the product is a "new drug," as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321 (p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
Furthermore, your product is a "prescription drug" as defined at section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because due to its toxicity or potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Indeed, all anabolic steroid drugs which have been approved for marketing by the FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug. 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. The long-term safety profile of SARMs remains unclear; more clinical evidence is necessary to alleviate critical safety concerns such as liver toxicity, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
The introduction or delivery for introduction, or causing the introduction or delivery for introduction, of a new drug lacking an FDA-approved new drug application (NDA) is a violation of sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)]. Your sale of the new drug "Super DMZ 4.0" without an approved NDA violates these provisions of the FD&C Act.
Misbranded Drug Violations
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended. 21 C.F.R. § 201.5. Because, by definition, prescription drugs can only be used safely under the supervision of a licensed practitioner, section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)A)], adequate directions cannot be written so that a layperson can use them safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)].
FDA has exercised its authority under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] to create regulatory exemptions from the requirements of section 502(f)(1) [21 U.S.C. § 352(f)(1)]. Among the terms that must be met to satisfy these regulatory exemptions, a prescription drug must have labeling that provides adequate information for its safe and effective use by practitioners for each of the purposes for which it is intended, including all purposes for which it is advertised or represented. 21 C.F.R. §§ 201.100(c)(1), 201.100(d).
Because your firm's "Super DMZ 4.0" product lacks a required approved application, it is not exempt under 21 C.F.R. § 201.115 from the requirement to bear adequate directions for use under section 502(f)(1) of the FD&C Act. Therefore, the product is misbranded, and the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of this misbranded product violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations.
The FD&C Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 [21 U.S.C. §§ 332 and 334]. You should take prompt action to correct the violations cited in this letter and to prevent their recurrence. Failure to do so may result in enforcement action without further notice. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the cited violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
