Source: https://www.casewatch.net/fdawarning/prod/2017/infantry.shtml
Timestamp: 2020-02-19 16:57:01
Document Index: 411180251

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 321', '§ 201', '§ 321', '§ 353', '§ 33', '§ 201', '§ 331']

FDA Warning Letter to Infantry Labs LLC 10/23/17
Case# 535333
UPS NEXT DAY SIGNATURE REQUIRED
John Fogarty and Steve Ludwig
Infantry Labs, LLC
4200 Spring Creek Ln
223 Fairway Green Dr.
Dear Mr. Fogarty and Mr. Ludwig:
This is to advise you that your firm’s distribution of the products “The Officer (MK-2866)” and “Lieutenant (LGD-4033)” violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), as described below. The Food and Drug Administration has safety concerns about several of your products marketed as dietary supplements that contain selective androgen receptor modulators (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.
The Officer: ((2S)-3-(4-cyanophenoxy)-N-{4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2- methylpropamide (Ostarine or MK-2866)
The Lieutenant: 4-((R)-2-((R)-2,2,2-trifluoro-1-hydroxyethyl) pyrrolidin-1-yl)-2-trifluoro Methyl) benzonitrile (LGD-4033)
“The Officer (MK-2866)” and “Lieutenant (LGD-4033)” are labeled as dietary supplements; however, these products do not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21
U.S.C. § 321(ff)]. and neither ostarine nor LGD-4033 were marketed as a dietary supplement or as a food before they were authorized for investigation as a new drug. Therefore, “The Officer (MK-2866)” and “Lieutenant (LGD- 4033)” which contain ostarine and LGD-4033, respectively, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321 (ff)(3)(B)(ii)].
“The Officer (MK-2866)” and “Lieutenant (LGD-4033)” are labeled to contain the SARMs Ostarine and LGD-4033, respectively. 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. MK-2866, known as ostarine, and LGD-4033 have been authorized for investigation and are the subject of substantial clinical investigations, which have been made public,1
Your website, where you take orders for The Officer (MK-2866) and Lieutenant (LDG-4033), and product labels include claims that indicate the intended uses of these products, such as the following:
o “Great for strength”
o “Great for lean mass gains”
o “Great for body recomposition
o “. . . [I]ncreases in lean body mass and decrease in body fat”
o “. . . [I]ncreases in strength, well being (sic), as well as healing possibilities”
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 a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution (21 C.F.R. § 201.128). Your products are intended to affect the structure or function of the body by, among other things, building muscle and increasing strength. Accordingly, “The Officer (MK-2866)” and “Lieutenant (LGD-4033)” are drugs.
Moreover, these products are “new drugs,” as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321 (p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.
Furthermore, your products are “prescription drugs” as defined at section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because due to their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. 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 any 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. §§ 33 1(d) and 355(a)]. Your sale of the new drugs “The Officer (MK-2866)” and “Lieutenant (LGD-4033)” without approved NDAs violates these provisions of the FD&C Act.
Because your firm’s “The Officer (MK-2866)” and “Lieutenant (LGD-4033)” products lack required approved applications, they are 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, these products are misbranded, and the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of these misbranded products violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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.
Attn: Russell K. Riley, Compliance Officer
Refer to the Unique Identification Number (Case# 535333) when replying. If you have questions regarding the contents of this letter, please contact Mr. Riley by phone at (312) 596-4219.
1 Ostarine: http://www.sec.gov/Archives/edgar/data/1260990/000095014405009387/g97259exv99w1.txt;,GTxInitiatesPhaseIIb Ostarine Clinical Trial for Cancer Cachexia, available at http://phx.corporate- ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID=1022240&highlight, (July 3, 2007) (indicating that Phase II trials had been initiated for ostarine in the treatment of cancer cachexia); GTx Announces Investigational Ostarine (TM) (MK-2866) Met the Primary Endpoint in the Phase II Cancer Cachexia Clinical Trial (available at http://www.businesswire.com/news/home/20081013005333/en/GTx-Announces-Investigational-Ostarine-TM-MK-2866- Met#.VFyqGclP1v4 (October 13, 2008) (stating that Phase II trials were completed); GTx Inc., FDA to Begin Trials on Cancer Drug, available at http://www.memphisdailynews.com/news/2011/jun/13/gtx-inc-fda-to-begin-trials-on-cancer-drug//print (June 13, 2011) (explaining that Phase 3 trials were being initiated for ostarine in the treatment of cancer cachexia.) VK5211 (formerly LGD-4033): Ligand Pharmaceuticals announced initiation of Phase 1 trials with LGD-4033 capsules, available at http://investor.ligand.com/press-releases/detail/45/ligand-initiates-clinical-trial-with-the-selective-androgen (June 17th, 2009); Viking Therapeutics announced initiation of Phase 2 trial with VK5211 (formerly LGD-4033) designed to evaluate acute hip fracture, available at http://www.prnewswire.com/news-releases/viking-therapeutics-initiates-phase-2- trial-of-vk5211-in-patients-recovering-from-hip-fracture-300170799.html (November 3, 2015); Viking Therapeutics states VK5211 demonstrated statistically significant increase in lean body mass in Phase 2 trial, available at http://www.vikingtherapeutics.com/pipeline/vk5211/.