Inspections, Compliance, Enforcement, and Criminal Investigations

Infantry Labs LLC 10/23/17

 

  

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Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI  48207
Telephone: (313) 393-8100
Fax: (313) 393-8139 
 
 

 

October 23, 2017
 
WARNING LETTER
 
Case# 535333
 
 
UPS NEXT DAY SIGNATURE REQUIRED
 
John Fogarty and Steve Ludwig
Infantry Labs, LLC
4200 Spring Creek Ln
O’Fallon, MO 63368
 
John Fogarty and Steve Ludwig
1 Nation Nutrition
223 Fairway Green Dr.
O'Fallon, MO 63368
 
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.
 
According to your product labels, your products contain the following ingredients:
  • 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
 
Unapproved New Drug Violations
 
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:
  • The Officer
o   “Great for strength”
o   “Great for lean mass gains”
o   “Great for body recomposition
  • The Lieutenant
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.
 
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 at the direction, and 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 for use 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 “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)].
 
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.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
 
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.
 
Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.
 
Attn:  Russell K. Riley, Compliance Officer
U. S. Food and Drug Administration
Division of Pharmaceutical Quality Operations III
 
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.
 
 
Sincerely,
/S/
Art O. Czabaniuk
Program Division Director
Division of Pharmaceutical Quality Operations III
 
 
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/.

 

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