• Save
FED /FDA Complaint relating to DMAA and GNC Holdings
Upcoming SlideShare
Loading in...5
×
 

FED /FDA Complaint relating to DMAA and GNC Holdings

on

  • 941 views

According to a complaint filed in Federal District Court in Pittsburgh, the F.D.A. conducted an inspection of the GNC warehouse in Leetsdale this month and collected physical samples, photographed the ...

According to a complaint filed in Federal District Court in Pittsburgh, the F.D.A. conducted an inspection of the GNC warehouse in Leetsdale this month and collected physical samples, photographed the products and seized shipping records. After the inspection, F.D.A. officials notified GNC that the products were adulterated and being illegally held by the company. On June 11, the F.D.A. ordered GNC to detain the products.

Federal prosecutors filed a similar complaint on Tuesday in Federal District Court in Anderson, S.C., seeking a seizure of the same products at a GNC facility there.

Because the dietary supplement industry tends to voluntarily heed F.D.A. public advisories, the agency rarely feels compelled to take the aggressive tack of seizing products.

Statistics

Views

Total Views
941
Views on SlideShare
512
Embed Views
429

Actions

Likes
0
Downloads
0
Comments
0

19 Embeds 429

http://ageorgialawyer.blogspot.com 316
http://www.ageorgialawyer.blogspot.com 42
http://ageorgialawyer.blogspot.ru 31
http://ageorgialawyer.blogspot.ca 6
http://ageorgialawyer.blogspot.de 6
http://ageorgialawyer.blogspot.co.uk 4
http://ageorgialawyer.blogspot.kr 4
http://ageorgialawyer.blogspot.jp 4
http://ageorgialawyer.blogspot.in 3
http://ageorgialawyer.blogspot.com.au 2
http://www.mybestcv.co.il 2
http://ageorgialawyer.blogspot.fr 2
http://ageorgialawyer.blogspot.com.br 1
http://ageorgialawyer.blogspot.ch 1
http://ageorgialawyer.blogspot.cz 1
http://www.ageorgialawyer.blogspot.ca 1
http://ageorgialawyer.blogspot.co.nz 1
http://ageorgialawyera.blogspot.com 1
http://georgia1064.rssing.com 1
More...

Accessibility

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

FED /FDA Complaint relating to DMAA and GNC Holdings FED /FDA Complaint relating to DMAA and GNC Holdings Document Transcript

  • 1UNITED STATES DISTRICT COURTFOR THE DISTRICT OF SOUTH CAROLINAANDERSON DIVISIONUNITED STATES OF AMERICA, ))Plaintiff, ) Case No.________)v. ))860 cases more or less, of an article )of food, labeled in part: ))(case) ))“*** PART # *** Lot # *** Exp. Date )*** 12-BT Per Case-90CT ***” ))(bottle) ))“*** USPlabs OxyELITE Pro® Super )Thermogenic™ *** DIETARY SUPPLEMENT )90 capsules *** Proprietary Blend *** )1,3-Dimethylamylamine HCl, *** )Manufactured for USPlabs, LLC (Dallas, )TX 75220) ***” ))and ))848 cases more or less, of an article )of food, labeled in part: ))(case) ))“*** PART # *** Lot # *** Exp. *** )6-BT Per Case ***” ))(bottle) ))“*** USPlabs Jack3d™ *** DIETARY )SUPPLEMENT *** 250g *** Proprietary )Blend *** 1,3-Dimethylamylamine HCl, )*** Manufactured for USPlabs, LLC )(Dallas, Texas 75220) ***”, ))and )8:13-cv-1675-JMC8:13-cv-01675-JMC Date Filed 06/19/13 Entry Number 1 Page 1 of 5
  • 2)all other articles of food labeled as )containing 1,3-Dimethylamylamine HCl )(DMAA) or its chemical equivalent in )various flavors, sizes, and forms and )various sized containers that are )located anywhere on the premises of )General Nutrition Centers, Inc., (GNC) )or Nutra Manufacturing, 4941 Liberty )Highway, Anderson, South Carolina, to )which are affixed labels bearing, )among other things, the name and )address of the manufacturer identi- )fied as USPlabs, LLC, Dallas, Texas, )which is located outside the state of )South Carolina, ))Defendants. )VERIFIED COMPLAINT FOR FORFEITURE IN REMNOW COMES the United States of America, William N. Nettles, United States Attorney forthe District of South Carolina, Leesa Washington and George Conits, Assistant United StatesAttorneys, respectfully state as follows:NATURE OF THE ACTION1. That this complaint is filed by the United States of America, and requests seizure andcondemnation of articles of food as described in the caption, in accordance with the FederalFood, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq.JURISDICTION AND VENUE2. That this Court has jurisdiction over an action commenced by the United States under28 U.S.C. § 1345 and 21 U.S.C. § 334.3. That there is at Anderson, South Carolina, in the possession of General NutritionCenters, Inc., (GNC), 4941 Liberty Highway, Anderson, South Carolina, or elsewhere within thejurisdiction of this Court, articles which are foods within the meaning of 21 U.S.C. § 321(ff), which8:13-cv-01675-JMC Date Filed 06/19/13 Entry Number 1 Page 2 of 5
  • 3consist in whole or in part of ingredients that were shipped in interstate commerce from outsidethe state of South Carolina.4. That this Court has in rem jurisdiction over the articles, because they are located in theDistrict of South Carolina.BASIS FOR FORFEITURE5. That the articles of food are adulterated when received in interstate commerce andwhile held for sale, within the meaning of the Act, 21 U.S.C. 342(a)(2)(C)(i), in that they containthe food additive DMAA, which is unsafe within the meaning of 21 U.S.C. § 348.6. That by reason of the foregoing, the articles are held illegally within the jurisdictionof this Court and are liable to seizure, condemnation, and forfeiture pursuant to 21 U.S.C. § 334.FACTS7. United States Food and Drug Administration (FDA) Investigators conducted aninspection of General Nutrition Centers, Inc., on May 29, 2013, thru June 6, 2013. During theinspection, the Investigators identified Jack3d™, and OxyElite Pro® Super Thermogenic™ asbeing labeled as containing 1,3-Dimethylamylamine HCl (DMAA). During the inspection, theInvestigators collected physical samples, photographed product containers and cases, andcollected interstate shipping records.8. All articles of food located anywhere at General Nutrition Centers, Inc., labeledas containing the ingredient DMAA or its chemical equivalent, shipped from USPlabs, LLC inDallas, TX to GNC, located in Anderson, South Carolina, are adulterated within the meaningof 21 U.S.C. § 342(a)(2)(C)(i).9. Under 21 U.S.C. § 321(s), a substance intended to become a component of8:13-cv-01675-JMC Date Filed 06/19/13 Entry Number 1 Page 3 of 5 View slide
  • 4food is a food additive unless (1) it is generally recognized among experts qualified byscientific training and experience to evaluate its safety, as having been adequately shown tobe safe under the conditions of its intended use; (2) it is subject to prior sanction; or (3) it isan ingredient described in 21 U.S.C. § 321(ff) (a dietary ingredient). The other exceptionslisted in 21 U.S.C. § 321(s) do not apply.10.DMAA is not a dietary ingredient, because it does not meet any of the elements of 21U.S.C. § 321(ff)(1).11.DMAA is not generally recognized as safe under the conditions of use in theseproducts. DMAA does not satisfy the second exception because it is not the subject of asanction or approval pursuant to the Act, or the other statutes identified in 21 U.S.C. § 321(s).DMAA is, therefore, a food additive.12.Under 21 U.S.C. § 348(a), a food additive is deemed unsafe unless it is used inconformity with a regulation prescribing conditions under which it may be safely used, it hasbeen granted an exemption for investigational use under 21 U.S.C. § 348(j), or it is a foodcontact substance. DMAA is not a food contact substance, there is no regulation prescribingthe conditions under which DMAA may be safely used, and no exemption for investigationaluse has been granted under 21 U.S.C. § 348(j). Therefore, DMAA is deemed unsafe under21 U.S.C. § 348 and, the defendant Articles containing DMAA are deemed adulterated under21 U.S.C. § 342(a)(2)(C)(i).13.By reason of the forgoing, the articles of food are held illegally within the jurisdiction ofthis Court and are liable to seizure and condemnation pursuant to 21 U.S.C. § 334.8:13-cv-01675-JMC Date Filed 06/19/13 Entry Number 1 Page 4 of 5 View slide
  • 514.WHEREFORE, the United States of America prays that:(a) a warrant of arrest issue for all articles of food as described in the caption that arelocated at General Nutrition Centers, Inc., Anderson, South Carolina;(b) condemnation and judgment be entered declaring the defendant articles of food beforfeited to the United States of America and grant plaintiff the costs of this proceedingagainst the claimant of the articles;(c) defendant articles be disposed of pursuant to the provisions of the Act;(d) and the United States of America be granted such other and further relief that theCourt deems just and proper.Respectfully submitted,WILLIAM N. NETTLESUNITED STATES ATTORNEYBY: s/Leesa Washington #6973Assistant United States AttorneyUnited States Attorney’s Office55 Beattie Place, Suite 700Greenville, SC 29601864-282-2100BY: s/George Conits #234Assistant United States AttorneyUnited States Attorney’s Office55 Beattie Place, Suite 700Greenville, SC 29601June 19, 2013 864-282-21008:13-cv-01675-JMC Date Filed 06/19/13 Entry Number 1 Page 5 of 5