Author Topic: FDA goes after IronMan Labs (and others) for adulterated ingredients  (Read 4155 times)

dknole

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https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ironmag-labs-622504-05042022?utm_medium=email&utm_source=govdelivery

This letter concerns your products CBD Gummies, Ephedra Stack, Lean Fuel V2 and Stimulate, which are labeled as dietary supplements.

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the products are adulterated dietary supplements.

Based on our review of your website https://ironmaglabs.com and other relevant evidence, CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate are unapproved new drugs sold in violation of section 505(a) of the FD&C Act [21 U.S.C. 355(a)]. Furthermore, your CBD-containing product is a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)]. As explained further below, introducing or delivering these unapproved and misbranded drugs for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act through links on FDAs website at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act and the FDA regulations at https://www.ecfr.gov/current/title-21.


Taffin

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Oh shit! :o

T

Skeletor

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The new FDA commissioner.


BB

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Not that big a deal. It's one of those fix your ads, and pull this, and we're good type things. They've been cracking down on supplement ads lately, Amazon made Palumbo pull some things recently, maybe they'll Species will draw the FDA's ire soon.

Rambone

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The new FDA commissioner.



Can very easily be bribed with a Goodwill seersucker suit w/ minimal cigarette burns

deadz

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The new FDA commissioner.


;D Just when Ironmagfag thought he won.
T

joswift

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The new FDA commissioner.



he did say he was getting a new job...


Rambone

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Show me the bodies

Taffin

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I know and am happily reporting on it tonight on my youtube channel

Excellent!  In a teensy bit of irony, I just noticed the response needs to go to an FDA guy called... Aaron... yeah I know, common name, but still ;D

"Your written reply should be directed to Aaron Dotson, Compliance Officer"
T

Ron

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #10 on: May 09, 2022, 03:56:58 PM »


11 companies received 'warning' letters regarding special ingredients they have in their products.  Gives them all a chance to remove them from the market soon...


Gym-Rat

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #11 on: May 09, 2022, 04:12:52 PM »
These letters are common and nothing (if you comply) Im sure Rob (IML) has been thru this many times.
Aaron (Redcon1) would have been fine if he just complied as well, rather than pull the shady shit that he and PJ did.

LurkerNoMore

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #12 on: May 09, 2022, 06:22:27 PM »
The new FDA commissioner.




Oh hell..   you win the internet for today.

webstar

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #13 on: May 09, 2022, 06:38:01 PM »

Flexacon

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #14 on: May 09, 2022, 06:48:07 PM »


The one advantage of being fat and black. Goodrum has fewer wrinkles than men half his age

LurkerNoMore

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #15 on: May 09, 2022, 06:53:58 PM »


In depth thought....  needs a compass to find his way back.

MCWAY

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #16 on: May 09, 2022, 07:30:18 PM »
I've used supplements, on and off, for decades. I've NEVER had any brand with "adulterated" ingredients.

 ;D

beakdoctor

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #17 on: May 09, 2022, 07:37:09 PM »
FDA couldn't get their story straight about the vax but Iron Mag labs is at the top of their priority list.

Federal agents should be busting down the doors of zpfizer, Moderna and 'Jansen.' But it's all a joke at this point.

Ironmag labs used to much alpha yohimbe so they got to pay the price.

What a fucking joke.

LurkerNoMore

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #18 on: May 09, 2022, 07:45:04 PM »
Seems like it could be dodged simply by changing and editing the marketing words and claims.

Sort of Joe Weider's Anabolic MegaPaks were back in the day.  They got cracked down on because they were not "anabolic" and Weider had to change the marketing for them.

Dave D

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #19 on: May 09, 2022, 08:16:34 PM »
FDA couldn't get their story straight about the vax but Iron Mag labs is at the top of their priority list.

Federal agents should be busting down the doors of zpfizer, Moderna and 'Jansen.' But it's all a joke at this point.

Ironmag labs used to much alpha yohimbe so they got to pay the price.

What a fucking joke.

Well said.

AbrahamG

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #20 on: May 09, 2022, 09:21:49 PM »
Can very easily be bribed with a Goodwill seersucker suit w/ minimal cigarette burns

Fucking dying here. Absolutely the post of the day!

Dave D

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #21 on: May 09, 2022, 09:49:40 PM »
Fucking dying here. Absolutely the post of the day!

X2

IronMagazine.com

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #22 on: May 10, 2022, 12:10:52 AM »
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ironmag-labs-622504-05042022?utm_medium=email&utm_source=govdelivery

This letter concerns your products CBD Gummies, Ephedra Stack, Lean Fuel V2 and Stimulate, which are labeled as dietary supplements.

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the products are adulterated dietary supplements.

Based on our review of your website https://ironmaglabs.com and other relevant evidence, CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate are unapproved new drugs sold in violation of section 505(a) of the FD&C Act [21 U.S.C. 355(a)]. Furthermore, your CBD-containing product is a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)]. As explained further below, introducing or delivering these unapproved and misbranded drugs for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act through links on FDAs website at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act and the FDA regulations at https://www.ecfr.gov/current/title-21.

As if we have never received an FDA warning letter before. At least get my company name right you moron.

IronMagazine.com

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #23 on: May 10, 2022, 12:12:35 AM »
Oh you forgot to include the other 10 companies that received the same FDA warning letter today.

IronMagazine.com

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Re: FDA goes after IronMan Labs (and others) for adulterated ingredients
« Reply #24 on: May 10, 2022, 12:26:13 AM »

I know and am happily reporting on it tonight on my youtube channel

Oh lord, and who besides you is going to watch it? lol