# Breaking News: FDA Bans 1,3-dimethylamylamine



## Arnold (Apr 28, 2012)

*Breaking News: FDA Bans 1,3-dimethylamylamine*

*Media Inquiries:* Siobhan DeLancey, 301-796-4668 or 202-510-4177, siobhan.delancey@fda.hhs.gov; Tamara Ward, 301-796-7567, tamara.ward@fda.hhs.gov
*Trade Press Inquiries:* Sebastian Cianci, 240-402-2291, sebastian.cianci@fda.hhs.gov

*Consumer Inquiries:* 888-INFO-FDA*FDA challenges marketing of DMAA products for lack of safety evidence 
*_Agency cites ten companies in warning letters_The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a "natural" stimulant.  The companies receiving warning letters and their product names are:

​
 Company Product(s) Exclusive SupplementsBiorhythm SSIN Juice Fahrenheit NutritionLean Efx Gaspari NutritionSpirodex iSatori Global Technologies, LLCPWR Muscle Warfare, Inc.Napalm MuscleMeds Performance TechnologiesCode Red Nutrex ResearchHemo Rage Black
Lipo-6 Black Ultra Concentrate
Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate
Lipo-6 Black Hers SEI PharmaceuticalsMethylHex 4,2 SNI LLCNitric Blast USP Labs, LLCOxy Elite Pro
Jack3D

"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program. 

Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.

The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.

The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.

The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters. 

*For more information:*How dietary supplements are regulatedDietary Supplement Health and Education Act of 1994New Dietary Ingredient notification process

Reporting adverse events associated with FDA regulated products#The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.​
FDA challenges marketing of DMAA products for lack of safety evidence


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## bigbenj (Apr 28, 2012)

jjjeeeeeeeeeeeeeeee-sus.
Nutrex just took a big fucking hit.


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## Arnold (Apr 28, 2012)

yeah, but they all knew this was going to happen, I am actually surprised it took this long.


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## oufinny (Apr 28, 2012)

My favorite stim... I FUCKING HATE the FDA.


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## bigbenj (Apr 28, 2012)

The good stuff always gets cut 
Will be interesting to see which direction they go from here.


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## ebfitness (Apr 28, 2012)

Well...back to buying the $7 bottles of caffeine at the drug store.


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## jwa (Apr 28, 2012)

I'm not a big fan of 1,3 but I know a lot of folks love it. Shame that this stuff needs to be regulated like it is.


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## keith1569 (Apr 28, 2012)

No big loss for me

Sent from Samsung Infuse 4G


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## MovinWeight (Apr 28, 2012)

I got halo


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## gamma (Apr 28, 2012)

I am sure *PRINCE* is working on a new formula  for some new product to replace this !


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## Resolve (Apr 28, 2012)

It's been a long time coming, but it's still a big loss


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## booze (Apr 28, 2012)

Where does it say its been banned? They've only been issued warnings and have 3 weeks to respond with the steps they're going to take?


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## ~RaZr~ (Apr 28, 2012)

Damn that sucks. If you like it, go stock up....


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## brundel (Apr 28, 2012)

We knew this was coming.......
Im sure so did the companies involved or at least most of em.
Something new will come along soon enough to take its place.


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## packers6211 (Apr 28, 2012)

Is the products bann already or can the supps sell what's left? Asking cause I was just about to get some more DS Craze!!!!


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## hypo_glycemic (Apr 28, 2012)

They always ban everything that actually works! It's ridiculous..


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## ~RaZr~ (Apr 28, 2012)

packers6211 said:


> Is the products bann already or can the supps sell what's left? Asking cause I was just about to get some more DS Craze!!!!



History has shown that companies are given a grace period to dump their stock. If you like any of the listed products, buy now!


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## packers6211 (Apr 28, 2012)

Yeah that's what I was thinking to lol. /Jack3d never did mych for me but DS craze has me moving like Taz in the gym. Sucks big time, I've already went through this crap with Xenadrine sob FDA.


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## Nightowl (Apr 28, 2012)

I have a few guys that work at shops that love a few of the products mentioned up above and in the beginning...years ago they were suggested to me.  Sorry, to hear this!


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## OTG85 (Apr 28, 2012)

Stocking up on jacked


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## Crank (Apr 29, 2012)

thank god i just got my jack3d and hemo rage last week! lmao!!!!


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## LAM (Apr 29, 2012)

yet you can still purchase a known carcinogen on every corner in the US...makes sense


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## girpy (Apr 29, 2012)

if you really like the stuff, go on ebay and pick up 100 grams of it for under 40 dollars, then you can mix it into any other pre workout you take for the rest of your life, that is my plan, otherwise you can blow tons of money on jacked and hemo rage just to get like......10 grams of the stuff total? just food for thought


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## SFW (Apr 29, 2012)

Bought in bulk a million times from nutraplanet back in the day. I made an aqueous blend in an old chem1 bottle. But...it loses its effectiveness fairly quickly with ed use. I liked that focus factor it gave, but PEA, imo, was better. Geranamine wont be missed by me, who cares. Its weak.

 A 10 dollar box of bronkaid and a can of folgers blows it away.


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## PushAndPull (Apr 29, 2012)

I agree with SFW. I could care less. 
If I want something more powerful than caffeine, i'll throw in some ephedrine.


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## packers6211 (Apr 29, 2012)

Yeah I noticed first time using Lean EFX, it lost effect around week 3. I can't ever find the good eph, the pharmacy around here are even banning bronkaid.


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## ~RaZr~ (Apr 29, 2012)

DMAA makes the prostate swell like a grapefruit...at least that's what I have been told


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## sofargone561 (Apr 29, 2012)

fuck im glad a have a few extra $ to stuck up now. =(


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## Hate4TheWeak (Apr 30, 2012)

Fuck the FDA! They've been trying to ban everything from Vitamin C to BCAA's without a prescription for years now and it'll happen...eventually.

Slowly but surely they'll save us all from being to stupid to decide what to put in our bodies. That's for our Dr's to decide and then we can pick up our scripts that where controlled by a federal sanctioning body who takes 40% of the company who manufactures these products annual revenue in order to "allow" them to produce these chemicals in the US.

Good thing they're not concerned about the really good healthy stuff like tobacco, alcohol, aspartame, sodium Nitrate, food coloring that cause cancer and countless others!!!! Not to mention the shit they put in shampoo, makeup, lotions etc...

Good job America!! Yays and high fives all around....

Piece of shit mother fuckers.


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## AKIRA (Apr 30, 2012)

We all knew this was going to happen.

But I didnt know you all were going to say it before I did.


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## Liftheavy&Often (May 3, 2012)

I'm not surprised. I liked 1-3 when it first came out but I am no longer a fan of it.


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## Diesel618 (May 4, 2012)

Fwiw, I talked to a buddy of mine last night about this. He manages a placebo shop and pushes placebos for a living. He said it's not been banned or being pulled, that the FDA just wanted the companies producing it to vouch for its safety or something along those lines. I picked up some Razor8 at his store just in case.


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## OMEGAx (May 4, 2012)

There is NO BAN date yet, and if you look close there is a chance the companies will win. The safety data for 1,3 is VERY good, so they can win on that argument.  Also GNC as a company en-whole is fighting the FDA do to the unfounded claims 1,3 is bad for you, and they have a yearly net of 2 BILLION plus , them and other will fight.  The only thing troubling that I read what the synthetics comment added byt he FDA, but many aminos and vitamins are made this way, so one can simply display that and extend the logic to botanicals


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## OMEGAx (May 4, 2012)

1,3 is VERY good, so they can win on that argument.  Also GNC as a company en-whole is fighting the FDA do to the unfounded claims 1,3 is bad for you, and they have a yearly net of 2 BILLION plus ........, them and others will fight.    The only thing troubling that I read what the synthetics comment added by he FDA, but many aminos and vitamins are made this way, so one can simply display that and extend the logic to botanical s.............  There are plenty of synthetics that got use patents and are recognized by the very same FDA as legitimate in the supp world...............  soo its going to come to paper pushing this out


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## Eiserner Hahn (May 4, 2012)

the FDA can eat the corn out of my shit


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## bodybuilder13 (May 5, 2012)

As long as they don't ban caffein I'm good. A cup of straight black coffee is all the motivation I need to hit the iron.


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## Lilarny (May 5, 2012)

There's no doubt people are freaking out though, I sold 4 cases of oxyelite to a couple navy guys yesterday. The big bottles to. Bookoo commission baby!!


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## jwa (May 5, 2012)

bodybuilder13 said:


> As long as they don't ban caffein I'm good. A cup of straight black coffee is all the motivation I need to hit the iron.



You and me both brotha! But I do love me some Craze


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## troubador (May 5, 2012)

> "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven???t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA???s Dietary Supplement Program.​



So is everything illegal until the fascists declare otherwise?


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## bmw (Apr 30, 2013)

~RaZr~ said:


> DMAA makes the prostate swell like a grapefruit...at least that's what I have been told



that's what I've experienced.  

No thanks!


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## bmw (Apr 30, 2013)

oufinny said:


> My favorite stim... I FUCKING HATE the FDA.



there's always meth.  cheap and easy to get.

molecularly similar too.


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## Arnold (Apr 30, 2013)

troubador said:


> So is everything illegal until the fascists declare otherwise?



Welcome to new America.


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