Breaking News: FDA Bans 1,3-dimethylamylamine

[ManimalPatB]

http://www.fda.gov/NewsEvents/Newsro.../ucm302133.htm

Holy shit!!!

DA NEWS RELEASEFor Immediate Release: April 27, 2012
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-FDAFDA challenges marketing of DMAA products for lack of safety evidence
Agency cites ten companies in warning lettersThe 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 Supplements	Biorhythm SSIN Juice
Fahrenheit Nutrition	Lean Efx
Gaspari Nutrition	Spirodex
iSatori Global Technologies, LLC	PWR
Muscle Warfare, Inc.	Napalm
MuscleMeds Performance Technologies	Code Red
Nutrex Research	Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers
SEI Pharmaceuticals	MethylHex 4,2
SNI LLC	Nitric Blast
USP Labs, LLC	Oxy 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 processReporting 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.

[data4]

Wow... I was kinda wondering if this was coming

[Hydroshake]

wait, is it actually banned or is it just being questioned on safety? the companies have to find a way to prove that it's safe before they continue selling it, right? That's what it sounds like. not a straight up ban.

[retwa]

Looks like they just sent out warning letters...it's not banned yet. Though it sounds like a ban is coming if these companies fail to adequately respond to the FDA.

[mrusa85]

Doesn't sound like a ban... yet.

[Wolver1ne]

And now it goes underground.

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[AVBG]

No great loss. Overrated as a supplement.ImageUploadedByTapatalk1335590012.113320.jpg


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[Big Baldwin]

They've been talking about this for awhile from what I understand. Most companies who were already using it removed it from their prewo's. I guess these are the ones who didn't get rid of it yet

[Ryan Bracewell]

Whether it gets banned or not, many companies has already changed their formulas or have a change in the works.

[Friendly Milkshake]

does craze have 1,3 in it?

[Ryan Bracewell]

does craze have 1,3 in it?

Craze has/had meth in it, lol. Seriously though, whatever it is/was wasnt DMAA

[Young Gotti]

wow huge loss, this stuff was amazing in supplements....i've heard numerous ppl complain about products that had it in it that now don't not being as effective and has forced them to switched to products that still contain it

[JessForce]

Instead of banning the products/ingredients that work can't we find away to ban the idiots that abuse it and ruin it for everyone else?

[Prince]

knew this was coming...

[LSMUSCL81a]

Instead of banning the products/ingredients that work can't we find away to ban the idiots that abuse it and ruin it for everyone else?

exactly...i have to show i.d to fkn buy ephedra...why not do this with other "questionble" products

[Ryan Bracewell]

In reality it's not that big of a loss. Other than giving you lots of energy DMAA doesn't really do anything for fat loss or improving performance, and has more side effects than ephedra

[Vince Goodrum]

Man, it was just a matter of time.

[lartinos]

This has been rumored for some time. Not surprised by it, I am guessing people will just try to pass another chemical off as natural next or more and more people will try to spike their products possibly too.

[machine]

sadly, I've never tried it. LOVE EPHEDRINE but due to some anxiety and stress in my life gotta wait till it calms down. How does this compare to ephedrine?

[LookinFit75]

sadly, I've never tried it. LOVE EPHEDRINE but due to some anxiety and stress in my life gotta wait till it calms down. How does this compare to ephedrine?

I've never tried efedrine but HemoRage Black is actually quite euphoric in nature and gives you quite the rush when you are working out. I was wondering what the active ingredient in it is that was giving me such a strong kick and now I know. I think I'll stop taking it now till further test are done to show it is safe.

[s2h]

Adderal works good...try that...so i here....

[OMEGA]

Actually its a warning letter and they have an opportunity to win.
1,3 has some of the best safety data for an ingredient.......its going to come down to fighting it out.

Unless this is an attack on sythetics as a whole under the guise of going after this one ingredient.........if thats the case then the entire supp industry is FUCKED

[LookinFit75]

Adderal works good...try that...so i here....

Works good for what?

[bjo12]

Muscle-Tech Neurocore has 1,3-Dimethylamine why isn't it not on the list? It should be #1

[Ryan Bracewell]

Muscle-Tech Neurocore has 1,3-Dimethylamine why isn't it not on the list? It should be #1

Neurocore is fairly new compared to all the products on that list. Most of the listed have been out for atleast a year if not two.

[lartinos]

Actually its a warning letter and they have an opportunity to win.
1,3 has some of the best safety data for an ingredient.......its going to come down to fighting it out.

Unless this is an attack on sythetics as a whole under the guise of going after this one ingredient.........if thats the case then the entire supp industry is FUCKED

Many supplements are naturally derived, so i will have to disagree with you on that one. Almost all are other than vitamins. If you mean they are going to ban vitamins, again I find that hard to believe. If that did happen I would think it would take many years.

[Tinyshrek]

Shit sucks anyways lol... It's a vasorestrictor not a diolater so it just geeks u out but fucks up ur pump...

[kraftwerk]

Adderal works good...try that...so i here....

Are you being serious? I actually just called my doc about possibly getting on adderall or ritalin something. Finally realized I must have adult ADHD-PI, after my friends/family sort of had an minor intervention and told me I need to do something about it. Worried that it might cut my appetite too much though.

[lilarnold]

Muscle-Tech Neurocore has 1,3-Dimethylamine why isn't it not on the list? It should be #1

Do your research kid....it has geranium but an entirely different species of the flower and does not contain dmaa

[Ryan Bracewell]

Do your research kid....it has geranium but an entirely different species of the flower and does not contain dmaa

apparently you dont research enough. Taken directly from the notice sent out by the FDA. notice the bold.

"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. "

[cheloz28]

Never tried Hemo Rage Black, do I guess I'll stock up since its on sale.


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[Prince]

Actually its a warning letter and they have an opportunity to win.
1,3 has some of the best safety data for an ingredient.......its going to come down to fighting it out.

true, they can fight it, the ban on Ephedra was over turned.

[JWolfe]

I didn't care for it that much, higher dosing felt like a low dose of cocaine but with more CNS stimulation than an equal rush of cocaine would be, also the next day after use my hair would always feel weird like it was full of static and my sleep apnea would be terrible. I didnt think it was from that so took a week off of it and tried it again and each time I had the same next day side effects.