FDA Halts DMAA Sales

[BendtheBar]

FDA orders halt to sale of products containing DMAA - News - Stripes

The U.S. Food and Drug Administration has ordered fitness supplement companies to immediately stop selling popular bodybuilding and weight-loss products containing DMAA, because of the substance’s potentially fatal side effects.

The agency has determined DMAA — which is sold as 1,3-dimethylamylamine, methylhexanamine, or geranium extract — is a synthetic substance that could cause heart attacks by elevating blood pressure in users. There have been 42 public complaints about products containing DMAA, indicating it might be linked to other serious health effects including nervous system and psychiatric disorders as well as death, the agency said Friday in a news release.

[bruteforce]

I might point out the actual deaths caused by tobacco and alcohol abuse, but then again, the FDA wouldn't care about the facts now would they.

[BendtheBar]

Here's more info for anyone interested:

FDA challenges marketing of DMAA products for lack of safety evidence

[Rich Knapp]

The problem is sup company's have been found lacing it (them), with small traces of steroids just so customers see results with a product. Easy to hide illegal substances behind these ingredient. This is why even the WADA is looking at banding it (them).

This has been in the works for almost a year now. lol To a natural tested BBer this is old news. lol

[bamazav]

42 complaints out of how many usages? There will be 42 auto accidents in the next few minutes, I don't see the FDA running to ban cars, gasoline or hot McDonald's Coffee. I don't use the product but I am not about running scared every time a few people complain about something they took and it had side effects. I took flomaxx a few years back. I was one of the 1% of 1% who had mood swings attributed to the meds. I didn't rush to get it pulled, I just started a different course of treatment. I wish people would use their common sense before dialing the attorney.

[BendtheBar]

The first thing that came to my mind is...how many complaints do they get against bottled water? I actually Googled that question, but found nothing yet.

One thing I learned from my time answering questions is that there are a small percentage of folks who come up with some really "interesting" side effects from the most tried and tested products. I've literally had people tell me that creatine caused their big toe to swell, and it lead to a nail infection.

I'm sure some of the claims are legitimate, but I also would wager a high percentage are unrelated or from inappropriate usage. I might be wrong.

[BendtheBar]

Something I found on Wiki, Wiki:

Anecdotal reports indicate that extremely high doses of methylhexanamine combined with caffeine and alcohol may be harmful.

[Tannhauser]

Originally Posted by bamazav

42 complaints out of how many usages? There will be 42 auto accidents in the next few minutes, I don't see the FDA running to ban cars, gasoline or hot McDonald's Coffee. I don't use the product but I am not about running scared every time a few people complain about something they took and it had side effects. I took flomaxx a few years back. I was one of the 1% of 1% who had mood swings attributed to the meds. I didn't rush to get it pulled, I just started a different course of treatment. I wish people would use their common sense before dialing the attorney.

Well, the FDA would have a job banning cars, unless someone's putting 'em in a capsule

I thought the 42 'events' associated with taking the products had alerted the FDA, but that the basis of their action was this:

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.

To me, it doesn't seem unreasonable that a company that introduces a compound to their products is required to submit evidence that it's safe.

I take BTB's point that people will routinely attribute side-effects incorrectly, but there is a logic behind the putative side effects in this case, given what the compound does. And with the 'events' including death, it's not necessarily trivial stuff.

I don't disagree with the principle that people should be allowed to take their own risks, but here's a case where manufacturers perhaps weren't even alerting the consumers, or even in a position to inform them.

[Chillen]

Do the availability of things, kill people, or do the people in which misuse it kill/injure/cause health complications?

For example: Alcohol is still legal, and its on a high list of beverages in which causes a plethora of complications, related deaths, injuries, dismemberment, and its not just health related. It is near the TOP of the list as the number 1 abused....drug.


Tobacco is another.

Neither of these will be illegal or stopped any time soon. Not that it would matter, when you consider the black market and the prohibition period.

The FDA: The F*U*C*K*E*D-UP DATA ADMINISTRATION.

[Hazzard]

Taking away our right to choose, one step at a time.