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.