FDA's Nov.7 response. Link. Long text.
- Thread starter Grunt76
- Start date
Brooklyn
Member
Well that entire response talks a lot but says little.
To sum it up, the FDA gives a basic overview of how they regulate supplements under DSHEA, acknowledges that the 5 supplements listed by Amy Shipley in the Washington Post are under investigation, reassures the Congressman that they are doing their job and generally give a runaround excuse about how supplements are regulated post-market.
The investigation here will center on whether the 5 supplements incuded a NDI (new ingredient not marketed commercially previous to the passing of DSHEA in 1994) and if so, whether:
1. That ingredient was submitted properly to the FDA for approval in the correct time frame by the manufacturer of said product.
2. Whether ingredient in question is actually DSHEA-compliant; that is, naturally present in the food chain without chemical alteration.
3. Whether said ingredient was commercially marketed or submitted for approval as a drug; or contains a mislabeled or misbranded drug.
If a company under investigation did not follow the rules regarding all this, then they may be in trouble.
I personally don't think our fair Congressman is going to be satisfied with a simple letter filled with what would likely sound to him excuses and placation.
To sum it up, the FDA gives a basic overview of how they regulate supplements under DSHEA, acknowledges that the 5 supplements listed by Amy Shipley in the Washington Post are under investigation, reassures the Congressman that they are doing their job and generally give a runaround excuse about how supplements are regulated post-market.
The investigation here will center on whether the 5 supplements incuded a NDI (new ingredient not marketed commercially previous to the passing of DSHEA in 1994) and if so, whether:
1. That ingredient was submitted properly to the FDA for approval in the correct time frame by the manufacturer of said product.
2. Whether ingredient in question is actually DSHEA-compliant; that is, naturally present in the food chain without chemical alteration.
3. Whether said ingredient was commercially marketed or submitted for approval as a drug; or contains a mislabeled or misbranded drug.
If a company under investigation did not follow the rules regarding all this, then they may be in trouble.
I personally don't think our fair Congressman is going to be satisfied with a simple letter filled with what would likely sound to him excuses and placation.
mywetnightmares
Kyra Gracie= my future wife
No, I think he might be, all he cares about is whether or not it LOOKS like he's protecting people, not whether he actually is.
Indigo6
New member
What I would like to see
I would like to see the criteria they use to determine if a substance is dangerous to the public and should be regulated. I would like to see this criteria explained in the context of explaining why certain supplements are banned but tobacco is not. I would llike to know what science they use and what planet it's from.
I would like to see the criteria they use to determine if a substance is dangerous to the public and should be regulated. I would like to see this criteria explained in the context of explaining why certain supplements are banned but tobacco is not. I would llike to know what science they use and what planet it's from.
I'm pitiful! 
Well that's my sig, it was made when my rep was like -89 or something and I had like 40 messages. Will edit it.