emergency ex parte, can i apply for one?

[Proserpina]

I'm still wanting to see the OP's answer to the question of how or what the FDA said.

Why?


Because that's not what the FDA does.

The FDA controls the sale and marketing of prescription and non-prescription drugs - it does NOT govern herbal and/or other supplements. There is no central database (in this country at least - we can ignore the German Monologues for now) which lists the safety and efficacy of herbal supplements. There is no info packet, no list of possible side effects, nothing. No information about dosage amounts. No list of contraindications. Nada. Zilch.

But let's ignore that part for a minute.

Once a drug (be it prescription or not) is approved, the manufacture of the drug is tightly controlled. The packaging must include the following:

1. Indications - the list of conditions that the drug is proven to treat
2. Known side effects
3. Contraindications - how it works (or more importantly, doesn't work) with other drugs
4. Does it become unsafe itself when other drugs are taken?

It also contains dosage information.

So we have that (and please don't ask me to explain what really happens post-marketing as it pertains to side effects and indications.... I haven't had nearly enough caffeine).

Here's the terrifically boring (but ultimately most important) bottom line:

Supplements are considered to be "food". They're treated far differently - they do not require FDA approval, hence there is no control over dosage, efficacy or purity. How then could the FSA give a definitive answer to the question of "Hey, is this safe?".

They don't. It really is THAT simple.

Now I expect OP is going to come back and tell us "Well that's what my doctor told me". But I'll go on the record saying that I believe we all know the reality.

Love,

Your handy dandy ex-clinical trials coordinator.


ETA: OOOOH... NOW I know where OP came up with the OSHA thing!

 

[TheGeekess]

I'm still wanting to see the OP's answer to the question of how or what the FDA said.

Why?


Because that's not what the FDA does.

The FDA controls the sale and marketing of prescription and non-prescription drugs - it does NOT govern herbal and/or other supplements. There is no central database (in this country at least - we can ignore the German Monologues for now) which lists the safety and efficacy of herbal supplements. There is no info packet, no list of possible side effects, nothing. No information about dosage amounts. No list of contraindications. Nada. Zilch.

But let's ignore that part for a minute.

Once a drug (be it prescription or not) is approved, the manufacture of the drug is tightly controlled. The packaging must include the following:

1. Indications - the list of conditions that the drug is proven to treat
2. Known side effects
3. Contraindications - how it works (or more importantly, doesn't work) with other drugs
4. Does it become unsafe itself when other drugs are taken?

It also contains dosage information.

So we have that (and please don't ask me to explain what really happens post-marketing as it pertains to side effects and indications.... I haven't had nearly enough caffeine).

Here's the terrifically boring (but ultimately most important) bottom line:

Supplements are considered to be "food". They're treated far differently - they do not require FDA approval, hence there is no control over dosage, efficacy or purity. How then could the FSA give a definitive answer to the question of "Hey, is this safe?".

They don't. It really is THAT simple.

Now I expect OP is going to come back and tell us "Well that's what my doctor told me". But I'll go on the record saying that I believe we all know the reality.

Love,

Your handy dandy ex-clinical trials coordinator.


ETA: OOOOH... NOW I know where OP came up with the OSHA thing!

Concur.

Signed,
Someone Else Who Has Extensively Dealt With the FDA on a Professional Level.

 

[TigerD]

The other posters have weighed in this supplement nonsense, so I won't beat a dead horse. Personally I think everyone involved with this situation is in need of counseling. Since Mom only has control over herself and the kids, she should set up some counseling for them and herself. The kids are being used as weapons against the other parent. While I concur that there is a lot more going here than we know, I suspect that abusive and controlling behaviors run both ways in this relationship.

Help your kids and get them some help learning how to accept and deal with parents that cannot function like adults around each other.

DC

 

[CJane]

Concur.

Signed,
Someone Else Who Has Extensively Dealt With the FDA on a Professional Level.

Me 3. AND worked for a company that MAKES herbal "remedies" and supplements.

 

[single317dad]

Because that's not what the FDA does.

...snip...

In my line of work, it's the same thing with the EPA. The EPA does not "approve" of any electronic waste disposal methods or companies, yet "EPA approved" is everywhere in this business.

 

[Just Blue]

I'm still wanting to see the OP's answer to the question of how or what the FDA said.

Why?


Because that's not what the FDA does.

The FDA controls the sale and marketing of prescription and non-prescription drugs - it does NOT govern herbal and/or other supplements. There is no central database (in this country at least - we can ignore the German Monologues for now) which lists the safety and efficacy of herbal supplements. There is no info packet, no list of possible side effects, nothing. No information about dosage amounts. No list of contraindications. Nada. Zilch.

But let's ignore that part for a minute.

Once a drug (be it prescription or not) is approved, the manufacture of the drug is tightly controlled. The packaging must include the following:

1. Indications - the list of conditions that the drug is proven to treat
2. Known side effects
3. Contraindications - how it works (or more importantly, doesn't work) with other drugs
4. Does it become unsafe itself when other drugs are taken?

It also contains dosage information.

So we have that (and please don't ask me to explain what really happens post-marketing as it pertains to side effects and indications.... I haven't had nearly enough caffeine).

Here's the terrifically boring (but ultimately most important) bottom line:

Supplements are considered to be "food". They're treated far differently - they do not require FDA approval, hence there is no control over dosage, efficacy or purity. How then could the FSA give a definitive answer to the question of "Hey, is this safe?".

They don't. It really is THAT simple.

Now I expect OP is going to come back and tell us "Well that's what my doctor told me". But I'll go on the record saying that I believe we all know the reality.

Love,

Your handy dandy ex-clinical trials coordinator.


ETA: OOOOH... NOW I know where OP came up with the OSHA thing!

Do tell....