health supplement caused coma

[TheGeekess]

Have you ever heard of a mislabeled product, because the contents were not properly labeled? It can result in massive fines, total product recalls or the product being pulled until little sticker labels with the correct info being put on the bottles. I'm sure you have seen the sticker label correction at one time or another.

One of my clients is a pharmaceutical company. I have designed labels that are FDA compliant. I know more about the FDA than you ever will.

 

[mtmon]

re:

The FTC has nothing to do with pharmaceutical production. And the FDA isn't going to test diddly.

"But the FDA requires supplement manufacturers to test the identity, purity, strength, and composition of their products."
FTC website

 

[mtmon]

re:

"But the FDA requires supplement manufacturers to test the identity, purity, strength, and composition of their products."
FTC website

Might contacting any of these help?

Who Cares About Dietary Supplements?
FTC
1-877-382-4357
(TTY: 1-866-653-4261)

FDA
1-888-463-6332

NIH, Office of Dietary Supplements

National Center for Complementary and Alternative Medicine
1-888-644-6226
(TTY: 1-866-464-3615)

National Institute on Aging
1-800-222-2225
(TTY: 1-800-222-4225)

Healthy Eating

USDA, Center for Nutrition Policy and Promotion
1-888-779-7264

 

[TheGeekess]

"But the FDA requires supplement manufacturers to test the identity, purity, strength, and composition of their products."
FTC website

Doesn't mean that the FDA tests diddly.

 

[OHRoadwarrior]

Yes, even filing a single complaint with the FTC and FDA can have a cumulative effect. The FDA or FTC might even give you some knowledge issues have happened before, if you ask. Make sure you have as much info as possible regarding lot number, sku, place of purchase, etc...

 

[mtmon]

re:

Yes, even filing a single complaint with the FTC and FDA can have a cumulative effect. The FDA or FTC might even give you some knowledge issues have happened before, if you ask. Make sure you have as much info as possible regarding lot number, sku, place of purchase, etc...

Thanks a lot! You guys (and gals) have been very helpful! I'll continue w/follow ups in regards to further inquires. Oh, BTW whatever became of Bathsalts or GHB (GHB is very similar in its action and effects to Phenibut)?

 

[mtmon]

re:

I found this...any importance?

Refusal Details as Recorded in OASIS by FDA
for Refusal AEK-7256452-5/1/1
Manufacturer FEI 3003680114
Manufacturer Name Black Peony Group Import & Export Co Ltd
Manufacturer Address line 1 No 47 Heping Road S Changzhou
Manufacturer Address line 2
Manufacturer's City Jiangsu
Manufacturer Province/State
Manufacturer Country/Area China
Product Code 66VAS99
Importer's Product Description PHENIBUT FOR USE IN MFR OF DIETARY SUPPLEMENTS
Refusal Date 02-Oct-2006
FDA District CIN-DO
Entry/doc/line/sfx AEK-7256452-5/1/1
FDA Sample Analysis No
FDA Record of Private Lab Sample Analysis No
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS 502(f)(1), 801(a)(3); MISBRANDING The article appears to lack adequate directions for use.
NOT LISTED 502(o), 801(a)(3); MISBRANDING It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

 

[Proserpina]

I found this...any importance?

Refusal Details as Recorded in OASIS by FDA
for Refusal AEK-7256452-5/1/1
Manufacturer FEI 3003680114
Manufacturer Name Black Peony Group Import & Export Co Ltd
Manufacturer Address line 1 No 47 Heping Road S Changzhou
Manufacturer Address line 2
Manufacturer's City Jiangsu
Manufacturer Province/State
Manufacturer Country/Area China
Product Code 66VAS99
Importer's Product Description PHENIBUT FOR USE IN MFR OF DIETARY SUPPLEMENTS
Refusal Date 02-Oct-2006
FDA District CIN-DO
Entry/doc/line/sfx AEK-7256452-5/1/1
FDA Sample Analysis No
FDA Record of Private Lab Sample Analysis No
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS 502(f)(1), 801(a)(3); MISBRANDING The article appears to lack adequate directions for use.
NOT LISTED 502(o), 801(a)(3); MISBRANDING It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

They're in CHINA?

Oh heavens to murgatroyd. Even IF you had a valid case (and I'm not convinced of that at all), you'd have to sue them in China.

And that will go absolutely nowhere, fast.

 

[mtmon]

re:

They're in CHINA?

Oh heavens to murgatroyd. Even IF you had a valid case (and I'm not convinced of that at all), you'd have to sue them in China.

And that will go absolutely nowhere, fast.

That's simply not true. Next.

 

[Proserpina]

That's simply not true. Next.

Have at it, champ. Now, how many attorneys have offered to take this case on contingency again?

Next.

 

[justalayman]

That's simply not true. Next.

So your true colors have finally been shown; A student and their homework.

 

[mtmon]

re:

Have at it, champ. Now, how many attorneys have offered to take this case on contingency again?

Next.

You have anger issues and are trolling. Your mothers calling, now go away.

 

[OHRoadwarrior]

You have anger issues and are trolling. Your mothers calling, now go away.

You are spilling vinegar. I suggest you clarify the relationship between the the label you bought and what is evidently/possibly their supplier, who has been caught being naughty. It would be more productive than arguing with a very knowledgeable senior that did not understand what your post meant.

From an information standpoint, the web can sometimes show you who the raw material supplier was. You need to do some variable web searching though. The info is usually found in news releases or financial filings. I don't see that it would help you at this point. Discovery of a dangerous substance in the pills/capsules would be a start. That requires lab analysis. The FDA might look for you, who knows.

 

[CJane]

"But the FDA requires supplement manufacturers to test the identity, purity, strength, and composition of their products."
FTC website

Know what they require that you test for? Micotoxins. E. coli. A few other things that are irrelevant to the discussion. If your coma wasn't induced by one of those things... And even if it WAS induced by one of those things, you'd have to prove that the company NEW their numbers were outside the GAS range, and sold the product anyway.

You chose to take a supplement that is GAS (generally accepted as safe), and experienced a negative outcome. It's not necessarily anyone's FAULT, and there is not likely to be a lawsuit here.

 

[Mass_Shyster]

Know what they require that you test for? Micotoxins. E. coli. A few other things that are irrelevant to the discussion. If your coma wasn't induced by one of those things... And even if it WAS induced by one of those things, you'd have to prove that the company NEW their numbers were outside the GAS range, and sold the product anyway.

You chose to take a supplement that is GAS (generally accepted as safe), and experienced a negative outcome. It's not necessarily anyone's FAULT, and there is not likely to be a lawsuit here.

I disagree.

If OP can show that the supplement was the cause of the seizure/coma and permanent damage, he'll have a very strong case.

The general theory behind products liability is that the company making the profits should bear the cost of damages done to innocent users of those products.