"FDA Hits Gaspari Nutrition"

[MeatFlaps]

"I train with bloody stools & mouth sores"

[Pleasurer]

Gaspari SuperPumped!

[Ndeserranno]

IN and awaiting Gaspari's reply

[quank]

what problems did PlamaJet cause other than a lighter wallet?

[GymRat128]

In Before SuperPump250 is discontinued and brought back as a Diuretic... SuperDiuretic250...million dollar idea right there...no Charge Gaspari...

[lilcrate]

IN and awaiting Gaspari's reply

I think they pretty much already did.

[jdaring]

why am i not surprised

[halberstram]

I wish the FDA would regulate the supplement industry. Drugs have to be proven to work, supplements should also be proven to work or pulled off shelves.

[ucsumma]

Yes you will. We've hired a MD, MPH and have a quality assurance staff managed by someone who formally worked for Merck (she's a chemical engineer). GMP's are extremely serious and while we try our best, we aren't perfect although we strive to be in this new regulatory environment. From what I've seen a lot of companies are getting in trouble for quality control issues of their products which to me is a bigger issue. Either way, the FDA is cracking down on the supplement industry whether you are big or small.

I formerly worked for a Fortune 100 Pharma company where I was in charge of stewardship (FDA/Health Canada/GAAP) and GMP standards are flat-out insane. The intent is to make sure that any supplements being produced are completely safe for human ingestion, but realistically most McDonald's branches would have trouble passing a comprehensive GMP audit.

With that being said, I'm glad to see the FDA increasing their scrutiny of supplement manufacturers but the hard truth is that there are likely 1,000 supp companies for every FDA inspector (their budget and resources are severely limited and no where near what you would expect).

Given their need to prioritize, it only makes sense to go after the biggest companies first (e.g., Gaspari), but just because a company is under investigation does not mean that it's unsafe (conversely, just because a company is NOT under investigation does not mean that it is safe).

I'm personally more afraid of the "fly by night" supp. manufacturers who are too small to even be on the FDA's radar.

[dekd]

lol strong agenda's itt

[tacticalreload]

In Before SuperPump250 is discontinued and brought back as a Diuretic... SuperDiuretic250...million dollar idea right there...no Charge Gaspari...

Man that s*** never gave me the s***s!

[lilcrate]

I formerly worked for a Fortune 100 Pharma company where I was in charge of stewardship (FDA/Health Canada/GAAP) and GMP standards are flat-out insane. The intent is to make sure that any supplements being produced are completely safe for human ingestion, but realistically most McDonald's branches would have trouble passing a comprehensive GMP audit.

With that being said, I'm glad to see the FDA increasing their scrutiny of supplement manufacturers but the hard truth is that there are likely 1,000 supp companies for every FDA inspector (their budget and resources are severely limited and no where near what you would expect).

Given their need to prioritize, it only makes sense to go after the biggest companies first (e.g., Gaspari), but just because a company is under investigation does not mean that it's unsafe (conversely, just because a company is NOT under investigation does not mean that it is safe).

I'm personally more afraid of the "fly by night" supp. manufacturers who are too small to even be on the FDA's radar.

Well put.

This thread makes you really think about what the hell we are taking in all day every day.

[drewkowsky]

Not really a fan of superpump anyways (too strong?), but I highly doubt this stuff is seriously harming people who are taking it and following the directions. Almost every supp store has a partial use return policy too.

[BB2K]

in before:

thread lock
thread deletion
mass banning
vulger nude photos of MattyH7688 are posted

[ucsumma]

Well put.

This thread makes you really think about what the hell we are taking in all day every day.

It's scary man.

I love samples and trying new supps. but sometime you'll receive just a packet with some powder or loose tabs and it really should make you pause and think about what the hell you're going to ingest.

I still love the scene from Bigger, Stronger, Faster where he hires 3 immigrant day laborers to make supps and then puts them on the market.

[xX-T-Calv-Xx]

oh lawd

[MattyH7688]

in before:

thread lock
thread deletion
mass banning
vulger nude photos of MattyH7688 are posted

as long as i have at least a half boner in the pic

[BB2K]

It's scary man.

I love samples and trying new supps. but sometime you'll receive just a packet with some powder or loose tabs and it really should make you pause and think about what the hell you're going to ingest.

I still love the scene from Bigger, Stronger, Faster where he hires 3 immigrant day laborers to make supps and then puts them on the market.

no names mentioned but i got samples the other day in the mail, it was a pre workout "shot". Mixed as directed and drank it. It burned my throat so badly i thought i was having a severe reaction to it.. i had to drink 12oz of ice cold water to calm it down. I wont be trying the other samples.

[BB2K]

as long as i have at least a half boner in the pic

stop PMing me asking me to be your personal "fluffer" bro.

[ucsumma]

EVERY drug/supplement needs to be measured on a personal risk-reward basis.

Just for perspective, possible side effects include:
-nausea
-vomiting
-heartburn
-stomach cramps
-headache
-kidney stones
-severe diarrhea

Vitamin C (from WebMD): http://tinyurl.com/4lt5lgc

[GymRat128]

Threads like this is why I only stick to the basic's...quality protein,fish oils and Multi, Quit everything else about 6-7 months ago and the first couple weeks were hard but then it got easy with no pre-workouts etc.....not that pre's,Intra's etc dont work...I just dont trust most company's labels on there products to be accurate and never know what else is in there prop blends.....not talkin about Gaspari Just in general.

[ucsumma]

no names mentioned but i got samples the other day in the mail, it was a pre workout "shot". Mixed as directed and drank it. It burned my throat so badly i thought i was having a severe reaction to it.. i had to drink 12oz of ice cold water to calm it down. I wont be trying the other samples.

I'm just as bad

I'll pop whatever in the hell I'm sent and then just cross my fingers and hope I wake up in the morning. I guess the first step is admitting you have a problem...my name's UCSUMMA and I'm a supplement addict.

p.s. good man not to name names (just PM it to me!)

[Massicio]

[rollo]

so were there any tainted supps or was gaspari just in breach of the new rules for supp companies?

[deserusan]

I formerly worked for a Fortune 100 Pharma company where I was in charge of stewardship (FDA/Health Canada/GAAP) and GMP standards are flat-out insane. The intent is to make sure that any supplements being produced are completely safe for human ingestion, but realistically most McDonald's branches would have trouble passing a comprehensive GMP audit.

With that being said, I'm glad to see the FDA increasing their scrutiny of supplement manufacturers but the hard truth is that there are likely 1,000 supp companies for every FDA inspector (their budget and resources are severely limited and no where near what you would expect).

Given their need to prioritize, it only makes sense to go after the biggest companies first (e.g., Gaspari), but just because a company is under investigation does not mean that it's unsafe (conversely, just because a company is NOT under investigation does not mean that it is safe).

I'm personally more afraid of the "fly by night" supp. manufacturers who are too small to even be on the FDA's radar.

I agree 100% with what you said here. Inspections haven't been "routine" in the supplement industry as they have been in pharma or food. Since 21 CFR 111 is now part of the enforcement "perspective" by the FDA we will certainly see more audits, inspections, and warnings handed down. The reality is, these are to the benefit of consumer regardless of the industry.

For us, wading the GMP waters has been a great experience. I was taught 21 CFR 111 by ex-FDA lab director and inspector Bill Ment. I was also fortunate enough to be taught labeling law by Betty Cambell who was Director in the Office of Food Labeling and Jim Hoadly, PhD who was a scientist at CFSAN and ONPLDS. Being exposed to ex-FDA employees really help change my perspective as to why the FDA takes issues with certain industries and in the end, they are looking out for the best interest of the public. I probably wouldn't have been exposed to all this necessary training, including manufacturing/vendor audit training, if it wasn't for 21 CFR 111. I can truly say it's help me be a better product designer.

I think it's safe to say many companies will be getting a visit this year if they haven't already. Through increased funding the FDA has increased it's inspector force greatly. Also, with the recent passing of Food Safety Modernization Act (HR 2751), you most certainly will see more enforcement. Anyone remember that huge peanut recall? It caused 8 deaths, 600 illnesses, and 1840 recalls. That's not cool.

Obviously with such rampant lack of regard for human safety, the government felt compelled to do more to protect America.Nowadays, companies are required by law to register their facilities because of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) too.

As someone in the industry who's been through an inspection and sat across the table from an inspector doing an investigation, I can truly say that is a humbling experience. However, they are doing their job to protect Americans and in the end, I think this will help clean up the supplement industry. We come from humble roots there is no doubt but we've come along way over the years and are lucky to be able to have great consultants, have MD, MPH's around, and have an excellent quality assurance staff headed by people from pharma. There will be bumps along the way but it makes us a better company.

[BigPapiJR]

Strong lack of reading comprehension going on in this thread. Are people actually reading the article? A few people had some very uncommon adverse reactions to some products... this happens with every supplement/medication- just check out the potential risks for common OTC drugs such as NSAIDs. I don't know why this would concern anybody- using PJ or SP250 is not going to cause harm 99.99999% of the time.

[MeatFlaps]

I formerly worked for a Fortune 100 Pharma company where I was in charge of stewardship (FDA/Health Canada/GAAP) and GMP standards are flat-out insane. The intent is to make sure that any supplements being produced are completely safe for human ingestion, but realistically most McDonald's branches would have trouble passing a comprehensive GMP audit.

With that being said, I'm glad to see the FDA increasing their scrutiny of supplement manufacturers but the hard truth is that there are likely 1,000 supp companies for every FDA inspector (their budget and resources are severely limited and no where near what you would expect).

Given their need to prioritize, it only makes sense to go after the biggest companies first (e.g., Gaspari), but just because a company is under investigation does not mean that it's unsafe (conversely, just because a company is NOT under investigation does not mean that it is safe).

I'm personally more afraid of the "fly by night" supp. manufacturers who are too small to even be on the FDA's radar.

Hey Quarter Pounders never gave me a bloody corn hole. Now the McRib, anythings possible.

[neddo]

I formerly worked for a Fortune 100 Pharma company where I was in charge of stewardship (FDA/Health Canada/GAAP) and GMP standards are flat-out insane. The intent is to make sure that any supplements being produced are completely safe for human ingestion, but realistically most McDonald's branches would have trouble passing a comprehensive GMP audit.

With that being said, I'm glad to see the FDA increasing their scrutiny of supplement manufacturers but the hard truth is that there are likely 1,000 supp companies for every FDA inspector (their budget and resources are severely limited and no where near what you would expect).

Given their need to prioritize, it only makes sense to go after the biggest companies first (e.g., Gaspari), but just because a company is under investigation does not mean that it's unsafe (conversely, just because a company is NOT under investigation does not mean that it is safe).

I'm personally more afraid of the "fly by night" supp. manufacturers who are too small to even be on the FDA's radar.

Well put.

[kappaz]

And which companies would those be?

http://www.fda.gov/ICECI/Enforcement...11/default.htm

[ucsumma]

Through increased funding the FDA has increased it's inspector force greatly. Also, with the recent passing of Food Safety Modernization Act (HR 2751), you most certainly will see more enforcement.

This really is reassuring.

The trend for supplement use is only going to continue to rise and the better prepared the regulators are, the safer we'll all be as consumers.