cGMP goes into effect June 2010...

[VaughnTrue]

how many companies does everything think will fold?
how many hormones will be removed from the market?
will ANY hormones remain at all?


the larger companies have to comply June 2009(now), however smaller companies have another year to get into gear.






just figured its a good time to start talking about it as it is no an "if" anymore, but a "when"

[solidwon]

Well.... If I'm reading into this correctly, we probably won't have some miscellaneous athlete claiming to have failed a test due to some creatine product. As for the designers... where there's a will there's a way over, under, or around the counter.

[_NimbusTim_]

Originally Posted by VaughnTrue

how many companies does everything think will fold?
how many hormones will be removed from the market?
will ANY hormones remain at all?


the larger companies have to comply June 2009(now), however smaller companies have another year to get into gear.






just figured its a good time to start talking about it as it is no an "if" anymore, but a "when"

Nimbus already is cGMP compliant....so we are good!

[WIULifter]

Originally Posted by VaughnTrue

how many companies does everything think will fold?
how many hormones will be removed from the market?
will ANY hormones remain at all?


the larger companies have to comply June 2009(now), however smaller companies have another year to get into gear.




just figured its a good time to start talking about it as it is no an "if" anymore, but a "when"

interesting.

Gotta take the bad with the good i guess , I have always thought that many of the supp companies would fold but i guess we will see. With such a booming industry though, how well is this gonna be enforced. Will companies find loop holes?

[VaughnTrue]

getting on my flight to georgia now...ill check this thread when i get to my hotel! hopefully some good discussion by then

[SCDiesel23]

What is the "new" rule going to require?

Is it going to require only that you claim cGMP compliance, or will it require certification? As it stands now, almost every company can claim cGMP compliance, but they aren't CERTIFIED cGMP compliant.

[SCDiesel23]

For those who care, here is the final rule: http://edocket.access.gpo.gov/2007/07-3039.htm

It is well over 100 pages long, it's a nightmare for agencies to promulgate new law.

Here is a synopsis:

CGMP Final Rule:

* The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
* The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
* The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
* The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
* The requirements include provisions related to:
o the design and construction of physical plants that facilitate maintenance,
o cleaning,
o proper manufacturing operations,
o quality control procedures,
o testing final product or incoming and inprocess materials,
o handling consumer complaints, and
o maintaining records.
* To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final CGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

[WIULifter]

ay yai yai, this could be doomsday for many small legit companies that dont have the means to do this.

[Yates Row T]

hope this gets rid of some of the ****ty companies only afloat bc of ****ty phs on the market.

[Rodzilla01]

IMO, most decent sized companies wont fold because they probably already have their products manufactured in a GMP certified facility. As for the PH/PS, I really have no idea of how that will play out. On a side note, we have spoken with tons of people in the industry including FDA officials and it seems like no one really knows exactly what GMP compliance entails.

[SCDiesel23]

Originally Posted by WIULifter

ay yai yai, this could be doomsday for many small legit companies that dont have the means to do this.

IMO, good. While the argument "you need to research what you're putting into your body" works for people taking supplements, it doesn't work when there are unknown contaminants present.

[iForce Dave]

Originally Posted by Yates Row T

hope this gets rid of some of the ****ty companies only afloat bc of ****ty phs on the market.

agreed

Originally Posted by Rodzilla01

On a side note, we have spoken with tons of people in the industry including FDA officials and it seems like no one really knows exactly what GMP compliance entails.

Not surprising at all

[WIULifter]

Originally Posted by SCDiesel23

IMO, good. While the argument "you need to research what you're putting into your body" works for people taking supplements, it doesn't work when there are unknown contaminants present.

right, agreed. Im just afraid that some of the companies products some of us have come to love will not be able to make the standards. Unless im strongly underestimating some of the sizes of these companies which is probably a strong possibility.

[Illadelphia]

Originally Posted by Yates Row T

hope this gets rid of some of the ****ty companies only afloat bc of ****ty phs on the market.

X100. The overnight ones....

I can think of a few in the past year that sprung up

[bkprice14]

Smaller companies who are good will also suffer, leaving only well funded companies. Its a shame though, lot of these big companies started off small, we will most likely see that go away.

I also wonder how this will effect the innovation in the industry, will it kill it or just let the big boys control the game.

[joakman]

Originally Posted by VaughnTrue

how many companies does everything think will fold?
how many hormones will be removed from the market?
will ANY hormones remain at all?


the larger companies have to comply June 2009(now), however smaller companies have another year to get into gear.

Originally Posted by SCDiesel23

For those who care, here is the final rule: http://edocket.access.gpo.gov/2007/07-3039.htm

It is well over 100 pages long, it's a nightmare for agencies to promulgate new law.

Here is a synopsis:

CGMP Final Rule:

* The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
* The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
* The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
* The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
* The requirements include provisions related to:
o the design and construction of physical plants that facilitate maintenance,
o cleaning,
o proper manufacturing operations,
o quality control procedures,
o testing final product or incoming and inprocess materials,
o handling consumer complaints, and
o maintaining records.
* To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final CGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

All the big companies are all set. Isn't this old news?

[SCDiesel23]

Originally Posted by joakman

All the big companies are all set. Isn't this old news?

Those are companies with 500+ employees, I wonder how many companies fall into that definition? 500 employees is a pretty massive enterprise.

[An Inconvenient Bro]

this can't be too prosperous for idiots like Black china labs, about the only thing they'll have left is mega colon blow

[iForce Dave]

Originally Posted by SCDiesel23

Those are companies with 500+ employees, I wonder how many companies fall into that definition? 500 employees is a pretty massive enterprise.

there probably literally a handful of supp companies that even come close to this

[deserusan]

A lot of companies will fold or fall by the wayside due to increased production costs and logistical QA in-house. I'm actually cGMP as part of the educational/training requirements so if you have any questions feel free to ask me any question regarding the GMP's. I can already see in this thread there is a lot of misinformation and a skewed perspective.

The GMP's are very clear when it comes to the QC components of the regulation. Starting this summer/fall there will be a massive inspection effort by the FDA and unfortunately a lot of companies think because their manufacturer is GMP they are "ok." This rule applies to the handling and distribution of finished goods, not just manufacturing. It involves stability testing, climate controlled warehousing, records of educational training, and A LOT of documentation.

[joakman]

Originally Posted by SCDiesel23

Those are companies with 500+ employees, I wonder how many companies fall into that definition? 500 employees is a pretty massive enterprise.

Yeah, I agree. My only point was that they have been set for some time now and that this isn't new news.

I wonder how many companies that have 30-50 employees will be cutting back to under 20 to gain an extra year.

[SCDiesel23]

Originally Posted by joakman

Yeah, I agree. My only point was that they have been set for some time now and that this isn't new news.

I wonder how many companies that have 30-50 employees will be cutting back to under 20 to gain an extra year.

Word. DSHEA always had a cGMP statute, but it required only that companies conform to food cGMP, so the supplement cGMP protocol is, in a sense, "new". I think the final rule was promulgated in 2007.

[An Inconvenient Bro]

Originally Posted by joakman

Yeah, I agree. My only point was that they have been set for some time now and that this isn't new news.

I wonder how many companies that have 30-50 employees will be cutting back to under 20 to gain an extra year.

I doubt there's too many companies with 30-50 people, probably less than you would think.

And the irony of the whole thing is that the bigger the company the higher the probability that they already have all their ducks in a row anyway. It's the stupid slapdick hormone only "company's" which is usually just someone named something like Leonard shipping **** out of his garage that need the wrath of the regulation the most

[cowboyathlete]

Originally Posted by Yates Row T

hope this gets rid of some of the ****ty companies only afloat bc of ****ty phs on the market.

I am with you on this one.

[WIULifter]

Originally Posted by An Inconvenient Bro

I doubt there's too many companies with 30-50 people, probably less than you would think.

And the irony of the whole thing is that the bigger the company the higher the probability that they already have all their ducks in a row anyway. It's the stupid slapdick hormone only "company's" which is usually just someone named something like Leonard shipping **** out of his garage that need the wrath of the regulation the most

i wonder what an average size is? Reading this thread has made me wonder how many employees companies like I-Force, DS, Thermolife, and the like employ. What about companies like Neogenix who are up n coming yet are smaller than the like?

[Adjusting]

Originally Posted by deserusan

A lot of companies will fold or fall by the wayside due to increased production costs and logistical QA in-house. I'm actually cGMP as part of the educational/training requirements so if you have any questions feel free to ask me any question regarding the GMP's. I can already see in this thread there is a lot of misinformation and a skewed perspective.

The GMP's are very clear when it comes to the QC components of the regulation. Starting this summer/fall there will be a massive inspection effort by the FDA and unfortunately a lot of companies think because their manufacturer is GMP they are "ok." This rule applies to the handling and distribution of finished goods, not just manufacturing. It involves stability testing, climate controlled warehousing, records of educational training, and A LOT of documentation.

You took training in cGMP?

[joakman]

Originally Posted by An Inconvenient Bro

I doubt there's too many companies with 30-50 people, probably less than you would think.

Yeah, I would imagine 90% of companies (if not higher) fall into that range (below 20).

[Yates Row T]

Originally Posted by joakman

Yeah, I would imagine 90% of companies (if not higher) fall into that range (below 20).

i bet most have 0-10 lol. actually i know quite a few that only have that many.


edit: not counting people paid with free product to pimp on bb.com

[deserusan]

Originally Posted by Adjusting

You took training in cGMP?

Yes. I've been to quite a few seminars and training sessions with ex-FDA and FDA officials since I've started with Gaspari. The most recent was a few weeks ago in DC.

[An Inconvenient Bro]

Originally Posted by Yates Row T

i bet most have 0-10 lol. actually i know quite a few that only have that many.


edit: not counting people paid with free product to pimp on bb.com

true but I don't think it's worthy of a lol, i mean if you can run a successful business with less people that just makes you a better business man and potentially able to pass the savings on to consumers. One thing for sure is that having more employees does not necessarily mean more prosperity