The One is discontinued...
- 08-25-2009, 01:56 PM
- 08-25-2009, 03:00 PM
As far as I know, the FDA only targeted one particular company. So they haven't specifically come after AppNu or The One. But the warning letter sent out to that company was very clearly a warning letter to EVERY company. The itemized list of violations all (except for one I believe) apply to The One. Companies are pulling out before the FDA decides to start issuing sanctions.
To be blunt, products like The One occupy a legal grey area. Companies have marketed their products as dietary supplements because the FDA has very little regulatory power over anything classified as such. In reality, as the FDA has pointed out, they aren't dietary supplements- they're new drugs that should involve NDAs. Some companies have been smarter than others about their products, and unfortunately the company that started all of this was just plain stupid about it. NOTHING about their products actually qualified them as dietary supplements- whereas most other companies have at least made cosmetic attempts to qualify their products as dietary supplements. There were also serious labeling violations that should never have been allowed by the company.
I'm personally of the mind that based on the logic that classifies steroids as Schedule-III substances, all prohormones should be illegal. That doesn't mean that I personally want to see them made illegal, but they do not fall under the purview of dietary supplements as defined by Congress and the FDA.
08-25-2009, 03:00 PM
08-25-2009, 03:49 PM
Welcome to the fun world of the FDA- where the only thing that's consistent is their support for big business.
08-25-2009, 04:13 PM
Time to start stocking up on some hormones!
“We are what we repeatedly do. Therefore, excellence is not an act, but a habit.”
08-25-2009, 09:48 PM
Needless to say, there are many other products in our lineup and more to come in the near future.
08-26-2009, 08:07 AM
08-26-2009, 11:50 AM
08-26-2009, 12:44 PM
08-26-2009, 01:33 PM
cGMP compliance for the industry also plays into this quite a bit- most of the contract mfrs. that manufacture for the rest of the companies on this board (not us, we are cGMP and do it ourselves) are up for inspection as of June 10. If a mandatory inspection occurs at a contract mfr. and they find out they have been mfg. PHs, they are in deep doo-doo.
At best, the inspection is going to be VERY invasive and the agents will do their best to find EVERY violation/observation that they can, and they will stay in the facility for at least a few days, in not weeks going through mfg. records, logs, intake records, plant cleanliness, plant construction, etc. At worst, the responsible person at said contract manfacturing facility and some of the management will end up going to jail (no bs) because they are knowingly manufacturing an unapproved new drug without a license. It is up to arbitrary agent enforcement, unfortunately
It is going to be very hard to find a lot of contract mfrs. that will even touch these compounds, especially since their bread-and-butter is more benign products, like BCAAs, creatine, vitamins, etc. I also don't see a lot of these marketing companies trying to set up their own facility and doing it themselves- it ain't easy, especially now. It takes a lot of technical skill, and knowledge of:
- cGMPs (whole different language)
- pharmaceutical machinery and how to fix something if it breaks (**** happens sometimes)
- validation of processes and process control
- site management and contract management
- training staff properly
- qualatative analysis and quality control
- analytical testing and in-process testing
- calibration and qualification of machinery
- facility design and engineering
- cleaning validation
- keeping proper records (we have 30 different logbooks to keep, plus 3,000+ pages of written SOPs)
- ton of other stuff beyond the scope of this list
It took me a long time to become proficient in all of the above- and a ton of training- the same with the rest of the manufacturers- they probably aren't going to put their livelihood on the line for something like PHs, especially when they account for a very small proportion of their revenue stream- doesn't make any sense. Some guys are undoubtedly going to try to go overseas and try to get these products mfr'd there, but then quality becomes a MAJOR issue- I can tell you some horror stories, LOL. I think this is going to be the end of this side of the market, but more due to enforcement on the cGMP-side of things, and no mfr. wanting to touch the stuff any more.
Dirk Tanis, BA, MSci
Chief Operating Officer, Applied Nutriceuticals
08-26-2009, 02:11 PM
Last edited by Rosie Chee; 08-27-2009 at 09:46 PM. Reason: Corrected typo.
08-27-2009, 11:28 AM
08-27-2009, 09:43 PM
08-27-2009, 09:59 PM
DONT WORRY HOW TO STORE THEM JUST WORRY ABOUT IT BEING THE LAST NIGHT TO BE ABLE TO BUY ONE GET ONE FREE, THATS ALMOST 3 CYCLES FOR 87.50 WTF. I KNOW I GOT MY 6 BOTTLES
08-28-2009, 09:11 AM
08-28-2009, 04:57 PM
Forgive me if this has been answered, but is there any chance of continuing to produce this in the EU?
Please, with cherries on top? Grin
08-28-2009, 05:46 PM
09-03-2009, 01:16 PM
I see the code no longer works... any chance it will work sometime in the future to get rid of the remaining stock?
09-03-2009, 04:58 PM
09-16-2009, 12:06 AM
I'm so glad I got my hands on a cycle of this before it is gone!
And I'm looking forward to those new products
SNS - Serious Nutrition Solutions
My advice is exclusively my own and may not correspond with the views of SNS
Questions or concerns? → conny[@]seriousnutritionsolutions.com
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