The One is discontinued...
- Thread starter small_guy
- Start date
lennoxchi
Well-known member
got the same e-mail. wow, everyone is pulling out
lyfespan
Well-known member
I just called and talked to AP and they said, yep no more the ONE, its buy 1 get 1 for free, just call its the fastest way to get orders processed, but they said it looks like ALL 17A methyls will be banned. SO sad, theres a short tyme to snatch up the PH/DS that you can afford, hahahahaha
STILL NO DEF. BAN DATE, BUT ITS COMING
STILL NO DEF. BAN DATE, BUT ITS COMING
mark118
Active member
are there PHs that arent 17a methyls?
lyfespan
Well-known member
I will leave that one to sumone that cares to argue, anyone care to explain the difference between PH's, DS's, and AAS's. Dont know all the technical jargon on this, and dont really care to get flamed any more.
lennoxchi
Well-known member
yes, as a matter of fact the one compound that started all this is not 17A (tren-like compounds)
sanchezgreg18
Well-known member
so whats gonna be left when this goes down or when the bill is passed and whatnot:sigh1:
lennoxchi
Well-known member
if your going to go that route, you might just want to go with AAS. i mean, if you're going to break the law
DenDestroys
Member
Yeah, might as well go all or nothing when risking it with customs.
TexasLifter89
Well-known member
hey guys, sorry for this to have to happen! Let me know if you have any questions.
Rosie Chee
The Female Terminator
No, this will NOT affect the new product releases that we have for later this year!
~Rosie
Team APPNUT
KDLMaj
Member
God, this breaks my damn heart. The One is the only PH I would even consider running as it appears to be the safest (and doesn't require me to illegally acquire a SERM).
I'm trying to figure out a tacit way to ask this, but let's just go with this:
Will the new products coming out this year be as effective as The One?
Rosie Chee
The Female Terminator
small_guy
Member
Thank you for that info- I was curious and good to hear.
lyfespan
Well-known member
Rosie, is there sumone already running a test log on this product?You will have to wait and see
~Rosie
Team APPNUT
Rosie Chee
The Female Terminator
:shrug:
Not sure...
There is more than one new product being released later this year...
~Rosie
Team APPNUT
KDLMaj
Member
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.
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.
EasyEJL
Never enough
Mostly because they think you are too stupid to make your own decisions about what goes into your body. Consider that the UK is being fined millions of dollars a year for refusing to allow US beef to be imported because it doesn't meet their standards. Government agencies are just plain silly, bureaucrats exist solely to provide for their own continued existence....
KDLMaj
Member
Funny you should bring up the beef ban- that was the first thing I thought of when I heard about the FDA letter. The same agency that is taking a hard stance against prohormones allows the Beef industry to pump their cattle with so many synthetic hormones (specifically synthetic estrogen) that the EU has refused to import it for years. They won't feed it to their citizens because it's so unhealthy. (side note: when gymbo's in the US rant and rave about soy increasing estrogen and then run off and eat a bunch of beef instead, I laugh at them)
Welcome to the fun world of the FDA- where the only thing that's consistent is their support for big business.
Rosie Chee
The Female Terminator
The FDA has been pretty clear that they want all prohormones and related products banned. To date their actions have been random and subjective. Although there is legislation from last June, this does not include the compound that is The ONE. However, Applied Nutriceuticals has evaluated all of the factors for and against and have made their decision.
Needless to say, there are many other products in our lineup and more to come in the near future.
~Rosie
Team APPNUT
lyfespan
Well-known member
Got all my stock in one of those ever fresh bags and then i put that into a ziplok freezer bag, make sure the lids are on tight too, have found that some manufactures lids are on a lil loose. Then i just put them in a dark,cool, dry place. I would vacu seal them, but dont own equip. There are a few other storage methods out there.
rms80
Board Sponsor
Interesting conversation- I will chime in- there is one issue that counts when it comes to discussing prohormones and legality: interpretation. For several years leading up to this event, dietary supplement companies were (and some still are) interpreting FDA inaction as acceptance of legality. Unfortunately, the FDA is taking an entirely different stance/interpretation- now they are classifying that PHs are actually unapproved new drug substances, and must be recalled or taken off the market immediately.
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.
Rosie Chee
The Female Terminator
If the bottle is unopened make sure that you store it in a dark, dry, cool place. It will last ~5 years this way (if unopened that entire time).
~Rosie
Team APPNUT
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Chub
Well-known member
that seems like a long time. do you think other pro hormones would still be good after that length of time? I've read heaps of times that havoc was good for up to 2 years if stored right.
Rosie Chee
The Female Terminator
Typo; my bad.
The shelf-life of The ONE is 2-5 years, depending on how it is stored: If not stored well it will last ~2 years (or less); if kept in a cool, dark (and dry) place it will last ~5 years.
~Rosie
Team APPNUT
Chub
Well-known member
ok cool
going to pick a bottle up next week, found a UK site that has some in stock still! always wanted to give it a try just not anytime soon. So i'll pick one up and sit on it!
Rosie Chee
The Female Terminator
Once The ONE is discontinued it is DISCONTINUED (i.e. it will no longer be manufactured, period).
~Rosie
Team APPNUT
Rosie Chee
The Female Terminator
ConcreteConny
Well-known member
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
//CC
And I'm looking forward to those new products
//CC