mw1
Sponsor
Nah I srs doubt it. They based the findings off % of patients with Liver damage that used OEP. If it were one or two people out of all the confirmed cases it would be a different story
Oxyelite pro (new version) powder &pills illness
- Thread starter 808shredded
- Start date
Nah I srs doubt it. They based the findings off % of patients with Liver damage that used OEP. If it were one or two people out of all the confirmed cases it would be a different story
chedapalooza
Legend
Huff post?
Perfect example of HORRIBLE media. I'd trust a class of 5th graders playing the game telephone before I trusted huff post for my news.
And I thiught it was said that versa was not affected. The misinformation or discrepancy in info is atrocious now.
Geoforce
Well-known member
Has USP came out and really said anything about refunds or the like? I tried to browse their forum for the first time just to see if they had made some statements and all I saw was that OEP and OEP powder are no longer products and they have no board to discuss them.
They may not be allowed to say anything, but I didn't know if I missed something other than the "we have no reason to believe a link exists between OEP and...."
They may not be allowed to say anything, but I didn't know if I missed something other than the "we have no reason to believe a link exists between OEP and...."
chedapalooza
Legend
QUOTE=]
The best advice I can give you is to visit the link and verify the UPC code on your bottle matches the UPC code listed; Invalid Link Removed. If the UPC code doesn't appear on the list, the product you have is not affected by the recall. If it does, please contact customer service at 1-800-890-3067 9am-5pm EST, Monday - Friday to process a return.[/QUOTE]
996ttelise
Banned
Chill. I just quoted the article about the damages being exactly what De__eB said they were. Maybe Huffington Post sux, but I find it interesting that they both came up with 22 million. Maybe they both know something neither you or the 5th grade class knows. Just maybe . . .
USPlabsRep
Board Sponsor
For refunds contact customer service, you will be sent a call tag by email for shipping paid by usplabs and a refund will be mailed promptly.
De__eB
Well-known member
Even paying the shipping? Well done.
I did predict the FDA would nix aegeline when you first started selling products with it.
Why no human safety study on isolated aegeline? Surely you've got the $$$. I'd really like to see a company do due diligence with a complete NDI + safety data on a synthetic ingredient using the 'other substance' clause of DSHEA, couldn't have been any less likely than the NDI that did get submitted right?
*shrug*
The 22 million number was in the FDA press release on it. People seemed shocked it was that high so my estimates were just to show how the number was entirely realistic. No magic conjuring on my part.
USPlabsRep
Board Sponsor
We have acute, sub chronic and chronic toxicity data on 2 animal groupsEven paying the shipping? Well done.I did predict the FDA would nix aegeline when you first started selling products with it.
T-Bone
Banned
De__eB
Well-known member
I doubt the FDA is going to be approving any new NDIs without at least a human short term safety study.
Not going to spend the resourced/risk incurring the FDA's wrath any more over aegeline I take it?
Had OEP Advanced Formula already been manufactured with Aegeline or was this all early enough to avoid losing that?
USPlabsRep
Board Sponsor
Why? If you can speak factually.
De__eB
Well-known member
Well, as a bit of light reading, I read all of the FDAs NDI responses from 2009 to present looking at the different reasons given for rejection.
The lack of a study in humans, at the dose intended for use in the supplement, for the duration the supplement is intended to be used was a very common reasoning for citing that the ingredient's safety can not be stated. Additionally, Fabricant has reiterated that reasoning in a couple of presentations recently.
The NDIs that *have* been approved do have these sorts of studies behind them.
Jiigzz
Legend
Nice job De_eB
USPlabsRep
Board Sponsor
Simple! you should lead SNS through the process.
De__eB
Well-known member
Not 'simple' as we all know
I'm just curious why more of the big players in the industry, who the FDA is obviously watching close right now, don't try to play the process more.You've already shown you're willing to spend the money on clinical trials and have published more than just about any company that isn't a subsidiary of a bigger foods company. It would be chump change compared to the cost of recalls/inventory destruction, no? A 50 person month long study ends up costing what, 200-300k depending on the university and the journal?
That said, and I'm not 110% positive on this, but I don't think SNS sells anything that isn't pre-1994, metabolite of pre-1994, non-chemically altered food constituent within the US currently.
USPlabsRep
Board Sponsor
Not 'simple' as we all know
You've already shown you're willing to spend the money on clinical trials and have published more than just about any company that isn't a subsidiary of a bigger foods company. It would be chump change compared to the cost of recalls/inventory destruction, no? A 50 person month long study ends up costing what, 200-300k depending on the university and the journal?
That said, and I'm not 110% positive on this, but I don't think SNS sells anything that isn't pre-1994, metabolite of pre-1994, non-chemically altered food constituent within the US currently.
I would gladly go through the process but there is no clear process and that is what industry is calling for (you could easily spend in the 7 figures and have an ingredient rejected).... but Aegeline was clearly in the food supply pre 1994.
You are 110% wrong, Huperzine A is an ingredient was rejected as an NDI. The metabolite has to be in the food supply. You have couple supplements and several ingredients non compliant.
De__eB
Well-known member
Yeah, the potential for loss is certainly a huge issue, especially for anybody that isn't already a big player in the industry or doesn't have big financial backing. The whole process does need to be more clear, and give manufacturers a set of guidelines for increasing chances of their NDI being successful.
Another issue with the NDI system is that while getting your NDI rejected can mean your supplement is adulterated, getting your NDI acknowledge in no way protects you from anything and the FDA still takes no responsibility for calling the ingredient 'safe'.
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Is Aegeline in the fruit of aegle marmelos as well as the leaves? The fruit certainly made its way to the U.S. pre-1994, but I've only seen references to aegeline in non- fruit portions of the plant. Obviously much cheaper and less likely to get outright rejection from the FDA to go with the pre-1994, no NDI needed approach on new ingredients though. If it hadn't been for the hepatitis thing (which I would still guess has nothing to do with the compound aegeline, and probably a contamination thing or bizarre unrelated issue) it probably would have ultimately been a big win for you.
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Huperzine was submitted as an NDI twice, once acknowledged, once rejected (how about that for FDA inconsistency, cordyceps is another ingredient where that has happened)
996ttelise
Banned
From violator to watch dog. Nice!
De__eB
Well-known member
If the FDA enforced 100% of the letter of the law, every single company and contract manufacturer would be a violator. As is over 70% of companies have violations on their most recent FDA inspection.
USPlabsRep
Board Sponsor
996ttelise
Banned
Is the issue truly a need for "concrete rules" or just an apparent selective enforcement of the rules leading one to believe that compliance is not really mandated? Selective enforcement would arise as there is perhaps absolutely no way to monitor everything. Taking advantage of this will only harm the industry as the good ole govment may find ways to narrow the industry so that monitoring is manageable. This may happen if numbskulls keep spiking products with meth, steroids, PHs, or distributing products causing actual harm to people.
Candidly, I think you guys know what is expected of you and you could easily hire a lawyer to advise you what is expected if you had questions . . . or you could pick up the phone and call the agency if you had questions to ensure compliance. I would do the latter if I was advising a client as to a grey area because I think human safety is more important that corporate greed.
USPlabsRep
Board Sponsor
Do you understand the process to make that candid statement? you can easily make the same "lawyer" call and then have a better understanding of the process and why companies don't seek it.
We want a process to follow and its not in the hands of a lawyer.
RecompMan
Well-known member
So was isopropyl octopamine. It's just a matter of time. It's unfortunate you are on the hit list.
De__eB
Well-known member
Actually he has a point here. A lot of the FDAs bullet points on their lists of goals each year involve figuring out how they even want to interpret their own regulations.
The FDA openly admits that many of their regulations are not clear.
In their attempt to clarify NDI requirements with their draft guidance a couple of years ago they produced a 40 page list of 'guidelines' for how to interpret it. I'm guessing the revision to those guidelines that is coming next year will be even longer.
As of right now, there is effectively no way to submit an NDI and be assured of acknowledgement, regardless of how much effort you put into it.
996ttelise
Banned
I have no doubt. Sounds about right for most government branches that regulate anything, but you even pointed out what could have or should have been done with the aegeline.
40 pages of definitions or explanations is actually light reading compared to the industries in which I primarily practice: health care; pharmacy industry; medical device and securities.
The problem is all of the mislabeled and contaminated crap we get in the supplement industry. I am not necessarily talking about you guys. There has been some recent articles noting 59% of all supps contaminated and 1/3 having no trace of the alleged main ingredient.
I see this as a serious problem and find it disingenuous to place the blame on the FDA for issues like those below.
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ConsumerLab.com purchased and tested more than 50 human and pet osteoarthritis supplements containing glucosamine, chondroitin, and MSM and found some of the products to be contaminated with lead, missing certain listed ingredients, or have inadequate labeling.
One-third of people who take multiple dietary supplements take a joint health supplement according to the latest ConsumerLab.com consumer survey.
See more at: Invalid Link Removed
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The study specifically found the following:
•59 percent of the products tested contained species of plants not listed on the labels (fillers and contaminants).
•33 percent of the products contained no trace of the product’s main labeled ingredient.
Only 2 of the 12 companies provided authentic products without any unlabeled substitutions, fillers and contaminants.
Invalid Link Removed