Oxyelite pro (new version) powder &pills illness
- 11-22-2013, 10:29 AM
- 11-22-2013, 11:12 AM
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.
- 11-22-2013, 11:12 AM
USP rep since you are posting again will you answer the question that people have been wanting to know now? A simple yes or no?
11-22-2013, 11:19 AM
11-22-2013, 11:27 AM
11-22-2013, 11:35 AM
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In their attempt to clarify NDI requirements with their draft guidance a couple of years ago they produced a 40 page list of 'guidelines' for how to interpret it.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.
SNS Representative - DeeB@seriousnutritionsolutions .com
11-22-2013, 11:40 AM
Results from the FDA are not linear
11-22-2013, 11:42 AM
Since you have been investigating the cause of the illnesses for a month can you confirm it was "counterfeit" OEP as originally claimed? Or did the recall cease any further investigation on your part.
11-22-2013, 12:41 PM
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.
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: http://www.nutraceuticalsworld.com/c....BdljIlBq.dpuf
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.
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