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Monday, January 04, 2016 10:48:55 AM
"Being a probiotic, the human testing is not a legal requirement"
Even as a foodstuff, as this product contains a new genetically engineered live bacterial strain, the FDA regulations are quite clear that it needs extensive testing both in animal species and humans in carefully controlled conditions to prevent it spreading into the wild until its safety has been proven beyond any doubt. this will take years and cost hundreds of millions of dollars.
A moment's thought will tell you that any other approach simply wouldn't make sense.
But as there product is claimed to treat the symptoms of a disease- lactose intolerance - then it requires both FDA approval through the normal IND and NDA process, as well as CBER approval because of the genetically altered nature of the live bacteria.
I've quoted the regulations many times on this board.
No one should fall for the lies of Ken Manzo,
Ray Barton and MMG on this blatant scam when ten minutes' DD is sufficient to prove it is a share-selling scam.
"It is difficult to get a man to understand something, when his salary depends upon his not understanding it."
Upton Sinclair
"Nobody ever went broke underestimating the intelligence of the American public."
H. L. Mencken
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