Once again, this is taking a small part of the FDA letter and trying to use it to falsely represent what was said about Sucanon. Additionally these falsehoods never seem to be corrected or addressed once pointed out. For example here were several recent statements responded to in detail with FDA quotes and links.
You state "this scams own BS press release tripped them up with the FDA and their denial." Actually, the press release simply cited a study in 97 Latino prediabetics in which 81% reverted back to a HbA1C in normal nondiabetic range after 12 weeks of treatment. This study was subsequently presented at the 2013 EASD annual meeting and published in their peer reviewed journal. That and previous preclinical and clinical Sucanon studies done prior to Dr Rojas involvement led FDA to state that Sucanon was subject to "substantial clinical investigations"
"This does not say it's a drug--but rather if this product is intended fro (sic) use as a drug..." See the words below and FDA link "appears to be a drug under the act and thus subject to the regulatory requirements of drugs". That is why Sucanon was not allowed as a supplement. FDA themselves said that they did not review the safety data or impugn Sucanon in any way.
"Based on the BS press release" FDA cited the subject study of the press release as "substantial clinical investigations"
"That it is subject to regulation-not that it is a drug" Read the quote below again "appears to be a drug under the act and thus subject to the regulatory requirements of drugs" That completely decimates your argument. Again, don't just take my word for it. Let's consult the entire unadulterated letter to evaluate the above claim. Here is the link so readers can evaluate for themselves as opposed to incomplete and misleading excerpts:
In the middle of page 2 the FDA letter states: "Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs."
So the FDA says Sucanon is a drug. They further state in the letter that Sucanon has been subject to "significant clinical investigations" and reference the Sucanon study in Latino prediabetics presented at the EASD 2013 annual meeting and included in their journal. Even more evidence is listed and source attributed in my previous posts on this issue.
FDA is pretty clear when their letter is actually read in context, so much so that the so called fraud had to be manufactured by the editing and posting of a Consumer Reports article in post 4477 and many following posts to falsely indicate that Sucanon was among products whose companies were warned by FDA. Unfortunately so much misinformation posted here requires readers to consult the source information like the entire unadulterated FDA letter and postings and the real unadulterated Consumer Reports article and Sucanon studies to do actual DD.
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