You state “Show me evidence that the FDA approved this scam-you can’t!!”
I never said that FDA approved Sucanon. I simply provided ample evidence that contrary to your false claims of a “ban” and evidence from your own posting of part of the FDA response that indeed FDA considered Sucanon a drug that underwent “substantial clinical investigations”. My post is included for any to verify. Since you demanded that I show evidence for a supposed claim, then it is certainly reasonable for you to provide evidence that “SEC has been notified” and “SEC is involved”
Several pieces of evidence categorically refute your ongoing statements and are expanded upon below with actual unmodified links: As for the misleading comment of an FDA ban, here are actual words and a link to the FDA letter to allow all to evaluate what the FDA actually said in context.
FDA states in the last sentence of the third paragraph in page 2 of their response letter that they did not review any of the safety data because Sucanon is not a supplement. As stated repeatedly in the first paragraph, FDA considers Sucanon a drug. FDA was also apparently impressed enough to state in the response letter that Sucanon is a drug that was subject to "substantial clinical investigations" and cite an example of the research, namely Dr. Rojas study in Latino prediabetics presented at the 2013 EASD annual meeting and published in the EASDs peer reviewed journal.
As for the repeated misleading comment of a "ban", Sucanon was never sold in the US and cannot be sold as a supplement because the FDA considers it a drug per the food and drug act and one that had undergone "substantial clinical investigations". Sucanon would require an investigational new drug application in the US and therefore focus is on other markets where Sucanon is approved and sold (Mexico) approved but not yet sold (Canada) and in the regulatory process (India).
I previously posted this relevant and verifiable information to ensure readers get accurate information (the stated purpose of this board). Your documented response to the above "NOT TRUE, they just DENIED this health (and financial) scam..." For the record I have only made one mistake of fact in my entire time posting here and that was promptly and respectfully corrected.
For the complete FDA letter 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 to falsely indicate that Sucanon was among products whose companies were warned by FDA. The logical fallacy is astounding because the FDA themselves clearly said that Sucanon is not a supplement. It therefore can't be in the category warned against by Consumer Reports because per the FDA Sucanon is not a supplement, it is a drug and subject to the application and evaluation requirements of investigational new drugs. Unfortunately so much misinformation circulated 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.
What is also lost in the continued misleading posting about an "FDA ban" is that logically: 1. Sucanon was never sold in the US. 2. Supplements, per FDA guidance, don't need an application for sale in the US market. 3. Out of an abundance of caution, ROTH sends FDA a letter to request review of proposed sale of Sucanon as a supplement since it contains a "natural product" and is based partly on Chinese herbal medicine. 4. As above FDA says Sucanon is a drug, we have not reviewed your safety data, but Sucanon would require a new drug application, citing publicly disclosed substantial clinical investigations. 5. Now logically, if a supplement doesn't require approval and safety information was not reviewed, the only reason FDA would have to say Sucanon can't be sold as a supplement in the US is because it is a drug. 6. The above is a reasonable conclusion based on Sucanons efficacy in published studies, namely outperforming (FDA approved prescription) Glyburide in a head to head double blinded placebo controlled trial.
Now don't just take my word for it. Read the source documents. All my facts are independently and publicly verifiable and I encourage all possible DD, including checking the accuracy of any information posted here.
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