Replies to post #10706 on PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

You continue to falsely post that FDA warns about this product. Several pieces of evidence categorically refute your ongoing statements and are expanded upon below with actual unmodified links:
1. Sucanon was never sold in the US. By definition it can't be "illegally marketed" here
2. You verifiably altered a published Consumer Reports article to falsely implicate Sucanon in the past
3. Mexican authorities approved the sale of Sucanon and it has been endorsed multiple times by the Mexican Diabetes Association. The statement that Sucanon is an unapproved or dangerous treatment is verifiably false.
4. Multiple studies, one published in the EASD journal, showed no adverse side effects associated with Sucanon use, consistent with the safety profile noted in preclinical testing.
5. Given the verifiable factual information above and below, the only way to implicate Sucanon is to alter or misrepresent the already available information.
6. The reason for posting the false information is listed in your own post 4550 to "scare others away"

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).

Jayyy posted a response to the above "NOT TRUE, they just DENIED this health (and financial) scam..."

For the complete FDA letter here is the link so readers can evaluate for themselves as opposed to incomplete and misleading excerpts:

https://www.regulations.gov/#!documentDetail;D=FDA-2014-S-0023-0011

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. 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 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.

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.