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When is a Vitamin Not a Vitamin?

When the FDA Says So!

In September of 2005, Council for Responsible Nutrition (CRN) senior vice president of scientific and international affairs, John Hathcock, PhD, wrote a letter to the FDA stating that “Pyridoxamine is unequivocally a dietary ingredient because it is one of the three primary natural forms of vitamin B6, and it is one of the two predominant forms in animal products used as human foods.”

But now, thanks to a petition filed with the FDA by Biostratum, the North Carolina-based manufacturer of a pyridoxamine-based drug called Pyridorin, which is designed to prevent the progression of diabetic nephropathy (kidney disease), on January 12 the FDA announced that pyridoxamine dihydrochloride was a “new drug.” This means that the FDA has now effectively prevented any substance containing pyridoxamine from being marketed as a dietary supplement. Never mind that the fish on your lunch salad and the chicken on your dinner table both contain pyridoxamine, as does brewer’s yeast!

The status of pyridoxamine has been debated by Biostratum and the Council on Responsible Nutrition (CRN) via FDA petitions since July, 2005. The issue was whether pyridoxamine was protected by DSHEA, the law protecting supplements passed in 1994.

Marketing pyridoxamine as a dietary ingredient is fully supported by the science behind this form of vitamin B6. The CRN statement warns that a precedent could be established in which the status of other ingredients is challenged as well. Companies have to keep long-term records to make sure they can substantiate that an ingredient has in fact been marketed previously as a dietary supplement. A key vitamin form that is presently at risk is P5P, the natural form of B-6 that can be used directly by the body without conversion. Because some people have difficulty converting synthetic B-6 to P5P, elimination of P5P could make them entirely dependent on drugs for survival (human beings cannot live without B-6). Yet another drug company petition has asked the FDA to ban P5P just as it has banned pyridoxamine. If you have not already sent a message to the FDA against banning P5P, please do so now.

Testimonials
“When I used SORGON on my last GH outbreak, I applied your cream every 8 hours for three days and I was clear of all signs. That is compared to taking Zovirax pills for 5 days at the same time using Zovirax cream for 5 days applying every 4 to 5 hours. Thank you for making my life easier!” A.W. ***************** “I have applied SORGON when I feel the beginnings of a cold sore on my lip. One or two applications and it goes away without ever showing up. WOW! P.L. *************** “I wanted to tell you of a novel use I had for SORGON. I found myself with a case of poison ivy on the back of one of my knees ad decided to give it a try. I’m very pleased to say it worked! It only took a few days over the weekend and a couple of applications to get relief. Thanks so much for letting me try SORGON. I’d use it again in a minute.” L.W. *************** “I was impressed how fast it worked. I woke up with a full blown cold sore on my lip and after 1 day it was pretty much gone!” M.S. *************** “I cannot thank you enough for the SORGON. I had to write and tell you how well it worked for me. My breakouts normally last anywhere from 10-14 days. And this is with using the Acyclovir Cream along with taking heavy doses of the pills as well. I would normally in the beginning of a breakout take up to four 800 milligram pills of Acyclovir a day and put on the Acyclovir Cream 3-4 times a day. For a few months I was even on the Acyclovir on a daily basis, because I was getting breakouts so often. Needless to say my bout with Herpes for the last four years has been less then fun -- But the exciting part that I wanted to write you about was how well the SORGON worked. I have to say I was completely shocked and amazed. Never in the history of my Herpes have I healed so quickly. I honestly think the shortest breakout I've ever had was 7 days. But this last time when I used the SORGON it went away in Three Days! I can't tell you how relieving it was. What amazed me more was that you said to apply it every two hours. My schedule did not work with that, so I only applied it about three times a day. So, I honestly wasn't expecting it to work as well as it did, since I wasn't applying it as often. Needless to say, it did and I am so grateful. Thank you so much!” D.B. *****************

Testimonials

“When I used SORGON on my last GH outbreak, I applied your cream every 8 hours for three days and I was clear of all signs. That is compared to taking Zovirax pills for 5 days at the same time using Zovirax cream for 5 days applying every 4 to 5 hours. Thank you for making my life easier!” A.W.

*******************

“I have applied SORGON when I feel the beginnings of a cold sore on my lip. One or two applications and it goes away without ever showing up. WOW! P.L.

*******************

“I wanted to tell you of a novel use I had for SORGON. I found myself with a case of poison ivy on the back of one of my knees ad decided to give it a try. I’m very pleased to say it worked! It only took a few days over the weekend and a couple of applications to get relief. Thanks so much for letting me try SORGON. I’d use it again in a minute.” L.W.

*******************

“I was impressed how fast it worked. I woke up with a full blown cold sore on my lip and after 1 day it was pretty much gone!” M.S.

*******************

“I cannot thank you enough for the SORGON. I had to write and tell you how well it worked for me. My breakouts normally last anywhere from 10-14 days. And this is with using the Acyclovir Cream along with taking heavy doses of the pills as well. I would normally in the beginning of a breakout take up to four 800 milligram pills of Acyclovir a day and put on the Acyclovir Cream 3-4 times a day. For a few months I was even on the Acyclovir on a daily basis, because I was getting breakouts so often. Needless to say my bout with Herpes for the last four years has been less then fun --

But the exciting part that I wanted to write you about was how well the SORGON worked. I have to say I was completely shocked and amazed. Never in the history of my Herpes have I healed so quickly. I honestly think the shortest breakout I've ever had was 7 days. But this last time when I used the SORGON it went away in Three Days! I can't tell you how relieving it was. What amazed me more was that you said to apply it every two hours. My schedule did not work with that, so I only applied it about three times a day. So, I honestly wasn't expecting it to work as well as it did, since I wasn't applying it as often. Needless to say, it did and I am so grateful. Thank you so much!” D.B.

*******************

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