Post by KNOWTHIS on Feb 13, 2009 21:17:51 GMT -5
secretsofnaturalhealing.blogspot.com/2009/02/vitamin-b-6-declared-drug-by-fda-to-be.html
Vitamin B-6 Declared a “Drug” by FDA; to be Banned from Vitamin Supplements
God help us, because the FDA has now opened the gateway for all vitamins to be declared “drugs” and removed from sale by the nutritional supplement industry.
What they have done is declared that pyridoxamine (one of the three primary forms of vitamin B-6 found in nature, and the most widely used form in multi-vitamin supplements) is in reality a “new drug,” thus clearing the way for it to be banned from sale as a nutritional supplement. (See the news article below this commentary for more details.)A North Carolina-based firm called Biostratum began manufacturing pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease). The company then petitioned the FDA to declare pyridoxamine a “new drug,” clearing the way for them to hold an iron-clad monopoly on its sale.
Today, the FDA agreed with Biostratum, and declared this most popular form of vitamin B-6 to indeed be a “new drug,” using the argument that its medical qualities had been under investigation for years before it was ever used as a nutritional supplement under the DSHEA, which ironically was enacted in 1994 in order to protect nutritional supplements from excessive FDA regulation.
Not to worry, said many observers in the nutritional supplement industry. After all, there are two other natural forms of vitamin B-6 that can still be used in multi-vitamin formulations. The problem is, another drug company has already petitioned the FDA to declare the second most popular form of B-6, pyridoxal 5'-phosphate, which is also called P5P, a “new drug,” apparently for the very same reason pyridoxamine has been declared a drug, i.e., it’s purely medical qualities have been investigated long before it was ever used as a nutritional supplement.
How much longer until the third most popular natural form of B-6 will be declared a “drug”? You can bet your boots the pharmaceutical companies are racing to get in on the FDA’s new fast-track for turning B-vitamins into drugs......
God help us, because the FDA has now opened the gateway for all vitamins to be declared “drugs” and removed from sale by the nutritional supplement industry.
What they have done is declared that pyridoxamine (one of the three primary forms of vitamin B-6 found in nature, and the most widely used form in multi-vitamin supplements) is in reality a “new drug,” thus clearing the way for it to be banned from sale as a nutritional supplement. (See the news article below this commentary for more details.)A North Carolina-based firm called Biostratum began manufacturing pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease). The company then petitioned the FDA to declare pyridoxamine a “new drug,” clearing the way for them to hold an iron-clad monopoly on its sale.
Today, the FDA agreed with Biostratum, and declared this most popular form of vitamin B-6 to indeed be a “new drug,” using the argument that its medical qualities had been under investigation for years before it was ever used as a nutritional supplement under the DSHEA, which ironically was enacted in 1994 in order to protect nutritional supplements from excessive FDA regulation.
Not to worry, said many observers in the nutritional supplement industry. After all, there are two other natural forms of vitamin B-6 that can still be used in multi-vitamin formulations. The problem is, another drug company has already petitioned the FDA to declare the second most popular form of B-6, pyridoxal 5'-phosphate, which is also called P5P, a “new drug,” apparently for the very same reason pyridoxamine has been declared a drug, i.e., it’s purely medical qualities have been investigated long before it was ever used as a nutritional supplement.
How much longer until the third most popular natural form of B-6 will be declared a “drug”? You can bet your boots the pharmaceutical companies are racing to get in on the FDA’s new fast-track for turning B-vitamins into drugs......