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.
This action by the FDA speaks to the fundamental need for reform of the agency. AAHF believes the FDA needs complete reform and restructuring in order to rebuild the American healthcare system and make it once again the envy of the world. Visit www.ReformFDA.org to sign the petition and learn more.