Patenting Nature? FDA in Bed with Big Pharma Over Vitamin B6...
Recently, it was brought to light that FDA Scientists are Revolting (against upper management, that is). Perhaps now it's time for a more general uprising against the FDA. When is enough too much already? It seems they're siding with Big Pharma against nature and the marketers of dietary supplements including vitamin B6 (pyridoxamine).
It seems that a company called BioStratum has recently made public research on a "new drug" based upon a vitamin B6 derivative, and has apparently turned the ear of the FDA to their cause (making the compound a protected "drug" and limiting dietary supplement manufacturers from continuing to include it in their lineup).
The Food and Drug Administration (FDA) has ruled that the vitamin B6 compound, pyridoxamine dihydrochloride, cannot be used in dietary supplements.
The decision, in response to a petition from a North Carolina-based firm called Biostratum, provoked the Washington DC-based Council for Responsible Nutrition (CRN) to issue a statement warning that a precedent could be established that could see the status of other ingredients challenged.
The problem is that under FDA rules, apparently compounds considered to be "new drugs" cannot be sold as ingredients in nutritional supplements, or something to that effect. There is however a grandfathering clause wherein it says that if such an ingredient has already been marketed in food, it is "grandfathered in" and not subject to exclusion from ingredient lists.
In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and “may not be marketed as such.” Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and (2) there is no “independent, verifiable evidence” of prior marketing of pyridoxamine as a food or dietary supplement.
There exists a grandfathering clause for ingredients that have been on the market for more than 15 years, but CRN said the way this list functioned “was not agreed upon”.
This 15-year period coincides with the enactment of the 1994 Dietary Supplements and Health Education Act (DSHEA), around which time much evidence was presented supporting ingredients such as pyridoxamine dihydrochloride.
“We are disappointed with FDA’s response to the recent citizen petition involving pyridoxamine that apparently views as inadequate the evidence presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA,” said CRN vice president of scientific and regulatory affairs, Andrew Shao PhD.
“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago.”
The question seems to come down to two things. 1) is this compound something that's been around for a long time and specifically marketed in food and/or dietary supplements, thus making it "grandfathered in" and legal to continue selling, as such? 2) Should the FDA let Big Pharma "patent" nature, and remove the right for manufacturers of dietary supplements to include said compounds in their products?
Such a precedent appears to be rather dangerous... Can Big Pharma "patent" natural molecules, call them "drugs" and get the FDA to ban them, except as "drugs" marketed by Big Pharma? What's next? Outlaw blueberries, pomegranates and acai berry products, because Big Pharma wants a lock on antioxidants as "drugs"? Ban oatmeal, Cheerios and garlic because they have cholesterol-lowering health benefits that Big Pharma wants to luck up in their "drugs" for a profit? Where does the line get drawn?