Monday, May 14, 2018 by Tracey Watson
Did you know that in the United States, if a pharmaceutical company can prove to the U.S. Food and Drug Administration (FDA) that an ingredient was not marketed as a dietary supplement prior to 1994, and that it was first investigated by a drug company, that said ingredient can be placed on a list that means it can never be lawfully marketed as a supplement? Ever? Or even developed by another pharmaceutical company?
As reported by Nutra Ingredients, the Dietary Supplement Health and Education Act of 1994 (DSHEA), which regulates dietary supplements in the United States, contains an amendment which has only rarely been invoked, but which “excludes ingredients that have first been investigated as drugs from the definition of legal dietary ingredients.”
Since ingredients used in supplements are natural, they can generally not be patented by greedy drug manufacturers. This legislative loophole allows such companies to “prove” that an ingredient has not been marketed as a natural supplement and can therefore be patented.
It’s one thing if a pharma giant discovers a new chemical compound and wants to protect its legal rights over that product, but it’s an entirely different issue when a drug company “steals” a vitamin, gets it put on the supplement exclusionary list, and then runs out of money to develop the product it needed the ingredient for in the first place. That leaves consumers unable to purchase that vitamin, and prevents even another pharmaceutical company from doing anything with it.
This is exactly what happened with a form of vitamin B6 known as pyridoxamine. Back in 1999, a company called Biostratum Inc. filed an Investigational New Drug Application for pyridoxamine, claiming it had not previously been marketed as a supplement and that the company wanted to develop it as a product called Pyridorin to treat diabetic neuropathy – a condition which affects upwards of 40 percent of diabetes patients and can result in end stage renal disease.
In 2005, Biostratum applied to have pyridoxamine removed from the list of legal dietary ingredients, and in 2009, the FDA agreed to their request.
The problem is, Biostratum ran out of money to develop the product, and as things stand, pyridoxamine is off limits forever as a supplement.
Why is this an issue? Because of how vitally important vitamin B6 actually is, and how critical it is that consumers have access to it. (Related: Large-scale study finds vitamin B6 deficiency common in the U.S.)
The health benefits of vitamin B6 or pyridoxamine include positive effects on skin conditions, immune system, co-enzymatic activities, improvement in metabolism, and premenstrual syndrome. It aids in hormone control and treating emotional disorders, carpal tunnel syndrome, multiple sclerosis, anemia, arthritis, and influenza. … This water-soluble vitamin is helpful in treating a vast number of problems related to the heart and skin, as well as depression, fatigue, the nervous system, and much more. (Related: Discover more of the secrets in Nature’s medicine cabinet at Nutrients.news.)
Now, the Council for Responsible Nutrition (CRN) has petitioned the FDA to revise its decision on pyridoxamine, arguing that it should never have been on the exclusionary list in the first place, since it was available as a supplement prior to 1994, and because the drug is no longer being developed by Biostratum.
CRN also points out that pyridoxamine is just the tip of the iceberg when it comes to this issue. Quite apart from the moral issues associated with Big Pharma grabbing natural ingredients and blocking access to them to protect their own bottom line, there is also the murky issue of what was and was not a recognized dietary supplement before 1994.
Nutra Ingredients reported:
When DSHEA was enacted, CRN and other stakeholders assembled lists of what was on the market in 1994. FDA did not accord official recognition to any of those lists at that time, but signaled in its latest version of the NDI draft guidance a willingness to work on the issue, though little official action has been taken since then.
It is unlikely that any action ever will be taken, considering the immense power Big Pharma exercises over regulatory bodies in the United States.