What a conundrum. If one must wait to ingest anatabine citrate (the 'drug') via a synthetic pill, I agree, we are looking at 5-10 years, if ever. It is a little crazy to me, and lacking common sense, that a mimicked extract from a vegetable, which has shown decent anti-inflammatory action (and no serious side effects), is being labeled a drug that needs an expensive, rigorous, and drawn-out series of clinical trials. If the company wanted to develop a pharmaceutical version, fine: make it more powerful, combine it with other compounds and look for synergies, etc. But to force this backwards, bureaucratic, biased restart of this product/compound, seems to contradict reasoned and compassionate judgement. From the standpoint of the current consumers, and potential consumers later: as more clinical confirmation of the benefits of anatabine come to pass (assuming it does), is the FDA protecting us? Or are they preserving a very broken and flawed medical system?
Was this not just a technical misstep...not applying for an NDIN before marketing? Why punish the beneficiaries of a supplement because of a technicality? Seems short-sighted to me. I feel like there can be a solution to get it back on the market with intelligent and reasonable discourse between the FDA and the company. Laws clearly can be confusing, misinterpreted, suffocating, biased, or just flat out stupid. If you like the decision, however, you can always 'hide' behind the 'law' (Who Am I? lol).
Another issue is 'filing an IND on a marketed supplement'. Another non-drug related technicality? Once again, if a product/supplement demonstrates a reasonable benefit from user accounts and human studies, and the manufacturer decides, as more evidence of efficacy comes to light, to pursue a pharmaceutical version, why should they (and consumers) be punished for that? Maybe there is a logical explanation, or maybe the law in this case is too restrictive or counterintuitive.
Finally, on the FDA written 'response', is there seriously an issue with the company referring to the product as "providing anti-inflammatory support"? If the FDA thinks they are protecting anyone from this language, it must only be complete morons, or those with serious mental disabilities. The language on the bottle couldn't be any more accurate, subtle, and to the point. Suffocating...
Rock Creek/Mullan must be very careful here. Cooler heads and careful dialogue must prevail, but so must not giving up on the supplement, which is helping people. Clearly Mullan sees the benefit of anatabine, and it would send a mixed message if he is not determined to restart supplement sales. Is there a solution to get the supplement version back on the shelves? What if they extract anatabine from the plant (which plant has the highest concentration of anatabine, and will cost the least to grow and extract?). Could they dry the selected plant, grind it, and form a pill that way (pepper pill?)? Obviously these are just cursory angles, and only intended to suggest that a way can be found to make everyone happy (and healthy). Where there's a will...
It would be frustrating to think that a very simple, chronically used, heavily ingested molecule, needs a prescription and a bevy of more time-consuming trials just to be vetted in a way that does not break the 'law'.
Idiotic indeed!
