I think that the folk talking about filing an Amicus Brief are forgetting something.
I'm no lawyer, but it occurs to me that this appeal is about the FDA's right to continue to block our shipments. and that is ALL it is about.
IMHO you need to forget all your charts, graphs and studies and focus on the topic of the appeal.
We need to show how the FDA is unfairly treating the two companies involved. Use the Walnut thing. Just because one company mis-advertised (according to FDA) The FDA did NOT stop the selling or importation of all walnuts. And the Cheerioes, One company got a warning, NOT all breakfast cereals shut down.
Use things that the FDA has been chastised for to show that they are being unreasonable and that they should not be allowed to continue to be unreasonable.
Judge Leon has already indicated that he is leaning toward this being a tobacco product. Show that since Judge Leon has stated this, that the FDA has no right to continue to treat this product as a drug delivery device until it is determined on way or another by Judge Leon.
At this point I don't think (and I could be wrong) that the appeals court can even look at the facts of the rest of the case, only what is on the appeal.
Sun: Am I explaining myself clearly. I don't know a lot about the law but some people seem to want to go off the deep end in this 'brief' and I think it should be very narrow and stay on topic. Only the blockage should be addressed.
I'm no lawyer, but it occurs to me that this appeal is about the FDA's right to continue to block our shipments. and that is ALL it is about.
IMHO you need to forget all your charts, graphs and studies and focus on the topic of the appeal.
We need to show how the FDA is unfairly treating the two companies involved. Use the Walnut thing. Just because one company mis-advertised (according to FDA) The FDA did NOT stop the selling or importation of all walnuts. And the Cheerioes, One company got a warning, NOT all breakfast cereals shut down.
Use things that the FDA has been chastised for to show that they are being unreasonable and that they should not be allowed to continue to be unreasonable.
Judge Leon has already indicated that he is leaning toward this being a tobacco product. Show that since Judge Leon has stated this, that the FDA has no right to continue to treat this product as a drug delivery device until it is determined on way or another by Judge Leon.
At this point I don't think (and I could be wrong) that the appeals court can even look at the facts of the rest of the case, only what is on the appeal.
Sun: Am I explaining myself clearly. I don't know a lot about the law but some people seem to want to go off the deep end in this 'brief' and I think it should be very narrow and stay on topic. Only the blockage should be addressed.