No, not directly. I would think that the FDA would still ask why some of the products are being shipped within the US and how much knowledge Biel has about it as part of any investigation before the FDA would go after those distributors.
Apparently can't Rx or buy them here yet. I had to get a buddy to send 3 down to me in NY from Toronto by Fedex. He had bought them on-line for tennis sprains. My doctor had heard of them but couldn't source them here. I showed it to him and after 3 days of constant use on my ankle he was blown away, swelling almost completely gone and I was mobile without pain. Gave him back the crutches he had loaned me.