Just my opinion, but this story about the FDA sending agents to check on B&M shops and online vendors with B&M shops doesn't seem right. And for several reasons.
It would take a massive force to check on every sku in every shop and online shop. At this point, the FDA can't find its ... with both hands, a mirror, and a map.
My guess has always told me the FDA never intended for the PMTA process to get as far as it has and reach this point. It got away from the FDA. IMO, one of the reasons why the FDA did not start the process in 2016 because it is a herculean and damn impossible task to check everything being sold. The only reason the FDA is starting the process now is because a court forced their hand.
Let's set up a scenario by which an FDA agent walks into a shop and wants to see a PMTA filing for every product. When the filing cost upwards of $500,000, the paperwork isn't at the shop. It's at the lawyer's office. Does the agent then go to the lawyer's office and demand to see the paperwork? Remember this is a lawyer's office. They won't be seeing anything without a court order and that takes time.
I don't know how this is all going to play out. But I do believe the FDA will be inundated with PMTA filings up the wazoo. They cannot possibly check every line item. We might just see a wholesale "approved" from the FDA. Some regulation about labs and manufacturing, but that's it.
I could be wrong.
It would take a massive force to check on every sku in every shop and online shop. At this point, the FDA can't find its ... with both hands, a mirror, and a map.
My guess has always told me the FDA never intended for the PMTA process to get as far as it has and reach this point. It got away from the FDA. IMO, one of the reasons why the FDA did not start the process in 2016 because it is a herculean and damn impossible task to check everything being sold. The only reason the FDA is starting the process now is because a court forced their hand.
Let's set up a scenario by which an FDA agent walks into a shop and wants to see a PMTA filing for every product. When the filing cost upwards of $500,000, the paperwork isn't at the shop. It's at the lawyer's office. Does the agent then go to the lawyer's office and demand to see the paperwork? Remember this is a lawyer's office. They won't be seeing anything without a court order and that takes time.
I don't know how this is all going to play out. But I do believe the FDA will be inundated with PMTA filings up the wazoo. They cannot possibly check every line item. We might just see a wholesale "approved" from the FDA. Some regulation about labs and manufacturing, but that's it.
I could be wrong.