Hey guys, a lot of my clients are ramping up for PMTA. In this vector it really does take a village, and it is important that we know who is on our side. The last thing brand owners and manufacturers need are companies poking holes in their lifeboats. One of those companies that can make or break an E-liquid are suppliers.
Now many of you out here tell me, “I have spoken to my suppliers and they “assured” me that they were reaching compliance.” That’s great! How have they done this? What information do you take to the FDA? What letter of reassurance do you have? What is considered viable data to send to the FDA? I am sure that the FDA will happily take a letter of assurance stating, “Well, Flavor Company “A” PROMISED they took care of it!” (just in case you can’t hear the sarcasm). FDA will NOT accept this kind of letter. FDA is all about procedure and data collection. As a community, we are looking at being regulated as a CFR 211! Which, in essence, means we will be standardized to “Over-the-Counter” Drug (OTC). Here are some questions you have to ask yourself in regards to your suppliers:
What should I be looking for when auditing my suppliers?
What data should be accessible from my suppliers?
What information DO I need for PMTA?
What can my suppliers do to be ready for upcoming regulations?
I already know which companies are cooperating and which ones are in la-la land. I have heard marketing ploys and promises up the wazoo. Some suppliers will not take my phone calls (you know who you are). The time is NOW to stop marketing to their clients and start HELPING their clients. This is NOT the time for some (excuse the language) bullshit sales pitch. You need results! You need data! You need responsibilities! We, as a vape community, need objectivity. Now don’t get me wrong, if Company “A” says they have it handled then they probably do! BUT, handshakes and hand-baskets don’t mean jack to FDA. It is the time for suppliers to lay their cards on the table and be as transparent as possible.
Now, brand owners and manufacturers, do you know what it will take to build this compliance? What part of this is YOUR responsibility? Suppliers are NOT the end all, but are part of the bigger picture. I place the burden of proof on the industry. Know who is in your boat because some of your allies are already drilling in the floor.
“The Nerd in the Back”