So if you’re all wondering, what do you have to do to get my liquids approved? What is the PMTA process? How long does it take? What does it cost? Those are excellent questions that nobody in the market seems to know the exact answers or have the same answers. That’s because no one has actually done this process. We’ve been calling around to all kinds of different companies out of curiosity, and we’ve gotten answers all over the grid. The people who actually have the answers, the FDA, never returned our call—shocking I know.
Here’s what we know: Two things are going to have to happen for you to get your liquids approved. One–You have to have a clean and proper environment up to ISO standards (also called GMP: Good Manufacturing Practices). If you aren’t a white coat/white glove type of person and don’t have a facility like this, you can make friends with a modern day “Doc” Brown and outsource your manufacturing by paying someone else to mix the liquids with your formula and ingredients. Ah—ingredients. That’s our number two.
If each of your liquid ingredients has a CAS (Chemical Abstract Service) Registry number, it seems it will be much easier for you to get your liquids approved. From what we understand, having a CAS number means that the necessary clinical testing has already been done on that ingredient. If your ingredients don’t already have CAS numbers, you may have to do your own clinical testing, which can get expensive. Call your product manufacturers to see if they have CAS numbers.
How much does all this cost? What a GREAT question. Again, we have gotten answers all over the place. One source told us if you didn’t have $10 million dollars to hang it up. I think he was having a bad day. Another source said that coming into compliance with ISO standards could cost $1 million in and of itself. It seems clear that the clinical testing costs are going to depend on how many flavors you have and how many chemicals are in each flavor. Only one chemical testing facility has given us a quote on testing and that was $250 per chemical. For example, if there are 40 chemicals in your bubblegum flavor, you’re looking at $10,000 for that flavor to do the testing. We’ve also heard the whole process could cost $600,000 to $1 million per flavor. Like I said—all over the place.
Moral of the story for small companies that want to stay in business: you may need to contract out your manufacturing and re-formulate your flavors to include ingredients with CAS numbers to avoid clinical testing costs. Or just pick your favorite flavor and ‘sayonara’ to the rest of them!