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Supplier Audits! Who’s Verifying This?

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Hello Fellow Vapers,

One thing I have noticed going over registration and product listing files is the large amount of misleading information. The registration process was supposed to be used for manufacturers who physically compound, blend, or label IN THE U.S. This DOES NOT include distributors who only distribute finished products, UNLESS they make changes to the finished product.  To test your knowledge, here are a few scenarios for you to review:

SCENARIO #1:

Jerry Juice (made up name) is the brand owner of Strawberry 12mg.
Vitamin Vape (made up name) is the co-packer who blends, bottles, labels, and places in individual boxes (not packing boxes but labeled boxes)
Who registers?

SCENARIO #2:

Shenzhen Sam (made up name) makes tanks and mods and ships fully finished product with label and bottle
Dime a Dozen Distro (made up name) distributes this product to retailers
Who registers?

SCENARIO #3HERE COME THE TRICKY ONES

Jerry Juice packs with Vitamin Vape BUT individually boxes Strawberry 12mg themselves.
Who registers?

SCENARIO #4

Shenzhen Sam makes bottled flavors but labels in the U.S. with Vitamin Vape
Who Registers?

SCENARIO #5

If the FDA stops to audit
WHO SHOULD CARE?

Now, I can tell by the companies on the registration listing site that some companies did NOT know the answers to these questions. Those that do, I commend you! It means you have a great team backing you up. However, it may be too late for some of you.

If you have misfiled your company registration and MULTIPLE retail stores to the FDA I am here to tell you, it’s okay. BUT, not for long. I spoke with FDA and they understand the miscommunication and assured me there will be no repercussion “currently” but we all know of changing tides. I have spoken to companies that used registration as a marketing ploy and let others bully them into something because they didn’t know better. Shame, shame, shame on those people.

Some clients have purposely filed their brands outside of their contract manufacturer with no problems. This was done for many reasons. Examples include lack of trust, not wanting to be bound to THAT specific manufacturer, or the manufacturer/co-packer didn’t want to take responsibility for making their products. Perhaps one company wanted anonymity on their formula and didn’t want to give it to another manufacture (which, by the way, there is a way to maintain that information as proprietary in the vape industry.)

EVERY BRAND OWNER SHOULD KNOW: 

One, TP NUMBERS DO NOT BIND YOU TO ANY MANUFACTURER. That’s what contracts are for. Second, a TP NUMBER DOES NOT MEAN COMPLIANCE. Sorry guys. Don’t believe the market ploy. If Jerry Juice hates Vitamin Vape and moves to a new manufacturer, Vitamin Vape has 6 months to tell the FDA of that. Which doesn’t mean Jerry Juice is non-compliant mind you. For all of you brand owners, you have to start asking for documentation of intent to comply.

WHAT ABOUT DISTRIBUTORS AND RETAILERS:

WHAT should retailers and distro’s be doing to make sure manufacturers are on the UP AND UP? One way is, requesting documentation from manufacturers stating their intentions to comply signed by the OWNER! TP numbers can be changed and forged but a well worded document signed by someone of authority holds more company liability. As an industry, we need companies to take responsibility. Another way to keep track of your manufacturers, is to keep inventory of batch numbers. This will come in handy if they FDA wishes to pull product made by the manufacturer, especially if recall and reimbursement is in order.

In conclusion, know that compliance is not a one-step process. There IS NO magic number. Make sure you build trust with your manufacturer and remember to always leave a paper trail.

As always, stay competitive and stay compliant.

Monica Schick
“The Nerd in the Back”

PS: IF ANY OF THE JUICE OR COMPANIES ARE REAL, I APOLOGIZE AS THESE ARE SIMPLY EXAMPLES. 

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Monica Schick

Vape industry blog, focusing on upcoming vape compliance. All statements are opinions of NGS.


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