Brand Owner Responsibilities

Shout out to all the contract manufacturer/packager people!

What should we require of the Brand Owners that we work with. Does the FDA require them to have a Recall Plan (it's their number on the product) or a Supplier Verification Program (for their ingredients and contracted facilities)? What would be the minimum they should be doing and what should we verify?

I hate to admit it, but we work with Brand Owners that don't seem to have a clue when it comes to quality. Occasionally we'll receive packaging that apparently hasn't been reviewed by anyone other than the marketing team, so it looks pretty but doesn't comply. 

Right now, we have quality agreements that say they will do the due diligence on labels, suppliers, etc. We are trying to update our systems to get what we need for our continued third party certification in cGMPs, complying with FSMA. We'll be asking our brokers and clients for the information on suppliers, etc.

We do various dry powder mixes, mainly dietary supplements, for over 300 clients and 1000's of different products a year.

In trying to be thorough but not overwhelm ourselves, what do other contract companies out there do for the Brand Owners and what do they require them to do. How would you "reject" a supplier for a client?

Thanks in advance!

What is your capacity in the mix?  Broker or agent? Etc?  That is a good place to start from.

We are the packager/manufacturer, we get the product in bulk and package it. 

We are the packager/manufacturer, we get the product in bulk and package it. ...

Thanks aaallen.

What requirements are in your own FSMA/FSMS system for approved suppliers? 

We've been under Nutritional Supplement GMP. Our auditor (NSF) is discontinuing that program and we'll have to be FSMA for everything (1000's of products needing supplier verification!) We have a Food Safety Plan and verify our packaging supplier, but only require a CoA for the products coming in.

Regarding non-compliant labels, be aware that in the US if you apply the label, you bear responsibility, even if you are not the brand owner.  I have also many times run across the situation where the label was designed by the marketing team without obvious review by someone who understands the regulations.  I always bring it to the customer's attention and explain in detail what is wrong and why (quoting the regulation)- preferably on a document that would be acknowledged by the customer in writing.  Fortunately, most of the label problems are not flagrant, but more of the type that FDA would just tell you to fix on the next label run.

FSMA requirements, including recall programs, apply to facilities that manufacture, process, pack, or hold an article of food.  If the brand owner is not performing one of these activities, he is not necessarily required to have a recall plan (although it would certainly be in his best interest to have one).

Regarding non-compliant labels, be aware that in the US if you apply the label, you bear responsibility, even if you are not the brand owner.  I have also many times run across the situation where the label was designed by the marketing team without obvious review by someone who understands the regulations.  I always bring it to the customer's attention and explain in detail what is wrong and why (quoting the regulation)- preferably on a document that would be acknowledged by the customer in writing.  Fortunately, most of the label problems are not flagrant, but more of the type that FDA would just tell you to fix on the next label run.

 

FSMA requirements, including recall programs, apply to facilities that manufacture, process, pack, or hold an article of food.  If the brand owner is not performing one of these activities, he is not necessarily required to have a recall plan (although it would certainly be in his best interest to have one).

Yes, analogous "responsibility" potentials have also been discussed here for UK, ANZFA. It's a complicated issue.

Shout out to all the contract manufacturer/packager people!

 

What should we require of the Brand Owners that we work with. Does the FDA require them to have a Recall Plan (it's their number on the product) or a Supplier Verification Program (for their ingredients and contracted facilities)? What would be the minimum they should be doing and what should we verify?

 

I hate to admit it, but we work with Brand Owners that don't seem to have a clue when it comes to quality. Occasionally we'll receive packaging that apparently hasn't been reviewed by anyone other than the marketing team, so it looks pretty but doesn't comply. 

 

Right now, we have quality agreements that say they will do the due diligence on labels, suppliers, etc. We are trying to update our systems to get what we need for our continued third party certification in cGMPs, complying with FSMA. We'll be asking our brokers and clients for the information on suppliers, etc.

 

We do various dry powder mixes, mainly dietary supplements, for over 300 clients and 1000's of different products a year.

 

In trying to be thorough but not overwhelm ourselves, what do other contract companies out there do for the Brand Owners and what do they require them to do. How would you "reject" a supplier for a client?

 

Thanks in advance!

Hi aaallen,

Our brand owners are generally responsible for their specifications, nutritionals, and suppliers (to an extent - we still approve their suppliers on our end even if we are co-manufacturing). They are also responsible for their own labeling artwork. We do review the labels for content and suggest changes when necessary. In some cases, they are also responsible for their own Research & Development if they have the resources.

If we had to "reject" a supplier, it would be based on not getting documentation we needed, or ingredient/product performance of that supplier. We would notify the client that we either need to have an on-site visit with supplier, or client needs to find an alternate supplier. It doesn't happen often, thankfully, but we have had to reject suppliers. 

While the brand owner's name is at stake, we don't want to jeopardize any other products because of problem suppliers.

Regarding non-compliant labels, be aware that in the US if you apply the label, you bear responsibility, even if you are not the brand owner.  I have also many times run across the situation where the label was designed by the marketing team without obvious review by someone who understands the regulations.  I always bring it to the customer's attention and explain in detail what is wrong and why (quoting the regulation)- preferably on a document that would be acknowledged by the customer in writing.  Fortunately, most of the label problems are not flagrant, but more of the type that FDA would just tell you to fix on the next label run.

 

FSMA requirements, including recall programs, apply to facilities that manufacture, process, pack, or hold an article of food.  If the brand owner is not performing one of these activities, he is not necessarily required to have a recall plan (although it would certainly be in his best interest to have one).

Hi fishlady,

I have a question for you. I'm responsible for labeling content of product, and due to GFSI standards, I've always checked for compliance of labels (regardless of whether we were brand owner or not). You bring up a good point about responsibility, so I was just wondering if there is a link to a regulation which clearly states this. I'd like to have it for justification in future discussions. I've been through the FDA labeling laws, but I've probably overlooked it.

In the Fair Packaging and Labeling Act (15 USC 1452) it states: “It shall be unlawful for any person engaged in the packaging or labeling of any consumer commodity ( as defined in this chapter) for distribution in commerce, or for any person (other than a common carrier for hire, or a freight forwarder for hire) engaged in the distribution in commerce of any packaged or labeled consumer commodity, to distribute or cause to be distributed in commerce any such commodity if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this chapter and of regulations promulgated under the authority of this chapter.”

Thanks a bunch, fishlady! Time for me to review and refresh.