Because the manufacturer carries its own exposure. If a product it makes is unlawful because of how it is labeled or what it claims, the facility that made it is part of the record, along with its procedures, its documentation and its inspection history.
Asking who reviews your labels and claims is a manufacturer qualifying a customer, in the same way you qualify a supplier.
What is the manufacturer actually worried about?
That a compliance problem originating on the brand side reaches into their facility. A label or a claim is not something they control, but the product carrying it was made on their equipment, under their procedures, with their batch records.
They are also worried about disruption to their other customers, who share those lines.
Isn’t labeling entirely the brand owner’s job?
Largely, yes, and a well-drafted quality agreement says so. But allocation between two companies is not the same as insulation from a regulator, and the practical consequences do not divide cleanly. Product on hold is on hold for everyone touching it.
What are they hoping to hear?
Something specific. Who reviews artwork and claims, at what stage, and what happens when the answer is no. A brand owner who can describe that process is a lower-risk customer than one who says compliance is handled.
What should be in the quality agreement?
At minimum: which party is responsible for label content and claims, which for manufacturing practices and records, who performs and retains which testing, how deviations are investigated and communicated, how long records are kept and who can access them, and who has authority to initiate a recall.
Vague agreements tend to resolve in favor of whoever has better documentation when it matters.
How does this change the way a brand owner should work?
It moves regulatory review earlier. Review before artwork is finalized, before the print run, and before the first commercial batch. That sequence is cheaper than any of the alternatives and it is also the answer your manufacturer is looking for.
Frequently Asked Questions
Can I just tell them our business attorney handles it?
You can, and it may be accepted. Expect a follow-up about who specifically reviews classification, labeling and claims, because those are the questions they are asking about.
Does having regulatory counsel guarantee they’ll take the order?
No. It removes one common reason for declining it.
Who writes the quality agreement?
Either side can propose it. Whoever drafts it tends to allocate favorably, so it should be reviewed by someone representing your interests before signing.
What if the manufacturer says their own regulatory team will cover our labeling?
Be careful with that. Their regulatory team advises their company. Where your interests and theirs diverge, you want your own review.
Is this specific to drug products?
No. Food, cosmetic and dietary supplement manufacturers ask the same questions for the same reasons.
Take the Next Step
Be the customer your manufacturer wants to take on. Contact Capote Law Firm today.
- Related video: Is My Contract Manufacturer Actually Compliant — or Am I on the Hook If They’re Not?
- Related video: What Does an FDA Compliance Attorney Do That My Regular Business Attorney Can’t?
- Service page: FDA Regulatory Counsel
Educational purposes only. This video and page are general information, not legal advice, and do not create an attorney-client relationship.