WHAT ARRIVES
Health Canada issues information requests during review and notices of non-compliance after it. CFIA issues findings against food and supplemented food requirements. FDA issues warning letters, and separately, untitled letters that carry less formal weight but still enter the record. Each has its own response window, its own expected form and its own consequence for a late or inadequate reply. Establishing which one you are holding is the first piece of work.
HOW RESPONSES GO WRONG
01
Answering more than was asked
A reply that volunteers adjacent problems opens them. Respond to the finding stated, completely and accurately, and no further.
02
Committing to corrective action you cannot complete
A response is a record. Undertakings made in it are checked later, and a missed commitment is a second finding on top of the first.
03
Fixing the instance, not the cause
Removing one non-compliant claim when the same claim appears across the website, the listing and the trade material produces a follow-up rather than a closure.
04
Treating the deadline as the target
Response windows are short and the evidence usually takes longer to assemble than the writing does. The work starts on receipt, not on the week the reply is due.
WHAT WE DO
A response is a record. Before anything is sent, we establish what was found, under which provision, how far it extends, and what evidence answers it.
Assessment of what was found, under which provision, and whether the finding is correct as stated.
Scope review across the product line, website, listings and marketing material to establish how far the same issue extends.
Corrective action plan that is deliverable, with owners and evidence attached to each item.
Drafting of the response itself.
Supporting evidence package: revised labels, substantiation, specifications, quality records or manufacturing documentation as the finding requires.
Preparation for follow-up correspondence or inspection.
Where the finding is contestable, the technical position for disputing it.
BEFORE IT ARRIVES
The cheaper version of this page.
The same review conducted voluntarily costs a fraction of what it costs under a deadline, and the findings are yours to sequence rather than someone else’s to enforce. Brands most exposed are those whose claims were written by marketing, whose labels were approved years ago under different requirements, or whose manufacturer has changed since the licence was granted.
Holding a letter with a deadline on it? Send the notice and the product details, and we will tell you what it actually requires.
A short conversation is usually enough to establish what the finding requires, how far it extends, and what the response needs to contain.