Got a TGA warning letter? What to do in the first week
What the letter asks for, and how to respond.
In short. A letter from the TGA about your advertising or your product is serious but manageable. What you do in the first week sets the tone for everything after. Read it closely, pause the claims in question, gather your evidence and respond on time.
Day 1: read it properly
Work out exactly what the TGA says you have done, which products, claims or channels it covers, and what it is asking for. Note the response deadline and who the letter is from. Do not reply from memory or in frustration.
Day 1 to 2: contain it
Pause or remove the specific claims named in the letter, across every place they appear: packaging files, your website, social posts, marketplace listings, emails and influencer content. Take dated screenshots first so you have a record of what changed.
Day 2 to 3: gather your file
Collect the product listing details, the claims you make for it and the evidence behind each one. Gather approvals, sign off records and any agency or influencer briefs. If you do not hold evidence for a claim, you need to know that now.
Day 3 to 5: widen the check
Check the rest of your range and channels for the same problem. Regulators look for patterns. Fixing one product while the same wording sits on another is the most common way a single letter becomes several.
Day 5 to 7: respond
Prepare a clear, factual response that sets out what you have changed, what you will change and how you will prevent a repeat. Consider legal advice before you send it, particularly if the letter mentions penalties or possible enforcement action.
What not to do
Do not ignore it, do not delete evidence, and do not argue the point in public or on social media. Do not assume a quick edit to one page closes the matter.
After the week
Put in place a claims register and a sign off step for any new claim. It is cheaper than the next letter.
This article is general information, not legal advice. If you have received a letter, get advice that fits your situation.
- Therapeutic Goods Act 1989 (Cth).
- Therapeutic Goods Advertising Code (No. 2) 2021, as in force.
- TGA, compliance and enforcement approach for advertising: tga.gov.au.
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