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Demo brand, Inc. · Unapproved New Drugs/Misbranded · dated Sep 11, 2026
9working days left · due Oct 2
8Quoted claims ruled
6Critical
1Same claim found in your other copy
FDA asks for a written response within 15 working days. The count runs from the letter’s date. If you received it later, count from the day it arrived. Your counsel files the response.
Every claim the letter quotes, with the corrective action
Critical
“DemoNerve Nerve Support 60 Daily Capsules Delivers Key Nutrients to Damaged & Inflamed Nerves.”
The brand name 'DemoNerve' implies the product makes neuropathy go away, which is a treatment claim in the name itself.
→ Rename the product; the name itself makes the treatment claim.
Standard: Product name implying treatment
Critical
“Damaged & Inflamed Nerves”
Describing nerves as damaged and inflamed names a disease state in a bullet, triggering Amazon suppression and FDA drug classification.
→ Remove disease terms from title, bullets, A+ content, and backend keywords.
Standard: Disease keyword in Amazon title/bullets
High
“resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption”
Time-to-result claim requires finished-product trial data supporting the exact 7-day timeframe.
→ Remove unless a trial supports the exact timeframe.
Standard: works in [X] days
High
“Consumption of DemoNerve resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption.”
Citing a pain-intensity outcome measure used in neuropathy populations implies a disease treatment claim.
→ Cite studies in healthy populations, or remove the citation.
Standard: Ingredient study on a disease population
Critical
“DemoNerve targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…”
Claiming to target the cause of pain is an explicit drug function claim.
Burning, tingling and numbness are symptoms of neuropathy; addressing them is a drug claim.
→ Remove.
Standard: relieves symptoms of
Critical
“Supports damaged and needy nerves.”
'Damaged nerves' names a pathological state rather than a normal structure/function.
→ Supports healthy nerve function.
Standard: Disease keyword in Amazon title/bullets
Critical
“R-Alpha Lipoic Acid (ALA) Protect nerves from damage…”
Protecting from damage is a disease prevention claim.
→ Supports healthy nerve function.
Standard: prevents
Ask about a claim
Paste a line you want to publish, or ask a question about one. It is ruled against the same 98 standards as your audit, and failing lines come back with rewrites that have been checked again. Answers usually arrive within a few minutes.
You asked · Sep 21, 16:07
“Can we say our formula balances cortisol and reduces anxiety?”
Critical
treats anxiety / for anxiety · Rule CV-NC-01
Anxiety is a named condition. Claiming to reduce it is a disease claim.
SafestHelps the body adapt to occasional stress.Amazon listing · Label (with the FDA disclaimer) · Website · Ads · Email · checked again: no findings
BalancedPromotes a sense of calm and helps the body adapt to occasional stress.Amazon listing · Label (with the FDA disclaimer) · Website · Ads · Email · checked again: no findings
Strongest allowedSupports healthy cortisol levels already within the normal range and promotes a sense of calm.Amazon listing · Label (with the FDA disclaimer) · Website · Ads · Email · checked again: no findings
Signed by Reviewer of record · Sep 21
Reviewer note: Use the safest option on the label.
You asked · Sep 21, 13:07
“Our ashwagandha gummies support restful sleep”
Allowed
No findings against the 98 standards. Keep the FDA disclaimer wherever this runs as a structure/function claim.
Instant ruling. The pharmacist signs it on request.
Findings and fixes
8 findings quoted in the letter, each with its corrective action.
Critical
“DemoNerve Nerve Support 60 Daily Capsules Delivers Key Nutrients to Damaged & Inflamed Nerves.”
The brand name 'DemoNerve' implies the product makes neuropathy go away, which is a treatment claim in the name itself.
→ Rename the product; the name itself makes the treatment claim.
Critical
“Damaged & Inflamed Nerves”
Describing nerves as damaged and inflamed names a disease state in a bullet, triggering Amazon suppression and FDA drug classification.
→ Remove disease terms from title, bullets, A+ content, and backend keywords.
High
“resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption”
Time-to-result claim requires finished-product trial data supporting the exact 7-day timeframe.
→ Remove unless a trial supports the exact timeframe.
High
“Consumption of DemoNerve resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption.”
Citing a pain-intensity outcome measure used in neuropathy populations implies a disease treatment claim.
→ Cite studies in healthy populations, or remove the citation.
Critical
“DemoNerve targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…”
Claiming to target the cause of pain is an explicit drug function claim.
Burning, tingling and numbness are symptoms of neuropathy; addressing them is a drug claim.
→ Remove.
Critical
“Supports damaged and needy nerves.”
'Damaged nerves' names a pathological state rather than a normal structure/function.
→ “Supports healthy nerve function.”
Critical
“R-Alpha Lipoic Acid (ALA) Protect nerves from damage…”
Protecting from damage is a disease prevention claim.
→ “Supports healthy nerve function.”
Claims section for counsel
The claims section of your response, drafted for your counsel to review and file.
Draft
client_report_demo_brand_warning_letter.pdf · Sep 20, 2026Open the sample
Approved claims
The compliant rewrites from your audit. Share them with your agency, affiliates and creators.
“Supports joint and muscle comfort”
Listing · Label (with the FDA disclaimer) · Website · Ads · Email
“Supports healthy nerve function.”
Listing · Label (with the FDA disclaimer) · Website · Ads · Email
AI answers
Asked as a shopper would: ChatGPT, Claude, Gemini, Perplexity, Grok, Rufus. Assistants draw on your listing, website, reviews and older copy. Keeping your own copy clean removes the claims they repeat.
High
“ChatGPT: "It is known to boost immunity and help fight off colds."”
Repeats an immune-boosting and cold claim your audit removed from the listing. Assistants draw on older copy and reviews. The fix is keeping every public source consistent.
Medium
“Rufus: "Customers say it is clinically proven."”
Drawn from a review, not your listing. Worth flagging. It is not a claim you made.
Category rank
Where each of your listings sits against the best sellers we scanned in its category, on the same standards. 1 is the highest risk.
11
of 161 in Immune
DEMO-LISTING · Immune support supplement, 90 capsules · scanned 2026-09-05
Label and licence checks
Amazon’s supplement policy bars listing amounts that don’t match your Supplement Facts panel, and your printed label answers to the same claim rules as your listing. We check your listing against your own label on file with the NIH, rule the claims printed on it, and for Canadian products compare your copy with what your Health Canada licence allows.
US label check: matched your label on file with the NIH. Every amount on the listing appears on the Supplement Facts panel.
Canada licence check: not run. No NPN was supplied for this product.
Change history
Every step on your file, dated.
Claims section drafted for counselSep 20, 2026 · 19:07
Every quoted claim ruled; other copy swept for the same claimsSep 19, 2026 · 19:07