Brand & Compliance Guide
How we keep your patch program fast, premium, and compliant—without risky claims.
Manufactured in the UK (FDA-registered, ISO 9001, cGMP). U.S. warehousing, packaging & fulfillment.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Information below is general guidance for marketing teams and does not constitute legal advice. Always consult your counsel.
1) Golden Rules (U.S. Market)
Public-facing terminology: lead with "natural topical patch" or "topical nutraceutical patch" for general U.S. wellness marketing. Product terminology and delivery claims should match the intended market and regulatory classification; wording that could imply drug-style or systemic delivery should receive regulatory review.
Claims style: structure/function language only (e.g., "supports," "helps maintain," "promotes," "helps manage occasional…").
No disease claims (no diagnose/treat/cure/prevent).
Avoid "clinically proven" unless you hold competent & reliable evidence for the finished product.
Don't reference Rx brands/actives or weight-loss promises.
Stick to factual features (e.g., hands-free, once-a-day, no sugar).
Manufacturing origin line: Manufactured in the UK. U.S. warehousing, packaging & fulfillment.
2) Required Disclaimers (Copy-Ready)
FDA/FTC:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Usage/Safety:
For external use only. Stop use if irritation occurs. Keep out of reach of children. Consult a healthcare professional before use if pregnant/nursing, under 18, on medication, or with a medical condition.
Testimonials (if shown):
Customer experiences are individual and not typical. Testimonials are not medical claims.
3) Labeling & Packaging Baseline
(Work with counsel)
Panels: Use an Ingredients panel with declared actives/botanicals, adhesives note (e.g., latex-free acrylic PSA), net quantity, lot/batch, and storage. Your counsel will determine if a "Supplement Facts" style panel is appropriate for your program.
Wear & placement: Apply to clean, dry, hair-free skin. Typical wear 8–24 h; varies by formula and skin type.
Storage: Store cool and dry, away from direct sunlight.
Traceability: Lot/batch on pack; COAs available upon request.
4) Acceptable vs. Avoid (Quick Reference)
5) SKU-by-SKU Compliant Blurbs (Pasteable)
6) Web & Ads Checklist
(5-minute preflight)
- ✓Headlines use support verbs; no disease words.
- ✓No before/after implying treatment.
- ✓No Rx brand references or weight-loss promises.
- ✓Feature claims are factual (e.g., no sugar, hands-free).
- ✓Disclaimers present near primary claims and in footer.
- ✓"Manufactured in the UK…" line visible on key pages.
- ✓Reviews/testimonials moderated for claims; add testimonial disclaimer.
- ✓Link COA on request (or gated request form).
- ✓For GLP-1/NAD/CBD pages, run an extra legal pass.
7) Content Substantiation File
(Keep on hand)
- • Ingredient specs & COAs (latest lots).
- • Facility credentials: FDA registration, ISO 9001, cGMP, product liability coverage.
- • Any human-use safety data (adhesive, dermatology patch test if available).
- • References supporting structure/function language at the ingredient level (quality sources).
- • Final artwork PDFs with claim locations flagged.
8) Adverse Events & Complaints
(Internal SOP)
- • Provide a contact email on labels and site.
- • Log product, lot, date, contact, description; escalate serious events to QA and counsel.
- • Keep records aligned to your cGMP documentation.
Natural topical patches. Not intended to diagnose, treat, cure, or prevent any disease. Documentation and COAs available upon request.