Regulatory and special refusals
Food, Drug, and Cosmetic Act (FDCA) — Trademark Office Action Guide
Marks for goods that violate the FDCA — unapproved drug claims, misbranded supplements, or non-compliant cosmetics — may be refused because use is not lawful in commerce.
What the USPTO is saying
Your goods or their labeling appear to violate the Food, Drug, and Cosmetic Act. This may involve unapproved drug claims, prohibited ingredients, or failure to meet FDA labeling requirements.
Why this issue is raised
Lawful use in commerce is required for registration. Products that violate FDA regulations cannot establish the legal use needed for a trademark.
How applicants typically overcome it
- Amend goods to remove unlawful claims or non-compliant products from the identification.
- Provide evidence of FDA compliance or approval where applicable.
- Remove drug claims from marks and marketing if goods are not approved drugs.
- Consult FDA regulatory requirements for your product category.
Related Office Action issues
Frequently asked questions
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