Cannabis-Derived Products (Federal FDA Rules)
Even though cannabis is legal under New York law, the U.S. Food and Drug Administration (FDA) regulates how cannabis-derived products are marketed, labeled, and described at the federal level. These rules apply especially where health, ingredients, food, or consumption claims are involved.
FDA violations can result in warning letters, enforcement actions, or fines, even if the product is lawful under state cannabis rules.
What This Covers
- FDA limits on marketing and health claims
- Restrictions on food and beverage ingredients
- Labeling and packaging standards
- Enforcement authority
Prohibited Health and Medical Claims
You may not make medical or therapeutic claims about cannabis or cannabis-derived products.
- Prohibited claims include statements that a product:
- Treats
- Cures
- Heals
- Prevents disease
- Is FDA-approved
- Claims may be explicit or implied
- Testimonials, graphics, or descriptions can still be treated as claims
Medical claims trigger FDA enforcement.
Food and Ingredient Restrictions
FDA rules apply to how cannabis-derived ingredients are used.
- You may not add cannabis or hemp-derived ingredients to food or beverages in violation of FDA rules
- Food additives must comply with federal safety and approval standards
- State cannabis approval does not override FDA food regulations
Non-compliant products can be ordered removed from sale.
Labeling and Marketing Standards
All labeling and marketing must meet federal truth-in-labeling rules.
- Labels and packaging may not imply:
- FDA approval
- Therapeutic or clinical benefits
- Medical effectiveness
- Claims must be truthful and substantiated
- Misleading health or safety claims are prohibited
Packaging, websites, menus, and promotional materials are all reviewed together.
Enforcement and Oversight
Identifies the enforcing authority.
- Enforcement agency: U.S. Food and Drug Administration (FDA)
- FDA may issue warning letters, demand corrective action, or pursue enforcement
What Operators Usually Miss
- State-legal cannabis products are still subject to FDA oversight
- “Wellness” language can still count as a medical claim
- Online descriptions and menus are treated as labeling
When This Comes Up
- Reviewing product labels and packaging
- Writing product descriptions or menus
- Marketing cannabis-derived products
- Adding ingestible or topical products
What Happens If You Ignore This
- FDA warning letters
- Forced label or marketing changes
- Product removal
- Federal enforcement actions
Related Pages
Source Material
