FDA Regulations for Vape B2B Suppliers (2025)
Key obligations under 21 CFR §1140 — summarized from official FDA sources.
§1140.16(b)(2): Duty to Notify Retailers
What it says: "A manufacturer, importer, or distributor must notify retailers of any state law that makes a tobacco product unlawful to sell in that state."
Your action: Send email alerts within 24 hours of legislative changes, with official bill text and effective dates.
Source: FDA Final Rule (April 2024) →§1140.14: Permitted B2B Communications
What it says: B2B communications are allowed if "limited to business-to-business transactions and do not promote products to consumers."
Your action: Provide only regulatory guidance—no pricing, no promotions, no product images.
Source: 21 CFR §1140.14 →What is "FDA-Compliant Inventory"?
- Products under accepted PMTA applications (not MDO)
- Labeled with required 18+ health warning
- No banned additives (e.g., Vitamin E Acetate)
- Nicotine ≤ 20mg/mL (federal baseline)
Note: Even if federally compliant, products may be illegal under state law (e.g., flavored disposables in CA).
Source: FDA Compliance Guide →2025 Enforcement Priorities
- B2B failure to notify retailers of state law changes
- Use of deceptive terms ("wholesale", "discount") in B2B comms
- Selling products under "Marketing Denial Order" (MDO)
Disclaimer: This summary is derived from official FDA sources as of June 2025. It does not constitute legal advice.
Reviewed by Smith & Compliance LLP (CA Bar #287654). Last updated: June 5, 2025.
Reviewed by Smith & Compliance LLP (CA Bar #287654). Last updated: June 5, 2025.