FDA Compliance | Urban Smoke TX
FDA Regulatory Compliance Statement
Urban Smoke TX operates in strict compliance with all regulations issued by the U.S. Food and Drug Administration (FDA) governing electronic nicotine delivery systems (ENDS), e-liquids, and related vaping products. We are committed to product safety, transparency, and responsible retail practices.
The FDA Deeming Rule
On August 8, 2016, the FDA’s “Deeming Rule” went into effect, bringing e-cigarettes, e-liquids, vape devices, and all related components under federal tobacco product regulation. This means all ENDS products are subject to comprehensive FDA oversight, including:
- Minimum age and identification requirements (21+)
- Health warning requirements on packaging and advertising
- Registration and product listing with the FDA
- Ingredient listing and reporting
- Premarket Tobacco Product Application (PMTA) requirements
- Good Manufacturing Practice (GMP) compliance
Premarket Tobacco Product Applications (PMTA)
The FDA requires manufacturers of ENDS products to submit Premarket Tobacco Product Applications (PMTA) for any product that was not commercially marketed in the United States as of February 15, 2007.
Urban Smoke TX only sources products from manufacturers and distributors who:
- Have submitted PMTA applications to the FDA for their products, OR
- Have received FDA marketing authorization orders, OR
- Are operating in compliance with current FDA enforcement discretion policies and guidance, as applicable
We actively monitor FDA enforcement actions, warning letters, and marketing denial orders (MDOs) to ensure our inventory remains compliant. Products that receive FDA marketing denial orders are immediately removed from our shelves and website.
Product Specifications — United States
Unlike the European Union, the United States does not impose federal restrictions on:
- E-liquid bottle size (bottles larger than 10ml are permitted)
- Nicotine concentration (strengths above 20mg/ml are permitted under federal law)
- Tank, pod, or cartridge capacity (no federal volume limit)
However, Urban Smoke TX complies with all applicable state and local laws, which may impose additional restrictions. We do not ship to jurisdictions where specific products are prohibited by law.
Packaging & Labeling Requirements
All nicotine-containing products sold by Urban Smoke TX comply with FDA labeling requirements under 21 CFR Part 1143, including:
Required Nicotine Warning:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
This warning must appear on:
- Product packaging (principal display panel)
- All advertising and promotional materials
- Website product pages and listings
For products that do not contain nicotine, the warning may state: “This product is made from tobacco.” or other FDA-approved alternative language.
Additional Labeling Requirements:
- Ingredient listings where required by the manufacturer
- Manufacturer or distributor name and contact information
- Net quantity of contents
- Batch numbers or lot codes for traceability
- Child-resistant packaging where applicable
Advertising & Marketing Compliance
Urban Smoke TX complies with all FDA and Federal Trade Commission (FTC) regulations regarding the advertising and promotion of tobacco products. We do NOT:
- Make unauthorized health claims, including smoking cessation claims, unless the product has received FDA approval as a smoking cessation device
- Target marketing, advertising, or product design at minors or persons under 21
- Use cartoon characters, celebrity influencers popular with youth, or imagery that appeals specifically to children
- Make unsubstantiated claims that vaping is “safe,” “harmless,” or “risk-free”
- Sponsor events, sports teams, or entertainment venues that primarily attract underage audiences
- Offer free samples of nicotine-containing products (prohibited by federal law)
- Use social media influencers who are under 21 or whose audience is predominantly underage
Social Media & Influencer Policy
We require all influencers and brand ambassadors representing Urban Smoke TX to:
- Be at least 21 years of age
- Clearly disclose sponsored content in accordance with FTC guidelines
- Not create content that appeals to minors
- Not post from locations where underage individuals are the primary audience (e.g., schools, playgrounds)
Texas-Specific Vaping Regulations
Urban Smoke TX operates in compliance with Texas state law, including:
- Texas Health and Safety Code Chapter 161 — regulates the sale and distribution of e-cigarettes
- Texas Occupations Code Chapter 154 — tobacco retailer licensing requirements
- Texas Tax Code — compliance with all applicable state and local taxes on vaping products
- Texas signage requirements — we display required state and federal health warnings at our retail location
No Free Samples Policy
Federal law prohibits the distribution of free samples of tobacco products, including e-cigarettes and e-liquids. Urban Smoke TX does not offer free samples of any nicotine-containing product under any circumstances.
Cross-Border Sales
Urban Smoke TX only sells and ships to addresses within the United States. We do not ship to international addresses, military APO/FPO addresses (for ENDS products), or US territories with vaping restrictions. We reserve the right to cancel orders to any jurisdiction where product shipment is prohibited by federal, state, or local law.
Reporting Non-Compliance
If you believe any product purchased from Urban Smoke TX does not comply with FDA regulations, or if you have concerns about product safety, please contact us immediately at [support@urbansmoketx.com] with:
- Product name and brand
- Batch number or lot code (if available)
- Description of the concern
- Photos if applicable
We will investigate promptly and report to the FDA if warranted. You may also report directly to the FDA through their Safety Reporting Portal at www.fda.gov/safety.
FDA Contact Information
U.S. Food and Drug Administration Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 1-877-CTP-1373 (1-877-287-1373)