✅ What Does FDA Registration Mean?

In the United States, all manufacturers, importers, and brands of tobacco and nicotine-containing products, including e-cigarettes and vape devices, are required to comply with regulations established by the Family Smoking Prevention and Tobacco Control Act.

For vape products, this includes:

• FDA establishment registration for manufacturers/importers (updated annually)

• Product listing for all nicotine-containing items sold or marketed in the U.S.

• Compliance with Premarket Tobacco Product Application (PMTA) requirements

• Accurate ingredient submissions, packaging disclosures, and warning labels

• Strict age-restriction marketing rules to protect minors

Being FDA registered means that MistyCretaceous has taken the legal steps necessary to operate transparently within the U.S. market and is included in the FDA’s database of registered tobacco product establishments.

🏷 MistyCretaceous FDA Compliance Overview

Note: As of now, no new e-cigarette brand has received full PMTA authorization. MistyCretaceous, like many responsible industry participants, has submitted products for PMTA review and adheres to all FDA enforcement guidance during the review period.

📋 What Products Are FDA Registered?

All MistyCretaceous vape products intended for sale in the U.S. have been:

• Registered under an FDA-verified manufacturing facility

• Properly listed by SKU and product name in the FDA database

• Accompanied by full ingredient disclosures

• Labeled according to U.S. FDA regulations with:

  • Nicotine addiction warning (in required font and position)

  • Manufacturer/importer contact details

  • Batch traceability codes

You may contact us at any time to verify the FDA listing of a specific MistyCretaceous product by providing its batch number or SKU.

📦 Packaging and Labeling Compliance

To meet FDA packaging and labeling requirements, we have implemented:

• The required warning:

  "WARNING: This product contains nicotine. Nicotine is an addictive chemical."
  displayed prominently on every unit box.

• Ingredient transparency and flavor naming guidelines (no youth-targeted branding)

• Child-resistant, tamper-evident packaging features

Our designs and wording strictly avoid any descriptors or visual elements that could appeal to minors, such as cartoon characters, candy branding, or misleading terms like “safe” or “healthy.”

🔍 What Happens Next with the PMTA Process?

MistyCretaceous has submitted a Premarket Tobacco Product Application (PMTA) to the FDA for applicable products in accordance with the agency's regulatory framework.

Until FDA reaches a final decision on these PMTAs, our products remain legally marketable under enforcement discretion, as long as they:

• Were on the U.S. market prior to the cutoff date (August 8, 2016)

• Have been timely submitted for PMTA

• Are not explicitly prohibited under marketing denial orders (MDOs)

We are committed to transparency throughout this process and will update our customers and partners as the PMTA review evolves.

🙋 Frequently Asked Questions (FAQ)

Q: Are MistyCretaceous products legal in the United States?
A: Yes. All our nicotine-containing products intended for U.S. sale are FDA registered and currently under PMTA review. We comply with all age restriction and marketing rules.

Q: Do you have an FDA registration number?
A: Yes. MistyCretaceous is registered as an FDA tobacco product establishment. You may request our registration number or confirmation document by contacting us.

Q: What’s the difference between FDA registration and FDA approval?
A: FDA registration means that our business and products are known to and listed with the FDA. FDA approval (through PMTA) is a longer process currently underway across the industry. We are operating under enforcement discretion until further notice.

❤️ Our Promise: Transparency, Legality, and Consumer Safety

We understand that the vaping landscape in the U.S. is constantly evolving. That's why MistyCretaceous is fully committed to:

• Registering all products with federal authorities

• Operating within the limits of current FDA guidance

• Providing complete and honest information to consumers

• Prioritizing user safety over short-term gain

Whether you're a retailer, consumer, or distributor, you can trust MistyCretaceous to be a responsible and compliant brand in the U.S. e-cigarette market.

MistyCretaceous Compliance Team
📍 FDA Registered Facility | 🔒 PMTA Submitted | ✅ Transparent Labeling
🌐 www.mistycretaceous.com

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