Regulatory Compliance Experts

Regulatory Compliance Experts can act as “3rd Party Agents” to help meet market approval requirements and stay-in-business. This statement of work is to advocate, educate, and assist business owners and operators of domestic tobacco product establishments to file with the FDA, in compliance with the Tobacco Control Act, including: • Who should make establishment registration and product listing submissions; • What information to include in the submissions; • When to submit the information; and • How to submit the information The failure to register, the failure to provide any information, or the failure to provide a notice required is prohibited. A tobacco product is deemed “misbranded” if it was manufactured, prepared, or processed in an establishment not duly registered, or if it was not included in a product listing as required. Violations are subject to regulatory and enforcement action. All electronic nicotine delivery systems or ENDS (including e-cigarettes, vape pens, personal vaporizers, etc.) are subject to the new regulations. ENDS products also include both the e-liquid and aerosolizing apparatus, whether sold as a unit or separately. Please contact us for more information: Tom Navarro, RAC Independent Regulatory Affairs Project Management Consultant Regulatory Compliance Experts LLC San Francisco Bay Area RA Operations, Labeling & Submissions Cynthia Cabrera Expert Vapor Industry Consultant The Cating Group Miami/Fort Lauderdale Area Monica Schick CEO, North Guide Solutions Greater Los Angeles Area Quality Consultant Dedicated to Small Businesses Success in the E-Liquid Sector