Vape | Tobacco | Hemp | Clark-esposito Law Firm, P.c.

Helping clients navigate the regulatory framework of the FDA, TTB and DEA requirements so that businesses can comply with their reporting requirements, operate lawfully in an ever-changing legal landscape, and be prepared for the inevitable government visit.

Vape | Tobacco | Hemp

Welcome to the Clark-Esposito Law Firm, P.C.

Guidance

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Key Words

Menu of services.

This menu reflects common services we provide and is not an exhaustive list of our capabilities.

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Establishment Registration and Product Listing with FDA

For companies who plan to start manufacturing, selling, or importing a finish tobacco product, including vapor products, under their own brand name.

Ingredient Listing Submission to FDA

For FDA registered companies that have yet to submit the ingredients, or in the case of a unit, e.g. a vape pen, component information, to FDA under this mandatory requirement.

Responding to an FDA Warning Letter

For retailers in need of a coherent and structured response to an allegation of wrong doing as presented in an FDA Warning Letter.

Responding to a Letter from OSHA

For manufacturers of e-liquids facing allegations or a request for information from OSHA about hazardous material violations or otherwise.

draft

Contracts

For businesses ready to streamline their operations, formalize relationships, and further protect the assets they've worked so hard to create. Contracts could relate to minimum standards with suppliers, exclusivity arrangements, quality control, cross-border agreements, supplier's ethical code of conduct, confidentiality, non-disclosure agreements, etc.

Creation of FDA Compliant Product Menu

For sellers seeking to demonstrate quality and build trust with current and potential customers by demonstrating FDA filings and other compliance measures taken through documentation.

Creation of a Hazardous Materials Program

For manufacturers of e-liquids aiming to avoid the allegations of OSHA violations and the threat of penalties from a failure to have hazardous materials protocols and safety measures in place.

Advertising

Analysis

For sellers who have print, web, audio, billboard or other advertising and seek to verify compliance with government requirements to avoid fines and other problems.

Label and Package

Analysis

For manufacturers, importers and exporters aiming to ensure that their product labels contain all government required statements and avoid the ramifications that accompany non-compliance.

Tobacco Products Retailer Training Program

For vape shops interested in preparing their business to be a more responsible one through implementing in-store training and other protocols, and be equipped to pass unannounced FDA investigations which can lead to a Warning Letter from FDA, or even worse, a No Tobacco Sale Order.

US Customs (CBP) Decision Request on Vape Products

For importers of vapor products that desire written confirmation from CBP about a product's classification, the admissibility of a product, e.g. that it is not considered drug paraphernalia, value determination, or otherwise.

Creation of Manufacturer Standard Operating Procedures (sops)

For manufacturers aiming to document and the standards it sets to run day-to-day operations and to have a quality management system where products are made systematically and with integrity.

Draft Retailer standard operating procedures (SOPs)

For vape shops aiming to meet the standard to have a quality system for in-store management and operations.

FDA Compliance

Review

For companies who have done some FDA filings and met other requirements without the assistance of counsel and seek to identify any areas of non-compliance so that they can be fixed.

Analysis of Compliance with Import Record Keeping Requirements

For importers who recognize that a customs audit is not a matter of "if" but "when" and want to be prepared for the inevitable customs audit.

Obtaining a TTB Tobacco Importer's Permit

For importers of tobacco, including cigars, loose tobacco, chewing tobacco, etc.

US Customs (CBP) Decision on any Product

For importers who either (1) want to determine the classification and duty rate of a product or (2) want to verify the admissibility of a product under consideration for foreign manufacture and/or importation.

Tariff classification number (HTSUS)

Review

For importers who want to verify the tariff classification number(s) currently being declared to US Customs is the correct one.

Tariff Engineering/Duty Recovery Analysis

For importers who want to determine if there is a more appropriate tariff number which should be used that can result in more favorable duty rate.

Foreign Supplier and Importer Due Diligence

For importers of products ready to formalize processes, including the design and implementation of Quality Control (QC) protocols, issuance of contracts (NDAs/Exclusive Distribution/Minimum Standards, etc), correct invoicing, matchmaking with US Customs Brokers, etc.

Foreign Supplier Questionnaire - Vendor Oversight

For those seeking new overseas suppliers and desire an understanding of the inner workings and compliance measures recognized and followed by the manufacturer.

Responding to a CBP Detention or Seizure Notice

time sensitive

For an importer of products whose goods have been detained or seized by US Customs, whether prior to or following the issuance of, a detention letter or seizure notice.

Responding to a CBP Notice of Action

Time sensitive

For an importer of products who wants to challenge the unexpected action taken by CBP that has changed the tariff (HTSUS) number and subsequently increased its duty rate.

Responding to a CBP Request for Information

time sensitive

For an importer of products who has received a request from US Customs about merchandise imported and seeks assistance in providing an appropriate response.

Creation of SOPs for Importing

For importers who want to document processes and procedures in order to streamline how import orders, receipts, supplier oversight, and customs entries are managed.

new Social Compliance Program Package

Includes a Supplier's Code of Conduct, Manufacturer's Certificates, Stakeholder Identification, Supplier Questionnaire, and Social Compliance Manual.

For importers who have their Reasonable Care obligations in order and need the creation and implementation of a Social Compliance Program to meet CBPs new reasonable care requirement on forced labor.

Creation of an Import Compliance Manual

For importers who are ready to - or need to - document their reasonable care and due diligence measures in their US Customs operations.

Prior Disclosure

TIME SENSITIVE

For vape importers aware of an error made in its customs procedures who prefer to disclose and correct such errors in advance of CBP discovering the wrongdoing itself, and therefore becoming at risk of significantly higher penalties and other ramifications, including increased scrutiny by CBP.

Helping clients navigate the regulatory framework of the FDA, TTB and DEA requirements so that businesses can comply with their reporting requirements, operate lawfully in an ever-changing legal landscape, and be prepared for the inevitable government visit.