FDA Regulation of the E Cig & E Liquid Industry
Orange County Law Firm with Extensive Experience within the E Cigarette, E Liquid, Vaping and the Electronic Nicotine Delivery Systems (ENDS) Industry.
The sale and use of electronic cigarettes (e-cigarettes) and Electronic Nicotine Delivery Systems (ENDS) has drastically increased over the past few years. As a result, the e-cigarette industry is burgeoning. And, while the FDA has taken a drastic approach to the industry with new regulations, other countries like the UK have welcomed these products as safer alternatives. Indeed, Public Health England has concluded that e-cigs are 95% safer than combustible cigarettes.
We are up to date on the new developments in the industry. We are actively working on issues unique to the industry like:
- Changing deadlines & enforcement of registrations and ingredient listings
- Determining who a “manufacturer” is under the new regulations (i.e., co-packers)
- Interpretation and compliance with FDA PMTA Guidance documents
- Non-PMTA FDA Guidance to the industry issues
- Health document submissions
- HPHC testing requirements
- Label and warnings issues
- Modified Risk Tobacco Product Applications (MRTP)
- FDA E-Submitter, FURLS and CTP Portal issues
- CLP (European reg’s – Classification, Labelling and Packaging of Substances) compliance
- EU Tobacco Products Directive (“TPD”)
- Right to Be Smoke Free v. FDA legal challenge to deeming Regulations
- New Indiana Laws / Security Requirements
- New state age restrictions
- Potential governmental revision of deeming regulations
- State & Federal regulation and legal status of CBD
- Controlled Substances Act and the DEA (Drug Enforcement Agency)
- CBD in e-liquids
Brown & Charbonneau, LLP offers a unique background of comprehensive experience dealing daily with e cigarettes, e liquids, vaping and related products, including advising on regulatory compliance, counseling on risk mitigation strategies and defending clients’ interests when disputes arise.
With the recent finalization of the primary source of the U.S. Food and Drug Administration (FDA) regulations, this industry is now subject to extensive Federal Regulation. Our firm has unparalleled industry focus, which allows us to advise e-cigarette and e-liquid companies through the maze of legal challenges now faced by the industry.
See FDA deadlines and compliance date summary
In addition to FDA regulations, individual states and countries have also passed additional and different regulations, requiring these companies to focus more on regulatory compliance matters. Our firm has guided industry leaders on the growing number of laws and regulations that impact their business.
Our Irvine attorneys can represent e-cigarette industry clients on a wide variety of areas affecting their business, including:
- FDA Deeming Rule, Regulations & Compliance
- PMTA Process
FDA Pre Market Tobacco Applications
- PMTA Compliance
- US State by State Regulations
- European Union Tobacco Product Directive (TPD)
- Proposition 65 Compliance
- Contract, fraud, shareholder and other business litigation
- Manufacturing & Related Contracts & Agreements
- Manufacturing requirements, including:
- Child Nicotine Poisoning Prevention Act of 2015
- Product Labeling & Warnings
- Products Liability & Related Issues
- Business, Corporate and Formation Issues
- Non-Compete and Non-Solicitation Cases
- Trade Secret and Breach of Confidentiality Claims
- Independent Contractor v. Employee Claims
- Breach of Contract
- Wrongful Termination
- Human Resources Issues
- General Counsel and consulting services
Click here for Frequently Asked Questions (FAQ)
On May 10, 2016 new regulations were passed granting the FDA authority to “deem” or include e-cigarettes, e-liquids, mods, devices and related products as “tobacco products”. These new regulations went into effect August 8, 2016. The deadlines have been extended by the FDA a few times, most recently on July 28, 2017. The new deadline for Pre Market Tobacco Applications (PMTA) for e cigarettes, e liquids and related vaping products is now August 8, 2022.
There are many lawsuits challenging the new FDA regulations. To date, none of them have been resolved.
Click here for “When Should I Use the PMTA Process?”
Electronic Cigarettes, Electronic Nicotine Delivery Systems and E-Liquids
The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are skilled contract attorneys and are up to date on all of the relevant issues affecting the industry. We are prepared to assist you. To learn more, call us today at 714.505.3000, or e-mail inquiries@bc-llp.com to set up a consultation. For more information about the e-cigarette, e-liquid and ENDS industry, please click here
