Neelam Gill advises clients in the areas of food and drug law and tobacco and e-vapor law, counseling both domestic and international corporations on product and regulatory compliance issues involving the U.S. Food and Drug Administration (FDA).
In her tobacco and e-vapor practice, Neelam advises tobacco, e-cigarette, and e-liquid manufacturers, distributors, retailers, suppliers, and trade associations on FDA, state, and global regulatory compliance issues. In the food and drug arena, she assists clients with a variety of FDA regulatory matters and labeling issues. Neelam’s background and experience in the pharmaceutical industry serves her well in advising clients on the complexities of the Family Smoking Prevention and Tobacco Control Act. Neelam’s background in quality systems and good manufacturing practices (GMP) provided the foundation for her to spearhead the practice’s Quality and Tobacco Product Manufacturing Practices (TPMP) and GMP section.
Neelam advises clients on preparation of FDA submissions, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, tobacco product master files (TPMFs), and quality issues pertaining to the entire tobacco and nicotine product lifecycle. She helps guide manufacturers of novel nicotine-containing products, e-cigarettes, hookah/waterpipe tobacco, and conventional tobacco products (e.g., cigarettes, smokeless tobacco, cigars, pipe tobacco, etc.). Neelam also assists clients with communications with FDA’s Center for Tobacco Products and advises on federal and state advertising and promotion restrictions and warning labels applicable to tobacco products, such as California Proposition 65. Neelam further assists tobacco and e-vapor clients with scientific literature review, stability and other testing requirements, marketing plans, post-market surveillance, client testimonials and social media considerations, age verification (online and in-person), and environmental assessments. She is regularly invited to train clients on preparing for FDA inspections and remote regulatory assessments. Additionally, she routinely advises clients on highly technical issues pertaining to tobacco and nicotine product research and regulatory requirements to support marketing applications.
Prior to joining Keller and Heckman, Neelam practiced FDA, life sciences, and consumer products regulatory law. She also has extensive experience in the pharmaceutical industry, where her work involved quality systems, current good manufacturing practices (cGMPs), Standard Operating Procedures (SOPs), product filings, regulatory inspections, product certification and testing, internal compliance programs, risk management, supply chain management, and other areas of FDA compliance. Neelam draws upon her industry knowledge and experience to assist clients with compliance and business concerns specific to FDA-regulated industries.
More Legal and Business Bylines From Neelam Gill
- DC Circuit Vacates MDO for Tobacco-Flavored myblu ENDS Products; Potential Impact on Pending Juul PMTA - (Posted On Friday, November 10, 2023)
- 2023 National Youth Tobacco Survey Shows Significant Decline in High School Vaping - (Posted On Monday, November 06, 2023)
- Largest U.S. E-Cigarette Clinical Trial Confirms Role in Smoking Cessation - (Posted On Wednesday, August 30, 2023)
- FDA Receives Authorization to Regulate Synthetic Nicotine - (Posted On Wednesday, March 16, 2022)
- Update on PMTA MDO Legal Challenges, Rescissions and PMTA Authorizations; CTP Leadership Presents at FDLI Conference - (Posted On Thursday, November 18, 2021)
- JUUL Enters Into Consent Judgment with North Carolina - (Posted On Monday, July 12, 2021)
Keller and Heckman LLP has been named a Go-To Thought Leader in the category of Biotech, Food, and Drug Law for 2022. Providing timely analysis on the topic of synthetic nicotine regulation in the United States, authors Azim Chowdhury, Neelam Gill, and Josephine Hsu article reached approximately 100,000 readers, demonstrating the extremely high quality of their thought leadership, as well as their authority regarding the FDA’s recent rulemaking. As the nicotine regulation landscape continues to change, the authors’ analysis serves as a valuable guide for attorneys and industry professionals.