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Benjamin Wolf practices in the area of food and drug law. Mr. Wolf provides state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers. His practice also includes providing advice to food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations.

Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of Regulatory Affairs (ORA). In his role as a regulatory counsel, Mr. Wolf worked closely with CTP, ORA, the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) to develop and implement policies including tobacco compliance and enforcement, tobacco premarket review, medical device compliance and enforcement, device premarket, and device and combination products good manufacturing practice. This work touched upon areas including tobacco substantial equivalence (SE), premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), investigational tobacco product applications (ITPAs), data integrity, medical device quality metrics, utilization of benefit and risk factors in determining appropriate FDA engagement for devices being marketed, laboratory developed tests (LDTs), and good manufacturing practice (GMPs) for medical devices and combination products.

Also while at the FDA, Mr. Wolf served as a reviewer of certain tobacco premarket applications and submissions; responded to Congressional, Government Accountability Office (GAO) and Office of Inspector General (OIG) inquiries; and trained in bioresearch monitoring for field investigators.

Mr. Wolf’s practice is benefited by his extensive background as a research and development engineer at a medical device company in Boston, Massachusetts. In that role, he gained experience in GMP compliance, preparing regulatory submissions and addressing FDA questions. He has executed numerous bench and animal studies to support regulatory filings.

Prior to law school Mr. Wolf completed graduate-level coursework in Aerospace and Mechanical Engineering at Boston University. While at George Washington University Law School, Mr. Wolf worked as a student attorney assisting clients with proceedings in the Vaccine Injury Compensation Program (VICP). His Student Note, written while serving as a member of the Federal Circuit Bar Journal (FCBJ) and regarding the VICP, was selected for publication as the best Student Note written for the FCBJ during the 2011-2012 academic year. Mr. Wolf was the recipient of the Henry R. Berger Award, awarded to one graduate annually for excellence in tort law.

On September 4, 2019, Michigan Governor Gretchen Whitmer announced soon-to-be-filed Emergency Rules banning the sale of flavored e-cigarettes in Michigan.[1] The proposed flavor ban, the first of its kind at the state-level, is being promulgated without any public notice and comment using the Michigan Department of Health and Human Services’ (MDHHS) emergency rulemaking powers.

Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This

As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by

The U.S. Food and Drug Administration (FDA) is expected to announce today detailed plans to curtail the growing number of youth who are using certain types of e-cigarette products. Below is a summary of the Agency’s recent actions and compliance deadlines.

September 12, 2018 Letters to Vuse, Blu, JUUL, MarkTen XL, and Logic

  • On September

On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their

In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections

Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143.  In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered

Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along

On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies.  Warning letters were issued to manufacturers, distributors, and retailers of eight products.

All

The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1]  On April