- In the last two years, the Supplemental Nutrition Assistance Program (SNAP; colloquially known as the “Food Stamps” Program) has been a major point of contention within political circles. For example,
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 November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating
- On November 14, the United States Department of Agriculture (USDA) announced that China plans to lift its ban on poultry imports from the United States. China originally instituted its ban
- While the Food and Drug Administration (FDA) is the primary regulatory authority for food, dietary supplements, cosmetics, tobacco products, and other related products, the Federal Trade Commission (FTC) regulates advertising
- As previously covered on this blog, food waste is a major issue in the United States. Government estimates indicate that Americans waste between 30 and 40 percent of the
- As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be
- On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations
- On September 13, deputy administrator of USDA’s National Organics Program (NOP), Jennifer Tucker, announced at the Natural Products Expo East in Baltimore, Maryland that the agency will soon release its
- The U.S. Department of Agriculture (USDA) announced on September 24 that it will hold a public meeting to provide interested parties an opportunity to address items on the agenda of
- On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy