The National Bioengineered (BE) Food Disclosure Law, passed by Congress in July 2016, directed the U.S. Department of Agriculture (USDA) to establish a national mandatory standard for disclosing foods that are or may be bioengineered. This engaging and interactive presentation, presented by Jonathan Havens, partner at Saul Ewing Arnstein & Lehr, will offer a primer on USDA’s recently-finalized national bioengineered (BE) food disclosure standard. He will discuss the scope of the rule, along with exceptions, exemptions, and questions yet to be answered by the USDA.
Jonathan Havens counsels clients on regulatory, compliance, enforcement, and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the U.S. Consumer Product Safety Commission (CPSC). Companies in the consumer health care products, life sciences, cosmetics, tobacco, and medical cannabis industries, among others, turn to Jonathan for advice on how to get and keep their products on the market. He advises companies throughout the product life cycle, including product development, formulation, manufacture, distribution, and promotion. More specifically, Jonathan handles matters involving labeling, good manufacturing practice (GMP), quality system regulation (QSR), product design, and registration and listing, to name a few. When disputes, including litigation, arise relating to these and other issues, Jonathan helps clients navigate them. This includes preparation for FDA inspections, response to inspectional observations (FDA Form 483) and warning letters, managing product recalls, and resolving import and export issues. He also counsels clients through business transactions that involve oversight by myriad federal and state agencies.
Beyond his FDA, FTC, and CPSC work, Jonathan’s experience extends to matters involving the U.S. Department of Agriculture (USDA), the U.S. Drug Enforcement Administration (DEA), U.S. Customs and Border Protection (CBP), a wide array of state and municipal agencies, state attorneys general, and district attorneys. His deep understanding of the complex regulatory and statutory requirements that govern a wide range of products and services is enhanced by his experience working in government and on Capitol Hill. Before entering private practice, Jonathan served as regulatory counsel with FDA, where he focused on compliance and enforcement related to promotion, advertising, and labeling. Jonathan has also held legislative and government affairs positions in which he facilitated the development and execution of strategic communications to members of Congress and their staff aides, and managed several areas of policy and drafted legislative proposals.
Excellent presentation - fine explanation of complex regulations
Excellent and informative
Excellent course for those interested in GE foods
New interesting area.
Very informative! I'm glad I took this course!
Quite interesting overview of a legal field with which I was not familiar.
Interesting topic and instructor explained well
Clear and well-organized.
Extremely well organized and concise.
Speaker presented the information in a very straight forward and easy to understand manner.
Interesting subject matter, well presented.
Good speaking, good examples
Very informative. Thank you!
Wow! This guy took something very dry and made it very interesting. Well done.
The presenter knows the subject matter very well and communicates it effectively.
Great presentation. Really informative.