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Food and Drug Law Articles by Eric F. Greenberg

RECENT ARTICLE
by Eric F. Greenberg

An interesting rulemaking, if you like that sort of thing

In today’s column, I try to persuade you that the way FDA has lately been making regulations is unusual, surprising, and interesting. Yes, I know how that sounds. But the regulations are crucially important to food companies, so it’s useful to watch them develop and perhaps even get involved.

The typical sequence for agencies making regulations (OK to call them “rules”) is, first, they issue a proposed regulation, inviting the public to comment on it. Second, they mull over all the comments, make changes to the proposal as they see fit, and third, issue the final regulation, revised perhaps in light of the comments, together with detailed explanations of why they did what they did. Fourth, the final regulation becomes effective at some date after its publication.

Watchers of the FDA’s seven separate proposed regulations growing out of the Food Safety Modernization Act were surprised in September, because FDA didn’t follow the typical sequence. They had been proposed, and had been commented upon by the public. But instead of issuing final versions of the regulations, which was the expected next step, FDA issued slightly revised proposed versions of four of them. Comments on the revised proposals are due by December 15. Final versions of the regulations are expected in 2015.

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Eric F. Greenberg P.C. - Law Firm Practicing: Food & Drug Law, Packing Law, and Commercial Litigation

We represent business clients at every level of the food and drug development, production, distribution, and packaging industries. Our Chicago, Illinois-based lawyers have extensive experience advising and representing food and drug producers, cosmetics and medical device manufacturers, and packaging manufacturers, converters and designers nationwide on issues involving:

  • FDA Requirements
  • Food Contact Notifications; GRAS Notices and Analyses
  • USDA Requirements
  • Labeling Requirements
  • Defense Against Allegations of FDA Violations
  • Preparation For Government Inspections

Our attorneys regularly provide advice and guidance on compliance with FDA regulations, including developing plans for compliance, implementation of compliance strategies, evaluation of current plans, and identification of weaknesses in current processes. We work closely with you to help you achieve complete adherence to rules and regulations.

We have considerable experience in analyzing and evaluating products and components to determine applicability of FDA jurisdiction, and successfully guiding companies through the FDA approval process, and in defending companies accused of regulatory violations.

Whether you seek to get FDA approval for your product, insure compliance with FDA regulations, or you are facing allegations of FDA violations, our team will work for you.

As experienced litigators with a thriving commercial litigation practice, we provide aggressive, effective representation in matters involving a broad range of commercial disputes.

Our firm is a proud member of the International Network of Boutique Law Firms, a select organization with members throughout the United States and the world.

International Network of Boutique Law Firms (INBLF)

Visit our Firm Overview and Practice Areas sections to learn more about us or contact us to speak with an experienced lawyer about how your company can benefit from our services.

Eric Greenberg Publishes Guide To Packaging Law, 2d Edition

See Eric Greenberg's article summarizing the FSMA in the American Bar Association's Antitrust Section's
"Agriculture and Food Committee e-Bulletin,"
Winter 2012, page 19. Click here.


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