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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.

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Phone: 312-977-4647
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e-mail: greenberg@efg-law.com

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

Kerry Toth Rost 
Chicago, Illinois
Associate
phone (708) 288-1569
fax (312) 977-4405
email Email Me

Bar Admissions:
Illinois, 2002
U.S. District Court Northern District of Illinois, 2003
Education:
Illinois Institute of Technology Chicago-Kent College of Law, Chicago, Illinois
J.D.
Honors: Summa Cum Laude
Honors: Order of Coif
Law Review: Chicago-Kent Law Review, 1999 - 2001


Dr. William M. Scholl College of Podiatric Medicine, Chicago, Illinois
B.S.
Honors: Summa Cum Laude
Major:  Biomedical Sciences


Dr. William M. Scholl College of Podiatric Medicine, Chicago, Illinois
D.P.M., Doctor of Podiatric Medicine
Major:  Podiatric Medicine


Creighton University, Omaha, Nebraska
B.A.
Honors: Dean's List
Major:  Psychology


Published Works:
What You Don't Know Can Hurt You: Why Managed Care Organizations have a Legal Duty to Disclose the Use of Financial Incentives to Limit Medical Care, 35 J. Hlth. L. 145, 2002


Policing the 'Wild West' World of Internet Pharmacies, 55 Food & Drug L. J. 619, 2000


Policing the 'Wild West' World of Internet Pharmacies, 76 Chi.-Kent L. Rev. 1333, 2001


Diagnosis and Treatment of Plantar Fasciitis Langer Biomechanics in Step, 1997


Honors and Awards:
1st Place, American Health Lawyer's Association Writing Competition, 2001 - Present


3rd Place, Food and Drug Law Institute's H. Thomas Austern Writing Awards Competition, 1999 - 2000


1st Place, Langer Biomechanics National Research & Writing Competition, 1997


2nd Place, Langer Biomechanics National Research & Writing Competition, 1996


American College of Foot & Ankle Orthopedics & Medicine Outstanding Student in Medicine Award, 1997


Professional Associations and Memberships:
Illinois Podiatric Medical Students Association, 1995 - 1996
President


Fraternities/Sororities:
Delta Zeta


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