Better Late than Never: FDA Issues Final Guidance on Serving Sizes, Dual Column Labeling and Other Miscellaneous Topics The Day Before the “New” Nutrition Labeling Regulations Go into Effect  
By: Carolina M. Wirth

With the compliance date of January 1, 2020 for food companies with more than $10 million in annual sales only hours away, the Food and Drug Administration announced the availability of a final guidance for industry entitled, “Food Labeling: Serving Sizes of Foods that Can Reasonably Be Consumed At One Eating Occasion, Referenced Amount Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics.” While FDA first issued regulations updating the nutrition labeling regulations for foods and dietary supplements in May 2016, the agency has been slowly issuing guidance documents on a variety of topics over the last few years. The final guidance, which finalized a draft guidance published in November 2018, only makes a few substantive changes; however, it took FDA over a year to finalize it, despite only receiving 40 comments on the draft. More >

AGG Webinar on Rx Drug and Medical Device Advertising and Promotion: Education and Compliance 
By: Alan G. Minsk 

On January 30, 2020, my colleague, Seth S. Ray, and I will present our second annual year–in-review webinar of the Food and Drug Administration’s regulation of prescription drug and medical device promotion. Seth previously served for more than 20 years in FDA’s Office of Chief Counsel and two years in the Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion. To register, refer to the Upcoming Events section below. More >

CBD Bill Proposed by Rep. Peterson is a Good Start, But We Can Do Better 
By: Robert Durkin 

On January 13th, 2020, Representative Collin Peterson (D-MN), with co-sponsors Rep. Thomas Massie (R-KY), Rep. James Comer (R-KY), and Rep. Chellie Pingree (D-ME), filed a bill that offers a reasonably pragmatic solution to address the current conundrum surrounding hemp-derived cannabidiol, otherwise known as CBD. The bill would amend the Federal Food Drug and Cosmetic Act by inserting: “other than hemp-derived cannabidiol or hemp-derived cannabidiol containing substances” after the phrase ‘an article’ found in the definition of a dietary supplement , referred to as the “exclusion clause”, or the “race-to-market clause”, that is currently preventing CBD from being a legal ingredient in products marketed as dietary supplements. This narrowly-crafted legislative amendment would simply pull CBD out of the exclusionary clauses, while requiring CBD-containing products to still adhere to all other aspects of the Act. The result would be that CBD remains an unlawful ingredient in conventional food because the prohibited act that prevents CBD from being legally marketed in conventional foods, would remain intact. In addition, firms that want to market CBD and CBD-containing dietary supplements would still need to follow the new dietary ingredient (NDI) notification statutory requirements. More >

AGG Partner Alan G. Minsk and Of Counsel Seth S. Ray Will Present a Complimentary One Hour Webinar 
AGG Partner Alan G. Minsk and Of Counsel Seth S. Ray will present a complimentary one hour webinar titled "FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: The Year in Review" on January 30th.

AGG Partner Alan G. Minsk Will Speak at Georgia Tech 
AGG Partner Alan G. Minsk will speak at Georgia Tech School of Chemical and Biomolecular Engineering lecturing on the legal and regulatory aspects of pharmaceutical development. The presentation will be on March 10th. [Closed to the Public]

AGG Partner Alan G. Minsk Will Present at the 44th International Good Manufacturing Practices Conference
Join AGG Partner Alan G. Minsk as he presents at the 44th International Good Manufacturing Practices Conference on the "Techniques of Communicating with the Food and Drug Administration" at the University of Georgia in Athens, GA on March 12th.

AGG Partner Alan G. Minsk Will be a Panelist at the Medical Device Research & Development Summit
AGG Partner Alan G. Minsk will be a panelist at the Medical Device Research & Development Summit presenting on "Precision Medicine: U.S. FDA Legal/Regulatory Considerations” in Tel Aviv, Israel on March 24th.