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 January 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice.

In this Issue

 Industry Insights

FDA Final Order Exempts Certain Class I and II Medical Devices from 510(k) Premarket Review 
By: Alan G. Minsk and Genevieve M. Razick 

On December 30, 2019, the Food and Drug Administration issued a final order that exempts certain class I and class II medical devices from 510(k) premarket review, subject to certain limitations. FDA’s action should decrease the regulatory burden on the medical device industry and eliminate private costs and expenditures associated with complying with certain federal regulations. 
More >

California’s Consumer Privacy Act is Now in Force, the Time to Comply is Now
By: Kevin Coy and Montserrat C. Miller

On January 1, 2020, the California Consumer Privacy Act (CCPA or the “Act”) became effective. At a high level, the CCPA gives California residents, with certain exceptions, new rights to know what types of personal information a business collects about them, information about the business’s data collection practices, the ability to request access to and deletion of personal information the business maintains about them, and, if applicable, the ability to request that a business not sell personal information about the individual. The law also affects service providers to businesses and certain third parties that receive personal information from a business. While implementing regulations proposed by the California Attorney General have not yet been finalized, enforcement nevertheless is scheduled to begin July 1, 2020 and organizations subject to the law should be working on their compliance program (if that work has not already been completed). More

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. 
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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 >

Upcoming Events

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.

Industry Activities and Recognition

AGG Partners Jennifer Downs Burgar and Alan G. Minsk are Recognized by Who's Who Legal for Life Sciences
AGG Partners Jennifer Downs Burgar and Alan G. Minsk are recognized as leading lawyers in the Life Sciences – Regulatory category of Who’s Who Legal’s Global Guide.


This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2020. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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