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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. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.
In This Issue
|Podcast Episode 2: I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues
In today’s podcast entitled “Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products,” AGG partners Alan G. Minsk and Brian A. Teras provide an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process. To listen to the podcast, please click here.
Each month, we'll release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues. Last month, AGG partners Alan G. Minsk and Michael E. Burke presented on "Quality Agreements for FDA-Regulated Products: Looking Under the Hood." To listen to the podcast, please click here.
Quality Agreements: An AGG Podcast Recap
A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada
We Have Come Full Circle: FDA Will No Longer Authorize Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
|Required Revisions to Nutrition and Supplement Facts Labels are to be Fully
|Implemented by January 1, 2021
| By: Robert Durkin
The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016. Eventually, implementation dates for these new regulations were set so that manufacturers with $10 million or more in annual sales were required to switch to the new label by January 1, 2020, and manufacturers with less than $10 million in annual food sales have until January 1, 2021, to comply. FDA also announced that it intended to exercise enforcement discretion to “work cooperatively with manufacturers and will not focus on enforcement actions during 2020 for larger manufacturers and during 2021 for smaller manufacturers.” More >
|Carolina Wirth and Genevieve Razick to Present at FDLI’s Introduction to Drug Law and Regulation on “Regulation of Over-the-Counter (OTC) Drugs” on November 12
|AGG attorneys Carolina M. Wirth and Genevieve M. Razick will be presenting on the regulation of OTC drugs at FDLI’s Introduction to Drug Law and Regulation virtual course on November 12, 2020. For more information or to register, please click here.
|Alan Minsk and Carolina Wirth Named as Discussants in FDLI’s Food and Drug Law Journal 2020 Symposium
AGG Food and Drug team leader Alan G. Minsk and team member Carolina M. Wirth are named as discussants in FDLI’s complimentary Food and Drug Law Journal 2020 Symposium on November 13, 2020. Alan and Carolina will serve as commentators on the following presentations: “Updating the Federal Approach to Regulating Personal Protective Equipment” and “Regulatory Reactivity: FDA and the Response to COVID-19.” For more information or to register, please click here.
|Industry Activities and Recognition
|Robert Durkin Quoted in Articles by Food Quality & Safety and WIRED
AGG Dietary Supplements team member Robert Durkin was quoted in a Food Quality & Safety’s article - titled, “FDA Requests Guidance on Nutrition Labeling for Sugars” on October 21, 2020. Bob provided comments on the requests for nutritional labeling for non-traditional sweeteners. To read the full article, please click here.
|On October 21, 2020, Bob was also quoted in a WIRED’s article - titled, “Americans Took Prevagen for Years - as the FDA Questioned Its Safety.” Bob commented on the adverse side effects of consuming Prevagen, a branded supplement. To read the full article, please click here.
|Alan Minsk Interviewed by NTD News on COVID-19 Vaccine Release Date
|AGG Food and Drug team leader Alan G. Minsk was interviewed by NTD News on October 16, 2020. Alan told NTD News that a pre-election vaccine for the coronavirus will not be available anytime soon. To listen to the full interview, please click here.
|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.