June 29, 2022

Volume XII, Number 180

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June 29, 2022

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FDA Provides Updates on Closer to Zero Plan

As we have previously blogged, FDA announced a three-phase “Closer to Zero” plan in 2021 to reduce the levels of arsenic, lead, cadmium, and mercury that babies and young children are exposed to.

In regard to arsenic and cadmium, the plan requires FDA to: (1) develop an interim reference level (IRL) for arsenic in phase 1 of the plan (April 2021 to April 2022); (2) propose a draft action level for arsenic and develop an IRL for cadmium in phase 2 of the plan (April 2022 – April 2024); and (3) finalize the arsenic action level and develop a draft action level for cadmium in phase 3 of the plan (April 2024 and beyond).

At a June 14, 2022 webinar on the draft action levels for lead in juice that the Agency recently published (see April 29th post), Conrad Choiniere, Director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), indicated that the Agency has received additional resources to focus on its Closer to Zero plan and that it is likely to release IRLs for both arsenic and cadmium by early 2023 and that draft action levels for both heavy metals would follow in late 2023 to early 2024.  He also reported that an action level for lead in baby food is currently undergoing interagency review and is expected to be released soon.

Keller and Heckman will continue to monitor and report on updates to the Closer to Zero Plan.

Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article. 

 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 172
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

415-948-2830
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