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Volume XII, Number 280

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Lawmakers Press White House on FDA’s Draft Guidance for Plant-Based Dairy Alternatives

The White House Office of Management and Budget (OMB) received FDA’s proposed guidance on “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements” on March 31, 2022. The draft guidance, which has not been publicly released, comes several years after the FDA requested comments from the public regarding the labeling of plant-based dairy alternatives and the standards of identity for dairy products.

In response, a group of bi-partisan lawmakers has sent a letter to OMB which urges the agency to reject the draft guidance to the extent that it “asks plant-based milk to identity differences without doing the same for animal milk.” For example, it would appear that the lawmakers would object to a guidance that adopted (to any degree) the Center for Science in the Public Interest’s suggestion that non-nutritionally equivalent plant-based dairy products bear a front-of-pack labeling disclosure or the National Milk Producers Association’s petition requesting “imitation” labeling for nutritionally inferior dairy alternatives. Notably, the lawmakers’ letter appears to take as a given that non-dairy alternatives will include qualifying plant-based terms (e.g.soymilk) and cites to a 9th Circuit decision which held that such qualifiers mitigated concerns about consumer confusion.

The last several years have included legal actions at all levels including in the courts (see e.g., above-cited 9th Circuit decision and Mikoyo’s vegan butter decision), in state legislatures (see e.g., Virginia and Wisconsin), and in Congress (see Dairy Pride Act). Whether FDA action, including issuance of the draft guidance, will resolve these issues or simply prompt further litigation and/or Congressional action remains to be seen. We are not aware of any timetable for OMB’s review, but we will continue to monitor and report on the guidance and related issues, which are of vital importance to many of our clients.

Nicholas S. Prust, Natalie E. Rainer, Frederick A. Stearns also contributed to this article.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 158
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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...

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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...

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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...

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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...

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