September 2021 Regulatory Update | 1 of 2
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update covers information from September 1-15. Please contact Paul Benson, Taylor Fritsch, Leah Ziemba or Nancy Cruz for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, to help navigate this challenging time, visit Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center.


FDA to Host New Era of Smarter Food Safety Summit on E-Commerce
FDA formally announced a three-day public meeting to discuss the safety of foods sold online and delivered directly to consumers. Given the increasing numbers of consumers ordering their foods online, which has soared during the COVID-19 pandemic, conveying this summit was a goal set in FDA’s New Era of Smarter Food Safety blueprint. The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers will take place virtually on October 19-21, 2021. The summit has been designed to help FDA improve its understanding of how human and animal foods are sold through Business to Consumer e-commerce models across the U.S. and globally. FDA intends to use the information resulting from the public meeting to determine what action(s), if any, should be taken to help ensure the safe production and delivery of human and animal foods sold through new e-commerce business models.

For more information regarding the summit, please refer to the official notice publication here.


FDA Announces Extension of Temporary Permit for Market Testing of “Ruby Chocolate”
In 2019, FDA issued a temporary permit to Barry Callebaut U.S.A. LLC to market test products identified as “ruby chocolate” that deviate from the requirements of the standards of identity for cacao products in 21 CFR part 163. FDA issued the permit to facilitate market testing of product that deviate from the requirements of the standard of identity for cacao products issued under section 401 of the Federal Food, Drug, and Cosmetic Act. 

FDA recently announced the extension of the temporary permit issued to Barry Callebaut. The extension allows the company to continue to evaluate commercial viability of the product and to collect data on consumer acceptance of the product in support of a petition to establish a standard of identity for “ruby chocolate.” FDA also invites other interested parties to participate in the market test.

For more information, please visit the notice publication here.


FDA and FTC Send Warning Letters to 10 Companies for Illegal Claims on Dietary Supplements
Warning letters were issued in the first half of September to 10 companies for illegally selling dietary supplements claiming to treat diabetes. The products cited in the letters are unapproved new drugs that have not been evaluated by the FDA to be safe and effective for their intended use. FDA requested responses from all 10 companies within 15 working days stating how they planned to address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law.

To find more information about warning letters issued by the FDA, please visit their database here.


FSIS Seeks Comments on the Labeling of Meat and Poultry Products Derived from Animal Cells
The FSIS recently published an advanced notice of proposed rulemaking (ANPR) to solicit comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act. The ANPR also discusses how FSIS will generally evaluate labels or these products if they are submitted before the Agency completes rulemaking.

In 2019, USDA and FDA announced a formal agreement to jointly oversee the production of human food products made using animal cell culture technology and derived from the cells of livestock and poultry to ensure that such products brought to market are safe, unadulterated and truthfully labeled.

FSIS will use comments and information submitted to inform future regulatory requirement for the labeling of such food products. Comments must be submitted on or before November 2, 2021. To view the ANPR and information on how to comment or submit information, please visit the FSIS website here.


FSIS to Hold a Virtual Meeting of the National Advisory Committee on Meat and Poultry Inspection (September 27 and 28, 2021)
FSIS recently announced a virtual meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI) to be held on September 27 and 28, 2021. The NACMPI provides advice to the Secretary of Agriculture concerning State and Federal programs with respect to meat, poultry and processed egg products inspection, food safety, and other matters that fall within the scope of the Federal Meat Inspection Act and the Poultry Products Inspection Act.

The FSIS will present two sets of charges to the Committee:

1) To consider how FSIS should clarify the Agency’s positions on the custom and retail exemptions to ensure that meat, poultry, and egg products produced under the exemptions are safe, wholesome, and correctly labeled and packaged

2) To consider actions FSIS should take to prevent and reduce illnesses associated with the handling or consumption of frozen, raw, stuffed not ready-to-eat poultry products, which may be breaded and par-fried and may appear ready-to-eat to consumers.

The virtual public meeting is scheduled from 10 a.m. to 5 p.m. EST on September 27 and 28, 2021. For more information, please refer to the official notice publication here.


Upcoming Deadline for Inspection of Egg Product Exports to the U.S.
The FSIS recently published a notice for mandatory inspections of egg substitutes and freeze-dried egg products imported into the United States. In October 2020, the FSIS published the final rule, “Egg Products Inspection Regulations,” which, among other things, announced that FSIS would begin exercising jurisdiction over plants that produce egg substitutes and freeze-dried egg products on October 30, 2023. This transition will be completed in phases, beginning with a Phase 1 deadline of October 30, 2021 and ending with Phase 3 on October 30, 2023.

Foreign countries currently exporting egg substitutes and/or freeze-dried egg products to the U.S. without an egg products inspection system equivalence determination by FSIS, as well as foreign countries not exporting that are interested in exporting such products to the United States under FSIS jurisdiction meet certain requirements by the deadlines provided in the notice. Foreign countries wanting to participate must notify FSIS of their intention to export egg substitutes and freeze-dried egg products to the United States (Phase 1) by October 30, 2021.

For more information regarding the requirements and deadlines, please refer to the official notice publication here.