These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from March 1 through March 31, 2020. Please contact Leah Ziemba, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

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The March 2020 Regulatory Update includes several MUST READ updates:

COVID-19 DEVELOPMENTS

  • FDA Releases Guidance on Temporary Nutrition Labeling Policy  MUST READ
  • FDA Releases Guidance on Onsite Audit Requirements  MUST READ
  • FDA Postpones Foreign Inspections Through April 2020  MUST READ
  • FDA and USDA Maintain COVID-19 Webpages  MUST READ

FOOD LABELING, CLAIMS & MARKETING

  • FDA to Reopen Comment Period on Ultrafiltered Milk in Cheeses  MUST READ
  • Proposed Class-Action Lawsuit Against Nestle’s “No GMO Ingredients” Claim Dismissed
  • PA Court Dismisses Dairy Farm’s Challenge to FDA Skim Milk Labeling Rules

FOOD SAFETY

  • FDA Releases Action Plan for Leafy Greens Safety  MUST READ
  • FSIS Publishes Annual Sampling Plan  MUST READ
  • FSIS Announces Results of Second Phase of Raw Pork Products Study

OTHER DEVELOPMENTS OF INTEREST

  • FDA Launches Educational Campaign for New Nutrition Facts Label
  • FDA Releases Congressional Report on CBD Product Education, Research, and Regulatory Enforcement 

COVID-19 DEVELOPMENTS

FDA Releases Guidance on Temporary Nutrition Labeling Policy  MUST READ
March 26:FDA announced the availability of a final guidance giving restaurants and food manufacturers flexibility in the labeling of certain packaged foods during the COVID-19 pandemic (“Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency”).
 
FDA will not object to a restaurant’s sale of packaged food without a Nutrition Facts label as long as it does not contain any nutrition claims and does contain other label requirements, including (as applicable): “a statement of identity, an ingredient statement, the name and place of the business of the food manufacturer, packer, or distributor, net quantity of contents, and allergen information required by the Food Allergen Labeling and Consumer Protection Act,” according to FDA’s Constituent Update. The same standards will apply to food manufacturers intending to sell packaged food to restaurants.
 
Furthermore, “if retail packaging for certain food products is unavailable,” FDA will not object “to the further production of food labeled for use in restaurants that is intended to be sold other than to restaurants until retail packaging is available.”
 
Read FDA’s Constituent Update here and access the guidance here.

 
FDA Releases Guidance on Onsite Audit Requirements   MUST READ
March 17: FDA announced the availability of a final guidance regarding food manufacturer audits during the COVID-19 public health emergency (“Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency”).
 
According to the Federal Register Notice, the final guidance states FDA’s intent “not to enforce certain onsite audit requirements” in the following food safety regulations during the coronavirus pandemic: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117); Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L). FDA will not enforce these requirements if other supplier verification methods “designed to provide sufficient assurance that hazards have been significantly minimized or prevented” are used instead.
 
Read the Federal Register Notice here and access the final guidance here.

 
FDA Postpones Foreign Inspections Through April 2020   MUST READ
March 10:FDA announced that it will postpone its inspections of products and manufacturers outside of the U.S. through April, deciding on “mission-critical” foreign inspections on a “case-by-case basis,” in response to the COVID-19 pandemic.
 
FDA will use interim measures to ensure the safety of U.S. consumers, including “denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records ‘in advance of or in lieu of’ on-site drug inspections,” according to the statement. FDA also will use and, as needed, adjust the PREDICT risk-based import screening tool to choose which foreign products and samples to investigate.
 
Read the FDA Statement here.

 
FDA and USDA Maintain COVID-19 Webpages   MUST READ
FDA and USDA are using their COVID-19 webpages to update the general public and consumer audience on various aspects of the novel coronavirus outbreak, including information about the agencies’ roles in addressing the outbreak, prevention methods, ongoing vaccine updates, and food safety procedures for food handlers and facilities.
 
Visit FDA’s main COVID-19 webpage here and FAQ page here

FOOD LABELING, CLAIMS & MARKETING

FDA to Reopen Comment Period on Ultrafiltered Milk in Cheeses   MUST READ
March 26: FDA is seeking additional public comment on a proposed rule amending the definitions of “milk” and “nonfat milk” in cheeses and cheese products to better align with international food standards of identity. 
 
Originally published in October 2005, the proposed rule (“Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk,” 70 Fed. Reg. 60,751) would alter FDA’s definitions of “milk” and “nonfat milk” to permit the use of fluid ultrafiltered milk (UF) – mechanically filtered raw or pasteurized milk – in cheese production. FDA’s current food standards of identity for cheeses do not conform with the international Codex standards, since its current definitions of “milk” and “nonfat milk” “do not provide for the use of fluid or dried filtered milk or … nonfat milk as basic dairy ingredients in standardized cheeses and related cheese products,” according to the rulemaking.
 
FDA will reopen the comment period to gather additional stakeholder comments. The current comment period closed on March 30, 2020, and the new comment period will close 120 days after publication of the notice in the Federal Register.
 
Read FDA’s Constituent Update here and the proposed rule here.

 
Proposed Class-Action Lawsuit Against Nestle’s “No GMO Ingredients” Claim Dismissed 
March 11: Latiff v. Nestle USA, Inc., a proposed class-action lawsuit alleging that Nestle misleadingly had used its own seals to suggest that certain products contained “No GMO Ingredients,” was dismissed in the U.S. District Court for the Central District of California.
 
Plaintiff Jennifer Latiff alleged that the “No GMO Ingredients” seal Nestle had used on various products (Coffee mate natural bliss Sweet Cream, Buitoni Chicken Prosciutto Tortelloni, and Lean Cuisine Marketplace Ricotta Cheese & Spanish Ravioli) made it seem as though the Non GMO Project had evaluated said products’ ingredients, when in fact only the company had done so. In 2019, the Central District Court of California had denied Defendant Nestle’s motion to dismiss the case, citing Plaintiff’s standing under California’s consumer protection laws.

 
PA Court Dismisses Dairy Farm’s Challenge to FDA Skim Milk Labeling Rules 
February 26: The U.S. District Court for the Middle District of Pennsylvania dismissed a Maryland dairy farm’s suit against FDA skim milk labeling rules, one of a growing number of lawsuits regarding food labeling restrictions.
 
In order to sell milk as “skim milk,” FDA requires that producers add back the vitamins A and D lost in the cream skimming process. Because South Mountain Creamery aimed to sell its skim milk in Pennsylvania without re-adding said vitamins, FDA regulations would require it to label its additive-free skim milk as “imitation.” South Mountain owner Randy Sowers raised First Amendment speech claims against this requirement, contending that following it would mislead his customers. The court found that South Mountain could not state a justiciable claim because the labeling rules did not pose a real threat to the company and because FDA had offered other labeling possibilities.
 
This case is one of various recent First Amendment challenges to labeling restrictions. In 2018 and 2019, Tofurky challenged laws regulating the use of terms like “meat,” “beef,” and “pork” on plant-based or lab-grown “meat-alternative” product labels in Arkansas and Missouri. In February 2020, Miyoko’s Creamery sued the California Department of Food and Agriculture for prohibiting the use of dairy nomenclature in the brand’s vegan butter label.

FOOD SAFETY

FDA Releases Action Plan for Leafy Greens Safety   MUST READ
March 5: FDA released its 2020 Leafy Greens STEC Action Plan, which delineates the agency’s plans to advance work on prevention, response, and addressing knowledge gaps regarding the safety of leafy greens. The action plan constitutes a response to frequently recurring outbreaks of foodborne illness from “STEC” (Shiga-toxin producing E. coli, the most common of which is E. coli O157:H7) in leafy greens and especially romaine lettuce.
 
The action plan involves implementing FSMA standards for safe produce, publishing an investigation of three E. coli O157:H7 outbreaks in Salinas Valley, California (forthcoming), and working with experts to research the ecology of pathogens in various leafy greens growing areas.
 
Read FDA’s Constituent Update here and the action plan here. Read the “FDA Voices” article on the action plan by FDA Commissioner Stephen M. Hahn, M.D and Frank Yiannas, Deputy Commissioner for Food Policy and Response, here.

 
FSIS Publishes Annual Sampling Plan   MUST READ
March 6: FSIS published its FY 2020 Annual Sampling Plan, which includes significant changes to its sampling programs testing for microbiological and chemical contaminants. The agency claims that the new sampling plan will align with FSIS’s Strategic Plan for FY 2017-2021 and FSIS’s FY 2020 Annual Plan by “maximizing public health benefits through prioritizing testing by degree of hazard.”
 
Read FSIS’s Constituent Update here (PDF) and its FY 2020 Annual Sampling Plan here (PDF).

 
FSIS Announces Results of Second Phase of Raw Pork Products Study 
March 6: FSIS announced the results of the second phase of the Raw Pork Products Exploratory Sampling Program, conducted to determine the prevalence of Salmonella and “STEC” (Shiga-toxin producing E. coli) in various raw pork products from June 2017 to May 2018. FSIS will use this data to develop future policies to limit Salmonella in raw pork products.
 
Of the samples collected from slaughter and processing establishments, FSIS found that “the national prevalence of Salmonella in raw pork products was highest in comminuted products (28.9%), followed by intact cuts (5.3%) and nonintact cuts (3.9%).” Less than 1% of the samples collected to analyze for STEC tested positive for the top seven types of STEC.
 
Read FSIS’s Constituent Update here (PDF). Access the results of the study here

OTHER DEVELOPMENTS OF INTEREST

FDA Launches Education Campaign for New Nutrition Facts Label 
March 11: As part of FDA’s multi-year Nutrition Innovation Strategy, the agency launched an education campaign entitled “The New Nutrition Facts Label: What’s In It For You?”  to raise awareness of the new Nutrition Facts label on packaged foods. According to FDA’s Constituent Update, the campaign is aimed at “the general population and sub-populations at increased risk of nutrition-related chronic disease” and will provide downloadable materials, informational videos, middle school and high school curricula, and modules for continuing medical education.
 
Though FDA finalized the new Nutrition Facts label in May 2016, it gave food manufacturers with $10 million or more in annual food sales until January 2020 to start using the new label (manufacturers with less than $10 million in annual food sales have until January 2021). The new label includes updated serving sizes and “is based on updated scientific information, including the link between diet and chronic diseases such as obesity and heart disease,” according to FDA’s news release.  
 
Read FDA’s Constituent Update here, news release here, and Nutrition Innovation Strategy here. Visit the education campaign landing page here and the campaign’s social media toolkit here.

 
FDA Releases Congressional Report on CBD Product Education, Research, and Regulatory Enforcement 
March 5: FDA released its first report on rulemaking for cannabidiol (CBD) to Congress in compliance with the Further Consolidated Appropriations Act of 2020. In a public update supplementing the report, FDA Commissioner Stephen Hahn, M.D. summarized agency efforts to educate the public about using CBD products, to conduct research on their hazards and potential benefits, and to regulate unlawful and potentially harmful CBD products.
 
The report indicates a continuing “risk-based enforcement policy,” with FDA focused on protecting the public from potentially risky CBD products and on monitoring CBD product marketing that is false or could influence consumers not to seek tested, safe medical treatments for illnesses.
 
In his supplementary statement, Commissioner Hahn outlined efforts to tackle the “data gaps” about the safety of these products, especially given that cannabis and cannabis derivatives with low THC levels are no longer controlled substances under the Agriculture Improvement Act of 2018. To fill these knowledge gaps, FDA will reopen a public docket calling for “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.” FDA will extend the docket’s comment period indefinitely and give stakeholders the ability to submit confidential data and information on the benefits and risks of CBD through the docket.
 
Read the FDA Statement here, the FDA report here (PDF), and Michael Best’s Client Alert here. Visit the docket here.
 

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