Regulatory Update: February 15 – July 30, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including proposed rulemaking relating to agricultural water, the proposed rule to protect poultry growers from abuse, a Minnesota bill allowing CBD in food despite FDA prohibition, and more.

FDA Updates

MUST READ: Proposed Rulemaking for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
On July 19th, the FDA issued a supplemental notice of proposed rulemaking to the requirements the agency recommended in a recent 2021 agricultural water proposed rule. If finalized, the pre-harvest agricultural requirements mandate covered farms to conduct system-based agricultural water assessments on an annual basis, to minimize potential risks associated with pre-harvest agricultural water. In its most recent update to the proposed rule, the FDA specifies the dates on which it intends to impose enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts. These dates range from 9 months to almost 3 years. Enforcement discretion would then allow for flexible application until January 26, 2025 for very small businesses, January 26, 2024 for small businesses, and January 26, 2023 for all other businesses.

FDA Announces Voluntary Phase Out of Certain PFAS in Food Packaging
In late February, FDA released new information regarding the Agency’s progress to voluntarily phase out certain short-chain PFAS used in food packaging. The phase out effects certain type of short-chain per- and poly-fluoroalkyl substances (PFAS), that contain 6:2 fluorotelomer alcohol (6:2 FTOH), which may be found in certain food contact substances used as grease-proofing agents on paper and paperboard food packaging Additional information regarding the FDA phase-out of PFAS in Food packaging can be found here.

FDA Launches Agricultural Water Assessment Builder to Help Farms Understand Agricultural Water Proposed Rule Requirements
In late March, FDA launched a new online Agricultural Water Assessment Builder aimed at helping farms understand the proposed requirements for agricultural water assessments in the Agricultural Water Proposed Rule. The Agricultural Water Proposed Rule was released in early January and, if finalized, it would require farms to conduct systems-based agricultural water assessments. The Agricultural Water Assessment Builder can be found here.

FDA Takes Steps to Limit Lead in Fruit Juice
The draft guidance lowers action levels for lead in juice and is intended to lower consumer exposure to toxic elements in food, especially for children. The full draft guidance for lead in juice can be found here.

Indirect Food Additives Amended Regulations: FDA limits the use of certain phthalates in food packaging and issues request for information about current food contact use and safety data
The amended regulation revokes authorizations for the food contact use of 23 phthalates that the agency has deemed abandoned. The substances are used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. This action now limits the use of phthalates in food contact applications to nine phthalates. Subsequently, the agency requested new use level, dietary exposure, and safety information regarding the phthalates currently authorized to reassess their safety and usage. The amended rule can be found here.

Final Guidance Issued for Reducing Microbial Food Safety Hazards in the Production of Seed Sprouts
On May 13, 2022, the FDA issued a final guidance addressing the agencies serious concerns with the continued outbreaks of foodborne illness associated with sprouts and providing recommendations for companies throughout the supply chain. The full guidance for seeds used for sprouting can be found here.

Groups Urge FDA for New Amendments for BPH
A coalition consisting of environmental groups, consumer groups, and a university recently submitted a petition to the FDA arguing that food additive regulations be amended to restrict or remove authorization for the use of bisphenol A (BPA) in food adhesives, resinous and polymeric coatings, and resins used in contact with food. More information regarding this proposed rule can be found here.

FDA Updates Public on 5-Year Veterinary Stewardship Plan
At the end of June, the FDA’s Center for Veterinary Medicine released a status update on Phase I of its five-year action plan for Supporting Antimicrobial Stewardship in Veterinary Settings. The report touts an 88% success rate for implementing the plan from 2019-2021, with twenty-one action items completed.  Phase II will begin soon and will continue efforts by the agency to protect public health while mitigating the development of antimicrobial resistance. Phase II actions include bringing more OTC drug under veterinary supervision, solidifying an approach for defining durations of use, building an approach for collecting data on antimicrobial use in food-producing animals, and continuing to advance AMR surveillance and monitoring programs through the activities outlines in the National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan

The original rule proposed in December 2021 can be found here.

Draft Guidance Issued on Conducting Remote Regulatory Assessments
In late July, the FDA issued draft guidance to describe the Agency’s current views on the use of remote regulatory assessments (RRAs) to increase public understanding of the FDA’s use and processes for conducting RRAs. The draft guidance can be found here.

FDA Warning Letters
  • Medina Baking and Power Products, Inc.: The Company was issued a warning letter when it misspelled ingredients, did not include required statements in Spanish on labeling, and omitted common names from product labeling.
  • Langlinais’ Baking Company: The Company was issued a warning letter citing failures to include allergen information on packaging, potential contamination of allergens on production lines, and improper sanitation.
  • Joy Gourmet Foods, LLC: The Company was issued a warning letter after it failed to conduct hazard analysis for food which enters their facilities, assess potential allergens, and identify and evaluate chemical hazards resulting from mis-formulation and incorrect labeling of substances. Contamination from drip and condensate from pipes and ducts were also noted.
  • Companies Illegally Selling Unapproved CBD Products for Animals: Several Companies were issued warning letters for selling CBD products for animals. FDA’s position is that under current federal law, these CBD products are considered to be drugs because their intention is to affect the structure or function of animals’ bodies. Because CBD products have not been approved by the agency, they are considered by the agency to be illegal drugs.
  • Unapproved Kratom Products: The FDA, in conjunction with the Federal Trade Commission, issued warning letters to four companies for selling unapproved kratom products for the treatment or cure of opioid use disorder and withdrawal symptoms. FDA has not approved any kratom products for this purpose and is currently evaluating concerning reports about the safety of kratom.

A database of warning letters issued by the FDA can be found here.

USDA Updates

USDA Publishes Origin of Livestock Final Rule for Organic Dairy
The USDA recently published the Origin of Livestock (OOL) final rule for organic dairy. This rule intends to promote a fairer and more competitive market for organic dairy producers, making sure that all certified USDA organic dairy products are produced to the same standard. USDA’s National Organic Program will oversee the new rule. Additional information on the Origin of Livestock rule can be found here. The USDA’s full report can be found here.

USDA Announces New Proposed Rule to Protect Poultry Growers From Abuse
USDA announced a new proposed rule which it asserts will provide more transparency and accountability in the poultry growing system. The new guidance takes steps to provide clarity for growers in ways such as requiring processors to disclose details into the ranking systems such as compensation and ranking attributes. The proposed rule can be read here.

USDA Eyes New Salmonella Standards for Raw Pork Products
As outbreaks emerge throughout the country, the USDA Food Safety Inspection Services (FSIS) is considering imposing new salmonella performance standards focused on raw pork products. A journal article outlining the changes in pork-related salmonella can be read here.

Other Items of Interest

Minnesota Bill would Allow CBD in Food Despite FDA Prohibition
Three Democrats in the Minnesota House of Representatives introduced HF2996 in early February. Under the proposed law, industrial hemp extract would be considered an approved food additive legal for intrastate commerce. Additional information on House Bill 2996 can be found here.

Packaging Material Prices Continue to Rise
Global supply chain woes leading to continued price increases for food packaging are expected over the next twelve months, resulting from the conflict between Russia and Ukraine, in addition to rising energy, transportation, and labor costs. A report by Rabobank expects energy and paper packaging costs to rise 3.4% and anywhere from 2.3% to 3.6%, respectively. The report published by Rabobank can be found here.

Cultured meat could come further out of the lab in 2022
Forecasters predict that the global market for cultured meat will reach almost $500 million by 2030. JBS, the world’s biggest meat company recently unveiled plans to invest $100 million in cultured meat products. Capital investment grew 336% last year to $1.38 billion, led by Future Meat Technologies. The company recently reported plans to identify future production sites in the US while also reporting it had cut the cost of producing cultured chicken breasts from $18 per pound to $7.70 in six months.

While businesses are taking note of the developments in the meat industry, so too are regulatory bodies. In the US, the FDA and USDA began in 2019 to establish regulatory framework for cell cultured products. In 2021, the USDA’s Food Safety Inspection Service solicited public comments and the Department announced a $10 million investment over the next five years to develop a National Institute for Cellular Agriculture at Tufts University.  More information about the National Institute for Cellular Agriculture can be found here.

Culver’s Restaurants Looking to Phase Out ‘Forever Chemicals’
Fast-food chain Culver’s is looking to phase out the usage of wrappers containing PFAS, sometimes referred to as “forever chemicals.” Consumer Reports tested 118 types of food packaging from 24 popular restaurants and 68% contained evidence of PFAS. However, currently, there is not enough reliable data available to estimate the risk from food packaging exposure. Generally, the chemicals enter the human body largely though drinking water. Data concerning ‘forever chemicals’ from Consumer Reports can be found here.

A Bill in Congress Aims to Open New Agency for Food Safety
In July, Congresswoman Rosa DeLauro (D-CT) and Senator Dick Durbin (D-IL) introduced the Food Safety Administration Act into their respective chambers aiming to establish the Food Safety Administration as the single food safety agency withing the U.S. Department of Health and Human Services. Onlookers have been critical of the functionality and effectiveness of the Food and Drug Administration, suggesting the agency has failed to recognize the dangers of prescription drugs and protect children from e-cigarette products. The proposed legislation would transfer all current authority on food to the new agency and be led by a food safety expert confirmed by the Senate. Currently, the FDA regulates approximately 80% of the U.S. food supply. The original text of the legislation can be found here.

Consumer Reports finds Potentially Harmful Bacteria in Ground Meat
Consumer Reports recently evaluated 351 packages of ground chicken, beef, turkey, and pork from supermarkets across America, finding the presence of salmonella in almost one-third of the seventy-five pounds of ground chicken packages tested. Earlier this year, Consumer Reports found a strain of e-coli in ground beef, which triggered a recall of more than 28,000 pounds of meat in seven Western states. In a statement to CBS News, the Food Safety and Inspection Service stated this finding underscores why FSIS is redeveloping its strategies to reduce salmonella in poultry products.

Infant Formula Recall Causes Supply Chain Disruptions
Though a shortage still exists, infant formula has begun to return to store shelves after a severe shortage of infant formula as a result of the 2021–2022 global supply chain crisis, compounded by a large-scale product recall after two babies allegedly died after consuming tainted infant formula. Efforts by numerous agencies were untaken to alleviate the shortage and make product available to key demographics, including special formulas for babies with allergies and diet restrictions as well as parents that rely on WIC funding for formula.

More information on the federal government’s response to the ongoing infant formula shortage can be found here.

This Regulatory Update covers information from February 15 – July 30, 2022. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba 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, visit

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