- The California legislature passed AB 1830, which is a bill that, if signed into law by Governor Newsom, would require that corn masa flour contain 0.7 mg of folic acid per pound of corn and that wet corn masa products contain 0.4 mg folic acid per pound of end product. The bill would also require that folic acid be declared on the nutrition label and that products declare that they contain corn masa flour or were manufactured through a wet corn masa manufacturing process.
- Corn masa flour is defined as a “dry-type product made from corn that has been treated with slaked lime or otherwise undergoes a process known as nixtamalization” while wet corn masa product is defined as a “food manufactured by using an alkali solution with corn kernels to transform them into nixtamal.”
- The bill exempts cottage food operations, food facilities (operations that provide food at the retail level), and grocery stores that offer for retail sale corn masa flour that does not contain folic acid so long as the grocery store also offers corn masa flour that meets the folic acid fortification requirements. Snack foods are also exempted.
- Folic acid deficiency in pregnant women is a common cause of defects in the neural tube, an embryonic tissue which develops into the brain and spinal cord. The law is intended to reduce the incidence of such disorders, particularly among Latin Americans, many of whom consume corn masa as a dietary staple. Although FDA mandates folic acid in all enriched cereal grain products (see e.g., 21 CFR 137.165(a)), the addition of folic acid in corn masa flour is optional (21 CFR 172.345(i)), and the California law indicates that only 10% of corn masa flour products are fortified with folic acid.
- If signed into law (as is expected), the provisions of the bill will be implemented starting on January 1, 2026.
FSIS Updates Guidance for Animal-Raising and Environmental Claims
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- On September 10, 2024, USDA’s Food Safety and Inspection Service published a Federal Register Notice related to the updated guidelines on substantiating animal-raising or environment-related labeling claims on meat and poultry products, that were released on August 28 and discussed in a previous blog. In the Federal Register Notice, USDA responds to previous comments, and includes information to submit new comments. Changes to the guidelines are related to updated scientific information, sampling data, online questions and answers, public comments, petitions, and stakeholder meetings.
- Examples of animal-raising claims include “Raised Without Antibiotics,” “Grass Fed,” “Free-Range,” and “Raised Without the Use of Hormones.” Environment-related claims include, among others, “Raised using Regenerative Agriculture Practices,” and “Environmentally Responsible.” These claims are considered “special statements and claims” that trigger the requirement to submit meat and poultry product labels to FSIS for approval before the products may be distributed in commerce. FSIS reviews labels bearing these claims on a case-by-case basis by reviewing the production protocol submitted with the application, which FSIS will approve if:
- The documentation supports the claim made;
- The claim is otherwise truthful and not misleading;
- The claim and any qualifying information is prominently and conspicuously displayed on the label; and
- The claim does not otherwise render the product misbranded under the Federal Meat Inspection Act and the Poultry Products Inspection Act.
- FSIS initially published the guidelines in October 2016 and first updated them in December 2019, when the Agency requested comments specifically on the use of the claim “free range” for poultry products in response to a petition. The guidelines are intended to advise establishments on the type of documentation they should submit to substantiate label claims and reduce consumer confusion regarding such claims.
- In response to comments on the animal-raising and environment-related claims, FSIS stated:
- It would not be codifying any animal-raising claims because of the constant innovation in animal production practices and evolving consumer expectations, which would make it impractical to maintain a list of allowable claims;
- It “strongly encourage[s] the use of third-party certifiers to substantiate animal-raising claims;”
- The kind and amount of supporting documentation depends on the claim and could vary according to circumstances and could include things like detailed written descriptions of processes, signed documents describing how the claim is not false or misleading, and written descriptions of the identification, control, and segregation of non-conforming animals or products;
- It strongly encourages the use of a routine sampling and testing program to test for the use of antibiotics in animals prior to slaughter or, alternatively, third-party certification to substantiate negative antibiotic use claims; and
- Establishments are encouraged to provide documentation such as environmental data or studies to substantiate environment-related claims.
- FSIS further emphasized that it encourages the use of third-party certifiers to substantiate these claims and stated that the Agency is “exploring options to determine whether there are lower-cost third-party certification programs, including those offered by the Agricultural Marketing Service (AMS), that meet the recommended criteria for third-party certifiers included in the revised guideline.”
- FSIS is accepting comments on the updated guidelines before November 12, 2024, under docket number FSIS-2024-0010.
FDA Publishes FY2022 Pesticide Residue Monitoring Program Report
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- On September 4, 2024, the U.S. Food and Drug Administration (FDA) made available its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2022 (FY 2022), which summarizes findings from FDA testing of human and animal foods for 757 different pesticides and selected industrial compounds from October 1, 2021, through September 30, 2022.
- FDA’s pesticide residue monitoring program tests FDA-regulated foods shipped in interstate commerce to determine whether they comply with pesticide tolerances, or maximum residue levels, set by the Environmental Protection Agency (EPA). FDA may take action if it is shown that the amount of pesticide residue on a food is over the tolerance, or when a pesticide is found and there is no tolerance established. FY 2022 findings show that the levels of pesticide chemical residues in the U.S. food supply are generally in compliance with EPA pesticide tolerances.
- Out of 2,800 total human food samples, 96.2% of domestic samples and 89.5% of imported samples were compliant were compliant. No pesticide chemical residues were detected in 42.7% of domestic samples and 44.6% of imported samples. In determining which products to sample, FDA may consider past problem areas, findings from state and federal monitoring, and foreign pesticide usage data. Fruits and vegetables accounted for majority (75.5%) of domestic samples.
Plaintiff’s Attorney Spencer Sheehan Sanctioned
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- Spencer Sheehan is a Plaintiff’s attorney who has filed hundreds of class action lawsuits against food companies for allegedly deceptive labeling and marketing. A small percentage of these lawsuits survive the motion to dismiss stage, let alone succeed on the merits. Indeed, many of his losses are suffered many times over as he has a practice of refiling essentially identical lawsuits in different jurisdictions, even after unfavorable rulings.
- His practices have increasingly drawn the ire of the courts, and this summer a United States District Court in Florida issued an order sanctioning him and making him responsible for attorney’s fees in the case.
- Specifically, the Court applied Florida fee shifting statutes, one mandatory and one discretionary, to hold Plaintiff and Sheehan responsible for the legal fees. However, the Court went further and sanctioned Sheehan for bad faith conduct. The Court noted Sheehan’s practice of re-filing failed lawsuits in other jurisdictions after “collect[ing] consumer plaintiffs through social media advertising.” Particularly troublesome to the Court was the contention that Sheehan was not an attorney of record for the Plaintiff even when his name appeared on the pleadings. The Court found that this was part of a broader practice of flagrantly violating court rules and that Sheehan had not been admitted pro hac vice to any of the twelve cases in which he is involved that are currently pending in the same district.
- Briefing in case continues as the Court decides on the final monetary award and whether or not to hold the local Florida counsel jointly responsible.
California School Food Dye Ban Approved by Legislature
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- On August 29, 2024 (Law360 subscription required), the California State Legislature passed Assembly Bill 2316, the California School Food Safety Act, sending it to the governor. If signed, the bill will prohibit school districts, county superintendents of schools, or charter schools with kindergarten through 12th grade from serving Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3, which researchers have linked to serious health issues.
- The California Assembly passed the bill in May 2024, finding that it is intended to protect the health and wellbeing of children. The bill was introduced following a 2021 report from the California Environmental Protective Agency that found that “consuming synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in some children.” According to the report, the FDA’s acceptable daily intakes for the dyes are based on outdated studies that did not detect behavioral effects in children.
- The California Assemblymember who introduced the “first-in-the-nation bill” stated that “California has a responsibility to protect our students from chemicals that harm children and interfere with their ability to learn.” The California State Superintendent of Public Instruction said the bill is “an important step forward to ensure that California’s schools are healthy and equitable learning environments for all.”
- California Governor Gavin Newsom will have until the end of September to sign or veto the bill. If signed, it will go into effect on December 31, 2027.
USDA Releases Updated Guideline Regarding Animal-Raising and Environment-Related Claims on Meat and Poultry
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- On August 28, 2024, the U.S. Department of Agriculture (USDA) announced the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling. According to USDA, the intent is to protect consumers from false and misleading labels.
- Animal-raising claims (e.g., “Raised Without Antibiotics,” “Grass-Fed,” “Free-Range”) and environment-related claims (e.g., “Raised using Regenerative Agriculture Practices,” “Climate-Friendly”) are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices. The documentation submitted by companies to support these claims is reviewed by USDA’s Food Safety and Inspection Service (FSIS) and the claims can only be included on the labels of meat and poultry products sold to consumers after they are approved by the agency.
- In the updated guideline, FSIS strongly encourages the use of third-party certification and more robust documentation to substantiate animal-raising or environment-related claims.
- Additionally, the updated guideline recommends that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing.
- Public comments will be accepted and reviewed for 60 days after publishing in the Federal Register.
- Keller and Heckman will continue to monitor and report on any rulemaking developments.
FDA Issues Warning Letter to Manufacturer of Lead-Contaminated Apple Cinnamon Products
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- On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall last year.
- The letter follows up on inspections that were conducted in December of last year and which “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation” in 21 CFR Part 117.
- The specific violations of these rules that were referenced include:
- The failure to conduct an appropriate hazard analysis to identify and evaluate lead as a known or reasonably foreseeable hazard requiring a preventive control. FDA noted that lead is often found in spices and that children (the intended consumers) are particularly sensitive to it. Although lead was identified as a hazard, the plan concluded that no preventive control was required based on vague and faulty rationales like “supplier without historical precedents [of lead contamination].”Although the plan concluded that no lead control was required, it nevertheless required that cinnamon be purchased from an approved supplier with certificates of analysis (COA). However, the supplier approval plan was not properly implemented and no on-site audits were conducted. FDA recommended that COAs from labs using scientifically valid methods and procedures document that supplied ingredients (e.g., cinnamon) meet food-grade production standards for every major analytical parameter (e.g., heavy metals).
- The plan for heavy metal monitoring in the finished product that was provided to FDA did not include critical information like what constituted a representative sample, what method would be used by the test lab, and how the company would assure that the method was properly followed.
- The warning letter is part of FDA’s continued efforts to reduce the incidence of lead and other heavy metal contamination.
Mondelēz Sued for Deceptive Cocoa Sustainability Labeling
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- Mondelēz International Inc. has been sued (Law360 subscription required) for allegedly using deceptive sustainability claims regarding its cocoa supply chain. According to the plaintiffs, Mondelēz’s supply chain “really contributes to ‘grievous and unsustainable labor abuses.’”
- Mondelēz launched its “Cocoa Life” program in 2012 to “help make cocoa sourcing more sustainable in key cocoa-producing countries.” Mondelēz affixes the Cocoa Life logo on its products to represent that those products “protect the planet” and “respect the human rights of people within our own operations and in our value chain.” However, according to the complaint, farms in Mondelēz’s supply chains are linked to unfair labor practices, hazardous child labor, and deforestation; therefore, the products are not responsibly sourced or sustainable, and the Cocoa Life logo is misleading.
- The product packaging directs consumers to the Cocoa Life website, which explains that the products “help enhance child protection systems” and improve communities and forests. The plaintiffs allege that these misrepresentations are false and deceptive because sustainability and ethical sourcing is important to consumers and “a majority of consumers would stop buying from brands they believe are unethical,” but that Mondelēz hides the unethical practices in its supply chain to sell products at higher prices.
- This is the second suit this year alleging that Mondelēz “greenwashes” its products with deceptive labeling that “hides evidence of environmental degradation, child labor and child slavery in its supply chain.” The first complaint, filed in January 2024, is set for a dismissal hearing in November.
- Keller and Heckman will continue to monitor this and other food labeling litigation.
First EU Application Submitted for Lab-Grown Meat Product as Novel Food
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- French start-up, Gourmey, has submitted the EU’s first application for novel food approval of a cultivated meat product, duck foie gras, which it is offering in both a pâté “semi-cuit” form and as whole pieces ready for frying.
- The European Commission (EC) will review before asking the European Food Safety Authority (EFSA) for a risk assessment, which the agency will start after verifying that the application contains all the required studies to prove that the product is safe for consumers to eat.
- While the application should theoretically take about 18 months to review, it will most likely exceed this timeframe, as it is the first cultivated meat product application.
- An EFSA approval may be controversial. Italy in particular is opposed to cultivated meat and, in December 2023, banned lab-grown food from the Italian market. The ban is arguably in breach of European law, since the Meloni government failed to respect EU standstill procedures, adopting the Italian bill before the end of the mandatory comment period, when a measure should be put on hold to allow other EU member states or EC to raise concerns.
- If the Gourmey foie gras – or any other cultivated meat or fish – is authorized at EU level under the novel foods regulation, the decision will be binding on Italy and the government will have to allow the product on the Italian market.
Second Circuit Affirms Win for Defendants in Challenge to Glucosamine Labeling on Federal Preemption Grounds
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- Last week the United States Court of Appeals for the Second Circuit affirmed a grant of summary judgment for Defendants Walgreen Co. and International Vitamin Corporation (IVC) on preemption grounds in a case involving dietary supplement labeling. IVC manufactured and Walgreens sold a glucosamine dietary supplement product which Plaintiffs argued was misleadingly labeled in light of the product formulation.
- Plaintiff alleged that Defendants should have declared the dietary ingredient as “glucosamine hydrochloride and potassium sulfate” (bold added) and not as “glucosamine hydrochloride potassium sulfate.” This argument hinged on the distinction between glucosamine sold as a single crystal form in contrast to a blended form. The single crystal form consists of a glucosamine-sulfate-potassium-chloride salt, while the blend consists of a mixture of a glucosamine-hydrochloride salt and potassium-sulfate salt. In an aqueous solution (as with the human body), both forms dissociate into the same glucosamine, sulfate, potassium, and chloride constituents.
- Dietary ingredients like glucosamine for which FDA has not established a Reference Daily Value or a Daily Reference Value must be declared by their common or usual name which, the court stated, is to be determined by testing the ingredient with a validated method of identification. In the absence of appropriate AOAC methods, “other reliable and appropriate analytical procedures” may be used, although FDA has indicated that, where available, it expects official compendial methods such as the U.S. and European pharmacopoeias to be used.
- It was uncontested that both forms of glucosamine (single crystal and blend) are consistent with the monographs for “Glucosamine Sulfate Potassium Chloride” in the U.S. and European pharmacopoeias. The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption provision which forbids states from establishing food labeling standards that are “not identical” to certain federal food labeling requirements, including the requirement that ingredients be identified by their common or usual names. Therefore, because the dietary ingredient declaration was consistent with the monographs in the pharmacopoeias, and such pharmacopoeias contained “reliable and appropriate analytical procedures” endorsed by FDA, the Court held that “glucosamine hydrochloride potassium sulfate” was the common or usual name under the federal regulations and that the name was insulated from legal challenge based on the FDCA’s labeling preemption provision.