Search results for: antibiotics, milk

  • In recent proposed legislation, Michigan (HB 5603) and West Virginia (HB 4911) have proposed allowing the sale of unpasteurized, raw milk within their respective states.  The Michigan bill is currently stalled in committee, while the West Virginia bill has been approved without the governor’s signature.
  • Currently, federal law prohibits dairies from distributing raw milk across state lines in final package form, and many states have full or partial bans on its sale within their borders.
  • Michigan’s HB 5603 was first introduced on the House floor March 24, 2024.  Under the proposed legislation, unpasteurized, raw milk may be sold to a final consumer or retail establishment in Michigan if the raw milk and raw dairy products comply with specific criteria.  This includes a warning that must be placed on the labels of covered products: “WARNING: unpasteurized milk and dairy products may contain disease-causing microorganisms. Individuals at the highest risk of disease from these microorganisms include newborns and infants; the elderly; pregnant women; individuals taking corticosteroids, antibiotics, or antacids; and individuals with a chronic illness or another condition that weakens immunity.”
  • West Virginia’s HB 4911 legalizes the sale of raw milk as long as the containers are clearly labeled as “unpasteurized raw milk” along with the seller’s name, address, the date of production, and a warning that “Consuming unpasteurized raw milk may increase your risk of foodborne illness, especially for children, elderly, immunocompromised individuals, and persons with certain medical conditions.”  The final version of the law does not include an originally proposed provision that would have made sellers of raw milk immune to lawsuit and liability for claims related to personal injury for actual or alleged act, error or omission that occurred as long as the act was not intentional.  The bill will become law 90 days after the legislature approved it on March 9, 2024.
  • Two lawsuits filed against Sargento Foods in December 2020 (Phan v. Sargento Foods Inc., No. 5:20-cv-09251 (N.D. Ca.)) and January 2021 (Beyond Pesticides v. Sargento Foods, No. 2021-CA-000178 B (Sup. Ct. D.C.)) assert that “no antibiotics” claims on Sargento’s cheese products mislead consumers into thinking that the cows that produced the milk used in the cheeses are never treated with antibiotics.  Sargento’s labels include a disclaimer that “no antibiotics” means that “our cheese is made from milk that does not contain antibiotics.”
  • The claims in the litigation alleging false advertising rely on a 2018 publication from Consumer Reports that says a majority of consumers believe a “no antibiotics” statement on a food label means that animals producing the food never received antibiotics, and as such, a reasonable consumer would be misled by Sargento’s “no antibiotics” claim, despite the disclaimer. The suits also allege that one Sargento cheese product did present detectable levels of sulfamethazine, an antibiotic that is prohibited from use in lactating dairy cattle. Sargento has not yet responded to either lawsuit.
  • Both FDA and USDA are working to address consumer concerns about antibiotic stewardship in food animal production. While antibiotics are sometimes used to treat bacterial infections in dairy cows, the Pasteurized Milk Ordinance developed by the FDA and adopted by most states require dairy farms to discard milk from cows treated with antibiotics for a specified withdrawal period and milk processers to test all milk, including organic milk, for the presence of beta-lactam antibiotics (such as penicillin and amoxicillin, among others) upon arrival at the milk processing facility before being added to a bulk supply. A fact sheet from the National Milk Producers Federation provides more details on antibiotic testing and this page from FDA provide more details on antibiotic testing. The USDA Food Safety and Inspection Service has also provided guidance for food labels that make animal raising claims, including claims about antibiotics.
  • On January 18, USDA published a final rule expanding the criteria of generic label approval for inspected meat, poultry, and egg products. The Expansion of Generic Labeling Rule is largely consistent with the proposed rule published in September 2020, which proposed to discontinue review of generically approved labels and expand the circumstances under which FSIS will generically approve food labels under its jurisdiction. Notably, the final rule does not eliminate the requirement to comply with USDA’s labeling regulations, but instead shifts the burden of compliance for generic labels onto the manufacturer.
  • Under the current regulations, FSIS evaluates sketches of some labels for approval, and approves others generically without submission to FSIS for sketch approval. To obtain sketch label approval, domestic meat and poultry establishments, egg product plants, and certified foreign establishments that are eligible to export product to the United States, or their representatives, are required to submit sketch labels to FSIS for evaluation, except when the label is generically approved by the Agency under 9 CFR 412.2. FSIS allows certain meat, poultry, and egg product labels that bear all required labeling features and that comply with the Agency’s labeling regulations to be generically approved (9 CFR 412.2(a)(1)). Generically approved labels do not need to be submitted to FSIS for sketch approval before they can be used on products in commerce. Generic label approval requires that all mandatory label features are prominent and conform to FSIS regulations. Although such labels are not submitted to FSIS for approval, they are deemed to be approved and, therefore, may be applied to product in accordance with the Agency’s prior label approval system.
  • The final rule will expand generic approval to products only intended for export that deviate from domestic labeling requirements and permit generic approval of the labels of products that receive voluntary FSIS inspection. It will also expand generic approval to:
    • (1) “Organic” claims that appear in a product label’s ingredients statement;
    • (2) Labels of products that receive voluntary FSIS inspection (e.g., exotic species);
    • (3) “Geographic landmarks” displayed on a product label (e.g., a foreign country’s flag, monument, or map); and
    • (4) “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients (e.g., statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”). However, the final rule does not include negative animal raising claims (e.g., “no antibiotics administered”).
  • As of the effective date, FSIS will no longer evaluate labels submitted to FSIS that are eligible for generic approval. FSIS will, however, continue to provide industry with relevant resources, including updated generic labeling guidance, and timely answers to generic labeling questions. FSIS has updated the FSIS Guideline for Label Approval and intends to update and reissue FSIS Directive 7221.1.
  • The final rule will become effective on March 20, 2023. Interested parties may submit comments on the revised FSIS Guideline for Label Approval on or before February 17, 2023 here. Keller and Heckman will continue to monitor and report on the USDA generic label approval rules.
  • As previously covered on this blog, for years, FDA, USDA, the European Food Safety Authority (EFSA) and stakeholder groups have grappled with how to address public health concerns about the use of antibiotics to promote growth or feed efficiency in food-producing animals. At the federal level in the US, FDA has outlined its strategy to phase out the use of medically important antimicrobials in food animals for production purposes in FDA’s Guidance for Industry #213.   Most recently, in a Statement from Commissioner Gottlieb, FDA announced its 2017 report on antimicrobials sold or distributed for use in food-producing animals. Among other findings, the report highlights a 33 percent decline between 2016 and 2017 in domestic sales of antimicrobials intended for use in food-producing animals.
  • In response to the continued issues surrounding antimicrobial resistance, the Pew Charitable Trusts and Farm Foundation, in partnership with organizations, such as McDonald’s Corporation, the National Milk Producers Federation, the National Pork Board, etc., released a new framework for antibiotic stewardship on farms. The voluntary framework defines core components of antibiotic stewardship programs, which are based on veterinary guidance and partnership, disease prevention strategies, and optimal treatment approaches, as well as effective recordkeeping and a culture of continuous improvement. The framework is meant to apply across the animal supply chain. In an article accompanying the framework, Pew noted that the framework is modeled after the Centers for Disease Control’s history of brokering consensus around the core elements of successful antibiotic stewardship programs in healthcare settings.
  • Industry will have to adopt the principles outlined in the framework for the program to be effective. Pew notes that the “actionable framework will enable the full range of stakeholders to adopt and implement best practices as part of existing and future antibiotic stewardship programs.” We will continue to monitor whether this voluntary, industry-driven framework proves effective in reducing the use of antimicrobials in food animals.

FDA survey finds few drug residues in U.S. dairy supply.

  • FDA partners with the states to ensure the safety of the U.S. milk supply, which includes monitoring milk products for drug residues.  Under the Pasteurized Milk Ordinance (PMO) — a model ordinance published by FDA and adopted by individual states — raw milk samples must be collected and tested for the presence of specific antibiotics.  If illegal drug residues are present, the milk may not be sold for human consumption.
  • In 2012, FDA collected milk samples from nearly 2,000 farms with the primary purpose of determining whether dairy farms with previous residue violations have more drug residues in milk than other dairy farms.  FDA has released the results from its milk sampling survey, stating that more than 99% of the samples were free of drug residues.
  • Although FDA’s constituent update affirms the safety of the U.S. milk supply, certain media outlets have focused on the violative findings.  FDA’s news release comes on the heels of other developments indicating growing consumer unease with antibiotics in the food supply, along with the food industry’s continuing efforts to reduce the use and presence of these drugs.