Food and Beverage News and Trends - October 20, 2023
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
FDA updates infant formula compliance program. On October 6, the FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the US food supply are safe and nutritious. This effort, the agency said, is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry. In 2022, an internal FDA evaluation recommended that the agency review and update its infant formula compliance program to ensure that it reflects the latest science on the bacterium Cronobacter and that it offers consistency and clarity regarding its inspection and compliance activities.
Canada: Interim policy on Nutrition Facts table for prepackaged human milk. Prepackaged human milk is a product made from human milk pooled from several donors. It is typically used in a clinical setting for pre-term infants who are otherwise unable to obtain sufficient breast milk. In Canada, it is subject to certain federal requirements, one of which is a Nutrition Facts table (NFt) on its packaging. However, because the product is made by pooling, there is significant variability in its composition, making it difficult to provide an accurate NFt. Health Canada has published an interim policy statement allowing prepackaged human milk and its prepackaged components to remain available without an NFt, until further regulatory changes are implemented. The policy statement does not apply to human milk substitutes or fortifiers intended for infants (up to one year of age) for which pre-market notification is required or for foods containing human milk or its components as an ingredient.
Vilsack on the next Farm Bill. The next Farm Bill should not just react to past concerns but should aim to help American agriculture succeed far into the future, Agricultural Secretary Tom Vilsack said at the International Dairy Federation’s World Dairy Summit on October 17. A lot of the conversation about the next Farm Bill, he stated, looks back and says “we have to fix what didn’t work,” such as disaster programs, whereas Congress should be working to make American agriculture stronger to face what is coming next. Vilsack’s comments, part of a summit discussion on the future of agriculture, specifically referred to the Partnerships for Climate Smart Commodities, a Biden Administration program developed to address the impact of climate change on agriculture and the supply chain. That program includes an evaluation of farm practices that may encourage carbon sequestration and seeks to help farmers improve their incomes by selling “climate-smart” commodities and marketing their carbon savings to industries that are seeking offsets. Vilsack told his audience – hundreds of dairy industry officials and dairy farmers from around the world – that he believes agriculture has the capability to be the world leader on climate change, ahead of sectors like energy and transportation.
CFIA updates guidelines for simulated meat and poultry products. Canada’s Food and Drug Regulations define simulated meat and poultry products as “foods that do not contain meat, poultry, or fish products, and that have the appearance of meat products or poultry products.” On October 5, the Canadian Food Inspection Agency announced it has updated the labeling guidance for such products to provide clarification, promote market consistency, and prevent mislabelling. The Food and Drug Regulations themselves have not been amended.
Over $3M awarded to two cell-based meat projects in Canada. The Canadian Food Innovation Network is awarding $3,159,379 to two foodtech projects: “Scaling Cultivated Pork Production Using Embryonic Stem Cells” and “Automation and Digital Twin Integration for Precision Fermentation Scale Up of Cell-Based Food Ingredients.” Both projects aim to improve resiliency within Canada’s food sector through cellular food innovation. The pork production project addresses production challenges by harnessing pig embryonic stem cells. The precision fermentation project will focus on producing essential food molecules such as flavors, binders, pigments, proteins, oils, and polymers from natural sources.
FDA is urged to take action to deliver consistent messages on health and debunk myths. On October 5, the Reagan-Udall Foundation for the FDA issued a report entitled “Strategies for Improving Public Understanding of FDA-Regulated Products” focusing on the need for the FDA and its employees to deliver “clear, consistent, and timely messages with a focus on pre-bunking potential misinformation.” The report finds that the current digital health information environment and reduced public trust in government institutions such as the FDA, “represent pressing challenges for the FDA.” It notes that “while the spread of inaccurate health information is a long-standing challenge, the ways and speed with which it spreads have changed as the news ecosystem becomes increasingly digital, fragmented, and fast moving.” The nonprofit Reagan-Udall Foundation was created by Congress to work closely with the FDA in advancing its mission.
Health Canada approves limited use of two types of pectinase. Pectinesterase and polygalacturonase, both which are food additives, have passed premarket safety assessments by Health Canada’s Food Directorate. Both these types of pectinase are enzymes produced by strains of Aspergillus oryzae, a microbe commonly used in the production of fermented food products. Pectinesterase and polygalacturonase have received approval for use in the production of fruit and vegetable products and wine.
New California law will ban four food additives. California has become the first state to ban four food additives commonly used in consumer goods, including popular candy brands. The California Food Safety Act, signed into law by Governor Gavin Newsom on October 7, prohibits the use of brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No 3 in foods and beverages sold and produced in the state. The food industry will have until 2027 to comply. These additives are not prohibited in food by the FDA, and the industry strongly opposed the bill. Sarah Gallo, vice president of product policy at the Consumer Brands Association, said that the ban “sets a dangerous precedent for circumventing our country’s science and risk-based reviews that prioritize consumer health and safety.” But the Center for Science in the Public Interest expressed support. “Most people would be quite surprised to learn that a known carcinogen is banned for use in lipstick but still widely used in thousands of foods, including many candies, baked goods, and drinks marketed to children,” said CSPI president Peter Lurie.
Do members of key federal nutrition panel have conflicts of interest? An October 4 report by US Right to Know (USRTK) says that nine out of 20 members of the federal Dietary Guidelines Advisory Committee (DGAC) have conflicts of interest involving food, pharmaceutical, or weight loss companies or industry groups with a stake in the outcome of the guidelines and that an additional four members have possible conflicts of interest. The DGAC is a panel of food and nutrition experts who make recommendations for updating the US government’s official dietary advice. USRTK compiled publicly available data from the last five years about each of the DGAC members’ ties with industry. The report concluded that “with high-risk conflicts of interest still present on the DGAC, the public cannot have confidence that the official dietary advice from the U.S. government is free from industry influence.” The New York Times quoted Gary Ruskin, executive director of the nonprofit, as saying that this finding “erodes confidence in the dietary guidelines,” which provide recommendations on how people can eat a healthier diet.
CRISPR chicken? A study published in the scientific journal Nature Communications on October 10 reports that scientists have used CRISPR gene editing to create chickens with some resistance to avian influenza. This development is urgent because of the unchecked global spread of the H5N1 bird flu virus, which has ravaged both wild bird populations and domestic flocks: in the US alone, from 2022 to early 2023, nearly 60 million domestic birds had to be culled. In the study, scientists initially tweaked the gene that codes for the ANP32A protein, which H5N1 hijacks to replicate itself, to create moderately resistant birds. The gene-edited chickens also seem to be otherwise healthy and lay eggs normally. The scientists are now working to create chickens with edits to three genes, to provide optimal protection. At this point, notably, the findings are primarily being seen as a proof of concept – the researchers themselves understand that manipulating the genome to increase flu resistance is only part of the work. Alewo Idoko-Akoh, the first author of the paper and a research associate at the University of Bristol, said, “It’s not just enough to develop the technology. It’s got to be done in such a way that it’s culturally sensitive and also acceptable.”
Court declines to dismiss deception case against Nordic Naturals. On September 28, a federal District Court for the Eastern District of New York denied Nordic Naturals’ motion to dismiss a putative class action alleging that the company deceived consumers because its brand name, which includes the word “Naturals,” suggests there are no synthetic ingredients in its supplements. The court stated that it could not conclude as a matter of law at this stage that reasonable consumers would not be misled by the use of the term “Naturals.” A reading of the label of a typical product label, the court also said, would not clarify matters for consumers, who could well be unaware that some listed ingredients sound like natural products but “are actually synthetic. Therefore, even if a consumer were to turn to the back label and see these ingredients, they may be no less in the dark as to whether the composition of defendant's product is entirely 'natural.'" The plaintiffs, the court said, had adequately pleaded that the defendant’s acts were “misleading in a material way.” The case will proceed.
Two specialists call for major changes in the nation’s dietary guidelines. An op-ed in the October 4 issue of The Hill by Mark Cucuzzella and Jeff Volek, both physicians and nutrition specialists, says the nation is facing a hidden national security threat because so many Americans are unhealthy and obese – so much so that many young Americans cannot qualify for military service. They also fault the federal Dietary Guidelines for Americans, charging they are outdated. “Our nation is facing an impending crisis and the federal government has the power to change this trajectory. Given the rising rates of obesity in society and the military, there is an urgent need to explore alternative scientifically credible nutrition approaches,” they write. “It is time for the federal government to acknowledge that most Americans are not healthy and update the Dietary Guidelines for Americans to reflect the current scientific literature that points to lower carbohydrates as an effective option for individuals with diet-related diseases, including obesity.”
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