In a recent request for information, the agency is turning its attention to how define and regulate high-protein yogurt and poppy seeds, reflecting its broader effort to modernize food standards and address consumer preferences, according to the agency.
FDA requests information on high protein yogurt, Greek yogurt or Greek-style yogurt, because these products’ manufacturing processes and ingredients may not align with the existing yogurt standard of identity (SOI), 21 CFR 131.200. Currently, there is no separate SOI for high-protein yogurts that are cultured with Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus.
The agency also requests information on verbiage for high-protein yogurt (e.g. Greek yogurt, Greek-style yogurt), in addition to company practices, trade convention and consumer studies.
Consumer preferences for high protein packaged foods have contributed to the development of high protein yogurts in the market. Brands like Nestle, Danone and Chobani launched products that tout higher protein content and low sugar and fat than conventional yogurts.
One way high-protein yogurts are manufactured is by reducing fat content in milk during processing instead of fortifying it with whey protein concentrate, for example, as previously reported in Dairy Reporter.
FDA cited previous deliberations about additional ingredients or processes impacting yogurt’s SOI.
During a 2019 public meeting on food SOI modernization, International Dairy Foods Association proposed updates to yogurt’s SOI for low-fat or non-fat claims. Instead of requiring specific milkfat levels, the organization suggests using total fat content as the basis for classification where regular yogurt contains 3 grams or more of fat per serving, low-fat yogurt contains less than 3 grams of fat per serving and non-fat yogurt contains less than .5 grams of fat per serving.
In addition to other comments on the FDA 2005 proposed rule, Food Standards; General Principles and Food Standards Modernization, “these comments supported establishing a new SOI for strained, high-protein yogurt. Industry has raised concerns that the existing yogurt SOI does not accommodate certain practices or technologies for manufacturing high-protein yogurt,” according to the agency.
Deadline for comments is April 25. Comments can be submitted electronically on Regulations.gov to docket number FDA-2024-N-5716.
FDA examines poppy seed safety concerns, focusing on potential opiate contamination
Through adverse reports, scientific literature and preliminary surveillance of samples, FDA found that poppy seeds contain opiate alkaloids in “varying amounts,” and that the opiate alkaloids may be present in poppy seeds and foods containing the seeds, such as baked goods, snacks and teas, among others.
FDA’s request for information on poppy seeds centers around the cultivation, harvest and post-harvest processes used for poppy plant crops, including equipment and cleaning practices. The agency also seeks detailed information on “methods to monitor and control opiate alkaloid levels” like testing and treatments, as well as supply chain activities during distribution that could reduce or affect opiate alkaloid levels.
Contaminated poppy seeds, which are not properly processed, may contain opiate alkaloids. Opiate alkaloids, or opiates like morphine and codeine, are pharmaceutical drugs in pain management, and have raised serious public health concern.
According to research, consumption of contaminated poppy seeds have been associated with “opium-like overdose symptoms, such as reduced consciousness and respiratory depression,” and death.
Opiates and poppy seeds come from the poppy plant. The seeds “contain no or negligible levels of opiates” when properly processed, according to the Center for Science in the Public Interest (CSPI).
CSPI calls on FDA to implement safe threshold for opiate contamination in poppy seeds
The non-profit submitted a petition to FDA in 2021 calling on “the agency to establish a safe threshold for opiate contamination in poppy seeds.” The petition gained public and government support from Arkansas, US senators and the House Appropriations Committee, along with over 3,200 comments responding to CSPI’s call to action.
Last year, CSPI sued FDA alleging that the agency’s failure to set a maximum limit for opiate alkaloid contamination in poppy seeds violates the Administrative Procedure Act. The lawsuit prompted the agency to commit to responding to the petition by Feb. 28, 2025.
“Not all manufacturers properly process their seeds, however, and some sellers even market poppy seeds using terms such as ‘unwashed’ to convey that they have high levels of opiates to consumers,” CSPI said.
The organization reported that poison control centers received “hundreds of exposure calls” linked to “unintentionally consuming contaminated poppy seeds” in addition to adverse impacts on employment and parental custody from positive drug test results.
Comments can be submitted via the Federal eRulemaking Portal to Docket No. FDA-2021-P-0168.
