FDA seeking comments on high-protein yogurt and poppy seeds

The U.S. Food and Drug Administration is seeking public and industry comments on poppy seeds and high-protein yogurt.

Poppy seeds
The RFI for poppy seeds seeks to provide the FDA with a better understanding of whether certain practices increase or reduce the presence of opiate alkaloids on poppy seeds. The agency intends to use information to help determine action that may be necessary to ensure that poppy seed products do not pose a health risk when consumed. The action has been prompted by reports of adverse events, including hospitalizations and deaths, related to the use of some poppy seed products.

According to the FDA, scientific literature and the FDA’s preliminary surveillance sampling show that poppy seeds have varying amounts of opiate alkaloids, and that opiate alkaloids may be present on poppy seeds or in poppy seed-containing foods. 

Unwashed poppy seeds have been documented to have high counts of opiate alkaloids. Use of such seeds, including brewing them for tea, increases the strength and therefore the danger of severe opiate reactions. 

The agency is seeking detailed information on the growing, harvesting, and post-harvest processes used for poppy plant crops, including types of equipment used and cleaning practices. The agency has also requested information on methods to monitor and control opiate alkaloid levels, such as testing and treatments, and details about the supply chain, including activities conducted during distribution that could reduce or otherwise affect opiate alkaloid content.

The FDA’s Request for Information on poppy seeds came one day after the agency rejected a petition from the Center for Science in the Public Interest that asked the agency to set maximum limits on opiate contamination in poppy seeds. The agency pointed to lack of information and resources.

The CSPI submitted the petition in 2021 on behalf of a group of consumers injured by contaminated seeds. While not lethal in the amounts typically consumed, when large amounts of seeds are steeped in hot water as a tea, sometimes with added acidic agents like lemon juice, the concentrated opiates can reach levels high enough to trigger dependence, overdose, and death, according to the CSPI. The CSPI has documented at least 19 fatalities and 20 non-fatal overdoses from poppy tea in a peer-reviewed medical journal article.  

In May 2024, the CSPI filed suit against FDA, alleging that the agency had unreasonably delayed responding to its petition. The suit succeeded in getting the agency to commit to respond to the petition by Feb. 28, 2025. That response was the letter issued Jan. 15.

High-protein yogurt
Information in relation to the Request for Information for high-protein yogurt (also referred to “Greek yogurt” or “Greek-style yogurt”) will be used by the FDA to better understand current manufacturing practices and ingredients used to make high-protein yogurt. 

Current standard of identity (SOI) practices may not align with the manufacturing products and ingredients used to concentrate protein in these products, according to the FDA. High-protein yogurts are cultured with, at minimum, Lactobacillus delbrueckii, subspecies bulgaricus and Streptococcus thermophilus.

A separate SOI for high-protein yogurt does not currently exist.

Stakeholder comments received in response to past proposed rules support establishing a new standard or identity for strained, high-protein yogurt. Industry has raised concerns that the existing yogurt standard of identity does not accommodate certain practices or technologies for manufacturing high-protein yogurt.

The Requests for Information are open for comment until April 15.

Submit electronic comments in the following way:
Federal eRulemaking Portal:https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. 

Because comments will be made public, those submitting them are solely responsible for ensuring that the comments do not include any confidential information, such as medical information, Social Security numbers, or confidential business information, such as a manufacturing processes. Please note that if comments include names, contact information, or other information that identifies the person or entity submitting the comments, that information will be posted on https://www.regulations.gov.

(To sign up for a free subscription to Food Safety News,click here)

Source: https://www.foodsafetynews.com/2025/01/fda-seeking-comments-on-high-protein-yogurt-and-poppy-seeds/