Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Food Policy,Our Blog on January 23, 2025
The U.S. Food and Drug Administration (FDA) recently issued a request for information from two industries.
Manufacturers of high-protein yogurt and those in the poppy seed industry (from agricultural to processors and distributors).
What does that mean? And what are they asking for?
Let’s first dive into what a request for information actually means, and what they want from each industry.
The FDA often announces a request for information to industries where changes could be made in the near future. To better understand processes or technical details, the organization goes to the source.
If they contacted each business directly, where thousands of individual manufacturers may exist, it would be a cumbersome process.
Instead, the agency (among other agencies) uses the Federal Register to get the job done.
The Federal Register serves as a sort of “national newspaper” to document and archive announcements as a public record.
What better place to put a topic you want to learn more about.
In this case, a request for information about certain topics. In this case, one for high-protein yogurt and another for the poppy seed industry.
Each request for information has key aspects listed that they want to know more about. Hopefully, this information will be used to better understand the industry and where processes can be improved and what safety regulations are needed.
On January 14, 2025, the FDA issued a request for information on “manufacturing processes and ingredients used to make certain dairy products.”
These include high-protein yogurts, Greek yogurt, or Greek-style yogurt – collectively referred to as “high-protein yogurt.” Manufacturers who use, at a minimum, Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus.
Per the announcement, “the FDA is taking this action, in part, because the existing yogurt standard of identity (SOI) may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture high-protein yogurt.”
There is not a separate SOI for high-protein yogurt. Currently, all yogurt is lumped into the same category.
This request is to determine if there are key differences where inspection observation, hazard analysis identifying critical control points, or manufacturing differences between high-protein yogurt and other yogurt manufacturing processes.
During previous comment sessions, the industry raised concerns that the existing yogurt SOI does not fully apply to or encompass those technologies and practices used to make high-protein yogurt.
The FDA listened and gave them a place to voice their comments.
According to the announcement, “The FDA is also seeking information regarding the usage of various names for high-protein yogurt (e.g., Greek yogurt, Greek-style yogurt), including specific company practices, trade convention, and consumer studies.
So far there has only been one publicly available comment.
That submitter writes, “These yogurts should be called “strained,” “drained” or “concentrated” yogurts. They are not true yogurt; water has been removed, which is the only reason they have “more” protein. Not explaining this is simply misleading consumers.”
As the deadline approaches, more comments should be available to review.
The agency has granted a 90 day submission window that will end by April 15, 2025.
Those wishing to comment must include the docket number FDA-2024-N-5716 on their written submission mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
Electronic submissions may be made at Regulations.gov online.
On January 14, 2025, the FDA announced a request for information on “industry practices relating to poppy seeds.” According to the announcement, this request for information is to better understand all aspects of the industry to determine “whether certain practices increase or reduce the presence of opiate alkaloids on poppy seeds.”
Aspects of the agricultural, industry, manufacturing, and supply chain practices that might contribute to the presence of opiate alkaloids are requested.
This request for information is to help the agency better understand how the product is made and how it may contribute to adverse reactions.
“The agency has received reports of adverse events related to the use of some poppy seed products.” These adverse events are often caused by varying amounts of opiate alkaloids present on the poppy seeds or in poppy seed-containing foods.
Adverse effects include, but are not limited to unusual dizziness or lightheadedness, respiratory arrest, and in some cases, even death.
The FDA wants specific information on the “growing, harvesting, and post-harvest processes used for poppy plant crops, including types of equipment used and cleaning practices.” They also want to know what methods are used to monitor and control those opiate alkaloid levels. Is any particular treatment applied or testing performed? Are aspects of the distribution processes contributing to opiate alkaloid content.
What are the trending comments?
Many of the publicly available comments appear to be a form letter. A letter stating that “As a consumer, I am concerned that the U.S. Food and Drug Administration (FDA) is allowing poppy seeds contaminated with opiates to be sold in the United States. These contaminated poppy seeds can cause serious harms, including false positive drug tests, overdoses, and deaths.” These commenters are not providing the requested information, but indicating their wish for stricter requirements for the product.
Others are indicating that they do not support this petition citing lack of evidence that there is a health risk associated with unwashed poppy seeds.
As I sift through the comments, few actually provide the information requested.
The agency has granted a 90 day submission window that will end by April 15, 2025.
Those wishing to comment must include the docket number FDA-2021-P-0168 on their written submission mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
Electronic submissions may be made at Regulations.gov online.
If you’d like to know more about food safety topics in the news, like “FDA Request for Information Announced From High-Protein Yogurt and Poppy Seed Industries,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!
By: Heather Van Tassell (contributing writer, non-lawyer)