Tag Archives: Closer to Zero

Ground cinnamon

FDA Highlights Steps Taken to Ensure Safety of Cinnamon Products

By Food Safety Tech Staff
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Ground cinnamon

The FDA has announced several additional steps it is taking to address concerns about elevated lead levels. Last week, the agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The agency is also recommending the voluntary recall of certain ground cinnamon products (see below) sold by a number of brands at six different retail chains that were found to contain elevated levels of lead.

The FDA is advising consumers to throw away and not to buy the ground cinnamon products with the lot codes listed below because samples of these products were found to contain elevated levels of lead as it is works with the firms listed to voluntarily recall the products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share its findings and request that the company initiate a recall.

Ground Cinnamon Distributor Ground Cinnamon Retailer(s) Ground Cinnamon Lot Code(s)
La Fiesta Food Products
La Miranda, CA		 La Superior SuperMercados 25033
Marcum, Moran Foods, LLC
Saint Ann, MO		 Save A Lot Best By: 10/16/25 10 DB; 04/06/25 0400B1
MTCI
Santa Fe Springs, CA		 SF Supermarket No codes
SWAD, Raja Foods LLC
Skokie, IL		 Patel Brothers KX21223
Best Before: July 2026
Supreme Tradition, Greenbriar International, Inc.
Chesapeake, VA		 Dollar Tree
Family Dollar		 Best By: 09/29/25 09E8; 04/17/25 04E11; 12/19/25 12C2; 04/12/25 04ECB12; 08/24/25 08A_ _; 04/21/25 04E5; and 2025-09-22 09E20
El Chilar
Apopka, FL		 La Joya Morelense, Baltimore, MD F275EX1026; D300EX1024

 

The FDA emphasized that the lead levels found in the ground cinnamon products listed above are significantly lower than lead levels in cinnamon in the recalled apple sauce pouches removed from the market this past fall. The products currently recommended for recall contain lead levels ranging from 2.03 to 3.4 parts per million (ppm) lead. This is approximately 2,000 ppm to nearly 5,000 ppm lower than the levels of lead associated with the cinnamon in recalled apple puree and apple sauce products. Therefore, these ground cinnamon products do not pose the same level of risk to human health as the apple sauce pouches but could be unsafe for prolonged use.

“Today’s actions serve as a signal to industry that more needs to be done to prevent elevated levels of contaminants from entering our food supply,” said Deputy Commissioner for Human Foods Jim Jones. “Food growers, manufacturers, importers, and retailers share a responsibility for ensuring the safety of the foods that reach store shelves. The levels of lead we found in some ground cinnamon products are too high and we must do better to protect those most vulnerable to the negative health outcomes of exposure to elevated levels of lead.”

The FDA reminds manufacturers, processors, distributors, and facility operators to follow the requirements of the rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, including the requirement to consider chemical hazards that may be present in foods when conducting hazard analyses required by this rule. While the agency continues to emphasize the importance of the cinnamon industry’s responsibility to take measures to prevent potential chemical hazards in its products, the letter to industry and recent recalls highlight how the FDA will request the removal of unsafe cinnamon products from the market.

As part of its Closer to Zero initiative, the FDA continues to pursue additional authorities from Congress to require manufacturers to test ingredients or final products marketed for consumption by infants and young children for contaminants before products enter the U.S. market. Under current federal law, there is no explicit requirement for manufacturers to conduct such testing. The President’s FY2024 Budget contains legislative proposals to explicitly require industry to conduct this testing, maintain testing results for FDA inspection and provide the FDA remote access to test results.

 

Apple Juice

FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice

By Food Safety Tech Staff
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Apple Juice

The FDA has issued a final guidance “Action Level for Inorganic Arsenic in Apple Juice,” which identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. The guidance supports the FDA’s goal to reduce exposure to environmental contaminants from foods commonly consumed by babies and young children.

The FDA noted that its testing results reflect a trend in reductions in the amount of inorganic arsenic in apple juice on the market, with an increasing percentage of samples testing below 3 ppb and 5 ppb. However, since the release of the draft guidance in 2013, the agency has identified some apple juice samples with inorganic arsenic levels above 10 ppb—the level the agency considers achievable with the use of good manufacturing practices.

Though non-binding, the FDA expects that the 10 ppb action level will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency said that it will continue its current practice of monitoring arsenic in apple juice samples and if testing identifies inorganic arsenic in apple juice above 10 ppb, the FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action.

 

Jennifer Allen
Food Safety Attorney

Protecting the Nation’s Tiniest Consumers

By Jennifer Allen
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Jennifer Allen

Does your company need to worry about regulations relating to foods designed for infants (considered to be anyone aged 0-12 months)? If you manufacture infant formula, then of course the answer is yes. But what if you manufacture baby food—those cute little jars of liquified goodness? Traditionally, those types of food haven’t been subject to any special FDA regulations. Manufacturers simply need to follow the regulations that govern all foods designed for consumption by humans of any age. That, however, is changing.

There is a growing push to limit, and ultimately eliminate, heavy metals, such as inorganic arsenic, lead, cadmium, and mercury, present in baby food. These elements are present in our food chain in amounts that are concerning to members of the U.S. Congress and other stakeholders because of modern manufacturing techniques, and they have an outsized effect on infant health.

Pending Legislation

On March 25, 2021, the Baby Food Safety Act was introduced in Congress. As of the time this article was written, it had not yet passed. If it passes, it will require manufacturers, within one year of its enactment, to reduce levels of inorganic arsenic in non-cereal foods to 10 ppb and in cereals to 15 ppb, levels of cadmium and lead to 5 ppb in non-cereals and 10 ppb in cereals, and levels of mercury to 2 ppb in non-cereals and cereals. Within three years of enactment, the Act requires that final regulatory levels be set that reduce these levels to an even lower amount. It also requires reevaluation of the current regulatory levels every five years thereafter.

But the Act would do much more than simply setting limits for heavy metals in baby food. It would also:

  • Add regulations to the Food Drug and Cosmetics Act requiring FDA to specifically regulate foods for consumers up to 36 months old
  • Require manufacturers to report levels of heavy metals biannually on their websites
  • Give FDA mandatory recall authority
  • Mandate creation of public awareness campaigns
  • Offer grants for farming research

Current FDA Actions

The FDA is already working to reduce heavy metals in baby foods. In August 2020, the FDA finalized guidance setting the limit for inorganic arsenic in baby rice cereals to 100 micrograms per kilogram. Fortunately, most manufacturers had already achieved those limits; sampling from 2018 showed that 76% of manufacturers were in compliance, up from 47% in 2014 and from just 36% between 2011 and 2013.

In early 2021, FDA launched an action plan to address heavy metals in foods consumed by infants and young children, called Closer to Zero. The overarching purpose of the plan is to gather data about heavy metal levels and then set tolerances for those substances, with the input from all stakeholders. Thus, the FDA has signaled its intent to act regardless of what Congress has in store.

More recently, the FDA issued draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children,” recommending that levels of lead be limited to 10 ppb in fruits, some vegetables, and yogurt, and to 20 ppb in root vegetables and dry cereal. The guidance is focused on processed foods, including foods served in jars, pouches, tubs, and boxes intended for children under two.

Whatever the ultimate outcome of these initial steps taken by Congress and FDA, one thing is clear: Concerns about heavy metals in the foods consumed by our tiniest citizens isn’t going away. So, if the product you manufacture or grow may be destined for a jar of baby food—even if you don’t think you manufacture baby food—it’s time to begin working to address the issue in your facilities and your fields.

Boy Drinking Juice

FDA to Hold March 2 Webinar on Action Levels for Lead in Infant Food

By Food Safety Tech Staff
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Boy Drinking Juice

On Thursday, March 2, 2023, at 1:00 pm (ET) the FDA is holding a webinar to discuss the recent draft guidance on lead action levels for foods intended for children less than two years of age. The draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry,” was issued in January. It covers the proposed action levels for lead in a wide range of commercial foods targeted to this population. These levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance the agency’s Closer to Zero action plan goals.

During the webinar the FDA will provide an overview of the draft guidance and answer stakeholder questions. Featured speakers include Dr. Susan Mayne, Director, Center for Food Safety & Applied Nutrition (CFSAN), Dr. Conrad Choiniere, Director, Office of Analytics and Outreach, CFSAN, and Dr. Paul South, Director, Division of Plant Products and Beverages, Office of Food Safety, CFSAN.

Stakeholders can register for the webinar and submit questions or brief comments related to this draft guidance on the registration page. Questions or comments must be submitted by Thursday, February 9, 2023.

The webinar will be recorded and posted to the FDA website.

 

FDA

FDA Seeks $57 Million in Investments in Food Safety Modernization and Funding to Reduce Chemicals in Food

By Food Safety Tech Staff
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FDA

Today the FDA announced its budget request as part of the President’s 2023 fiscal year budget. Within the food sector, the agency is asking for $43 million for food safety modernization (including animal food safety) oversight—which includes efforts in continued implementation of the New Era of Smarter Food Safety initiative. The funding will also go towards improving preventative food safety practices, data sharing, predictive analytics and traceability, which will help the agency respond to outbreaks and recalls faster. “In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented,” the FDA stated in an email release.

The FDA also requested $14 million in funding to reduce exposure to harmful chemicals and toxins in food. Last year the agency came under fire following a report released by Congress that stated there was an alarming amount of toxic heavy metals found in baby food. In response, the FDA devised a “Closer to Zero” action plan with a goal of reducing the presence of dangerous metals in foods commonly consumed by babies and young children. “Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation,” the FDA stated.

Under the FDA’s funding requests that serve its core operations, the agency asked for $68 million for data modernization and enhanced technologies, which includes improving infrastructure aligned to the food programs; and $24 million to optimize inspections, including increasing support for recruiting and training new FDA investigators.

The FY budget covers October 1, 2022 through September 30, 2023.

FDA

Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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FDA

At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:

FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.

Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.

FDA

FDA’s ‘Closer to Zero’ Action Plan to Reduce Exposure to Toxic Elements in Baby Food

By Food Safety Tech Staff
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FDA

Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:

  • Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
  • Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
  • Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.

“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.