Tag Archives: arsenic

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.

 

Jonathan Sharp, Environmental Litigation Group
In the Food Lab

How Baby Food Companies Can Minimize the Concentration of Heavy Metals in Products

By Jonathan Sharp
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Jonathan Sharp, Environmental Litigation Group

On February 4, 2021, the U.S. House of Representatives made public a report concerning the existence of heavy metals in baby food. The heavy metals of concern were cadmium, arsenic, lead and mercury, which pose a tremendous hazard to developing children’s health. After reviewing internal documents and test results from seven of the largest baby food manufacturers in the country, the Subcommittee on Economic and Consumer Policy found each company’s products to contain dangerously high concentrations of heavy metals.

Four of the companies, Nurture, Beech-Nut, Hain and Gerber, responded to the request. They provided internal testing policies, test results for ingredients and finished products, and documentation about how they handled finished products and ingredients that exceeded their internal testing limits.

On the other hand, Walmart, Campbell and Sprout Organic Foods refused to partake in the investigation. The Subcommittee on Economic and Consumer Policy members are very concerned that the lack of cooperation of these manufacturers could obstruct the presence of even higher levels of heavy metals in their products than their competitors.

Practical Measures Baby Food Companies Can Take to Ensure Products Are Safe for Children

Baby food manufacturers may not intentionally add heavy metals to their products, but their lack of testing and a lack of regulation in this sense is a cause for great concern. The main ingredients in baby foods such as rice, sweet potatoes, wheat, and carrots absorb heavy metals from the soil and water and metal-containing pesticides and industrial pollution.

Therefore, the companies that manufacture baby food should tackle the issue of heavy metals at the root of the problem and abide by strict safety measures and protocols to ensure low concentrations of heavy metals, particularly arsenic. Some of the steps that they could take to minimize this issue are the following:

  • Sourcing cereals, fruits, and vegetables from fields with lower arsenic concentrations in the earth
  • Growing crops with natural soil additives that reduce heavy metal uptake
  • Using strains of food that are less prone to absorb heavy metals
  • Altering irrigation practices
  • Preparing the food with excess water that is afterward poured off
  • Blending it with lower arsenic grains in multi-grain products

Subsequently, when the end product is finished, manufacturers should collect a sample from the finite product and test it for cadmium, arsenic, lead and mercury. Fortunately, nowadays, testing baby food for heavy metals is easier than ever and cost-efficient. Every food facility that must comply with FSMA must implement HACCP and establish preventive controls. HACCP, which is recognized internationally, ensures the health and safety of consumers by avoiding hazardous toxins in food. When it comes to baby food companies, they should focus on chemistry testing, as it addresses chemical and physical hazards, including heavy metals.

Alternatively, baby food companies can test their products by using the guidelines of the Environmental Defense Fund. The non-profit advocacy group advises manufacturers to prohibit arsenic, cadmium explicitly, and lead in any packaging or food handling equipment and strictly avoid brass and bronze unless they are confident that no heavy metal was added. Manufacturers of baby food should test the products per se, the ingredients, and the packaging for arsenic, cadmium, and lead. More specifically, companies should:

  • Consistently test baby food and their main ingredients that may be contaminated with arsenic, cadmium, or lead by using the method approved by the FDA and examine potential sources of heavy metals where measurable concentrations are found
  • Periodically test the packaging that comes in contact with food anywhere along the supply chain for arsenic, cadmium, or lead through a CPSC-accepted, third-party certified lab that evaluates baby food for heavy metals

In December of 2019, the cost of heavy metal testing was between $50 and $100 per sample. Nevertheless, companies that produce baby food should invest in heavy metal testing, no matter how small or large. This is the only way of making sure they put exclusively clean and safe products of high quality on the market.

To make sure baby food companies keep following the guidelines concerning heavy metals and do not fail to test their products for these neurotoxins regularly, the authority of the FDA should be expanded. Accordingly, the agency should be able to request a recall of adulterated or misbranded baby food whose concentration of heavy metals exceeds the safe limit. Moreover, the FDA should establish health-protective standards for each heavy metal and implement a testing program for neurotoxins in foods eaten by infants and toddlers that could be similar to the agenda of the Consumer Product Safety Commission for children’s toys.

The Ethical Measures Baby Food Companies Should Take to Avoid Selling Tainted Products

Baby food companies should exercise their social and moral capacity at all times. Nonetheless, while few people achieve the extent of influence necessary to change society itself, the food industry can drastically change societies. Moreover, it can also act in morally beneficial or detrimental ways, which inevitably affects people, the environment, and, ultimately, the planet itself.

To prevent your baby food company from developing unethical conducts, such as allowing dangerous concentrations of heavy metals in the products that end up on the market, there are a series of measures you and the other people who are in charge of the business can take, the paramount being the following:

  • Hiring accredited, trustworthy and competent people is perhaps the most important, as well as the first, step you can take to ensure no foul play will occur, as they will be unlikely to cover up essential information from you and the other higher-ups
  • Sourcing your ingredients from ethical suppliers, that are, preferably, local farmers, as they usually employ transparent business practices
  • Make sure that your facilities are maintained clean 24/7 by hiring the right people to take care of this not-so-easy job as if you neglect the condition of your facilities. Other contaminants may end up in the food you sell
  • Systematically testing your baby food for cadmium, arsenic, lead and mercury to ensure the products you allow to go on the market do not contain dangerous levels of heavy metals
  • Partnering with experienced laboratories to have your baby food regularly tested for heavy metals, which may help you save money if it is going to be a win-win situation
  • Having clear labels, even if you add ingredients that are not so healthy in your products, which will result in the consumers you target trusting you as a company
  • Voluntarily recalling a line of baby food products as soon as you receive the positive test results for one or multiple heavy metals, which will spare you some liability if you willingly take your food off the market

The Changes the Baby Food Safety Act May Bring About if the Bill Becomes Effective

On March 26, 2021, Representative Raja Krishnamoorthi introduced the Baby Food Safety Act, a bill to set maximum limits for each heavy metal in infant and toddler food, which is defined as food manufactured for children younger than 36 months. The initiative was taken because the concentration of neurotoxins in baby food is poorly regulated in our country. There is only a maximum limit for arsenic set by the FDA, which is considered dangerous by multiple other health agencies. It applies solely to infant rice cereals. The other three harmful heavy metals are not regulated at all.

If the Baby Food Act of 2021 becomes effective, companies that manufacture, process, pack or hold baby food need to ensure that their food complies with the limits on heavy metals set by the bill. Furthermore, baby food companies would also have to provide public information, such as test results for neurotoxins in their infant and toddler.

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.

FDA

FDA Responds to Subcommittee Report on Toxic Metals in Baby Food

By Food Safety Tech Staff
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FDA

Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.

“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”

FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).

The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.

U.S. House of Representatives Seap

House Subcommittee Releases Report on Dangerous Levels of Toxic Heavy Metals in Baby Food

By Food Safety Tech Staff
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U.S. House of Representatives Seap

Last week a report released by Congress cited dangerous levels of toxic heavy metals in several brands of baby food. Back in November 2019, the Subcommittee on Economic and Consumer Policy asked for internal documents and test results from baby food manufacturers Nurture, Inc. (Happy Family Organics), Beech-Nut Nutrition Company, Hain Celestial Group, Inc., Gerber, Campbell Soup Company, Walmart, Inc., and Sprout Foods. According to the staff report, Nurture, Beech-Nut, Hain and Gerber responded to the requests, while Walmart, Campbell and Sprout Organic Foods did not.

The findings indicate that significant levels of arsenic, lead, cadmium and mercury were found in the baby foods of the four manufacturers who responded to the Subcommittee’s requests (Nurture, Beech-Nut, Hain and Gerber). It also stated the alarming point that, “Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”

The Subcommittee voiced “grave concerns” that the baby food made by Walmart, Sprout Organic Foods and Campbell was “obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products” due to their lack of cooperation.

In addition, the report states that the Trump administration “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods” in August 2019.

“To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report stated (infant rice cereal is the only baby food held to a stringent standard regarding the presence of inorganic arsenic).

As a result of the findings, the Subcommittee has made several recommendations:

  • FDA should require baby food manufacturers to test their finished products for toxic heavy metals.
  • FDA should require manufacturers to report toxic heavy metals on food labels.
  • Manufacturers should find substitutes for ingredients that are high in toxic heavy metals or phase out the ingredients that are high in toxic heavy metals.
  • FDA should set maximum levels of toxic heavy metals allowed in baby foods.
  • Parents should avoid baby foods that contain ingredients that test high in toxic heavy metals.

The 59-page report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, is available on the U.S. House of Representatives’ website.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Many Bad Apples Spoil the Bunch

By Susanne Kuehne
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Susanne Kuehne, Decernis
Rotten apples
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Food fraud can have a substantial impact on a consumer’s health, like in this case of fruit juice that was sold (including to school lunch programs) in spite of contamination with arsenic and mycotoxins. The fruit used for the juice was decomposing, and also processed in a facility that unacceptably violated hygiene and food safety standards. The FDA filed a lawsuit against the company, which in the meantime has ceased operations.

Resource

  1. Vigdor, N. (November 10, 2020) “School Lunch Program Supplier Sold Juice With High Arsenic Levels, U.S. Says in Lawsuit”. The New York Times.