Tag Archives: lead

FDA

FDA to Limit Lead in Juice

By Food Safety Tech Staff
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FDA

FDA is continuing its efforts to reduce negative health effects as a result of dietary exposure to lead. The agency recently issued draft action levels for lead in single-strength, ready-to-drink apple juice, and other juices and juice blends.

“Exposure of our most vulnerable populations, especially children, to elevated levels of toxic elements from foods is unacceptable,” said FDA Commissioner Robert M. Califf, M.D. in an agency release. “This action to limit lead in juice represents an important step forward in advancing FDA’s Closer to Zero action plan, which we are confident will have a lasting public health impact on current and future generations.”

The draft guidance outlines recommended limits of lead in juice that can be achieved by industry and progressively lowered as appropriate. The draft action levels are part of the agency’s Closer to Zero action plan announced last year. [https://foodsafetytech.com/news_article/fdas-closer-to-zero-action-plan-to-reduce-exposure-to-toxic-elements-in-baby-food/]

“As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study, Toxic Elements in Food and Foodware program and sampling assignments,” said CFSAN Director Susan Mayne, Ph.D., in an agency release. “In addition, our work in this important area of food safety will progress with advancements in science. For example, action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium and mercury in foods eaten by babies and young children.”

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.

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Top 10 Food Safety Articles of 2019

By Food Safety Tech Staff
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#10

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

#9

Lead in Spices

#8

Three Practices for Supply Chain Management in the Food Industry

#7

Changes in the Food Safety Industry: Face Them or Ignore Them?

#6

How Technology is Elevating Food Safety Practices & Protocols

#5

Five Tips to Add Food Fraud Prevention To Your Food Defense Program

#4

2019 Food Safety and Transparency Trends

#3

Sustainability Strategies for the Food Industry

#2

Is Food-Grade always Food-Safe?

#1

E. Coli Update: FDA Advises Consumers to Avoid All Romaine Lettuce Harvested in Salinas, California

Karen Everstine, Decernis
Food Fraud Quick Bites

Lead in Spices

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Food fraud usually does not make people sick, but we know that it can. Fraud in spices, and particularly lead adulteration of spices, appears to be getting more attention lately. Herbs/spices is one of the top five commodity groups prone to fraud, according to the data in our Food Fraud Database. Looking at the past 10 years of data for herbs/spices, chili powder, turmeric, and saffron have the highest number of fraud records and chili powder, turmeric, and paprika have the highest number of distinct adulterants associated with them (see Figure 1).*

Adulterants, herbs and spices
Comparison of herb/spice ingredients by the number of distinct adulterants and number of records (2010-2019). Source: Decernis Food Fraud Database

Fraud in spices usually involves “bulking up” the spice with plant materials or other substances or the addition of unapproved coloring agents. A wide range of pigments have been detected in spices, from food-grade colors to industrial pigments, including lead-based pigments. Lead oxide was added to paprika in Hungary in the mid-1990s to improve the color, causing lead poisoning in many consumers. Lead chromate is another lead-based pigment that has been used to add color to spices. In 2017, ground cumin was recalled in the United States due to “lead contamination,” which was determined by the New York State Department of Agriculture and Markets to be lead chromate.

However, there is also an issue with lead contamination of agricultural products due to environmental contamination and uptake from the soil. Therefore, when recalls are posted for spices due to “elevated lead levels,” it may not immediately be apparent if the lead was due to environmental factors or intentionally added for color.

Laboratory methods for detecting the form of lead present in food are challenging. Typical tests look to detect lead, but do not necessarily identify the form in which it occurs. Testing for lead chromate, specifically, may be inferred through a test for both lead and chromium, and recent studies have looked at the development of more specific methods. There is not currently an FDA-established guideline for lead levels in spices although, the maximum allowable level for lead in candy is 0.1 ppm (0.00001%). New York State recalls spices with lead over 1 ppm and a Class 1 recall is conducted with lead over 25 ppm.

Two recent public health studies have evaluated lead poisoning cases and have linked some of those cases to consumption of contaminated spices. One study, published earlier this year, analyzed spice samples taken during lead poisoning investigations in New York over a 10-year period. The investigators tested nearly 1,500 samples of spices (purchased both domestically and abroad) and found that 31% of them had lead levels higher than 2 ppm. This study found maximum lead levels in curry of 21,000 ppm, in turmeric of 2,700 ppm, and in cumin of 1,200 ppm.

Another study conducted in North Carolina looked at environmental investigations in homes and testing of various products related to 61 cases of elevated lead levels in children over an eight-year period. The investigators found lead above 1 ppm in a wide variety of spices and condiments, with some levels as high as 170 ppm (in cinnamon) and 740 ppm (in turmeric).

A separate study, conducted in Boston, involved the purchase and analysis of 32 turmeric samples. The researchers detected lead in all of the samples (with a range of 0.03-99.50 ppm), with 16 of the samples exceeding 0.1 ppm (the FDA limit for lead in candy). The paper concluded that turmeric was being “intentionally adulterated with lead” and recommended additional measures on the part of FDA to reduce the risk of lead-contaminated spices entering the U.S. market and the establishment of a maximum allowable level of lead in spices.

Although the above studies did not report the form of lead detected, the high level of lead in many of the samples is not consistent with environmental contamination. A newspaper report in Bangladesh indicated that turmeric traders used lead chromate to improve the appearance of raw turmeric and quoted one spice company as saying that some of their suppliers admitted to using lead chromate. Lead consumption can be extremely toxic, especially to children. There is evidence that lead contamination of spices in the United States is an ongoing problem and that some of it is due to the intentional addition of lead-based pigments for color. This should be one area of focus for industry and regulatory agencies to ensure we reduce this risk to consumers.

*Given the nature of food fraud, it is fair to say that the data we collect is only the tip of the food fraud “iceberg”. Therefore, while this data indicates that these ingredients are prone to fraud in a number of ways, we cannot say that these numbers represent the true scope of fraud worldwide.

Karen Everstine, Decernis
Food Fraud Quick Bites

What Is on the Food Fraud Horizon?

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

People like to ask “what is the next melamine?” Of course, this is an impossible question to answer. However, methods of perpetrating food fraud are rarely novel. Even melamine had a history of use in feed products for nitrogen enhancement.

Examples of recurring food fraud in recent history include:

Spices, food fraud
Spices continue to be a big target of food fraud.

Herbs and spices: High-value commodities, especially when sold in dried, flaked or ground form, have been targets of fraud for ages. Although recent work looking specifically at oregano shed new light on the problems in that particular herb, the group as a whole is long known to be prone to substitution with other plant material and addition of dyes to improve color. Lead chromate and lead oxide have both been used in spices to add color. A recent study in the United States conducted testing on spices recovered from the homes of children diagnosed with lead poisoning and determined that some lead poisoning cases can be attributed to high levels of lead in spices consumed by children.

Milk: Milk has been repeatedly prone to the addition of protein-mimicking compounds such as urea, the addition of other fats such as vegetable oil, and the addition of preservatives such as formaldehyde. Melamine addition to milk discovered in 2008 was not entirely novel. The addition of melamine to artificially enhance the apparent protein content of a product was documented in scientific papers in the 1980s.1

Meat: The two main concerns with meat fraud are species substitution and misrepresentation of production practices. The recent scandals involving horse meat and sick cows slaughtered for meat illustrate the continuing incentive to substitute less expensive species and to misrepresent the production practices of meat.

Liquor: Alcoholic beverages are also a high-value target, especially if they are a popular brand. Counterfeit alcohol is a common form of food fraud cited in the Food Fraud Database. Unfortunately, the use of methanol in unregulated liquor production repeatedly results in illnesses and deaths in consumers.

What forms of food fraud will be common in the coming years? Millennials reportedly place value on sustainability, convenience, high protein, and production practices such as organic and “local.” Verifying claims around production practices through long food supply chains is notoriously challenging. Increasing interest by consumers in these types of label claims may increase this type of fraud in the future.

Reference

  1. Bisaz, R., and A. Kummer. “Determination of 2, 4, 6-triamino-1, 3, 5-triazine (melamine) in potatoe proteins.” Mitt. Gebiete Lebensm. Hyg 74 (1983): 74-79.
Thomas Tarantelli
In the Food Lab

Lead Found in Recalled Ground Cumin

By Thomas Tarantelli
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Thomas Tarantelli

Laboratory reports recently acquired by the Freedom of Information Law from the New York State Department of Agriculture and Markets show the Sol Andino brand ground cumin to contain 1090 ppm lead as well as 259 ppm chromium. The spice was also analyzed by IS:2446, 1980 method, “Detection of Lead Chromate in Chillies, Curry Powder and Turmeric by diphenyl carbizide.” A positive result was given, indicating the presence of hexavalent chromium, which is a component of lead chromate. Lead chromate is a yellow pigment, not allowed in food anywhere in the world as it is toxic, containing both lead and hexavalent chromium. The New York State Department of Agriculture and Markets posted a Class I recall of the Sol Andino ground cumin on July 10, 2017, without mention of the extremely high concentration of lead in the product.

Sol Andino, ground cumin
Sol Andino ground cumin recalled

The author could find no record of an FDA recall for the Sol Andino brand cumin powder containing excessive lead.

Some of us remember the four FDA Class I recalls of Pran brand turmeric for excessive lead in October 2013. These recalls were initiated by the New York State Health Department due to an illness complaint—most likely a child with high blood lead levels. The recalled Pran brand turmeric contained 28–53 ppm lead.

Also worthy of mention is the FDA/Illinois Class I recall of Nabelsi brand Thyme (actually a spice mix containing Thyme) on March 17, 2017.

“There have been two cases of high blood levels of lead associated with this product to date. Both cases have been reported through the Illinois Department of Public Health, Environmental Health Protection.”

According to the recall, the “Thyme” was found to contain 422 ppm lead.

Wondering if the 422 ppm lead was caused by adulteration of the “Thyme” with lead chromate or another lead pigment, a food chemist at the New York State Food Laboratory (a Division of NYS Dept. of Agriculture and Markets) requested from Illinois a sub-sample of the “Thyme” for analysis. Lab analysis of the spice found 323 ppm lead, 109 ppm chromium and a positive result for the chromate test. Thus, this recalled “Thyme” contains lead chromate.

In both cases, Pran turmeric and Nabelsi Thyme, illness complaints led to the recall of lead adulterated spices.

The New York State Department of Agriculture and Markets has a proactive program. Random samples of spices are sampled from retail markets and subsequently analyzed for unallowed colorants, undeclared allergens and heavy metals. In 2016 this resulted in the Oriental Packing Class I recall of 377,000 lb. of turmeric containing spices for excessive lead. (A typo in the FDA recall attributes the recall to the New York State Health Department, instead of the New York State Dept. of Agriculture and Markets.)

Still, it’s even better to analyze spices being imported into the country at receiving warehouses before the product reaches retail markets. Lead concentrations above 10 ppm can be determined instantaneously with a handheld XRF analyzer.

Adulteration with Sudan Dye Has Triggered Several Spice Recalls