New report says arsenic, other metals consistently contaminate baby foods

by Coral Beach

A new congressional report has revealed highly dangerous levels of arsenic and other poisons in baby food. It also reveals that Walmart, Campbell Foods, and Sprout Organic Foods refused to cooperate with the subcommittee’s investigation.

“Nurture, Beech-Nut, Hain and Gerber cooperated with the subcommittee’s investigation, despite the fact that doing so exposed their reckless disregard for the health of babies,” says the 59-page report released yesterday by the U.S. House of Representatives.

“With that in mind, the subcommittee questions why Walmart (Parent’s Choice), Sprout Organic Foods, and Campbell (Plum Organics) would refuse to comply with the investigation. None of them produced testing results or specific testing standards and Sprout never even responded to the Subcommittee’s repeated inquiries.

“The subcommittee is greatly concerned that these companies might be obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products.”

The report, requested in November 2019, reviewed four toxic heavy metals: inorganic arsenic, lead, cadmium and mercury. The Food and Drug Administration and the World Health Organization have declared them dangerous to human health, particularly to babies and children, who are most vulnerable to their neurotoxic effects. Even low levels of exposure can cause serious and often irreversible damage to brain development, according to the report.

On Nov. 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufacturers of baby food in the United States, including makers of organic and conventional products. Those manufacturers were:

Beech-Nut Nutrition Co.
Hain Celestial Group Inc., which sells baby food products under the brand name Earth’s Best Organic
Gerber
Walmart Inc., which sells baby food products through its private brand Parent’s Choice
Sprout Foods Inc. which sells baby food under the name (Sprout Organic Foods”
Campbell Soup Co., which sells baby food products under the brand name Plum Organics
Nurture Inc., which sells Happy Family Organics, including baby food products under the brand name HappyBABY

Arsenic was present in baby foods made by all responding companies.

Nurture (HappyBABY) sold baby foods after tests showed they contained as much as 180 parts per billion (ppb) inorganic arsenic. Over 25% of the products Nurture tested before sale contained over 100 ppb inorganic arsenic. Nurture’s testing shows that the typical baby food product it sold contained 60 ppb inorganic arsenic.

Hain (Earth’s Best Organic) sold finished baby food products containing as much as 129 ppb inorganic arsenic. Hain typically only tested its ingredients, not finished products. Documents show that Hain used ingredients testing as high as 309 ppb arsenic.

Beech-Nut used ingredients after they tested as high as 913.4 ppb arsenic. Beech-Nut routinely used high-arsenic additives that tested over 300 ppb arsenic to address product characteristics such as “crumb softness.”

Gerber used high-arsenic ingredients, using 67 batches of rice flour that had tested over 90 ppb inorganic arsenic.

The Food and Drug Administration has declared that inorganic arsenic, lead, cadmium, and mercury have “no established health benefit” and “lead to illness, impairment, and in high doses, death.”

“The subcommittee’s investigation proves that commercial baby foods contain dangerous levels of arsenic, lead, mercury, and cadmium. These toxic heavy metals pose serious health risks to babies and toddlers. Manufacturers knowingly sell these products to unsuspecting parents, in spite of internal company standards and test results, and without any warning labeling whatsoever,” says the conclusion section of the report.

The report also concludes the time is now for FDA to determine whether there is any safe exposure level for babies to inorganic arsenic, lead, cadmium, and mercury, to require manufacturers to meet those levels, and to inform consumers through labels.

A failure to release information during the previous presidential administration, the report states, did not help efforts to address the problems:

“Last year, the Trump Administration ignored new information contained in a secret industry presentation to federal regulators about toxic heavy metals in baby foods. On Aug. 1, 2019, FDA received a secret slide presentation from Hain, the maker of Earth’s Best Organic baby food, which revealed that finished baby food products contain even higher levels of toxic heavy metals than estimates based on individual ingredient test results. One heavy metal in particular, inorganic arsenic, was repeatedly found to be present at 28 percent to 93 percent higher levels than estimated.”

Suggestions and conclusions
The report suggests several steps to help resolve the heavy metal issues. One goal is to restore the public’s trust. The burden for that is on the shoulders of industry, according to the report. Manufacturers should immediately reduce the levels of toxic heavy metals in their baby foods to as close to zero as possible. If that is impossible for foods containing certain ingredients, then those ingredients should not be included in baby foods.

According to the report one example of an ingredient that might not be suitable for baby foods is rice. Throughout this report, rice appeared at or near the top of every list of dangerous baby foods.

“If certain ingredients, like rice, are highly tainted, the answer is not to simply lower toxic heavy metal levels as much as possible for those ingredients, the answer is to stop including them in baby foods. The subcommittee urges manufacturers to make this change voluntarily,” the congressional report states.

The subcommittee also recommends the following:

• Mandatory Testing: Only one of the companies reviewed by the Subcommittee routinely tests its finished baby foods, even though the industry is aware that toxic heavy metals levels are higher after food processing. Baby food manufacturers should be required by FDA to test their finished products for toxic heavy metals, not just their ingredients.

• Labeling: Manufacturers should by required by FDA to report levels of toxic heavy metals on food labels.

• Voluntary Phase-Out of Toxic Ingredients: Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals, or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.

• FDA Standards: FDA should set maximum levels of inorganic arsenic, lead, cadmium, and mercury permitted in baby foods. One level for each metal should apply across all baby foods. The level should be set to protect babies against the neurological effects of toxic heavy metals.

• Parental Vigilance: Parents should avoid baby food products that contain ingredients testing high in heavy metals, such as rice products. The implementation of recommendations one through four will give parents the information they need to make informed decisions to protect their babies.

Report’s deep dive into the context of arsenic
The subcommittee report says in terms of baby food there are only two FDA regulations for specific products — an unenforceable draft guidance issued in July 2013, but never finalized, recommending an action level of 10 ppb for inorganic arsenic in single-strength (ready-to-drink) apple juice, and an August 2020 final guidance, setting an action level for inorganic arsenic in infant rice cereals at 100 ppb.

Arsenic is ranked number one among substances present in the environment that pose the most significant potential threat to human health, according to the Department of Health and Human Services.

Studies have concluded that arsenic exposure has a “significant negative effect on neurodevelopment in children.” This negative effect is most pronounced in Full Scale IQ, and more specifically, in verbal and performance domains as well as memory. A study of Maine schoolchildren exposed to arsenic in drinking water found that children exposed to water with an arsenic concentration level greater than 5 parts per billion (ppb) “showed significant reductions in Full Scale IQ, working memory, perceptual reasoning and other functioning.

A study of children in Spain found that increasing arsenic exposure led to a decrease in the children’s global motor, gross motor, and fine motor function scores. Boys in particular were more susceptible to arsenic’s neurotoxicity.

The subcommittee’s investigation showed arsenic was present in baby foods made by all responding companies:

Gerber used high-arsenic ingredients, using 67 batches of rice flour that had tested over 90 ppb inorganic arsenic.

For detailed information on the findings for all four heavy metals, please see the report.

This story by Coral Beach first appeared in Food Safety News, and is reposted here with the author’s permission

Why Recalls Happen: Sunshine Mills, Inc., Part 3

Recalls don’t just happen.

Whether bacterial, chemical, a natural toxin or an undeclared allergen, there is always a triggering event.

In the case of Sunshine Mills, Inc., the trigger was a pair of abnormal findings reported by two different states.

Georgia

On August 4, 2020, the Georgia Department of Agriculture (GDA) reported having recovered Salmonella in a sample of Nature’s Menu Super Premium Dog Food brand Natural Dog food with A Blend of Real Chicken & Quail (3-lb bags; Lot code TE2 22 APRIL 2020).

The GDA carries out routine retail-level sampling of pet foods for Salmonella and other pathogens. The Salmonella-positive sample was part of this routine testing program.

On August 12th, Georgia notified Sunshine Mills of the Salmonella-positive result.

Sunshine recalled the offending product on August 24, 2020.

Louisiana

The Louisiana Department of Agriculture and Forestry (LDAF) also performs routine retail surveillance sampling of commercial feeds, including pet foods.

According to a spokesperson for the LDAF, the state analyzes more than 2,000 such products annually, testing for protein, fat, fiber, moisture and minerals. In addition, depending on the products and the time of year, some samples may be tested for one or more of: mycotoxins (including but not limited to Aflatoxin, Fumonisin, and Vomitoxin), toxic heavy metals (i.e. Mercury, Cadmium, Chromium, Arsenic and Lead), Acid and Neutral Detergent Fiber, Total Digestible Fiber, Salmonella spp., Listeria monocytogenes, coliforms, antibiotics, pesticides and herbicides.

On August 17, 2020, the LDAF detected aflatoxin in a sample of Family Pet Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food, manufactured by Sunshine Mills for Midwood Brands LLC. The product was sold in Family Dollar stores.

The level of aflatoxin in the dry dog food was four times the US Food and Drug Administration’s (FDA) action level for pet foods.

Upon finding the positive test results, the LDAF contacted the company to request a recall, and also placed a “stop sale” order on the product.

Sunshine Mills recalled the offending product on September 2nd, along with two other brands of dry dog food with similar formulations.

FDA steps in

Both the August recall due to Salmonella and the September recall due to elevated alfatoxin levels were announced on the FDA’s recall page.

On September 8, 2020, an FDA inspector presented a Notice of Inspection to Philip V. Bates, Chief Operating Officer of Sunshine’s Tupelo manufacturing plant. The inspection would continue, off and on, until October 27, 2020.

The FDA has declined to state (in response to a direct question from eFoodAlert) whether this inspection was triggered by the Salmonella contamination or by the alfatoxin finding. However, the timing of the inspection suggests that Louisiana’s detection of elevated aflatoxin in a dog food sample was the catalyst.

Once on the scene, the FDA inspector investigated both contamination issues, reporting on numerous deficiences, summarized in Part 1 and Part 2 of this series.

Questions left unanswered

Who notified the FDA?

Companies are required to notify the FDA within 24 hours “when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals.”

In 2018, when this same manufacturing plant learned that some of its pet foods contained elevated levels of Vitamin D, company management neglected to inform report this finding to the agency’s Reportable Food Registry within the mandatory 24 hour period. On that occasion, six days elapsed between the time Sunshine had confirmed the problem and the time the company’s management notified the FDA.

The FDA has declined to respond to eFoodAlert’s question as to whether the company or the state agencies notified FDA of the Salmonella and aflatoxin problems.

How much aflatoxin was in the contaminated corn ingredient?

Sunshine’s lab technician tested a sample of bulk yellow corn on April 3, 2020 and accepted that load of corn, even though the level of aflatoxin in the corn exceeded the company’s own rejection level.

We do not know how much aflatoxin was in the corn. That is considered by the FDA to be Confidential Commercial Information (CCI).

We do not know what Sunshine’s rejection level is for aflatoxin. This, too, is considered by the FDA to be CCI, and was redacted from the report that was supplied in response to eFoodAlert’s Freedom of Information Act request. It is likely, though, that Sunshine would have set a rejection level that matches the FDA’s 20 parts per billion (ppb) action level for aflatoxin in pet foods and pet food ingredients.

How much did Sunshine know and when did they know it?

At some point after the company had distributed pet foods containing the contaminated corn, the company found elevated aflatoxin levels in samples of three product formulas, specifically:

Savory Beef, Chicken, Cheese 18%
Complete Nutrition 21-10
TSC Bites & Bones

The Savory Beef, Chicken, Cheese formula was covered in the initial aflatoxin recall dated September 2, 2020.

The remaining two formulations were included in the expanded recall dated October 8, 2020.

According to the lot code information contained in the recall notices, all of the recalled products were manufactured during April 3–5, 2020.

The FDA has declined to reveal either the date (or dates) on which Sunshine performed aflatoxin tests on these products, or the level of aflatoxin found in the three product formulas, citing—you guessed it—Confidential Commercial Information.

What next for Sunshine Mills?

On June 25, 2019, the FDA issued a formal Warning Letter to Sunshine Mills, Inc., listing multiple violations that led to the presence of excessive vitamin D in its pet foods, and expressing dissatisfaction with the company’s corrective actions.

Despite the Warning Letter, the first item cited in this summer’s investigation was a repeat observation from the previous inspection. Specifically, the company “did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.”

The FDA inspector’s report also makes clear that the company’s corrective actions in response to both the Salmonella and the aflatoxin contamination issues were inadequate.

What are the consequences for a repeat offender? Will there be another Warning Letter? Another slap on the wrist?

Or will the Food and Drug Administration take more drastic action?

Stay tuned for developments.

Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 2 (Salmonella)

On August 4, 2020, the Georgia Department of Agriculture detected Salmonella in a sample of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail, manufactured by Sunshine Mills, Inc. (Sunshine).

The state notified Sunshine of its finding on August 12th.

Twelve days later, the company announced a recall of multiple lot codes of the Nature’s Menu dog food.

On September 8, 2020, the US Food and Drug Administration (FDA) began an investigation of Sunshine’s Tupelo, Mississippi facility.

What the FDA inspector found

Finished product storage bins that are not covered by the company’s environmental monitoring program or sanitation schedules
Inadequate sanitation prevention controls, including dry dog food build-up on the surface of certain equipment and pitted and porous surfaces on interior surface welds
Sanitation control monitoring records that are not reviewed by a responsible individual
Inadequate corrective action after receiving notification from Georgia of the Salmonella-positive result
Inadequate evaluation of the scope of Salmonella contamination across multiple batches of finished product
Pre-filling of the sanitation checklist before the sanitizing procedures were carried out

How Sunshine responded

The company responded to most of the FDA inspector’s observations by acknowledging their accuracy and promising corrections.

In response to the inspector’s complaint about the inadequacy of Sunshine’s corrective actions regarding the detection of Salmonella, Phil Bates, Chief Operating Officer of Sunshine Mills, Inc., placed a portion of the blame on the State of Georgia, saying,

“We were in the process of investigating the detection of Salmonella spp. in the finished dog food product. Upon notification from the State of Georgia, a request was made for a split sample of the product in question which is required to be provided under Georgia law. The investigation proceeded with testing for Salmonella spp. in the retain sample of the product in question which was negative. We were subsequently informed that Georgia would not be able to provide the split sample for testing. The inability of Georgia to provide the split sample for testing delayed the investigation and implementation of corrective actions.”
Obtained in response to Freedom of Information Act request

Bates also blamed the leader of the sanitation crew for pre-filling the checklist, adding that the proper procedure had since been reviewed with the Sanitation Lead and with each member of the crew.

Why Salmonella contamination of a pet food matters

The FDA has this to say about the risks of Salmonella infections to dogs and cats.

Salmonellosis is uncommon in dogs and cats, but they can be carriers of the bacteria. This means that even if the pets don’t show symptoms of salmonellosis, they can still shed Salmonella in their stool and saliva and then spread the bacteria to the home environment and to people and other pets in the household. For example, cats can spread Salmonella through shared litter boxes or when roaming throughout the house, such as on kitchen countertops. Some ways dogs can spread the bacteria is when they give people kisses or have stool accidents inside the home. Pet waste from both sick and healthy pets can be a source of infection for people.

When the disease is seen in an adult dog or cat, the animal typically has another infection or health problem at the same time. Puppies and kittens are more likely to show signs of disease. Signs of salmonellosis in dogs and cats include:

Vomiting;
Diarrhea (which may be bloody);
Fever;
Loss of appetite; and
Decreased activity level.

The Salmonella incident investigation overlapped with the FDA’s investigation of aflatoxin contamination in pet food manufactured in the same Sunshine facility (See Part 1). Stay tuned for Part 3 of this series, which will look at the interweaving of the two incidents and how they relate to conditions that were revealed at the manufacturing plant in 2018, when the company’s pet foods were found to contain excessive levels of vitamin D.

Note: Information contained in this story was obtained from the FDA website and from documents furnished by FDA in response to a Freedom of Information Act request.