openPR Logo
Press release

FDA’s New Arsenic Guidelines Fail To Protect Babies From Neurological Impact

08-06-2020 09:21 AM CET | Health & Medicine

Press release from: Healthy Babies Bright Futures (HBBF)

The 100 ppb limit suggested, released today, did not consider IQ loss or other forms of neurological impact, allowed cancer risks far outside of protective limits, and failed to account for children who have unusually high exposures to arsenic in rice.

[WASHINGTON, DC] — Today, the FDA released guidance to manufacturers on the suggested levels of arsenic in rice cereals for infants. Arsenic is strictly regulated in drinking water, but until today, has been unrestricted in infant rice cereal, without a maximum recommended limit. Setting a protective, health-based limit for arsenic in infant rice cereal presents an opportunity to make a significant difference in children’s health and safety.

However, at Healthy Babies Bright Futures, our research has shown that FDA’s 100 ppb “action level” is not a protective, health-based limit for babies. In setting this limit, the agency did not consider IQ loss or other forms of neurological impact, allowed cancer risks far outside of protective limits, and failed to account for children who have unusually high exposures to arsenic in rice.

And FDA failed to consider harm from the multiple toxic heavy metals - arsenic as well as lead, cadmium, and mercury - that contaminate not only rice but other common baby foods as well, all of which contribute to risks for a baby’s healthy development. A 2019 HBBF study found toxic heavy metals in 95 percent of 168 baby foods tested.

Arsenic is a potent human carcinogen and a neurotoxin shown to permanently reduce children’s IQ. At least 13 studies link arsenic to IQ loss and other neurodevelopmental impacts for children exposed in utero or during the first few years of life. HBBF’s 2019 study found six times more arsenic in infant rice cereal than in other types of infant cereal. Our study also showed that rice cereal, babies’ top source of arsenic exposure, contained 85 ppb of arsenic, on average.

“The FDA’s announcement is a step towards ensuring that babies’ brains are protected from exposure to harmful chemicals, but it is not a large enough step,” said Charlotte Brody, National Director of Healthy Babies Bright Futures. “When we released our baby food study in 2019, we suggested that the FDA set an enforceable, health based limit for arsenic in infant rice cereal and other rice based foods to protect infants from both cancer and neurological harm. Three years later, this newly announced guidance is not the solution. It’s just the first step in the right direction.”

This action by the FDA will do little to lower babies’ risks from toxic heavy metals in rice-based foods. Due to their high levels of heavy metal contamination, 15 foods consumed by children under two years of age account for 55 percent of the risk to babies’ brains. Topping the list are rice-based foods — infant rice cereal, rice dishes and rice-based snacks. These popular baby foods are not only high in inorganic arsenic, the most toxic form of arsenic, but also are nearly always contaminated with three additional toxic heavy metals, lead, cadmium, and mercury.

Lead and arsenic in rice-based foods account for one-fifth of the more than 11 million IQ points children lose from birth to 24 months of age from dietary sources. This concentrated risk underscores the need for more clear and protective action from the FDA and baby food companies.

The lack of guidance on this issue has also played a role in inequality and racial health disparities.

Children with celiac disease often eat rice in place of gluten-containing grains. They ingest 14 times more arsenic than other children, on average.
National diet surveys show that Hispanic infants and toddlers are 2.5 times more likely to eat rice on a given day than other children.
Asian Americans eat nearly 10 times more rice than the national average.
Black toddlers are 2 to 3 times as likely to eat arsenic-laden rice snacks.

“Making the food that babies eat safe should be the baseline,” Brody said. “Setting a standard for the maximum amount of arsenic allowed in baby foods is a start to keeping them safe — but 100 ppb is still far too high. No amount of arsenic, lead or other toxic heavy metal is safe for babies.”

###

Healthy Babies Bright Futures (HBBF)
703 Concord Ave,
Charlottesville, VA
22903

Press Contact:
Paige Glidden- Communications Director
443-801-3074
pglidden@hbbf.org

ABOUT HEALTHY BABIES BRIGHT FUTURES
Healthy Babies Bright Futures (HBBF) is an alliance of scientists, nonprofit organizations and donors working to create and support initiatives that measurably reduce exposures to neurotoxic chemicals in the first one thousand days of development. Our efforts are inspired and supported by science and data, and designed to help restore the chance for a full life to children who would otherwise face brain-diminishing exposures to toxic chemicals. www.hbbf.org

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release FDA’s New Arsenic Guidelines Fail To Protect Babies From Neurological Impact here

News-ID: 2104591 • Views:

More Releases for FDA

FDA Compliant Blood Storage and Preservation
Accsense Monitoring System Automates Data Archive and Alarming CAS DataLoggers provided the temperature alarming and monitoring system to a hospital blood bank looking to replace their old paper chart recorders as they became unreliable and spare parts were harder to find. For proper blood storage and preservation, the lab’s medical units needed to maintain storage temperatures between 2°C to 6°C (36°F to 43°F), given the perishability of blood components. The facility
Peyronie’s Disease Market - Only FDA approved product
The market is dominated by a single player, Endo International plc who sells the only FDA approved Peyronie’s disease product. In May 2015, the American Urological Association presented the first ever treatment guidelines for Peyronie’s disease recommending the use of Xiaflex. Furthermore, the company is creating awareness through its “Ask About the Curve” campaign. Also, reimbursement from the U.S. insurance providers will boost the demand for this product. The product
FDA grants orphan drug status to Vicore
US Food and Drug Administration has awarded Vicore Pharmaceuticals with orphan Drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF). FDA’s Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug
New FDA Design Control Training Courses
Salt Lake City, Utah - February 23 2017 - Procenius Consulting is a medical device consulting firm specializing solely in medical device design controls regulation (21 CFR 820.30). Announcing New Design Control Training Courses Procenius Consulting has just launched two new training courses covering basic and advanced topics of medical device design control regulation. These courses focus on compliance, practical implementation and industry best practices techniques for developing or improving a
fda online training
GRC Training Solutions provides end-to-end FDA compliance solutions for those companies who want to maximize security, minimize operational costs, improve staff productivity and stay on top of all their compliance documentation. GRC Training Solutions boasts a team of experts and specialists who have a proven track record in working with the biotechnology, medical device, diagnostic and pharmaceutical fields. Our team will work with you closely and develop solutions that meet
11-09-2016 | Science & Education
GRCTS
FDA online training
Description: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Initially, FDA issued a 28-page Proposed Rule that would amend its regulations regarding