Background

Over the last few years there has been increased awareness of heavy metals and metalloids in the food supply. This is, in part, due to the growing concern among consumers about the presence of heavy metals in food products and the potential public health impact that consumption of these products could have. While some heavy metals and metalloids are naturally occurring, some are from environmental or industrial contamination and remain in our environment. 

What is lead?

Lead (known as Pb and number 82 on the periodic table) is a naturally occurring metal found in the environment. Lead is used in plumbing, batteries, metal pipes and solder, paints, ceramic products, stained glass production and health care products. 

Where do we find lead?

Lead can be found in chipped, lead-based paint in older homes; in food through environmental contamination such as fossil fuel burning, mining, and manufacturing; and in drinking water mostly through pipe leaching, but also through earth deposits into well water.   

Why is there concern and what are the health effects?

Lead is a health hazard and there is no safe level of lead in the blood. Exposure to lead can occur from ingesting contaminated food or water, breathing dust containing lead, or by eating paint chips containing lead.  Adverse effects of long-term exposure to lead include damage to the brain and nervous system, slowed growth and development, learning, behavior, hearing and speech problems. 

What is being done?

Over the years, lead use in gasoline, paint, solder, electronics and other materials have been reduced or eliminated in an effort to reduce consumer exposure. In the U.S., the removal of lead from gasoline resulted in more than a 90% reduction in the average blood lead concentration from 1976 to 1995. While the mean blood lead level in the U.S. today remains low, In an effort to safeguard young children, The Centers for Disease Control and Prevention (CDC) monitors children’s blood lead levels.

In an effort to reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods, FDA has published an action plan, Closer to Zero, which identifies the approach the Agency plans to take to reduce exposure to toxic elements in foods commonly eaten by babies and young children—to the lowest possible levels. Some of the activities outlined in Closer to Zero include research and evaluation of changes in dietary exposures to toxic elements such as Lead, setting action levels, encouraging adoption of best practices by industry, and monitoring progress.

Since 1991, The FDA monitors the levels of lead in food through its Total Diet Study. If unsafe levels are detected, the FDA can take enforcement actions, including recalls or import alerts.

What are the current regulatory requirements?

Authorized Uses and Established Limits

There are no FDA regulations that authorize lead for use as a color additive or food additive, including use in cookware.  FDA works to limit the level of lead in foods and will use its authority to take action on a case-by-case basis when determining whether food containing a contaminant, such as lead, is unsafe.  FDA has established action levels for specific contaminants, including lead, in certain foods. When there is no action level or tolerance, FDA can take action at the minimal detectable level of the contaminant. 

Action Levels for Lead recommended by FDA

FDA has set Action Levels for lead in the following foods:

Food Category Action Level
Foods Intended for Babies and Young Children
Fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
10 ppb
Foods Intended for Babies and Young Children
 
Single-ingredient root vegetable
20 ppb
Foods Intended for Babies and Young Children
Dry infant cereals
20 ppb
Candy likely to be consumed by Small Children 100 ppm
Juice (Draft)
Single-strength apple juice (ready-to-drink)
10 ppb
Juice (Draft)
All other single-strength juice, including juice blends that contain apple juice
20 ppb
Drinking water
*EPA sets limits for drinking water systems
15 ppb
Bottled water 5 ppb

Import Alerts

FDA uses import alerts to protect consumers against products with a history of known violations. FDA has issued import alerts for certain food and products and certain manufacturers that may be unsafe due to the lead contamination of food. Specifically, these included:

What is the food industry doing to assure the safety of the food supply?

Food manufacturers and processors have the responsibility to consider risks from chemical hazards, including heavy metals such as lead, and implement controls to significantly minimize or prevent any of the identified chemical hazards. For example, some manufacturers may conduct verification activities such as ingredient testing or implementing additional supply chain verification activities.

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