Draft Supporting Document for Establishing FDA’s Action Levels for Lead in Juice

<< Draft Guidance for Industry: Action Levels for Lead in Juice

Lead is toxic to humans and can affect people of any age or health status. Lead is especially harmful to vulnerable populations, including infants, young children, pregnant women and their fetuses, and others with chronic health conditions. Even low lead exposure can harm children's health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects (HHS/NTP, 2012). Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time (Flannery et al., 2020).

Lead is widely present in the environment due to its natural occurrence and human activities that have introduced it into the environment. Because lead may be present in environments where food crops used to make juices are grown, juices may contain unavoidable but small amounts of lead. Potential sources of lead in juice include contaminated soil where the crops are grown, contaminated water, old lead-containing equipment, processing aids, and atmospheric deposition from industrial activities. It may be possible in some cases for manufacturers who have found elevated lead in sources of fruit or fruit juice to choose sources of fruit or fruit juice concentrate with lower lead levels or no detectable lead. It may be possible, in some cases, for manufacturers who have found lead in water used to dilute concentrates to reduce or limit levels of lead in ready-to-drink juice by examining and controlling lead levels in water used for dilution of juice concentrate. Recent research by FDA shows that the use of some filter aids to remove sediments in juice can contribute to elevated lead levels. Changing or treating filter aids may reduce the levels of lead in filtered juices (Wang et al., 2017; Redan et al., 2020).

The purpose of this document is to present the background and rationale for the Food and Drug Administration’s (FDA’s) action level of 10 micrograms/kilogram (µg/kg) or 10 parts per billion (ppb) for lead in single-strength (ready-to-drink) apple juice[1] and action level of 20 µg/kg or 20 ppb for lead in all other single-strength juices, including juice blends that contain apple juice. The action levels for lead in juice are included in an FDA draft guidance entitled, "Action Levels for Lead in Juice: Guidance for Industry." FDA considers the action levels for lead in juice to be achievable by industry when control measures are taken to minimize the presence of this contaminant.

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[1] Juice includes both liquid and puree forms (21 CFR 120.1(a)).