Skip to main content

Does FDA establish Heavy Metal Limits in Flavoring Compounds?

Get Answers

Does FDA establish Heavy Metal Limits in Flavoring Compounds?


What are the FDA standards (or limits) of heavy metals (arsenic, cadmium, copper and lead) in a food flavoring compound?


The U.S. Food and Drug Administration (FDA) has not established regulatory limits for heavy metals in flavoring additives or finished food products other than bottled water. However, the Agency has provided guidance on some heavy metal levels in certain foods (such as candy and juice). For juice, FDA stated in its "Guidance for Industry: Juice HACCP Hazards and Controls" that lead levels in juice above 50 ppb may constitute a health hazard. With respect to candy, FDA recommends a maximum lead level of 100 ppb in candy likely to be consumed by small children.

FDA has also stated that it is "seriously considering setting guidance or other level for inorganic arsenic in apple juice and [is] collecting all relevant information to evaluate and determine an appropriate level," in a November 21, 2011 letter to several consumer organizations. The letter was in response to a call from the organizations for FDA to set tolerance levels for heavy metals, including arsenic, in apple products. The Agency explained that establishing a guidance was preferable to setting a tolerance level since the latter would require a formal rulemaking, and tolerance levels are difficult to change in the event that scientific understanding of an issue changes. Also in the letter, FDA pointed out that, under Section 402(a)(1) of the Food, Drug, and Cosmetic (FD&C) Act, if it finds a contaminant in a food that poses a health hazard, such that the food is deemed to be adulterated, it can and intends to take appropriate enforcement action.

Not everyone agrees with FDA's stance that a guidance is preferable to rulemaking. U.S. Representative Frank Pallone, Jr. (D-NJ) introduced the Apple Juice Act of 2012 (H.R.3984) on February 8, 2012. The bill, which was referred to the House Subcommittee on Health on February 10, would require FDA to promulgate a final regulation establishing a tolerance under Section 406 of the FD&C Act to limit the quantity of total arsenic in beverages containing fruit juice.

Ask an Attorney

We invite you to submit a question related to the regulations of packaging materials to our Keller and Heckman packaging attorneys.
Ask a Question