U.S – The U.S. Food and Drug Administration (FDA) has recently issued a final guidance for the industry, titled “Action Level for Inorganic Arsenic in Apple Juice”, establishing an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice.

This aligns with the action level proposed in a draft guidance released in 2013.

Over the years, FDA’s testing initiatives have shown a decline in the presence of inorganic arsenic in apple juice available on the market, with a growing percentage of samples testing below 3 ppb and 5 ppb.

In 2008, we established a level of concern (Ref. 19) of 23 ppb for inorganic arsenic in single-strength (ready-to-drink) apple juice as part of a hazard assessment.

This level of concern, which is no longer in use, focused on non-cancer endpoints and average consumption of apple juice with higher levels of arsenic for a limited (not lifetime) period of time.

However, despite these improvements, the FDA has detected certain apple juice samples that exceed 10 ppb of inorganic arsenic since the draft guidance was introduced.

Consequently, the FDA is finalizing the action level of 10 ppb, considering it to be an attainable level when manufacturers adhere to good manufacturing practices.

Although the 10 ppb action level is non-binding, the FDA anticipates that it will serve as an incentive for manufacturers to further reduce levels of inorganic arsenic in apple juice.

The agency will maintain its ongoing practice of monitoring arsenic levels in apple juice samples. Should testing reveal inorganic arsenic levels surpassing 10 ppb, the FDA reserves the right to take enforcement actions, while considering other relevant factors.

Recognizing that lower arsenic levels provide greater protection to public health, the FDA plans to revisit the action level as part of its “Closer to Zero” action plan.

By continually assessing scientific evidence and industry practices, the FDA remains committed to ensuring the safety of apple juice consumed by the public.

The FDA has also been actively involved in monitoring and regulating contaminants in other food and beverage products.

For instance, the agency has set regulatory standards for levels of heavy metals, including lead and cadmium, in baby food.

This action aims to protect infants and young children who may be more susceptible to the harmful effects of such contaminants.

The FDA continues to work with industry stakeholders to reduce and mitigate potential risks associated with these substances in food products.

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