Unleaded Juice: FDA needs to start with public health—not market impact

Tom Neltner, Senior Director, Safer Chemicals 

This is the fifth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program. 

FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:

• Action levels should not impact more than 5% of the market. Unfortunately, FDA does not appear to consider market trends or whether the products were made using best practices shown to reduce contamination.
• Action levels should help ensure 90% of young children have a dietary intake of lead that is below FDA’s Interim Reference Level, the maximum daily intake from food. Unfortunately, this effectively ignores the top 10% or 2.4 million of the most-exposed young children.[1]

To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.

We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.

FDA’s approach to setting draft lead levels

FDA went through five questions when developing its draft action levels for lead in juice.

1. Could limits be tightened? FDA evaluated its available databases on juice to determine if lead limits could be tightened. It concluded that “industry can generally manufacture juice with lead levels much lower than the 50 ppb lead level currently recommended in FDA’s Juice [Hazards Analysis Critical Control Point] HAACP guidance.”
2. What limit would impact no more than 5% of products? FDA followed the approach used by Codex Alimentarius for international juice standards. FDA considered the percent of juice samples that would be unable to meet the action level and evaluated the impact of progressively tighter limits. All but three common juice types (grape, pomegranate, and berry) could meet a 20-ppb limit with less than 5% failure rate.
3. What juices are the most commonly consumed? FDA considered the relative consumption of different juice types and set tighter limits for the most popular, apple juice. It concluded that all but 5% of apple juice could meet a 10-ppb limit.
4. What effect does the limit have in reducing lead exposure for children at the 90^th percentile consumption level for that product? FDA calculated that the 10-ppb limit for apple juice would reduce exposure to lead from apple juice for children at the 90^th percentile consumption level by 46%, while the 20-ppb limit for other juices would reduce lead exposure from those juices by 19% for children at the 90^th percentile consumption level. The agency did not consider more aggressive options to ensure more children are below its Interim Reference Level for lead.
5. Can at least 95% of samples achieve the limit? FDA determined that no more than 5% of apple juice and 3% of other juices combined would fail the limit on a consumption-weighted basis.

FDA should consider alternatives that impact more than 5% of sampled products?

Codex Alimentarius sets international standards for food that become the baseline for the world’s markets. Participating countries can be more – but not less – stringent. For contaminants, the standards are set “as low as reasonably achievable” (ALARA).

When it became clear that there was no known safe level of exposure to lead, FDA agreed to coordinate Codex negotiations to adopt tighter standards on most food types, including juices. The assumption was that ALARA meant that no more than 5% of the market would be impacted – meaning that at least 95% of the market would be able to meet the standard. There was no evaluation of market trends, potential socioeconomic benefits, or whether foods were produced using commonly available practices to reduce lead contamination.

After many years of negotiations, in 2016 Codex lowered its 50 ppb maximum level for lead in juice to 30 ppb for most fruit juices, 40 ppb for grape juice, and 50 ppb for other juices from berries and small fruits. In 2021, the Commission agreed that the limits also apply to juices for infants and children. This year, EDF submitted comments to FDA and the U.S. delegation making clear our concerns that limits for lead based on ensuring that no more than 5% of the sampled products would be affected were not protective enough.

Nonetheless, FDA used the 5% assumption as the benchmark to set lead in juice standards. It did not even analyze options beyond that benchmark for most juices.

In the table below, we took FDA’s source data and calculated what the lead action levels for different juices would be if FDA had set more aggressive limits based on 10% and 20% market failure rates – that is, if the agency’s levels required 1 in 10 or even 1 out of every 5 juice samples to reduce current lead levels to meet the new limits.

This type of evaluation reveals the opportunity presented by tighter limits. For example, grape juice has significant contamination even when 20% of samples fail to meet the limit. The highlighted juices were grouped into “other juices” by FDA but could meet tighter limits and still not exceed FDA’s 5% benchmark. In fact, juices such as mango, orange, and pineapple could meet a standard twice as stringent, with only 5% or less of samples failing to meet the limit.

FDA should consider alternatives that do not leave behind the 2.4 million children who are most exposed to lead

FDA typically uses the 90^th percentile to evaluate exposure to contaminants or additives. We have not seen a rationale for selecting this value over more protective ones—such as the 95^th percentile commonly used in Europe for food, 97.5^th percentile for U.S. Centers for Disease Control and Prevention to set an elevated blood lead level, or 99^th percentile for pesticides in the U.S.

While percentiles may seem abstract, we think it is important to recognize that, in this case, they represent lead-exposed children. Using the 90^th percentile means that the 2.4 million children from 1 to 6 years old who are exposed to higher levels of lead are not taken into account.[3] The estimated loss in IQ for an individual child exposed to lead may be small, but when millions of children experience the loss, it is a significant public health impact – one that can be quantified in terms of lost lifetime earnings potential. Of course, there are other public health impacts from lead exposure that are more difficult to quantify.

We are not suggesting that FDA drop the 90^th percentile altogether. Rather, they should also consider higher percentiles, giving context to the percentile by calculating the number of children over the selected exposure percentile.

FDA should calculate the socioeconomic benefits of greater health impact reductions

When FDA evaluates impacts, it should calculate the socioeconomic benefits of the alternatives. The federal government has established methods like increased lifetime earnings and longer lives that provide a scientific basis to develop robust estimates. For example, in a previous blog, we showed that eliminating young children’s overall dietary intake of lead would yield $17 billion in increased lifetime earnings for the four million children born each year. While eliminating lead is not realistically achievable, reducing their overall dietary exposure to lead by only 6% would yield $1 billion a year in benefits.

This approach would then give the agency a better means to evaluate the investments that industry would need to make to achieve these action levels using best practices.

[1] FDA used ages 1 to 6 years inclusive.

[2] See Table 3 in FDA’s Supporting Document for Proposal.

[3] Approximately 4 million children are born each year. Over a six-year period, that would mean ~24 million children in the age range.