EDF Health

Broken GRAS: FDA’s half-step to limit bias and conflicts of interest in GRAS determinations may backfire

By / Published: March 15, 2023

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

What Happened? FDA finalized a long awaited guidance for industry in December to help reduce conflicts of interest and bias when a chemical manufacturer chooses to convene an expert panel to assess whether a new chemical additive is generally recognized as safe (GRAS).

Why It Matters: As written, FDA’s Best Practices for Convening a GRAS Panel guidance is excellent. If food companies convene GRAS panels consistent with the guidance, the panels’ evaluations will be more credible because they should have less of the pervasive bias and conflicts of interest that plague the current system and all too often result in unsafe chemicals being added to food. But that’s a big if.

Our Take: Unfortunately, we think the guidance is likely to backfire because of the limited scope — FDA explicitly makes GRAS panels optional – a choice the agency made when it finalized the GRAS rule in 2016. Chemical manufacturers will simply avoid convening GRAS panels, relying solely on their employees or a consulting firm they hire to conduct these safety evaluations. These employees and consultants typically have significant bias and conflicts of interest because positive opinions help their employer or client. We raised this issue in comments to FDA, calling for the best practices to apply to everyone involved in the safety evaluation process. FDA did not address our comments in their recommended best practices in the revised final guidance.

While making GRAS panels optional is a serious problem, a more fundamental concern is that FDA may not have an opportunity to review the GRAS safety evaluations made by employees or hire consultants because the company chooses not to notify the agency. FDA’s Office of Food Additive Safety fails to consider just how often companies choose not to tell the agency that a new chemical is being added to food. In our Broken GRAS series, we provided six examples of the serious risk posed by the GRAS system, the most public being hundreds of people sickened due to consumption of tara flour, an ingredient in a Daily Harvest frozen meal. Last November, using marketing materials we showed FDA that the number of new chemicals bypassing its review likely outnumber those voluntarily submitted to the agency.

We see no evidence that the agency systematically investigates or even audits the GRAS determinations that bypass their review despite promises made by the agency over the years and a scathing 2010 report by the U.S. Government Accountability Office calling for action.

Next Steps: In his effort to reform FDA’s dysfunctional food safety program, FDA Commissioner Califf told a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1] If he follows through, fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. If he fails, the agency will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety.

Go deeper: Broken GRAS series, Neltner et al (2013) Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance; Toxic Free Act; Food Chemical Reassessment Act.

[1] FoodFix, January 31, 2023 edition.

Posted in FDA / Tagged , , , , , | 1 Response

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“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. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, Health Policy, Health Science, Public Health, Unleaded Juice / Read 1 Response

Unleaded Juice: FDA’s challenge of continuous improvement and compliance assurance

By / Published: October 2, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the sixth 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 the implications for the agency’s Closer To Zero program. 

A core tenet of FDA’s Closer to Zero program is the “Cycle of Continuous Improvement” represented by the image below on the program’s webpage. The four-stage, outer ring represents FDA’s process for revising its action levels for food contaminants. The inner, grey ring describes the agency’s on-going monitoring, research, and compliance program.


This approach makes sense, and we fully support it. However, the success of this approach relies on FDA addressing several significant structural weaknesses.

  • Future funding is not guaranteed: In March 2022, Congress appropriated $11 million in Fiscal Year 2022 (FY22) funding for FDA’s maternal and infant health work—in part to support the agency’s efforts to reduce arsenic, lead, and cadmium in children’s foods. Last year’s request and appropriations were a significant increase over previous years, but that funding level is not guaranteed for future years.
  • Action levels are guidance—not legally binding requirements: FDA’s action levels for contaminants in food are established in guidance. The guidance introduction makes it clear that “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.” It assumes that the food industry—from the largest multinational corporation to the smallest entrepreneur—will comply.
  • The agency has limited means to monitor compliance: FDA largely relies on physical inspections and market sampling, supplemented by voluntary reporting, to assure compliance with action levels. Inspections at high-risk facilities must occur every three years (but likely have been delayed due to the COVID pandemic). We understand that most facilities will see an inspector once every eight years. This is particularly problematic because FDA says it lacks the authority to require food companies to provide requested documents without the physical inspection, and the agency does not require ongoing testing and reporting by companies for action levels.
  • Action levels must be consistently strong enough to drive research and impact markets: FDA correctly points to its success in setting an action level for inorganic arsenic in infant rice cereal as a model to lower contamination. Unfortunately, the model assumes the action level for a contaminant is set low enough to result in research investments and increased product and ingredient testing and to provide FDA with sufficient information to act on problems. This is not the case for lead in juice.
     
    We explore each of these weaknesses below.

Read More »

Also posted in Public Health, Unleaded Juice / Tagged , , , , , | Comments are closed

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

By / Published: September 22, 2022

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.

Read More »

Also posted in Unleaded Juice / Tagged , , , , , | Comments are closed

FDA Acknowledged Ortho-Phthalates Could Be Grouped Into Classes For Safety, Then Punted

By / Published: September 16, 2022

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.

FDA’s obligation to evaluate related chemicals as a class

FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]

But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]

In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.

A phthalate scorecard: Where we stand on which phthalates can be used and their health effects

The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.

Read More »

Posted in FDA / Tagged , , | Comments are closed

Consumers continue to rate chemicals in food as top food safety concern

By / Published: September 14, 2022

Tom Neltner, Senior Director, Safer Chemicals

For the eighth year in a row, consumers rated chemicals as their top food safety concern according to the annual industry survey of consumer perspectives on food issues. In the survey conducted in March 2022, 48% of consumers rated chemicals as their top category of food safety concern – about the same as 2021 – compared to 22% for foodborne illness from bacteria. The chemicals category includes: cancer-causing chemicals (15%); pesticides (13%); food additives and ingredients (11%); and heavy metals (9%).

Last year, we examined the International Food Information Council’s (IFIC) 2021 Food and Health Survey in detail. Our takeaway was that consumers continue to be concerned about chemicals in food, partly because they lack confidence that the federal government is actually ensuring additives—like artificial sweeteners—are safe. (Nearly 70% didn’t know that’s the government’s role).

As a result, consumers do their best to protect their health and safety by avoiding ingredients that sound like chemicals—the only way they see to control the perceived risk. In reaction to consumer concerns, some food companies have undertaken “clean label” programs, which, according to a 2017 analysis by Center for Science in the Public Interest, either remove these ingredients (which can be helpful if the removed ingredients are unsafe) or use names that do not sound like chemicals (which obscures the facts and can be misleading).

Read More »

Posted in FDA / Tagged , , , | Comments are closed