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Selected tag(s): Food safety

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / 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.

Updated April 9, 2023 to add link for Broken GRAS series.

Posted in Broken GRAS, Conflict of interest, FDA, GRAS / Also tagged , , | Authors: / Read 1 Response

Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

Posted in FDA, GRAS / Also tagged , | Comments are closed

Chemicals in food continue to be a top food safety concern among consumers

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2021

Chemicals in food continue to be a top food safety concern among consumers

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The latest annual food industry survey demonstrates that U.S. consumers continue to have significant concerns about chemicals in food. Specifically, the survey from the International Food Information Council (IFIC) found:

  • 29% of consumers rated chemicals in food as their top food safety concern, more than any other issue, including foodborne illness from bacteria. Everyone rated chemicals in food among the top three concerns. Chemicals in food has been the top concern every year since 2017, tying risk from COVID-19 from food last year. It has been a significant concern back to the first IFIC Food and Health Survey in 2009.
  • 69% of consumers did not realize that the U.S. government is responsible for reviewing the safety of low-calorie sweeteners, which are among the most well-known food additives.
  • 54% of consumers reported it is important that ingredients do not have “chemical-sounding names” including 26% that rate it “very important.” Their opinion is primarily based on food safety and healthfulness concerns.

Our takeaway is that consumers continue to be concerned about chemicals in food, partly because they are not confident that the federal government is actually ensuring additives are safe. Therefore, they do their best to try and 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, food companies have undertaken “clean label” programs that either remove these ingredients (which can be helpful) or use names that do not sound like chemicals (which obscure the fact and can be misleading).

A better approach is to actually ensure the chemicals in food are safe and healthy rather than leaving consumers to judge products based on the sound of the ingredient names. Actual safety is the outcome that Congress intended when it adopted the Food Additives Amendment of 1958. Instead, the Food and Drug Administration (FDA), the agency with both the responsibility and the authority for food safety, allows companies to decide in secret that additives are safe, fails to consider the cumulative health effect of chemicals in the diet, and lacks any systematic reassessment of past decisions even when new evidence shows potential harm.

FDA needs to step up and address these shortcomings to make our food safe and restore consumer confidence. This involves not only improving its approach to addressing ingredient safety but also their approach towards contaminants that enter our food from the environment, from the packaging, or from food processing.

Read More »

Posted in FDA, Food, GRAS / Also tagged , , | Comments are closed

Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2018

Tom Neltner, J.D., is Chemicals Policy Director

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

Read More »

Posted in FDA, Food, GRAS, Health policy, Public health / Also tagged , , | Authors: / Comments are closed

Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant.

[pullquote]

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

[/pullquote]

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

Read More »

Posted in FDA, Food, Health policy, International, Regulation / Also tagged , , , , , , , | Comments are closed

A path to leadership: Food packaging product stewardship considerations released

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 13, 2018

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

Read More »

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