Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, consultant

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”

– Helena Bottemiller Evich

from Politico article

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article.

For chemical additives, FDA:

  • Has avoided difficult regulatory decisions on unsafe additives until the evidence of harm is overwhelming or industry agrees;
  • Has adopted a rule that puts industry in the driver seat for safety decisions leaving its staff unable to get answers to safety questions;
  • Relies on voluntary notification processes so lacking in transparency that stakeholders cannot challenge them until it is too late; and
  • Has failed to follow through on a promising effort to modernize its science after 8 years.

FDA has often pointed to resource limitations for these problems. Last month, Congress provided the agency with $7 million in funding to start modernizing its science. And while additional funding is definitely needed, the problems are deeper than simply insufficient funding.

Delays in decision-making and misleading reports on food and color additive petitions.

Congress established two types of petitions – food additive and color additive petitions – as the primary means by which companies are to seek FDA approval to use chemicals in food or materials that contact food.

Unfortunately, the agency has allowed industry to bypass the petition process, letting companies make their own determination that a chemical is “Generally Recognized as Safe” (GRAS) or by submitting a Food Contact Substance (FCS) notification. The Environmental Working Group documented that only 10 of the 766 novel chemical additives to food FDA has reviewed since 2000 went through the petition process.

Not only are petitions now rarely filed by industry to determine whether novel food chemicals are safe, but consumer advocates that use the petition process to fix safety concerns often find FDA unwilling to make a final decision as required by law. Since 2014, consumer advocates have filed five petitions seeking to remove FDA approvals based on safety concerns. Three were successful, one was denied on procedural grounds, and the fifth is still pending after six years.

Under federal law, FDA has 180 days to act on a petition, though the agency generally gives itself 360 days to complete a review. In only one of the five petitions, however, did the agency come close to meeting its 360-day goal – a 2016 petition to ban long-chain PFAS – which should have been an easy, but important, decision. Three decisions came only after petitioners went to court to force FDA to decide after an unreasonable delay. After filing each lawsuit, the agency quickly agreed to a deadline to decide, suggesting the final decision was stuck in management. (See table below)

 

Chemical at issue Filing date Decision Days to decision Action on objections Lawsuit filed
Perchlorate as FCS 12/31/14 Denied 5/4/17 on procedural grounds. NGO’s objected. ~850

 

Denied objections on 4/24/19 (719 days). Yes
Long-chain PFAS as FCS 1/7/15 Accepted 1/4/16 362
Carcinogenic flavors 8/17/15 Accepted 10/9/18 ~1,140 Yes
Ortho-phthalates as FCS 4/12/16 Anticipated by 5/19/22 ~2,220 Yes
Lead acetate in hair dyes[1] (cosmetic) 2/24/17 Accepted 10/31/18. Industry objected ~616 Denied objections on 10/8/21 (1073 days)

Despite these delays, FDA told Congress in its annual budget justifications that it completed 100% of reviews within 360 days over the last eight years. The only way we can rationalize that claim is that technical staff completed its review leaving the final approval waiting on management to make a formal decision.

On rare occasions, FDA has acted on its own to restrict harmful chemicals based on overwhelming evidence. The best example of FDA action on chemical additives came in 2015 when the agency determined that partially-hydrogenated oils (aka artificial trans fats) were not safe because they contributed to thousands of heart attacks and deaths each year. But even there, it wasn’t until 2020 that food was finally free of trans fats, even though the risks first became clear in 2002 when the Institute of Medicine advised against their consumption.

Voluntary notice processes lack transparency and accountability.

In 2016 FDA finalized a rule that explicitly allows industry to make GRAS safety determinations for novel chemicals without notifying the agency. When a company voluntarily submits a GRAS notification, they are free to put the chemical on the market at any time, even before they reach out to FDA. They can also withdraw the notice when FDA scientists raise tough questions about the safe use of their products. We discuss this issue in more detail in our “Broken GRAS” series.

This approach undermines both the food additive petition process set up by Congress and the FCS notification program by providing industry with an option to avoid scrutiny by agency scientists.

By not mandating that companies provide FDA with notice, the agency made it virtually impossible to have the information it needs on chemicals to ensure food is safe from the cumulative effect of related chemicals in our diet. FDA also lacks the mechanism to ensure food companies are complying with its rules.

Finally, the process by which the agency manages the GRAS and FCS notices lacks transparency and accountability. The agency fails to post its evaluation of the notice or allow for public comment, effectively leaving the public or other interested stakeholders without a means to challenge the action.

Effort to modernize science stalled shortly after committing to fixes.

In addition to relying on industry to determine the safety of food chemicals, FDA has failed to modernize its safety reviews and continues to rely on outdated scientific processes.

FDA did initiate a review of its chemical safety assessment program ten years ago, in the midst of growing scrutiny of the safety of additives and contaminants like bisphenol A and phthalates. The review’s purpose was “to ensure that the agency is making the most effective and efficient use of its chemical safety resources.” The review was focused on the program’s scientific capacity and management and included interviews with its scientists, as well as senior managers from other federal agencies who were experienced in chemical safety.

Interviewees’ responses to the science-related questions had a common theme: FDA’s guidance and methods to evaluate chemicals’ risk were outdated.

In 2014, FDA posted the results of the review on its webpage and invited public comment. Outside experts also commented on a final draft of the report and provided recommendations. Disappointingly, any subsequent action was put on hold, and remains so. We’re still waiting.

Summary

Our work with the agency confirms many of the disfunctions identified in Politico’s investigation. The article was titled “FDA’s Food Failure,” and we think this is an apt description when it comes to FDA’s work regulating chemicals added to, or contaminating, food.

Congress recently provided FDA with additional funding to address food chemical risks. More food safety funding is important, but along with the funding we also need fundamental changes, or we will continue to face uncertainty about the safety of chemicals in our food.

One of the changes we support is putting a single person in charge of food safety. We also think, when it comes to food chemicals, FDA needs to mandate that companies provide notice of GRAS safety determinations, be more transparent on its evaluations of notices, and establish a new Office of Chemical Reassessment with sufficient funding dedicated to addressing the safety of existing chemicals using the best available science and methods.

[1] Color additive petitions for food and cosmetics follow the same process and have similar problems.

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