The U.S. Food and Drug Administration (FDA) launched the new Human Foods Program on Oct. 1. The program will reorganize the agency to make it better at overseeing and protecting the human food supply.
Some of the changes under this program include having a systematic post-market assessment of chemicals in food, such as food and color additives, substances that are Generally Recognized As Safe (GRAS), food contact substances, and unintentional food contaminants.
Many academics and lawyers in food regulation hope that this new program will lead to stricter regulation on food additives approved under the GRAS label.
The GRAS designation allows food companies to determine the safety of additives without mandatory FDA review, raising concerns about the lack of transparency and oversight of potential health risks.
“One of the big concerns, is that there are unknown ingredients in the food supply that the FDA and the public doesn’t know about,” Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health, told The Epoch Times.
“Industry self-regulation for GRAS substances and FDA’s lack of a formal approach for reviewing substances already in our food are inadequate to protect public health,” she said during the FDA’s Sept. 25 public meeting, which was focusing on developing this post-market review process.
In response to The Epoch Times, the FDA said that while it is committed to improving safety oversight, the post-market review process will be limited by budget and current law.
The agency is still taking public comments for its post-market system until Dec. 6, and the system is set to launch in 2025.
The Epoch Times reached out to the FDA for comment.
What Will the Program Do?
The FDA’s
Human Foods Program (HFP) marks the largest reorganization in the agency’s modern history, affecting over 8,000 employees. This initiative aims to strengthen the FDA’s oversight of the food supply, enhance food safety, and address new industry challenges.
A significant aspect of this reorganization includes focusing on food inspections, investigations, and imports.
The proposed reforms under the HFP aim to:
- Enhance Oversight: The program plans to create a more thorough review process for GRAS substances and food additives, ensuring that safety data is carefully evaluated.
- Focus on Nutrition: By emphasizing nutrition, the FDA hopes to help combat diet-related diseases and promote better health for everyone.
- Strengthen Partnerships: The FDA plans to work more closely with state regulators and embrace new food technologies to effectively manage the increasingly complex food landscape.
- Adapt to Change: This program will help the agency respond to challenges like globalization, climate change, and the evolving ways people produce and consume food.
Understanding the GRAS Controversy
Food and regulation experts hope that the new program can provide more stringent control on food additives approved under GRAS, which has allowed the food industry to introduce new food chemicals without FDA oversight.
The GRAS designation originated from the 1958 Food Additives Amendment, which exempted certain substances from rigorous testing if they were “generally recognized” as safe by qualified experts. While this was meant to streamline approvals for common ingredients, it has created significant regulatory gaps as time went on.
At the time, most people consumed few ultra-processed foods and the agency would not have anticipated the volume of ultra-processed foods Americans consumed now, Pomeranz said. “Ultra-processed foods didn’t exist as a mainstay of the American diet.”
“‘Generally recognized as safe’ substances, could be determined in two ways: if they were already in the food supply, like salt and pepper, or by submitting evidence of safety,” Pomeranz said.
While the FDA evaluates the safety of new chemicals before they enter the market, it differentiates between “food additives,” which require approval, and “GRAS” ingredients, which do not. This distinction means that companies can determine GRAS status based on historical use or their own safety assessments without needing to inform the FDA. As a result, some food companies can use the GRAS designation to introduce unvetted substances, such as natural sweeteners and preservatives.
From 1990 to 2010, approximately 1,000 substances were labeled GRAS by manufacturers without notifying the FDA. Since 1997, the FDA has allowed the food industry to independently determine which substances qualify as GRAS, allowing companies to conduct their own safety assessments without informing the FDA. Although the agency encourages disclosure, this is voluntary and many new substances enter the food supply without notification.
As the FDA launches its new HFP, it aims to address these gaps.
“FDA is only starting to utilize its post-market powers to review a tiny number of ingredients in the food supply, even though evidence of harm has been present for decades,” study co-author Emily Broad Leib, director of Harvard Law School Center for Health Law and Policy Innovation, said in a statement.
Budget Challenges
At the public meeting, Jim Jones, deputy commissioner for human foods, said that budget constraints hinder the FDA’s ability to conduct comprehensive post-market reviews.
“We’re entering another fiscal year where our programmatic needs to meet our public health mandate are greater than our available resources,” he stated.
Though the FDA public meeting discussed ways to strengthen and improve a post-market review, many comments at the meeting suggested that this would not be enough, Pomeranz said.
They need more staff to effectively review scientific data and manage the proposed post-market assessments, she noted, adding that more funding is needed to effectively implement these changes.
Despite requesting increased funding from Congress—$30 million to review safety concerns—the FDA has received only $7 million in recent years.
Update: the article has been updated with comments from the FDA.
