It doesn’t seem like too much to ask for the public to be able to count on the FDA to ensure that all substances added to foods are proven safe. The FDA disappointed many interested in a safer food system earlier this month when it released its final ruling detailing its authority for the Generally Recognized as Safe (GRAS) process. Food safety advocates saw the FDA’s request for comments in 1997 and again in 2010 as opportunities for the agency to improve the process designating new food additives as safe, by ensuring that the process was based on science and not the interests of the companies making the products. But after 20 years of rulemaking to formalize the voluntary GRAS procedure, the FDA did not make significant changes to address the biggest issues with the program, which I describe below.
Generally Recognized as Safe…according to whom?
The GRAS process was created as a part of the 1958 Food Additives amendment to the Food, Drug, and Cosmetic Act to give a regulatory alternative to the lengthy food additive process, allowing certain substances to enter the food system without pre-market approval from the FDA. For a description of the GRAS process, watch this great video by the Center for Public Integrity (CPI).
There are currently over 600 items on the GRAS list, which is publicly available and includes the letters of GRAS notification and response letters from the FDA. But because the GRAS notification process is voluntary, companies ultimately determine if a substance is safe, and then may decide whether or not to submit a GRAS notification to the FDA.
This is where the break in accountability occurs. According to Leltner et al., there are likely over 1,000 “secret” GRAS substances, the safety of which is determined by the manufacturing company and has never been reported to or affirmed by the FDA. Of those GRAS notifications that do make their way to the FDA, the odds of a GRAS determination are in the food industry’s favor, seeing as the FDA has only rejected a handful (17) of GRAS notifications since 1998.
The major change that FDA has made with the new rule is codifying the GRAS process as a voluntary notification procedure rather than a voluntary affirmation. Sound similar to you? That’s because there really isn’t much of a difference. Minor changes were made in the definitions of terms and in spelling out the requirements of the GRAS notification, but the process will not undergo substantive changes due to this ruling. The voluntary notification structure will not change the way that companies currently continue to consider a host of substances GRAS without notifying the FDA, meaning that there’s no way to track exposure to certain unlisted ingredients. Other issues that remain with the process include the way in which the food industry uses industry-friendly GRAS panels to complete safety reviews of products and the fact that the FDA still does not have a system in place for the agency to reconsider a GRAS determination if new evidence shows that a substance is harmful to human health.
Inherent GRAS conflict of interest issues
When companies submit a GRAS notification, they must provide justification that the product is safe, demonstrating a consensus among scientific experts. Some of the time, companies do this by convening an expert panel of a few scientists to review the evidence. As it stands, the FDA does not require that food companies disclose the conflicts of interest of expert panel members or require that they be unbiased.
In 2010, CPI took a look at the makeup of expert panels commissioned by industry to look at the safety of proposed GRAS substances and found that companies often select reviewers from a small pool of scientists, several of whom had prior industry interests. Of the 379 panels that had reviewed GRAS substances over 17 years, CPI found that at least one from a heavily relied-upon group of ten scientists had served on 75 percent of the panels. Four out of those ten individuals had served as scientific consultants for tobacco companies, which of course have a long history denying and manipulating scientific findings. Other researchers analyzing the makeup of GRAS expert panels have found a similar trend.
The Government Accountability Office (GAO) recommended in a 2010 report that the FDA “develop a strategy to minimize the potential for conflicts of interest in companies’ GRAS determinations.” How did the FDA respond to these concerns in its final rule? Well, the FDA plans to “issue guidance in the near future to: (1) Provide recommendations regarding the use of a ‘GRAS panel,’ including the potential for conflict of interest; and (2) remind the food industry that the same standards apply to a conclusion of GRAS status regardless of whether the conclusion is submitted to us as a GRAS notice or is not submitted to us.” Unfortunately, a gentle reminder for the industry will simply not be strong enough to make lasting improvements to the scientific integrity of the process.
Rare reconsideration of GRAS status based on new evidence of harm
There are several examples of products once deemed safe that when reexamined as new information came to light, were considered harmful. While there is FDA precedent for rescinding GRAS status from certain additives that were found to be unsafe, including a cancer-causing flavoring agent, allergy inducing sulfites, and recently trans fats, the GAO found that the FDA had not adequately developed a system for reconsidering the safety of GRAS substances as new scientific information emerges.
In lieu of its own system, the FDA should at least be responsive to the citizen petition mechanism that allows members of the public and public interest organizations to raise safety concerns with the agency. Historically, the FDA has not actively considered citizen petitions that challenge the safety of GRAS substances, only deciding on the merits of one out of 11 petitions submitted to the agency between 2004 and 2008, according to the GAO report. In its new ruling, there is no indication that the FDA will address this issue.
An example of a GRAS substance that should be reexamined and has been brought to the agency’s attention via citizen petition is added sugars. In 2013, the Center for Science in the Public Interest (CSPI) submitted a petition to the FDA asking the agency to review GRAS status for added sugars (sucrose, high fructose corn syrup, corn sugar, invert sugar and corn syrup), considering the mounting scientific information on added sugars’ negative impacts on health at current consumption levels. The FDA provided an interim response to CSPI saying that the agency had “not reached a decision” based on the petition and has not acted further on the matter since 2013.
New rule leaves much to be desired
Several of GAO’s recommendations still have not been addressed by the FDA, so the final rule essentially codifies a flawed system. The FDA’s weak solution to process-wide issues will not solve the underlying problem of the lack of transparency and accountability of the GRAS process. It will not empower the FDA to appropriately regulate the safety of food additives, because it will remain voluntary. Safety determinations of the new ingredients added to our foods will still rely on expert panels that are likely to have conflicts of interest rather than independent reviewers. The GRAS process is just one example of how deep scientific integrity issues run through science-based decision making and why we are fighting to ensure that science, not money or power, are at the heart of decisions impacting public health and safety.
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