Just last week, we wrote an update on the GRAS controversy in our TAG newsletter, but even as it was being published, news broke on both sides of the fence; 

From an organization’s investigative report on the dangers of GRAS additives such as lupin and mycoprotein and a coalition’s 80-page document of safety concerns associated with GRAS to FDA’s request for comment on its upcoming Redbook update�"including that for GRAS ingredients, prickly GRAS is growing high in industry’s front yard.

“Why doesn’t the government know what’s in your food?” asks the investigative report from the Center for Public Integrity (CPI), answering,

“Because industry can declare on their own that added ingredients are safe.” In some cases, this is leading to allergic reaction and even death, the report contends, stating that lupin is a peanut-related legume that has caused reaction in peanut-allergic people and is considered to be a major food allergen in Europe, thus must be labeled accordingly on packaged foods. Although lupin has not been designated as GRAS by FDA, the report said, companies have “taken advantage of a loophole in a decades-old law that allows them to deem an additive to be ‘generally recognized as safe’ �" or GRAS �" without the agency’s blessing, or even its knowledge.”

The report uses mycoprotein as a second example, citing a lawsuit filed on behalf of a child who died after eating a Quorn burger. The lawsuit alleges that the child, who had a mold allergy, suffered a fatal allergic anaphylactic reaction to the mycoprotein, a fungus-based ingredient in a burger he ate.

In 2002, FDA accepted the ingredient as GRAS in certain foods, based on the information provided by brand-owner Marlow Foods and other available information, stating that “the agency has no questions at this time regarding Marlow’s conclusion that mycoprotein is GRAS under the intended conditions of use.”

The issue with Quorn has been around for many years and keeps coming up as an example, yet it has never gotten significant traction with FDA, which I think is largely because the FDA does not recognize Quorn as a public-health risk.

The GRAS safety concerns were filed with FDA by a coalition including the Center for Science in the Public Interest (CSPI), Consumers Union, Environmental Working Group (EWG), and Natural Resources Defense Council (NRDC).

The regulatory comment focuses on FDA’s 1997 and 2010 proposals “to use a voluntary notification process to designate a substance intended for use in food for humans or animals as ‘generally recognized as safe’ (GRAS),” stating that the 1997 proposal is an invalid interpretation of the Food Additives Amendment of 1958 (FAA) and needs to be brought into compliance.

Additionally, among the concerns cited by the coalition are that:

• Of the roughly 10,000 additives used in food, more than 3,000 have never been substantively reviewed by FDA. Safety decisions were made for about 1,000 of these by the food industry without any notice at all to FDA.
• Deputy FDA Commissioner for Foods Michael Taylor was cited in an August 2014 Washington Post article as saying, “We simply do not have the information to vouch for the safety of many of these chemicals.”
• While manufacturers can withdraw a GRAS notifications if FDA raises questions about the substance, this doesn’t prevent other companies from using the ingredient in food.
• GRAS determinations can be made by a trade association of chemical manufacturers.

The comment is being filed for consideration in the final rule on GRAS substances that FDA is required to publish by August 2016. Included among the coalition’s recommendations are:

• GRAS designations should not be used for novel chemical ingredients or for substances flagged as risks by authoritative scientific bodies.
• GRAS notifications shouldn’t be based on unpublished studies and should be made by experts without a conflict of interest.
• “FDA must make GRAS notifications mandatory and public, not voluntary and secret.” This point seems at odds with my understanding of the GRAS process which, by definition, is public. Although it is not posted on the FDA website, it is readily available. 

FDA Initiative

Meanwhile, on the other side of the fence, FDA has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input on a framework for assessing food ingredients, including that of additives and GRAS ingredients.

The FDA is particularly interested in comments with specific examples, precise wording, or other clear and direct suggestions on:

• Which parts of the Redbook should be updated, and how FDA should prioritize updates.
• The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
• New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
• Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
• Ways to make the guidance more useful to stakeholders.
• Ways to make our processes and criteria for safety assessment clearer to stakeholders.
  Comments can be submitted at Federal Register, docket FDA-2014-N-1497.

Our newsletters have repeatedly focused on GRAS over the last 12 months and for one simple reason �" the GRAS issue has become one of the major touch points for consumer groups. My view is that there is no way that FDA can review all of the additives currently under GRAS status �" the Agency simply does not have the resources to do that and, frankly, I don’t think FDA sees these issues as a high enough public health concern to seek the resources.

There have been a number of posts in the blogosphere over recent weeks about how FSMA is going to fix the GRAS issues. Since FSMA will require food companies to focus on significant risks, and since food companies will say anything determined as GRAS is not a significant risk, I don’t think FSMA will have the impact of addressing some people’s concerns about GRAS.

My view of all of this is that the GRAS process has suffered from a lack of transparency, and where there is lack of transparency, consumer groups will see deception. I have no doubt that sometimes this is happening, but it is not the general rule when it comes to GRAS.

My greatest fear is that some solution will be developed in Congress, or among those that don’t understand the real issues, which will result in maximum spending and minimum public health benefit. This will then detract from much more significant public health issues which is not where we should have our focus.

So, yes, let’s build a better GRAS process, but not at the expense of losing focus on more pressing food-related public-health issues.

Dr. David Acheson is the Founder and CEO of The Acheson Group and brings more than 30 years of medical and food safety research and experience to the firm. www.achesongroup.com 

David graduated from the University of London Medical School and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and became an Associate Professor at Tufts University in Boston, studying the molecular pathogenesis of foodborne pathogens.

Prior to forming The Acheson Group, David served as the Chief Medical Officer at the USDA Food Safety and Inspection Service and then in 2002 joined the U.S. Food and Drug Administration as the Chief Medical Officer at the FDA Center for Food Safety and Applied Nutrition (CFSAN). After serving as the Director of CFSAN’s Office of Food Defense, Communication and Emergency Response, David was appointed as the Assistant and then Associate Commissioner for Foods which provided him an agency-wide leadership role for all food and feed issues and the responsibility for the development of the 2007 Food Protection Plan, which served as the basis for many of the authorities granted to FDA by the Food Safety Modernization Act.

Since founding the food safety practice within Leavitt Partners in July 2009, David has used his regulatory insight, food safety knowledge, and expertise in crisis response to advise food industry clients around the globe on how to best manage risk in a global supply chain and evolving regulatory landscape.

David has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. He is a sought after speaker and regular guest on national news programs. He serves on a variety of boards and food safety advisory groups of several major food manufacturers. Additionally, David is a fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America, and a member of the American Society for Microbiology (ASM), Institute of Food Technologists (IFT), and International Association for Food Protection (IAFP).