The Center for Science in the Public Interest (CSPI) is a non-governmental lobbying organization that took in $35 million in 2022, largely by scaring consumers about the food they eat. A recent reporti from CSPI grossly misrepresents flavor safety and the FEMA GRAS program to further their fundraising interest under the guise of protecting consumers. Interestingly, CSPI contradicts themselves within their own report—asserting falsehoods about FEMA GRAS in the executive summary while providing citations to the contrary within the report’s chapters. To help the public understand the facts about flavor safety and the FEMA GRAS program, we are sharing the following:

FACT: Flavorings are evaluated for safety by the FEMA Expert Panel, composed of eight board-certified medical doctors and scientists who are leading experts on flavor and food safety. 

  • The panel members have academic appointments at various universities and colleges, including Vanderbilt University, the University of Nebraska, the University of Minnesota, Imperial College London in the UK, and Wageningen University in the Netherlands, to name a few.
  • The experts who serve on the FEMA Expert Panel are routinely appointed to and participate in government panels, including for the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), the European Food Safety Authority, the Japan Ministry of Health and Welfare, the German Federal Institute for Risk Assessment (BfR), and the UK Food Standards Agency, to name a few.

FACT: FEMA GRAS flavorings are safe and are NOT secret. CSPI deliberately misleads readers by suggesting that FEMA GRAS flavorings are unsafe and hidden when it is known that:

  • FEMA GRAS flavor ingredients and their safety information are publicly available. A simple Google search for FEMA GRAS will reveal the FEMA Flavor Ingredient Library, which not only contains the entire list of FEMA GRAS flavorings but also links to the safety information as published by the FEMA Expert Panel, the FDA’s Scientific Literature Reviews, and the World Health Organization’s Joint Expert Committee on Food Additives (JECFA) safety reviews. 
  • Following an audit of GRAS in the United States, the U.S. Government Accountability Office concluded the “FEMA GRAS process achieves a level of public disclosure and agency notification similar to FDA’s voluntary GRAS notification program.” 
  • FDA knows what flavorings are added to food as demonstrated by the agency’s inclusion of FEMA GRAS flavoring substances in the FDA’s food ingredient inventory, which is available to the public.
  • CSPI knows this is available as they cite the FEMA Flavor Ingredient Library and FDA’s Substances Added to Food Inventory within their own report.

FACT: FEMA GRAS is a rigorous evaluation of safety, as evidenced by the commonality of approved flavorings by global risk assessment bodies and widespread global acceptance. After sixty years, regulators and health officials trust FEMA GRAS as a reliable source of robust safety evaluations of flavorings.

  • FEMA GRAS flavorings have also been determined to be of no safety concern by the EU, the World Health Organization, and the Japan Ministry of Health and Welfare.   
  • Over 100 countries accept FEMA GRAS in principle or via regulation.

FACT: Isoeugenol is not a human carcinogen.

  • Isoeugenol is a carcinogen in rodents only, and this fact is not relevant to human risk assessment for its use as a flavoring material. This is why it remains FEMA GRAS and has also been determined to be of no safety concern by the World Health Organization’s JECFA and the European Food Safety Authority.
  • CSPI acknowledges that risk is relevant in evaluations of food ingredients that are positive in animal carcinogenicity assays as it states that “the mere presence of these substances in our food through spices or natural flavor does not mean they pose a major risk to consumers and does not mean that consumers need to adjust their eating habits.”ii Yet, CSPI will likely file a food additive petition with the FDA, forcing the agency to spend millions of taxpayers’ dollars to make a Delaney finding on isoeugenol, a naturally occurring substance in foods that bears no risk to humans when consumed.iii These wasteful petitions tie up the FDA’s time and resources and prevent the agency from focusing on more impactful issues to public health.

FACT: The FEMA Expert Panel regularly re-evaluates the safety of FEMA GRAS flavorings.

  • As a result of these re-evaluations, the FEMA Expert Panel has removed FEMA GRAS status for flavorings when the data available no longer meets the FDA’s safety standard of reasonable certainty of no harm. 
  • As an example, also cited in the CSPI report, the FEMA Expert Panel removed the FEMA GRAS status of methyl eugenol in 2016 for safety concerns, given research published by European Union scientists in 2014-2016. The public should feel confident that the FEMA Expert Panel addresses safety concerns relevant to humans to ensure the safe use of flavor.

FACT: Flavor labeling provides consumers with transparent information about when flavors are added to food and beverage products and whether the flavors are natural or artificial, according to the FDA’s definitions. If CSPI simply reviewed the FDA’s labeling regulations and provided an honest assessment, it would be clear that:

  • FDA established flavor and food labeling regulations to provide uniform labeling rules to protect consumers. This means that flavor labeling should be consistent across products, allowing consumers to quickly identify when flavor has been added to food and whether those flavorings are natural or artificial.
  • The U.S. flavor and food labeling regulations are consistent with such regulations in other countries and regions. No country or region requires the listing of the individual ingredients of flavor mixtures that are added to food and beverages.
  • These flavor labeling rules established by the FDA require that the individual flavorings added to a product be labeled collectively as “natural flavor” or “artificial flavor.” This approach, to label individual flavorings added to a product collectively as “flavor,” is mirrored in the flavor labeling rules in countries around the globe.
  • Additionally, all FEMA GRAS flavoring substances are identified publicly in the FEMA Flavor Ingredient Library.

FACT: A flavor labeled as “natural beef flavor” must contain beef.

  • The flavor labeling rules in the U.S. are clear that how the flavor is described depends on what the flavor tastes like AND the source of the flavorings in it. The flavor labeling rules in the U.S. are not a way to “hide” flavoring ingredients.
  • FDA’s flavor and food labeling regulations require the labeling of flavor on the back of a package to be in concert with how the flavor is described on the front of the food package.
  • CSPI writes in its report that a “natural beef flavor” could be sourced only from non-beef flavoring. This is incorrect. A flavor could not be labeled as “beef flavor” or “natural beef flavor” if there is no flavoring derived from beef in it. Such a flavor that tastes like beef but contains no beef could be described on the front of the package as “artificial beef flavor” or similarly to signal to the consumer on the front packaging that there are no beef derivatives used in the flavor.

FACT: Major food allergens are mandated to be disclosed on product labels—flavors are not exempt from this requirement.

  • These disclosures provide vital information for people with major food allergies, enabling them to steer clear of ingredients that could pose harm.
  • Further, flavorings rarely contain protein, as flavorings are made via processes that eliminate allergenic proteins. For instance, many flavorings (e.g., peppermint oil) are made using steam distillation, which would remove any protein given their fundamental biochemical properties.

FACT: The FEMA Expert Panel abides by a strict published and publicly available conflict of interest policy, which ensures there is no financial incentive for positive outcomes. Further, the Expert Panel routinely publishes information on flavor safety in peer-reviewed scientific journals that also require disclosure of potential sources of conflict.

FACT: FEMA Expert Panel members do not have a “strong interest” to provide positive reviews. 

  • Expert Panel members receive honoraria for the time spent in meetings regardless of either the number of new flavorings reviewed or the number of flavorings that are determined to be FEMA GRAS. If the evaluation of a material is put on hold by the Expert Panel because it concludes that additional data are needed, the material may return to the Expert Panel for a continued evaluation, which would include the new data. 
  • The Panel meets three times a year regardless of whether there are new flavorings to review. The review of new candidate flavorings is just one part of the Expert Panel’s role as they also re-review existing FEMA GRAS substances when new scientific data becomes available or when exposure to consumers has increased to ensure the flavoring’s use continues to meet the FDA’s safety standard of a reasonable certainty of no harm.

 

About FEMA:
The Flavor and Extract Manufacturers Association of the United States (FEMA) is composed of flavor manufacturers, flavor users, flavor ingredient suppliers, and others with an interest in the U.S. flavor industry. Founded in 1909, it is the national association of the U.S. flavor industry. FEMA is committed to assuring a substantial supply of safe flavoring substances. More information about FEMA is available at www.femaflavor.org.

Contact:
Meredith Huddle
202-293-5800
[email protected]

i Galligan, T., Jose, J., Musicus, A., Sorscher, S., Center for Science in the Public Interest. (2024). “Hidden Ingredients: What are 'Flavors' and 'Spices,' and are They Safe?”

ii Galligan et al., page 24.

iii Galligan et al., pages 13 and 22.