{"id":11725,"date":"2023-06-15T10:56:10","date_gmt":"2023-06-15T15:56:10","guid":{"rendered":"https:\/\/blogs.edf.org\/health\/?p=11725"},"modified":"2023-06-15T11:33:58","modified_gmt":"2023-06-15T16:33:58","slug":"the-fdas-squishy-definition-of-adverse-health-effects-of-substances-in-food","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2023\/06\/15\/the-fdas-squishy-definition-of-adverse-health-effects-of-substances-in-food\/","title":{"rendered":"FDA\u2019s squishy definition of adverse health effects of substances in food"},"content":{"rendered":"

Maricel Maffini, consultant<\/em>, and Tom Neltner<\/em><\/a>, Senior Director, Safer Chemicals<\/em><\/p>\n

What Happened<\/strong><\/p>\n

A recent peer-reviewed publication<\/a> criticized FDA\u2019s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency\u2019s criteria are \u201cinadequate because they are not science-based.\u201d<\/p>\n

Why It Matters<\/strong><\/h3>\n

FDA is responsible for protecting food safety and the public\u2019s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided\u2014so the agency\u2019s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.<\/p>\n

Adverse Effects Dismissed by FDA<\/strong><\/h3>\n

In 2020, the director of The Pew Charitable Trusts\u2019 food safety project argued<\/a> that FDA failed to \u201cprotect Americans from preventable illnesses\u201d because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described<\/a> the toxin\u2019s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.<\/p>\n

In a 2019 final rule<\/a> approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant \u201cchanges in blood chemistry, blood clotting ability, and blood globulin values\u201d as potential health effects. In its response to the objection, the agency argued that \u201cstatistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.\u201d FDA further stated that for the color additive to cause the blood changes to be \u201cpotentially adverse\u201d it should:<\/p>\n