Regulatory Disconnect: The US, The WHO, Acetaldehyde

BIG DISCONNECT — In the United States acetaldehyde is commonly added to many foods and beverages because the U.S. Food and Drug Administration considers it an ingredient that is “Generally Recognized As Safe (GRAS). (use CTRL+F to search the list at the link). Acetaldehyde is also a permitted food additive in China and a designated food additive in Japan.

For its part, the FDA states that acetaldehyde is considered a safe additive in food products, and is used to impart a green apple taste sensation.

FDA finds acetaldehyde safe as a food additive.

ONE BIG THING — WEAK SCIENCE

The AAH-causes-cancer speculation persists because of  the total absence of any controlled clinical human studies that indicate a causal relationship between alcohol and cancer.

While there are plenty of studies of AAH in rats or in test tubes, more than 90 percent of murine (rodent)-based trials of promising pharmaceuticals fail to receive government approval because of poor performance in human trials.

Further, published studies on humans and alcohol published so far are the result of a type of study called “observational.” These types of studies do not provide causal data. However, they offer links, connections, indications, or other possible relationship. Observational study designs such as case controls and cohorts have a lower strength of evidence and can only produce  links and associations that fall short of causality.

Significantly, the same situation exists with studies that indicate no harm, or even benefits from moderate consumption. Because the so-called “French Paradox” is based on observational studies, it exists in the same causally conditional uncertainty.

WAITING FOR TOXIC SANTA — Sometimes regulators will hedge the uncertainty. For example,  the U.S. National Toxicology Program (NTP) has issued an equivocal opinion by stating that, “Acetaldehyde is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals.” Anticipation is best reserved for children waiting for Santa.

REALLY WEAK SCIENCE FROM THOSE WHO SHOULD KNOW BETTER — The IARC, a unit of the World Health Organization issued a poorly sourced paper based on weak science at the end of December 2023 adding fuel to the fire.

That paper — picked up in a sensational manner by the international media — was based on a hodge-podge review  previous studies, none of which were causal.

Indeed, even the IARC acknowledged on the third page of its paper that the strength of evidence of five of the paper’s sections were “inadequate” or “limited.” The other two that they deemed “sufficient” were observational studies and, by definition, not causal. Most importantly, Cohort and Case-Control studies are “observational” and do not yield causal data. More on strength of evidence at this link: Grading The Strength Of Evidence (Credibility & Trust) + Complicating Factors For Different Types of Human Studies.

Despite the weaknesses, paper received wide acclaim in the global media just in time for New Years celebrations, despite the fact the science cited did not justify the conclusions of causality..

STATE OF THE NATION: UNCERTAINTY — The CDC Finds Acetaldehyde Carcinogenic. NTP Says Maybe. FDA Says It’s Safe. NHANES Does Not Care

The National Health and Nutrition Examination Survey — NHANES –is a series of ongoing assessments of the U.S. population’s exposure to environmental chemicals. It monitors hundreds of chemicals, including 12 aldehydes — none of which is acetaldehyde. This indicates that it is not a chemical of concern. Tables and searches here: Biomonitoring Data Tables for Environmental Chemicals.

CAUTION LIGHT — Drinking too much too fast can outpace the limits of metabolism (about one standard drink per hour) may allow acetaldehyde to accumulate. That could cause hangovers.

TAKE AWAY — Healthy people have evolved a sturdy metabolism that makes short work of the acetaldehyde which lurks in their morning yogurt and myriad other places.

 

 

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