CHPA, other stakeholders push hard to maintain access to titanium dioxide

 The Consumer Healthcare Products Association (CHPA) and other industry groups have pushed back hard against a request that titanium dioxide (TiO2) should be banned as a color additive in food.  

In a citizen petition filed in March, four groups requested the Food and Drug Administration remove its approval on the use of synthetically-prepared TiO2. The petition was filed by the Environmental Defense Fund, the Center for Food Safety, the Center for Science in the Public Interest and the Environmental Working Group. 

Petitioners: FDA should follow EU’s lead in banning TiO2 

FDA approved the safety of TiO2 as a color additive in 1973, but that was before the pharmacokinetics of nanoparticles was widely understood, according to the petition. 

“Recent scientific studies raise serious questions about the safety of the chemical's use in food such that there is no longer the legally required ‘convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive,’ after considering the probable consumption of synthetic TiO2 from its use in food, the cumulative effect of synthetic TiO2's use after taking into account pharmacologically-related substances in the diet, and appropriate safety factors,” petitioners wrote to FDA. 

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The petition cited a determination by the European Food Safety Authority (EFSA).  

The EFSA evaluation of TiO2 determined much of the ingredient consisted of particles of 100 nanometers in diameter or less, and it concurred with the generally held opinion that the biological activity potential of TiO2 particles is low. But it also found the nanoparticles could accumulate in organ tissue over a period of years with unpredictable results. 

EFSA therefore determined it could not rule out the possibility that synthetic TiO2 nanoparticles could pose a safety hazard over time, although it did not identify any present safety concerns. 

The EU Commission subsequently banned the use of TiO2 as a food additive. As of August 2022, no food sold in the EU may contain synthetic TiO2. The regulation did allow for manufacturers to sell their existing inventory. An evaluation of the need for TiO2 in drug products is pending. 

Now the citizen petition has asked FDA to follow the lead of EFSA and the EU. 
“A chemical that builds up in the body and could harm the immune and nervous systems should not be in candies and treats marketed to children,” Melanie Benesh, vice president of government affairs at the Environmental Working Group, said in a May 30 news release from the petitioners. 

Comment deadline approaches 

FDA opened a docket for comments, which at publication time contained 22 postings. The deadline for comments is set for Sept. 1, 2023. 

Industry groups who commented to FDA include CHPA, the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), the International Food Additives Council (IFAC), the Consumer Brands Association, the Pet Food Council and Black Diamond Regulatory Consulting LLC. All the industry comments opposed the petition. 

One brand holder commented as did several private citizens.  All those comments recommended FDA ban TiO2. 

Consulting firm: TiO2 provides important benefits 

Titanium dioxide provides a brilliant white color and is known to many oil painting hobbyists for that reason. As a food additive, it provides that benefit too—a shining white hue—but it has other technical benefits as well. 

“There simply is no good alternative that can provide the key properties needed to provide strong opacity and light protection for key food and drug ingredients and appropriate mouthfeel required for many products,” David R. Schoneke, owner and president of Black Diamond Regulatory Consulting, wrote to FDA. “Comments already submitted which state that there is no nutritive value for TiO2 and therefore it should be banned do not understand the technical benefits of using TiO2. There is a reason it has been used in more products than almost any other additive historically.” 

Schoneke included a comparison of the opacity and light protection of TiO2 and several other possible replacements that have been suggested, such as calcium carbonate, kaolin and talc. TiO2 filters out more than 90% of incoming light, as measured by contrast ratio. Calcium carbonate, kaolin and talc notched values of 12.6%, 10.8% and 8% on this measure, respectively, according to Schoneke. 

CHPA: Nanoparticle absorption minimal 

The EFSA opinion is not supported by available data, according to CHPA, which maintained there is minimal absorption of TiO2 nanoparticles and there is no demonstrated safety concern associated with them. 

“There is a substantial body of scientific evidence that has been extensively reviewed by a diverse set of regulatory authorities that supports the safe use of TiO2 as a food additive,” Douglas MacKay, CHPA’s senior vice president of dietary supplements, wrote to FDA. “Dismissing this extensive evidence and adopting EFSA’s precautionary approach without scientific justification would disregard the wealth of accumulated scientific research spanning several decades.” 

Comments: Knee-jerk reaction didn’t reflect real-world exposures 

The International Food Additives Council noted the EFSA evaluation did not reflect real-world exposures and thus is of little value in assessing real risk. 

“The EFSA opinion and EU decision to ban TiO2 are not based on sound risk assessment, but rather a hazard assessment that is not reflective of human exposures and irrelevant to TiO2 usage in food and beverage products,” Robert Rankin, executive director of the IFAC, wrote to FDA. 

“IFAC therefore strongly suggests that the FDA reject the petition.” 

MacKay argued banning the color additive would be unwarranted at this time, considering its safety profile. 

“While consumer safety is of paramount importance, a knee-jerk ban on TiO2 in food and dietary supplements would be unjustified,” he concluded. “Based on extensive scientific research and regulatory evaluations, TiO2 is deemed safe for use as a food additive when consumed within established regulatory limits. The safety of TiO2 as a food additive is evidenced by the lack of significant absorption across the gut, low toxicity, absence of carcinogenicity, and lack of evidence demonstrating genotoxicity.”