News

The most important take-away point from this publication is the conclusion which states: "The 34 robust datasets reviewed here, do not support a direct DNA-damaging mechanism for TiO2 in either the nano or micro form."

If you want to know what the real risks might be for the use of TiO2 (E171) in pharmaceuticals, you NEED to read this article from independent toxicology expert Lyle Burgoon!!! See the link below. Please read both this article as well as the detailed article at the link within this article which shows how he did his calculations that resulted with these incredible numbers!!

The BOTTOM LINE....even if we were to believe that the overly precautionary genotoxicity concerns voiced by EFSA were true (and we know that is simply not true as smartly seen by regulators like Health Canada, the UK FSA and recently FSANZ who did detailed scientific assessments of the data), the actual risks to a patient would be essentially zero unless that patient were to take 681 tablets every 6 hours (4 times a day), every day for the next 8.5 years!!!!!

After a significant scientific review of all the data, FSANZ posts a New Report: Review of titanium dioxide as a food additive

In this report, FSANZ states that they have completed a review of the safety of titanium dioxide (TiO2) as a food additive and their review found that there is currently no evidence to suggest dietary exposure to food-grade titanium dioxide is a concern for human health.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. The FDA are taking this action in response to a color additive petition (CAP) submitted by Colorcon, Inc.

If you have an interest in the ongoing discussions related to the safety of TiO2 (E171), you will want to read the article linked to the LinkedIn post below. Lyle Burgoon, a totally independent toxicologist has done a critical review of the key studies that EFSA relied on to say that there were some uncertainties related to the genotoxicity of E171. As you will see, he has found major FLAWS in many of these studies which brings into serious question why EFSA relied on them for any type of assessment when these studies are less than credible!!

An important paper has been recently published in the Journal of Pharmaceutical Sciences (JPharmSci) by the IQ Consortium that addresses the benefits of using TiO2 in pharmaceutical applications and the challenges that exist with trying to use the various TiO2 alternatives that currently exist.

A California resident's lawsuit prompted an expert toxicologist to look at just how many Skittles would it take to reach the dose required to see genotoxicity. Bottom-line: it's very unlikely to ever happen. Do you really think people might eat 4080 Skittles every day for over 9 years? I doubt that!!

The EFSA opinion, that the European Union used to justify the TiO2 ban, relies on a paper that is our opinion unreliable and published in a journal that is highly questionable. EFSA's failure to properly vet the science underlying their opinions is driving fear and loathing in US families.

A BALANCED VIEW ON TiO2 SAFETY: I would like to share this article from Scientific American which actually provides a much more balanced approach regarding the media attention that this crazy Skittles lawsuit is getting. I think the subtitle of this article tells the whole story: "A recent lawsuit claims a chemical called titanium dioxide, used in Skittles candies, harms people. It’s hard to find strong evidence for that, however"

Episode 32 • 2nd August 2022 • CPhI Podcast Series • Informa Markets

Health Canada comes to a different conclusion on TiO2 safety than EFSA in their overly precautionary opinion! Health Canada finds TiO2 to be safe for use in food.

Do you want to learn more about the FACTS related to the recent ban of TiO2 (E171) in Europe for food uses and the potential impact this could have globally on pharmaceuticals?

In September 2021, a Novel Excipient Review Pilot Program was launched in the US that would allow excipient manufacturers to get their novel excipient approved for use in pharmaceuticals prior to use.