News

I am honored to have virtually participated in this year's NAFDAC conference on APIs and Excipients in Nigeria to provide training on various excipient regulatory topics to NAFDAC regulators and representatives from the local Nigerian industry and academia. I just received this very nice letter of appreciation for the presentations I made at this conference last month from NAFDAC's Director General.

A study by internationally renowned expert David B Warheit further assesses the safety of food grade titanium dioxide (TiO2), E171 and concludes that E171 is safe for human consumption.

EFSA made a MANIFEST ERROR regarding the safety of TiO2 (E171) as a food additive!!!

This is the conclusion reached by Dr. David Warheit in the linked article he just published on July 19, 2024, which provides a really good summary of the FACTS related to TiO2 (E171) safety for use in foods. David is a world-renowned toxicology expert who has done amazing work on TiO2 in the past. His article provides a great overview of all the credible safety data that exists and why it supports that TiO2 (E171) is SAFE!

A safety review of titanium dioxide by an international body emphasizes the importance of streamlined assessments to enhance efficiency and consistency in regulatory decisions, according to Duffy MacKay of the Consumer Healthcare Products Association and David Schoneker of Black Diamond Regulatory Consulting.

Check out my PODCAST where I talk with Processing Magazine about titanium dioxide safety and regulation in food and pharma products and the current status of TiO2 around the world. 

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

Go to the link below to get a copy of a really great paper that has just been published by the IQ Consortium related to the technical and regulatory challenges that would exist if the EU Commission were to extend their unjustified ban of TiO2 (E171) to pharmaceuticals.

Here is a great article (see link below) that was published recently in RAPS that provides a summary of the current TiO2 situation as it relates to pharma in the EU and ongoing industry efforts to bring science into the discussion.

Of course, the big information that has now come out on Nov. 24th, which is not covered in this article, is that JECFA (Joint Expert Committee on Food Additives) has published their opinion on the safety of TiO2 and JECFA concluded that they have no safety concerns with TiO2. The JECFA review included world-class toxicology and safety experts from all over the world.

JECFA’s risk assessment of titanium dioxide risk released TODAY!!! JECFA re-affirms the safety of TiO2 (INS 171, E171) for use in Foods. Governments around the world need to take note of this JECFA Opinion when assessing TiO2 safety.

BDRC Wins “Best of Lansdale Award” in consulting category!

An article that I co-authored with several other IPEC-Americas experts has just been published in Tablets and Capsules. This article outlines the importance of fully qualifying any alternate supplier of an excipient that you intend to use in your drug product.

Happy Holidays from Black Diamond Regulatory Consulting, LLC (BDRC)!!! I hope you all are enjoying the holidays with your families.

I would like to thank all of you who have utilized BDRC for your consulting needs related to regulatory and quality issues with excipients, food additives, dietary ingredients and other projects this year!! It is much appreciated!!

FDA SAYS TiO2 IS SAFE FOR USE IN FOODS!!!!! - Check out this great Food Navigator article which provides some significant information about what both FDA and Health Canada's position is on the safety of TiO2. The article also provides an update on the dismissed lawsuits against Mars and Skittles which never had any merit!

You will want to check out this great article about the TiO2 situation in the EU written by Kevin Hughes. It provides a great summary of the all the key issues related to the potential ban of TiO2 in Pharma in the EU and why this would be a really BAD idea since there is no real safety risk which has been identified!!

In a judgment delivered on 23 November 2022, the General Court of the European Union has ruled that titanium dioxide (TiO2) is not a category 2 carcinogen by inhalation in line with Regulation (EC) No 1272/2008 on classification and labelling.

EU Court Decision on TiO2 REACH classification TODAY!!! - General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the harmonized classification and labelling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms.

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."