News

Here is one of the best summaries of the FDA's Proposed GRAS Rule that I have seen.

FDA Proposes Mandatory GRAS Notification Requirement | Advisories | Arnold & Porter

There are many summaries out there, but this one really captures the key points well and provides good advice about what companies should be doing NOW to prepare.

I was involved in presenting a webinar last week for the IFT Maryland group on the challenges in switching from Synthetic Colors to Natural Colors in various food products where I provided the facts related to the safety of synthetic colors and outlined the key challenges that exist in reformulating away from synthetic colors with natural colors. We also had speakers from natural color manufacturers Kalsec and GNT who provided information on how their companies have been dealing with some of these challenges in certain types of applications.

In a significant victory for manufacturers and retailers of personal care products and for sound science, the U.S. District Court for the Eastern District of California struck down California’s Proposition 65 as applied to titanium dioxide in cosmetics and personal care products.

The EU Commission has published a COMMISSION STAFF WORKING DOCUMENT on TiO2 in Medicinal Products. The outcome is that TiO2 will remain acceptable for Medicinal Uses!!! This is really big news!!  Here is the link to the full document from the EU Commission.

Here is a great article from two well-known toxicology experts regarding why simply moving away from synthetic food colors to "natural' food colors is not such a good idea! I agree with everything they say, and I urge you to read this to get the facts concerning these colors.

Here is a really great article which explains the FACTS regarding all the efforts that FDA puts in to make sure that all color additives (including the FD&C colors) are safe. This article provides a great summary of the history of the regulations and what is involved in the regulations which includes a very sound scientific review by FDA of all color additive petitions and their supporting data which is extensive.

FactCheck.org recently shared a helpful fact-check of Health and Human Services Secretary Robert F. Kennedy Jr.’s recent comments on food dyes. You are going to want to read this article for a science-based examination of the actual evidence surrounding the safety of synthetic food colorings.

Big announcement from FDA TODAY!! - The authorized use of FD&C Red 3 in food and drugs is being revoked. This action is in response to a petition submitted to FDA based on the Delaney clause. The Delaney Clause applies when data demonstrates a substance can cause cancer in man OR animals. Data on Red 3 shows that it can cause cancer in male rats at extremely high dosages way above any level that humans could experience! While additional information shows this effect doesn't occur in humans, FDA concluded that the Delaney Clause applies since this antiquated law does not allow for any type of scientific risk assessment to be used even when an animal study is shown not to be relevant to humans!

The results of this study provide scientifically robust information regarding the reproductive toxicity and preneoplastic potential of E171 that should be considered in establishing the ADI. This provides additional supporting data showing that TiO2 is safe for use in foods and drugs.

I'm excited to be participating in an upcoming IFT webinar on October 11, 2024 at 12:00 PM CT, where we'll delve into the evolving landscape of artificial food colors and their implications for consumers, policy, and the food industry.

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.