Black Diamond Regulatory Consulting, LLC

Black Diamond Regulatory Consulting, LLC Black Diamond Regulatory Consulting, LLC is a consulting firm specializing in providing regulatory a

Significant Misinformation in RFK Jr.’s Comments on Food DyesFactCheck.org recently shared a helpful fact-check of Healt...
04/18/2025

Significant Misinformation in RFK Jr.’s Comments on Food Dyes

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.

https://www.factcheck.org/.../hits-and-misses-in-rfk-jr.../

This is a really great article! It explains very well how absolutely wrong RFK Jr. is in his recent comments about the safety of the synthetic food colors. This article is very factual and makes it clear that there is no data showing that these colors cause cancer and that there is also no significant data that shows that these colors cause hyperactivity.

Read the section titled: "Food Dyes Not Established to Cause Human Cancers" to get the facts related to the nonsense about cancer being spewed by RFK Jr. and various non-credible consumer groups like CSPI and EWG!!

Concerning RFK Jr's comments about hyperactivity and ADHD, here is what Dr. Ronald Kleinman, a pediatrician who studies nutrition at MassGeneral Hospital for Children had to say about the facts:
"I think that taken as a whole, there really is very little convincing evidence that food coloring contributes to attention-deficit/hyperactivity disorder, and banning them for that reason seems to me to be out way ahead of where the evidence is right now,”

The article also clears up the untrue comments being made these days stating that these colors are banned everywhere else. It states: "Kennedy is also incorrect in categorically stating that food dyes aren’t used in any other country. Regulations on food dyes vary around the world, and companies have reformulated some foods to eliminate synthetic dyes for certain markets. The European Union, for example, requires that foods containing certain food colors have warning labels stating that they “may have an adverse effect on activity and attention in children.” However, synthetic food dyes are allowed outside the U.S."

In fact, these colors are allowed in Europe and in most of the countries of the world and even in Europe, their own EFSA scientists reviewed the Southampton studies discussed in this article and concluded that there was no need for a warning label because these studies were flawed and did not show any causal link to hyperactivity. However, the politicians in the EU Parliament went ahead and required this warning label anyway because this issue had gotten a lot of media exposure. This was a political decision! There is no science supporting this warning label and the FDA came to the same conclusion back in 2008 after careful review of the Southampton studies and holding an advisory committee hearing on the subject.

We need to get these facts out into the public and legislators' hands since they are currently being influenced by misinformation being promoted by RFK Jr., CSPI, EWG and other groups about the safety of these colors!

In recent weeks, Health and Human Services Secretary Robert F. Kennedy Jr. has said that "very, very strong studies" link food dyes to cancer and ADHD. Experts are concerned about the impacts of unhealthy diets and obesity in the U.S., but some say Kennedy overstates the role of food dyes in chronic...

09/29/2022

GREAT NEWS!!! - FSANZ IN AUSTRALIA/NEW ZEALAND ALSO CONCLUDES THAT TiO2 IS SAFE FOR USE IN FOODS - AGREES WITH HEALTH CANADA AND UK FSA - DISAGREES WITH EFSA IN THE EU!!!

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.

In line with the outcomes of recent reviews conducted in the United Kingdom (UK) and Canada, FSANZ found no safety concerns.

This is a significant development and demonstrates the major flaws in the EFSA opinion on TiO2 (E171).

The EU Commission should RECONSIDER their overly precautionary decision to ban TiO2 (E171) in foods in the EU after seeing the consistent results of these scientific assessments by the UK, Canada and now Australia/New Zealand! Even EFSA's Opinion did not say that there actually was any REAL safety concerns demonstrated. Simply that there were some data gaps. Other regulators have examined this data and have determined that these data gaps were insignificant!

Certainly, there is no justification for expanding their ban to pharmaceuticals and cosmetics in the EU. Additionally, all other countries should postpone any decisions on acceptability of TiO2 in foods until after JECFA finishes their detailed scientific review in 2024.

You can access the FSANZ Report at the following website:

https://www.foodstandards.gov.au/consumer/foodtech/Pages/Review-of-titanium-dioxide-as-a-food-additive.aspx

GREAT NEWS!!! - FSANZ IN AUSTRALIA/NEW ZEALAND ALSO CONCLUDES THAT TiO2 IS SAFE FOR USE IN FOODS - AGREES WITH HEALTH CA...
09/29/2022

GREAT NEWS!!! - FSANZ IN AUSTRALIA/NEW ZEALAND ALSO CONCLUDES THAT TiO2 IS SAFE FOR USE IN FOODS - AGREES WITH HEALTH CANADA AND UK FSA - DISAGREES WITH EFSA IN THE EU!!!

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.

In line with the outcomes of recent reviews conducted in the United Kingdom (UK) and Canada, FSANZ found no safety concerns.

This is a significant development and demonstrates the major flaws in the EFSA opinion on TiO2 (E171).

The EU Commission should RECONSIDER their overly precautionary decision to ban TiO2 (E171) in foods in the EU after seeing the consistent results of these scientific assessments by the UK, Canada and now Australia/New Zealand! Even EFSA's Opinion did not say that there actually was any REAL safety concerns demonstrated. Simply that there were some data gaps. Other regulators have examined this data and have determined that these data gaps were insignificant!

Certainly, there is no justification for expanding their ban to pharmaceuticals and cosmetics in the EU. Additionally, all other countries should postpone any decisions on acceptability of TiO2 in foods until after JECFA finishes their detailed scientific review in 2024.

You can access the FSANZ Report at the following website:

FSANZ has completed a review of the safety of titanium dioxide (TiO2) as a food additive. Our review found there is currently no evidence to suggest dietary exposure to food-grade titanium dioxide is a concern for human health.

https://blackdiamondregulatory.com/news/the-role-of-titanium-dioxide-e171-and-the-requirements-for-replacement-materials...
09/12/2022

https://blackdiamondregulatory.com/news/the-role-of-titanium-dioxide-e171-and-the-requirements-for-replacement-materials-in-oral-solid-dosage-forms-an-iq-consortium-working-group-review

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.

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.

07/22/2022
If you want to learn more about the FACTS related to the recent ban of TiO2 (E171) in Europe for food uses and the poten...
03/28/2022

If 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, I suggest that you check out this Expert Panel Discussion that I participated in along with several other experts in the area. Please remember that there have been NO scientifically credible safety concerns demonstrated with the use of TiO2 in foods or pharmaceuticals. Simply a few data gaps which will be addressed by industry in the near future.

This discussion covers many of the key topics related to the current regulatory situation in the EU and the significant technical and patient availability challenges that would exist if this ban were to be extended to pharmaceuticals.

You can hear the first 10 minutes of the panel discussion at the link below and this will then give you access to the full panel discussion (about 60 minutes) if you simply provide your name and email address.

If 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, I suggest that you check out this Expert Panel Discussion that I participated in along with several other experts in the ar

I was very happy to be able to present information concerning excipient composition and enhancing supplier communication...
10/26/2021

I was very happy to be able to present information concerning excipient composition and enhancing supplier communication concerning excipient compositional profiles at last week's AAPS meeting in Philly. It was great to be able to attend a F2F meeting again and see many of my friends from around the industry.

Pharmaceutical Technology just published a great article about the need for Novel Excipients and an independent safety a...
03/05/2021

Pharmaceutical Technology just published a great article about the need for Novel Excipients and an independent safety assessment pathway for Novel Excipients at regulatory agencies. I was interviewed along with a number of other experts from the excipient and pharma industry concerning the importance of this issue.

If you are a drug formulator or someone from an excipient manufacturer or distributor, I encourage you to read this article and help us convince FDA to move forward with their pilot program for qualification of novel excipients that was proposed in the Federal Register in December 2019!! This type of program is critically important to drug development and innovation in both the drug and excipient industry that will ultimately help patients have higher quality medications that perform at a reasonable cost.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

I will be speaking on the Importance of Excipient Composition at the upcoming EXCIPERIENCE virtual conference along with...
01/19/2021

I will be speaking on the Importance of Excipient Composition at the upcoming EXCIPERIENCE virtual conference along with many other great speakers. I hope you will consider registering for this event!

I will be presenting a talk on the Importance of Excipient Composition and it’s Impact on Drug Performance at the upcoming EXCIPERIENCE virtual conference. Please consider registering for this event.

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