FDA – Jeffrey Shuren, M.D., J.D.

Medical Social Worker Requests Investigation of FDA Conflicts of Interest

. . . re: Dr. Jeffrey Shuren’s baseless statements on the lack of adverse biological effects of Wireless RF Microwave Radiation

Apr 18, 2022

The following is a 2022 request to the FDA for an investigation related to possible conflicts of interest at the FDA submitted by Kevin Mottus, Medical Social Worker, specifically in regards to FDA’s Dr. Shuren who provided false assurances to the FCC regarding cell phone and wireless RF microwave radiation from cellular telephone devices and infrastructure antennas.

Request for Investigation of Malfeasance and Conflicts of Interest of FDA’s Jeffrey Shuren

. . . and a Petition of the FDA Requesting a Declaration of Imminent Hazard in regards to the Safety of Exposure to Non-ionizing Radiation in Dec 2021.

“Dr. Shuren’s family benefits from a billion-dollar telecom practice in the Arnold & Porter law firm where his wife is a partner. Most alarming was this quote from the law firm’s website: “We played a lead role in every transaction undertaken by AT&T (formerly SBC) since the passage of the 1996 Telecommunications Act . . .”

———- Forwarded message ———
From: Kevin Mottus
Date: Thu, Apr 14, 2022 at 9:18 AM
Subject: Urgent Supplement to Our Filing of March 15, 2021
To: FDA

Dear Mr. Scavdis:

Relevant to our request for investigation filed with your office March 15th of last year (attached), what we feared and what was the basis for the urgency of our filing, has occurred. False and misleading information published by the FDA with respect to wireless telecommunications RF microwave radiation emissions is now the subject of an active Imminent Hazard action involving the offices of Secretary Becerra and Acting FDA Commissioner Woodcock.

The population is at risk, based on the detrimental reliance of businesses, nonprofits, NGOs, individuals, and government entities on non-existent FDA safety standards for wireless exposure. The attendant risks underscore both the validity and the urgency of our plea to the Inspector General to investigate malfeasance and conflicts of interest at the FDA with respect to this critically important and rapidly evolving issue.

It has been more than a year since our filing with no response from your office on progress or disposition. As conveyed prior, and as the present time urgency compels, we stand ready to assist in any way possible. Lives depend on it. https://www.regulations.gov/docket/FDA-2021-P-1347/comments

Please confirm that you have received this email communication, reviewed the acompanying documents, and kindly send along any progress you can share on the overall investigation.

Sincerey,

Kevin Mottus
Medical Social Worker
Kevin.calibta@gmail.com

Download Documents Related to the Requested FDA Investigation

Excerpts from the request for investigation submitted to Inspector General :

“In February 2020, the Food and Drug Administration (FDA), under the signature of Dr. Jeffrey Shuren, released to the public a report entitled, “Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer”. This report was subsequently cited by the Federal Communications Commission (FCC) as their exclusive scientific rationale to forego updating 25 years old safety standards for wireless devices and infrastructure that were based on technologies that no longer exist . . .

For example, on November 1, 2018, Dr. Shuren released a confusing public statement disagreeing with the findings of a multi-million-dollar National Toxicology Program study, commissioned by Dr. Shuren’s own FDA, which concluded “clear evidence of carcinogenicity” from cell phone exposure. The statement by Dr. Shuren carried the wireless industry position that, despite the study results, cell phones were safe. Several months later, on April 24, 2019, in a communication with the FCC, Dr. Shuren advised unequivocally that cell phones have the ‘all clear’ as far as safety, even though the review cited above that was commissioned within his FDA as the basis for decisions on the cancer-causing potential of cell phones, was not completed until 9 months later, in February 2020. Our investigative findings, highlights of which are appended hereto, compelled us to reach out to you, the Inspector General, as it has revealed that the documents herein, and other prior communications and public releases, exhibit a pattern of apparent collusion and possible conspiracy among the FCC, the FDA and the many trade association and corporate appendages of the wireless industry.

It further shows that this behavior has been spearheaded by Dr. Shuren, who we learned is replete with both personal and professional conflicts of interest. For example, Dr. Shuren’s family benefits from a billion-dollar telecom practice in the Arnold & Porter law firm where his wife is a partner. Most alarming was this quote from the law firm’s website: “We played a lead role in every transaction undertaken by AT&T (formerly SBC) since the passage of the 1996 Telecommunications Act . . .

Further, decisions by Dr. Shuren’s department with regard to diagnostic imaging can be construed to limit his ability to consider the dangers of wireless technology independently, as recognition of cell phone dangers that would compel alterations to prior FDA positions would also be disruptive to health care delivery. The sum total is that these apparent collusive and possibly conspiratorial actions serve to mislead the American public about the safety of a technology which now reaches virtually every man, woman and child in the country.”


Feb 2, 2018 Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure

Source web page here.

One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity.

With cell phones, we have relied extensively on a myriad of scientific evidence developed over many years to help inform our regulatory thinking. Although the Federal Communications Commission (FCC) sets the standard for radiofrequency energy exposure limits from cell phones, the FCC relies on the FDA and other health agencies for scientific expertise and input regarding those standards.

We respect the recently released research conducted by our colleagues at the National Toxicology Program (NTP), which is part of the National Institute of Environmental Health Sciences within the National Institutes of Health, on radiofrequency energy exposure. When we nominated this topic for study in 1999, there were limited epidemiological and long-term animal studies investigating the effects of radiofrequency energy exposure from cellular phones. Fortunately, since then, there have been hundreds of studies from which to draw a wealth of information about these technologies which have come to play an important role in our everyday lives. Taken together, all of this research provides a more complete picture regarding radiofrequency energy exposure that has informed the FDA’s assessment of this important public health issue, and given us the confidence that the current safety limits for cell phone radiation remain acceptable for protecting the public health.

In this latest study, the NTP looked at the effects of high exposure to radiofrequency energy in rodents. It’s important to understand that – as is commonly done in these types of risk assessment studies – the study was designed to test levels of radiofrequency energy exposures considerably above the current safety limits for cell phones to help contribute to what we already understand about the effects of radiofrequency energy on animal tissue. In fact, the current safety limits are set to include a 50-fold safety margin from observed effects of radiofrequency energy exposure. From the FDA’s understanding of the NTP results, male rats that showed carcinogenic activity were exposed to a radiofrequency energy exposure rate that is much higher than the current safety standard. As our colleagues at NTP note in a statement issued earlier today, “the levels and duration of exposure to radiofrequency radiation were much greater than what people experience with even the highest level of cell phone use, and exposed the rodents’ whole bodies. So, these findings should not be directly extrapolated to human cell phone usage.”

Looking at the results in animals, the conclusions still require careful discussion, as our preliminary understanding of the NTP results is that the study found mostly equivocal, or ambiguous, evidence that whole body radiofrequency energy exposures given to rats or mice in the study actually caused cancer in these animals. There are additional unusual findings from the study, such as the exposed rats living longer than the control group rats, that we are assessing to understand how that may be relevant to the results. The FDA looks forward to participating in the peer review of this study in March, which is an important and crucial step in scientific research to assure the integrity and quality of the data and the conclusions that can be drawn from it. Public comment is welcome during this period and can be provided through the NTP’s Federal Register notice.

As part of our work to assess this important public health and consumer safety issue, the FDA has reviewed many sources of scientific and medical evidence related to the possibility of adverse health effects from radiofrequency energy exposure in both humans and animals and will continue to do so as new scientific data are published. We have reviewed the 2016 interim NTP results and are currently reviewing the full set of data from the NTP draft final report. The FDA will work quickly to thoroughly review the data and consider any impact of this work within the context of the full body of scientific evidence on this exposure.

In the meantime, I want to underscore that based on our ongoing evaluation of this issue and taking into account all available scientific evidence we have received, we have not found sufficient evidence that there are adverse health effects in humans caused by exposures at or under the current radiofrequency energy exposure limits. Even with frequent daily use by the vast majority of adults, we have not seen an increase in events like brain tumors. Based on this current information, we believe the current safety limits for cell phones are acceptable for protecting the public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.