The FDA’s 2022 rejection of an “imminent hazard” petition did not address HHS’s separate statutory duties to research electronic-product radiation, evaluate exposure, develop exposure-minimization methods, coordinate with other agencies, and consider product performance standards.
Ahead of the National Health Federation’s monthly Zoom meeting, an email circulated among people involved in promoting the program. It warned that someone should consult an attorney “before John Coates gets listeners too hopeful about this rabbit hole.”
I am John Coates, founder of RF Safe, and Public Law 90-602 is the supposed “rabbit hole.”
I welcome legal scrutiny. People should challenge claims about federal authority before repeating them publicly. But the concern expressed in this email rests on a basic category error: it treats an FDA decision about an “imminent hazard” regulation and medical-device classification as though it resolved HHS’s separate responsibilities under the federal electronic-product-radiation-control program.
It did not.
The email is responding to a legal argument I am not making.
The earlier petition asked HHS to declare an “imminent hazard” under 21 C.F.R. § 2.5.
RF Safe is asking what HHS is doing to satisfy its continuing research, exposure-evaluation, exposure-minimization, interagency-coordination, and performance-standard responsibilities under 21 U.S.C. §§ 360ii and 360kk.
Those are different legal questions, involving different statutory provisions and different forms of agency action.
What the FDA letter actually decided
The email highlights footnote 3 of a May 23, 2022 FDA response to a citizen petition. That footnote says smartphones, Wi-Fi routers, cell towers, antennas, smart meters, and other wireless products generally are not “devices” under § 201(h) of the Federal Food, Drug, and Cosmetic Act because they are not intended to diagnose, cure, mitigate, treat, or prevent disease.
That statement concerns the statutory category of a medical device.
It does not mean that smartphones and other wireless products fall outside FDA’s electronic-product-radiation authority.
In fact, the body of the same FDA letter expressly states that the products identified by the petitioners are “electronic products” governed by the Radiation Control provisions. FDA explained that some products, such as X-ray machines, can be both medical devices and radiation-emitting electronic products, while other products can be regulated solely as electronic products.
The petition requested that HHS declare an “imminent hazard” under 21 C.F.R. § 2.5. FDA concluded that this regulation did not apply because the electronic-product-radiation provisions do not use the statutory phrase “imminent hazard to the public health.” FDA therefore denied the particular action requested.
That is the holding.
The letter did not determine whether HHS is adequately:
- conducting or supporting modern RF research;
- evaluating contemporary exposure conditions;
- developing techniques to minimize unnecessary exposure;
- coordinating health research and recommendations with the FCC;
- evaluating chronic, pulsed, modulated, or combined exposures; or
- administering the performance-standard provisions of Public Law 90-602.
The highlighted footnote is therefore not a rebuttal to RF Safe’s position. Properly understood, the letter confirms that nonmedical wireless products fall within the separate electronic-product-radiation framework.
A document-date correction
The email describes the attached material as FDA’s response to a petition filed on May 4, 2023. The attached FDA letter is dated May 23, 2022 and says it responds to a petition received on December 21, 2021. Whatever occurred in 2023, this particular PDF cannot be a response to a petition filed a year after the letter was issued.
Public Law 90-602 is an entire statutory framework
The Radiation Control for Health and Safety Act of 1968—Public Law 90-602—is not one medical-device provision and not one “imminent hazard” theory.
Its operative provisions are now codified at 21 U.S.C. §§ 360hh through 360ss. The law defines “electronic product radiation” to include ionizing or non-ionizing electromagnetic radiation emitted through the operation of an electronic circuit. It defines an “electronic product” broadly enough to include manufactured products that contain electronic circuits and emit such radiation. The statutory notes specify that “Secretary” means the Secretary of Health and Human Services.
Section 360ii states that the Secretary “shall establish and carry out” an electronic-product-radiation-control program designed to protect public health and safety.
As part of that program, the Secretary shall:
- develop and administer performance standards under § 360kk;
- plan, conduct, coordinate, and support research and operational activities directed at minimizing unnecessary emissions and human exposure;
- maintain liaison with government agencies, professional organizations, industry, labor, and other organizations;
- study and evaluate emissions and conditions of exposure;
- develop, test, and evaluate exposure-minimization procedures and techniques; and
- consult with other federal agencies about testing, evaluation, and performance standards.
Those duties are not confined to products used in medical treatment. They are part of a distinct electronic-product-radiation program that expressly encompasses non-ionizing electromagnetic radiation.
Section 360ii also authorizes HHS to publish research information, make recommendations, issue grants, enter contracts, and procure electronic products for research and testing. The core program functions in subsection (a) are mandatory; the publication, recommendation, grant, and contracting mechanisms in subsection (b) are powers Congress gave the Secretary to carry them out.
What the performance-standard provision does—and does not—require
Section 360kk provides that the Secretary shall prescribe electronic-product performance standards if the Secretary determines that such standards are necessary to protect public health and safety.
The statute permits standards addressing product testing, measurement of radiation emissions, warnings, labels, and instructions for installation, operation, or use. It also requires consideration of the latest scientific and medical data, recommendations from other federal agencies and expert organizations, technical feasibility, and reliable testing procedures.
RF Safe is not claiming that § 360kk automatically dictates one predetermined numerical exposure limit.
Nor are we claiming that it automatically creates a nationwide tower-setback law. Tower siting, licensing, FCC exposure rules, and state or local land-use authority involve additional provisions of communications law. Public Law 90-602 itself says it does not supersede the functions of other federal agencies.
The defensible statutory position is this:
HHS has continuing research, exposure-evaluation, exposure-minimization, coordination, and standards-administration responsibilities. Those functions should produce a scientifically current record capable of supporting a reasoned determination about whether additional product performance standards are necessary.
A conditional duty to issue a standard does not eliminate the mandatory program that should inform the condition.
Why Secretary Kennedy cannot treat this as somebody else’s problem
Robert F. Kennedy Jr. is now the Secretary of Health and Human Services.
He was also listed as counsel on the joint briefs in the 2021 D.C. Circuit litigation challenging the FCC’s decision to retain its radiofrequency-exposure guidelines without initiating a new rulemaking. It is more precise to say that Kennedy helped litigate the challenge than to say he personally was the petitioner who “sued the FCC.”
The court granted the petitions in part and remanded the matter because the FCC had not adequately explained its treatment of significant record evidence concerning:
- harmful effects unrelated to cancer;
- children’s exposure;
- long-term exposure;
- RF pulsation and modulation;
- the ubiquity of wireless devices;
- technological developments since the guidelines were last updated;
- cellphone compliance-testing procedures; and
- environmental effects.
The court did not rule that the FCC limits had been scientifically proven unsafe. It expressly said that it was taking no position in the scientific debate and held only that the FCC’s cursory treatment of significant evidence was legally inadequate. The court also found that the FCC had adequately explained its cancer-related conclusion, including its response to the NTP and Ramazzini animal studies.
That distinction matters.
Kennedy’s prior litigation role does not automatically become an official HHS finding that a particular standard is necessary under § 360kk. But it does establish that the present Secretary is not a newcomer to this record. He cannot plausibly claim unfamiliarity with the long-term, non-cancer, testing, modulation, technological, and environmental questions presented to the court.
He previously helped argue that the federal response was inadequate. He now leads the department Congress charged with maintaining the electronic-product-radiation health program.
That is not proof of a predetermined outcome. It is a compelling basis for accountability.
FCC controls communications rules—but depends on health agencies
The FCC is the agency that establishes and enforces its RF-exposure limits for cellphones, transmitters, and communications facilities. But the FCC has itself acknowledged that it is not a health and safety agency and that it gives substantial weight to FDA and other expert organizations capable of evaluating biological and medical research.
FDA likewise states that it shares regulatory responsibilities with the FCC. FDA says it provides scientific input and expertise, consults on testing and evaluation, and collects and makes available scientific information concerning electronic-product-radiation hazards and controls, while the FCC sets the applicable RF-emission limits for cellphones and similar wireless products.
The institutional division can therefore be summarized plainly:
The FCC owns its communications regulations. HHS owns a substantial part of the federal health-science program that should inform those regulations.
HHS cannot simply order the FCC to rewrite an FCC rule. But neither can HHS treat the adequacy of the health research as solely the FCC’s responsibility.
When the FCC relies on HHS and FDA expertise, the quality, currency, transparency, and completeness of the HHS research record become indispensable.
The current research gap demands an answer
The National Toxicology Program’s cellphone-RF research page currently lists the program status as “Completed.”
The original NTP studies reported:
- clear evidence of an association with malignant heart schwannomas in exposed male rats;
- some evidence involving malignant brain gliomas in male rats;
- some evidence involving adrenal-gland tumors in male rats; and
- increased DNA damage in several tissues under the study conditions.
Those studies involved high whole-body exposures and signals associated with 2G and 3G technologies. They cannot simply be translated into a quantitative prediction of human risk from contemporary cellphone use, Wi-Fi, or infrastructure exposures. The D.C. Circuit recognized those limitations when it upheld the FCC’s explanation regarding the cancer evidence.
But the appropriate response to limitations in older studies is better research—not institutional silence.
NIEHS subsequently developed a smaller follow-up exposure system. Its current page says the work was technically difficult and more resource-intensive than expected, that the system was not representative of 4G, 4G-LTE, or 5G technologies, and that NIEHS has no further plans to conduct additional RF-exposure studies at this time.
We do not need to allege a conspiracy to identify the policy problem.
A federal research system built around 2G and 3G signals was found unsuitable for answering questions about newer technologies. The follow-up effort ended, and no additional RF-exposure studies are currently planned by NIEHS. Meanwhile, exposures, devices, network architecture, modulation patterns, usage behavior, and population dependence on wireless systems continue to evolve.
That is exactly when Public Law 90-602 should matter most.
The federal framework remains centered on thermal protection
The current FCC mobile-phone limit uses specific absorption rate, or SAR. The Government Accountability Office previously described the limit as having been designed to protect users from the thermal effects of acute RF exposure and recommended a formal reassessment of both the exposure limit and cellphone-testing requirements.
The 2021 D.C. Circuit decision did not establish that nonthermal injury occurs below the limits. It did hold that the FCC had not adequately explained its treatment of record evidence concerning alleged non-cancer effects, long-term exposure, pulsation, modulation, children, and technological change.
A thermal compliance test can answer an important question: whether RF energy absorption remains below the regulator’s thermal-centered limit.
It cannot, by itself, resolve every biological question involving chronic exposure, signal characteristics, vulnerable populations, adaptive responses, or subtle changes in cellular regulation. Those questions require appropriately designed biological research.
The research program should not assume that the absence of excessive heating is the same thing as the absence of every biologically relevant interaction. That proposition should be tested, not embedded as an unexamined gatekeeper determining which effects are considered worthy of investigation.
Low-fidelity biology: a research hypothesis, not a declared diagnosis
RF Safe proposes a broader research framework that I call low-fidelity biology.
The hypothesis asks whether chronic exposure to complex electromagnetic environments can reduce the precision, resilience, or regulatory fidelity of biological signaling without immediately producing one conventional disease endpoint.
At the systems level, I use the term meta-disease state to describe a proposed loss of biological fidelity that could, in principle, alter susceptibility across multiple pathways rather than mapping neatly onto one diagnosis.
These terms are not established medical diagnoses, and they should not be presented as settled science. They are hypotheses that a competent research program should be capable of testing.
That research could examine, among other targets:
- RF Safe’s proposed density-gating framework;
- voltage-sensitive S4 sensor domains and other charge-responsive protein structures;
- ion-channel gating and electrophysiology;
- membrane and protein signal transduction;
- calcium regulation;
- redox balance and oxidative signaling;
- mitochondrial function;
- DNA damage and repair dynamics;
- neurodevelopment and neural signaling;
- reproductive and endocrine function;
- immune regulation;
- circadian control; and
- interactions among duration, intensity, frequency, polarization, pulsation, modulation, duty cycle, and combined exposures.
The research question is not merely, “Does this exposure produce a named tumor?”
It is also:
Can long-term exposure alter the fidelity of biological regulation before a conventional disease endpoint becomes detectable—and, if so, under what exposure conditions, through what mechanisms, and with what consequences?
HHS does not have to accept RF Safe’s mechanistic model before conducting relevant research. The point of rigorous research is to test competing hypotheses, identify null results, establish dose-response relationships, determine reproducibility, and distinguish genuine biological effects from artifacts.
What reinvigorating Public Law 90-602 should mean
A credible reinvigoration would not consist of announcing one literature review or promising an unspecified future study. It would create a visible, auditable program tied to the statutory functions Congress identified.
1. Publish a current § 360ii accounting
HHS should identify the current studies, grants, contracts, interagency programs, exposure assessments, training activities, and operational work that satisfy each component of § 360ii(a).
2. Develop modern exposure systems
Research platforms should be capable of studying contemporary technologies and real-world signal characteristics rather than being limited to 2G and 3G exposures that federal researchers themselves acknowledge are not representative of newer systems.
3. Study realistic chronic exposure paradigms
Research should examine duration, intermittency, modulation, pulse structure, near-field and far-field conditions, multiple simultaneous sources, developmental windows, cumulative exposure, and potentially susceptible populations.
4. Require independence, replication, and open methods
Protocols, dosimetry, environmental controls, temperature data, code, raw results, exclusions, and statistical plans should be sufficiently transparent for independent replication.
5. Produce a formal HHS-to-FCC scientific record
HHS and FDA should state what the current evidence does and does not support, where uncertainty remains, what research is needed, and whether HHS recommends any change in testing, consumer information, exposure minimization, or regulatory policy.
6. Address § 360kk directly
HHS should disclose whether it has made, considered, or declined to make a current determination concerning the necessity of additional electronic-product performance standards—and identify the scientific and administrative record supporting its position.
7. Use the statute’s public-information authority
Section 360ii authorizes HHS to publish research information and make recommendations concerning radiation hazards and controls. Where uncertainty exists, the public should receive accurate explanations of what is known, what remains unknown, how products are tested, and what practical exposure-reduction measures are available.
The questions Secretary Kennedy should answer
Secretary Kennedy does not owe RF Safe a predetermined scientific conclusion. He does owe the public a transparent account of how his department is performing its statutory work.
The relevant questions are:
What current HHS research program satisfies § 360ii(a)(2), (4), and (5) for modern wireless technologies?
What work now addresses long-term, low-intensity, pulsed, modulated, cumulative, and combined exposures?
What replaced the NIEHS follow-up system that was found unrepresentative of 4G and 5G technologies?
What grants or contracts are supporting independent mechanistic and chronic-exposure research?
What formal scientific recommendations has HHS or FDA provided to the FCC since the issues identified in the 2021 court decision?
What current administrative record supports HHS’s position under § 360kk concerning whether additional product performance standards are—or are not—necessary?
How does Secretary Kennedy reconcile his prior role in challenging the adequacy of the FCC’s review with FDA’s continuing public statement that the weight of evidence has not linked cellphone RF radiation with health problems? FDA’s present public page continues to make that statement while also acknowledging its responsibility to monitor the evidence and provide scientific expertise to the FCC.
These are not demands for HHS to announce a conclusion before performing the work.
They are demands that HHS show the work.
This is not the argument the FDA rejected
The people in the email chain may have been trying to prevent overstatement. That instinct is reasonable.
But the conclusion drawn from the FDA letter is wrong because it attacks a claim RF Safe is not advancing.
We are not arguing that:
- an ordinary smartphone must be classified as a medical device;
- 21 C.F.R. § 2.5 applies to every radiation-emitting electronic product;
- FDA must issue an “imminent hazard” declaration;
- § 360kk automatically commands RF Safe’s preferred numerical standard;
- Public Law 90-602 automatically creates nationwide tower setbacks; or
- low-fidelity biology has already been established as a medical fact.
We are arguing that:
Congress created a continuing electronic-product-radiation-control program covering non-ionizing electromagnetic radiation. HHS must be able to demonstrate how it is carrying out that program for the wireless technologies and exposure conditions of the present—not merely those of decades past.
The attached FDA letter does not close that question.
It confirms that the products in question are electronic products governed by the Radiation Control provisions, then rejects a separate and inapplicable imminent-hazard mechanism.
Conclusion: the moral urgency is ours; the statutory program is Congress’s
Public Law 90-602 is not a rabbit hole.
It is a congressional framework assigning HHS responsibility for electronic-product-radiation research, exposure evaluation, exposure-minimization techniques, interagency coordination, and performance-standard administration.
Secretary Kennedy’s prior participation in the FCC litigation does not legally predetermine what HHS must conclude. But it places him in a unique position of knowledge and responsibility. He was counsel in a case that successfully challenged the adequacy of the FCC’s explanation. He now leads the department whose scientific expertise the FCC relies upon and whose Secretary is named in the radiation-control statute.
He cannot reasonably claim that the underlying questions were never brought to his attention.
The appropriate demand is not:
“Announce our conclusion because we say so.”
It is:
Rebuild the research capacity. Test modern exposures. Investigate biological mechanisms. Publish the methods and results. Coordinate transparently with the FCC. Apply the statutory criteria. Then show the American public the scientific and administrative record.
HHS does not owe us a predetermined outcome.
It owes the country a lawful, modern, transparent, and scientifically credible process.
