Two lamps
Where the line actually is, according to the two cases that drew it. This page is the public record, not our opinion of it.
Not even an E-Meter
Prepared and used as a religious practice. This is not a drug, not a medical device, and not medical advice. Nothing here diagnoses, treats, cures or prevents any disease, and no claim is made that it improves health or bodily function.
In United States v. An Article or Device "Hubbard Electrometer", 333 F. Supp. 357 (D.D.C. 1971), a device was held to have no medical value and was still not forfeited — the First Amendment protected its use in bona fide religious practice, on condition it carried this notice:
The E-Meter is not medically or scientifically useful for the diagnosis, treatment or prevention of any disease. It is not medically or scientifically capable of improving the health or bodily functions of anyone.
The rule that produced that outcome is the one worth stating plainly: Classification follows intended use, and intended use is shown through claims — not through ingredients, name, or method of administration. A court may not decide whether a religious practice is true. It may regulate a medical promise.
We start further back than the disclaimer requires. We do not assert the efficacy that notice had to deny. We publish what the studies found — including the ones that found nothing — and we grade our own weakest entries weak. A library that does that is not making a claim. It is showing its work, and leaving the weighing to you.
And the case that went the other way
In United States v. Ghadiali, 165 F.2d 957 (3d Cir. 1948), a colour-therapy lamp — a cabinet with a 1000-watt bulb, a fan and a water container for cooling, two condenser lenses and five ordinary coloured glass slides — was held a misbranded device and its owner's conviction was affirmed on twelve counts. Its label had said:
Measurement And Restoration Of The Human Radio-Active And Radio-Emanative Equilibrium By Attuned Color Waves — No Diagnosis — No Drugs — No Manipulation — No Surgery
Both devices were found to have no medical value. One went home to its church; the other was condemned. The devices are not what differ — the sentences differ. A religious frame is not a shield raised after the fact over a sentence that promises a cure. The E-Meter kept its practice by surrendering its claim; Spectro-Chrome kept its claim and lost the device, the literature and the practice.
Two lamps
Both devices were held to have no medical value. One went home to its church under a court-ordered disclaimer; the other's owner was convicted on twelve counts, and his literature was destroyed. The devices are not what differ. The sentences differ.
| device | year | the sentence | outcome |
|---|---|---|---|
| E-Meter 333 F. Supp. 357 (D.D.C. 1971) |
1971 | The E-Meter is not medically or scientifically useful for the diagnosis, treatment or prevention of any disease. It is not medically or scientifically capable of improving the health or bodily functions of anyone. |
released No medical value found — and no medical claim left standing once the disclaimer was ordered. Bona fide religious use was protected. |
| Spectro-Chrome 165 F.2d 957 (3d Cir. 1948) |
1948 | Measurement And Restoration Of The Human Radio-Active And Radio-Emanative Equilibrium By Attuned Color Waves — No Diagnosis — No Drugs — No Manipulation — No Surgery |
condemned The label promised measurement and restoration of the body by colour. That is an intended use, and the device was misbranded for it. |
That is the intended-use doctrine with the abstraction taken out of it, and it is worth more than any amount of general caution because it is specific: it names the exact register of sentence — measurement, restoration, equilibrium, attunement — that converts a description into a claim.
And the part that should stop anyone reaching for the religious frame as a shield
- He was religious, and it is in the record.
The 1943 opinion opens by identifying the plaintiff as "a Parsee Zoroastrian by birth" and a naturalised citizen. The court never reached religion, because Spectro-Chrome had never been framed as religious practice — only as better medicine, and then as protected speech.
A religious frame is not a shield you can raise after the fact over a sentence that promises a cure. It has to be what the practice actually was. - He argued free speech — that he was only lecturing.
The 1943 opinion rejected it: the court held the lecture was the practice.
Describing an intended use is not saved by calling the description a lecture. - He was sincere, and nobody suggested otherwise.
Sincerity was never the question. The question was the claim, and the claim was an efficacy claim.
A court may not decide whether a religious practice is true. It may regulate a medical promise. Those are different questions and only the second one was ever asked.
The guidance this rests on, with its dates
The two cases above are from 1948 and 1971 and they do not move. Guidance does, quietly, and a citation with no date on it cannot be audited. So:
| document | dates |
|---|---|
| General Wellness: Policy for Low Risk Devices — Guidance for Industry and Food and Drug Administration Staff supersedes “General Wellness: Policy for Low Risk Devices” issued on September 27, 2019 docket FDA-2014-N-1039 · document 1300013 |
issued 2026-01-06 checked 2026-09-09 |
| Clinical Decision Support Software — Guidance for Industry and Food and Drug Administration Staff supersedes “Clinical Decision Support Software” issued on January 6, 2026 docket FDA-2017-D-6569 · document GUI01400062 |
issued 2026-01-29 checked 2026-09-09 |
| Software as a Medical Device (SaMD): Clinical Evaluation — Guidance for Industry and Food and Drug Administration Staff | issued 2017-12-08 · withdrawn 2026-01-06 checked 2026-09-09 |
The substance did not change. The two-factor test and the two categories of general wellness intended use are unchanged from the superseded 2019 document. Nothing in the 2026 revision alters the intended-use doctrine this module encodes.
FDA states the purpose of the reissue in one line: Final Guidance published on January 6, 2026, to clarify how non-invasive sensing can be considered a general wellness product.
And the half of the doctrine that is not a prohibition
Everything else on this page is a negation. This is the one federal document that says what a surface like this one is allowed to be about. A general wellness product, in the guidance's own two factors, is one that are intended for only general wellness use, as defined in this guidance; and present a low risk to the safety of users and other persons. The first category of such claims may relate to: weight management, physical fitness, including products intended for recreational use, relaxation or stress management, mental acuity, self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem), sleep management, sexual function.
Among FDA's own worked examples in that category: Claims to increase, improve, or enhance the flow of qi “energy”
And the sentence closest to this library's whole posture, which is the agency's,
not ours: A product’s inclusion under the general wellness policy in this guidance does not establish that it has been shown to be safe and/or effective for its intended use.
Being inside the policy is not a
finding that anything works. We say the same thing, and we grade our weakest entries weak.
The same page, from another surface’s point of view
The doctrine does not change; the sentence a given surface has to avoid does. colour · entrainment · practices · reports · exams
This is not a laboratory result. No specimen was taken and no clinical assay was run. It is a record of self-administered measurements — the same kind of thing as a sleep diary or a home blood-pressure log — laid out so a clinician can read it quickly.