The FDA’s Most Elastic Phrase: “Appropriate for the Protection of Public Health”
Is it a Standard or a Rorschach Test?
In my travels and meandering across the X-sphere, I came across this post from a Cardiologist, Dr. Marine. I don’t follow him, but as a consumer with an interest in harm reduction, definitions, and specifically words and phrases from the Food and Drug Administration with more than one interpretation (Twisty Science and Definitions), and other “public health” organizations in general. It hit a nerve. I was intrigued. And inspired.
I do very much appreciate posts outside my bubble questioning the integrity of the words and phrasing. I replied below his post (as did Phil): “Please, also add ‘for the protection of public health’…forgetting the ‘appropriate for the protection of public health’, a key phrase we in the vaping world hear constantly.
FACT: The FDA (Food and Drug Administration) just authorized a product from Glas.
Beyond a doubt, non-combustible nicotine products are far less harmful than smoking.
Safe and effective?
To be clear, they use this phrase/definition for drugs, not tobacco.
What does ‘safe and effective’ mean to the Food and Drug Administration? I thought you’d never ask. I asked Grok to do the interpretation to narrow it down to three bullet points. Here’s what it came up with:
Multi-phase clinical trials: Phase 1 (safety in small groups), Phase 2 (preliminary effectiveness), Phase 3 (large-scale confirmation of safety + effectiveness).
Benefit-risk review: FDA weighs whether benefits outweigh known risks for the intended use. No drug is 100% safe.
Ongoing monitoring: Post-approval surveillance, manufacturing inspections, and additional studies.
That’s a rigorous, well-defined process found here.
Appropriate for the Protection of the Public Health
What do these examples and their own words from the FDA imply?
“There’s no safe tobacco product”
“To protect public health….”
“Regulation improves public health… protects consumers”
So many questions.
A note for anyone in media: The FDA does not “approve” any tobacco product. They AUTHORIZE them. I’m amazed at how professional journalists do not know or understand this difference.
Let’s move on, if we can, to the definition of “appropriate for the protection of public health”. Above I ‘found’ the definition of ‘safe and effective’ via the FDA themselves.
This time, not so much. Huh. Imagine that?
What I found was this in the abstract of “What Is “Appropriate for the Protection of the Public Health” Under the U.S. Tobacco Control Act? [1]”, from Eric N. Lindblom, Food and Drug Law Journal, with bold and italics from me:
“Gaps in the statute leave certain aspects of this public health standard unsettled”.
(In the references at the bottom of this blog [4], I include the 2023 revised edition of the “FDA Deems Certain Tobacco Products […]” PDF.)
So again, I asked Grok to do the interpretation, as I did above with three bullet points. Here’s what it came up with:
“Appropriate for the Protection of the Public Health” (AFPPH) under the U.S. Tobacco Control Act:
Population-wide net benefit: FDA must determine that the action produces an overall positive impact on the health of the U.S. population as a whole.
Health-only criterion: Non-health factors (economics, illicit trade, etc.) don’t count except through their effect on total population health.
Broad discretion: FDA can act even with uncertainty and some risk of negative effects, as long as it’s not arbitrary or capricious.
But where did AFPPH come from?
“The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the U.S. Food and Drug Administration (FDA) broad authority over the regulation of commercial tobacco products. The statute also established a new standard to guide the FDA’s decision-making: its actions must be “appropriate for the protection of the public health” – commonly referred to as the public health standard…” (Link).
There’s no universally fixed scientific threshold for defining, or for applicants to conclusively demonstrate under a Premarket Tobacco Product Application (PMTA)—what “Appropriate for the Protection of the Public Health” ultimately means in practice. It is a broad statutory standard built around interpretation, projection, and regulatory discretion.
The TCA was written to ‘grandfather’ cigarettes. Isn’t that fun? As Ross pointed out, it is often described in commentary as the Marlboro Protection Act.
The same kind of broad, durable institutional language appears in the Master Settlement Agreement from a decade earlier, where long-term tobacco revenue structures became deeply embedded into state systems, and never expires.
Then I asked Grok: The AFPPH: It’s really ambiguous, isn’t it?
This was the response:
Yes, it is notably ambiguous.
Statutory gaps on key terms: The Tobacco Control Act doesn’t define “appropriate,” specify how large or likely a net public health benefit must be, or clarify how to weigh uncertain future impacts—leaving these largely to FDA’s discretion.
Risk of negative effects unclear: It doesn’t explicitly say whether an action that carries some risk of net harm can still qualify as AFPPH, or what balance of potential benefits vs. harms is acceptable.
Broad discretion, limited guardrails: This vagueness gives the FDA flexibility but also invites legal challenges, as courts review only whether the agency’s determination was arbitrary or capricious.
The standard prioritizes overall population health but leaves substantial room for interpretation.
In other words, AFPPH is not primarily asking whether a product is less harmful for an individual smoker—it is asking how that product might affect population behavior as a whole over time.
In practice, this means two products with similar toxicological profiles can face very different regulatory outcomes depending on how future population effects are modeled.
It starts to resemble a Rorschach test (the ink blot test used in psychiatry where interpretation varies by observer).
None of this means population-level concerns are imaginary. It means the standard itself leaves enormous room for interpretation in how those concerns are weighed, projected, narrated, and ultimately decided.
This matters because when a regulatory standard is defined by interpretation rather than measurement, outcomes can shift depending on how population outcomes are modeled, weighted, and projected - rather than what the underlying science shows.
What About Children, Flavors, Youth?
THEN I asked: Does it mention children or flavors or youth?
This was the response:
No direct mentions of flavors.
Youth/children: The paper briefly references “protecting youth” (and “minor children” in related versions) only as an example of a common misassumption — i.e., some people wrongly think FDA must give higher priority to youth protection over adult smokers under the AFPPH standard. The article argues the opposite: the standard focuses solely on net population-wide health impact, without special weighting for any subpopulation.
I always ask variations of “at what age is someone who smokes considered a ‘smoker’…at what age is it appropriate for harm reduction to ‘start’? Well, no one likes that question. However, there are answers.
In 2016, Truth Initiative said: “E-cigarettes pose substantially less harm than traditional cigarettes.”[6]
In 2018, Former Iowa Attorney General Tom Miller said:
“The most intensive adolescent e-cigarette users are far more likely to also be smokers. They may potentially benefit from e-cigarette use. There is no ethical basis for ignoring public health harm reduction benefits to those under 18.” - Former Iowa Attorney General Thomas J. Miller [7]
Also:
My consistent question that aggravates some, because “no child should” is always the immediate defense:
If the argument of “think of the children™,®, ©” ideology is SO important, and anyone (the few left) -18 and 18-20 since they’ve been restricted, already smoke, wouldn’t you want them to (under parental supervision for -18), immediately switch to a less harmful alternative? In harm reduction terms, that raises the same question we ask in other public health contexts: if risk is already present, what is the safer alternative pathway?
After all my best deciphering with my secret decoder ring, I’ve concluded there is no answer to my question of what is “appropriate for the protection of public health”.
AFPPH is not a precise scientific standard. It is a broad legal and regulatory framework built on interpretation, projection, and discretion.
"Deem": to consider or judge something in a particular way (Link), and I’ve always had trouble with the word “deem” in a public health setting.
In other words, these standards are not always fixed measurements. They are interpretations. Certainly, those can change over time, depending on who’s doing the interpretation.
Ok, fine - it’s a legal standard so broad and elastic that almost anything can be argued under it.
I did find one other site with an AFPPH reference. [3]
Final thoughts:
As a consumer, I know feelings about ‘illegal’ products are a fine line of widely varying difference of opinion. I don’t care about 40-something ‘authorized’ products that no one can find yet. I care about choice.
I care about people having immediate access to lower-risk alternatives to reduce or eliminate the harms associated with smoking until the FDA stops delaying meaningful access to lower-risk alternatives. Snus, pouches, and vaping [5] products are meaningful harm reduction choices for people who smoke. If they could access them.
That said, I agree with Dan. My response was polite, to target Susie Wiles and acting FDA Commissioner Kyle Diamantas.
Here’s what Dan stated on X:
Here was my response to his truth:
“I certainly hope @SusieWiles47 and @FDA_KyleD are listening.
The FDA has done nothing to help smokers quit smoking combustible cigarettes.
In reality, they have actively deterred quitting by failing to inform the public about the massive risk differences between cigarettes and lower-risk nicotine products, by withholding clear information, and by shrugging their shoulders, refusing to correct misleading rhetoric from nonprofits and media for more than a decade.” (You can read more from my post here).
[1] What Is “Appropriate for the Protection of the Public Health” Under the U.S. Tobacco Control Act? (Non-profit site)
[2] FDA’s “Efficiency” Promise: I’m Still Skeptical (Mine)
[3] What is FDA’s Standard of Appropriate for the Protection of Public Health? (Non-profit site)
[4 Author note:] Here are the exact quotes containing the phrase (or very close variants) from the PDF.1. Background section (Section II.A, approximately page 3 of the document)
[4 Author note:] Cigar warnings section (in the discussion of the optional alternative reproductive health warning for small-packaged cigars, around page 10).
[5] E-Cigarettes Are Saving Lives
[6] E-cigarettes pose substantially less harm than traditional cigarettes (Truth Initiative)
[7] Re: Youth tobacco and nicotine use – proportionate and responsible reaction
