PE R S PE C T IV E
ported our right to make judg- “vaccines don’t prevent Covid This article was published on May 18, 2022,
ments about the certification sta-
tus of physicians to whom we
grant the credential.
As the ABIM confronts the
danger of medical misinforma-
tion, we recognize that there are
many clinical issues on which
physicians legitimately hold a
spectrum of opinions, all sup-
ported by evidence; such justifi-
able positions would not make it
as “distractors” on our exam, nor
would they meet our definition
of “false information,” as deter-
mined by experts consulting the
An audio interview literature. A whole
with Dr. Baron is range of statements
available at NEJM.org with which many —
or even most — physicians might
disagree would therefore not trig-
ger our disciplinary process. On
the other hand, when someone
certified by the ABIM says some-
thing like “the origin of all coro-
nary heart disease is a clearly
reversible arterial scurvy” or
“children can’t spread Covid” or
The Dietary Supplement Listing Act of 2022
Institutionalizing Misinformation — The Dietary Supplement
Listing Act of 2022
Pieter A. Cohen, M.D., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.​​
B efore the Covid-19 pandemic,
58% of American adults used
vitamins, minerals, botanicals,
live microorganisms, or other
dietary supplements to prevent
or treat various conditions, in-
cluding viral infections, memory
loss, and heart disease.1 Many
people have similarly sought out
supplements to prevent or treat
Covid-19, which contributed to
Americans spending an estimat-
ed $55 billion on dietary supple-
ments in 2020.
Dietary supplements are often
n engl j med 387;1  nejm.org  July 7, 2022
The New England Journal of Medicine
Downloaded from nejm.org on July 20, 2022. For personal use only. No other uses without permission.
Copyright © 2022 Massachusetts Medical Society. All rights reserved.
Physicians Spreading Misinformation on Social Media
deaths or hospitalizations,” we
are not dealing with valid profes-
sional disagreement; we are deal-
ing with wrong answers.
With nearly 1 million Ameri-
cans dead from Covid, and deaths
— some of them clearly prevent-
able — continuing at a rate of
more than 200,000 per year, it
has become imperative for our
profession to empower our insti-
tutions to signal clearly who is
— and who is not — providing
evidence-based information. We
physicians need to use the insti-
tutions we’ve created for profes-
sional self-regulation to main-
tain public trust by establishing
some recognizable boundaries.
There aren’t always right an-
swers, but some answers are
clearly wrong.
Disclosure forms provided by the authors
are available at NEJM.org.
From the American Board of Internal Medi-
cine, Philadelphia (R.J.B., Y.D.E.); and
Brown University, Providence, RI (Y.D.E.).
sold alongside over-the-counter
medications, but the regulatory
frameworks for these products
differ substantially. Unlike over-
the-counter and prescription
drugs, supplements aren’t vetted
by the Food and Drug Adminis-
tration (FDA) before being intro-
duced, and their advertising is
often deceptive.
The risks associated with sup-
plements are real. A Centers for
Disease Control and Prevention
study estimated that about 23,000
emergency department visits and
at NEJM.org.
1. Coleman C. License revocation as a re-
sponse to physician misinformation: pro-
ceed with caution. Health Affairs Forefront,
January 5, 2022 (https://www​.­healthaffairs​
.­org/​­do/​­10​.­1377/​­forefront​.­20211227​.­966736/​­).
2. Mello MM. Vaccine misinformation and
the First Amendment — the price of free
speech. JAMA Health Forum 2022;​ 3(3):​
e220732 (https://jamanetwork​.­com/​­journals/​
­jama​-­health​-­forum/​­f ullarticle/​­2790169).
3. Spreading COVID-19 vaccine misinfor-
mation may put medical license at risk.
Washington, DC:​Federation of State Medi-
cal Boards, July 29, 2021 (https://www​.­fsmb​
.­org/​­advocacy/​­news​-­releases/​­fsmb​-­spreading​
-­covid​-­19​-­vaccine​-­m isinformation​-­m ay​-­put​
-­medical​-­license​-­at​-­risk/​­).
4. Newton W, Baron RJ, Nichols DG. Joint
statement on dissemination of misinforma-
tion. Philadelphia:​American Board of Inter-
nal Medicine, September 9, 2021 (https://
www​.­abim​.­org/​­media​-­center/​­press​-­releases/​
­joint​-­statement​-­on​-­d issemination​-­of​
-­misinformation/​­).
5. Baron RJ, Emanuel EJ. Politicians should
not be deciding what constitutes good med-
icine. Stat News, March 7, 2022 (https://
www​.­statnews​.­com/​­2022/​­03/​­07/​­politicians​
-­should​-­not​-­be​-­deciding​-­what​-­constitutes​
-­good​-­medicine/​­).
DOI: 10.1056/NEJMp2204813
Copyright © 2022 Massachusetts Medical Society.
Physicians Spreading Misinformation on Social Media
more than 2000 hospitalizations
each year are attributed to adverse
effects of dietary supplements.2
Other investigators reported that
the incidence of liver failure re-
lated to dietary supplements in-
creased by a factor of 8 between
the passage of the law currently
governing these products, the
Dietary Supplement Health and
Education Act of 1994 (DSHEA),
and 2021.3
Little is known about which
of the tens of thousands of sup-
plement products available for sale
3
PERS PE C T IV E
in the United States pose the
greatest risk to consumers. The
FDA is tasked with removing
dangerous dietary supplements
from the market, but it doesn’t
have a systematic approach for
monitoring safety, nor can it
track which supplements are cur-
rently being sold to consumers.
Congress is trying to close this
information gap, but it is off to a
poor start.
A bill introduced by Senators
Dick Durbin (D-IL) and Mike
Braun (R-IN) in April, the Die-
tary Supplement Listing Act of
2022, would require supplement
manufacturers to provide the FDA
with a product’s name, ingredi-
ents, and health claims. For new
products, submissions would
need to be made before the sup-
plement is put on the market.
The proposed law would also
require the FDA to create and
maintain a publicly searchable
database of the estimated 80,000
supplement products available for
sale in the United States. The bill
is designed, according to Durbin,
to “protect consumers’ health and
save lives.” The FDA has sought
enhanced capabilities for promot-
ing supplement safety, suggest-
ing that certain steps, including
the establishment of a registry,
could permit the agency to “take
appropriate action to protect con-
sumers” from dangerous supple-
ments.4
There is little chance, however,
that the proposed law would meet
these important clinical and pub-
lic health goals; rather, it would
create the impression of reform
while leaving the current lax reg-
ulatory framework largely un-
touched. For example, the legis-
lation doesn’t provide the FDA
with a mechanism to confirm a
product’s ingredients before this
4 n engl j med 387;1  nejm.org  July 7, 2022
The New England Journal of Medicine
Downloaded from nejm.org on July 20, 2022. For personal use only. No other uses without permission.
Copyright © 2022 Massachusetts Medical Society. All rights reserved.
The Dietary Supplement Listing Act of 2022
information is imported into the
new database, even though sup-
plement labels are known to of-
ten be inaccurate. Thousands of
products have been found to not
contain the advertised ingredients
or to include toxic ingredients not
listed on the label. Recent exam-
ples include vitamin D supple-
ments without the declared quan-
tity of vitamin D, potassium
supplements with more than
twice the listed quantity of po-
tassium, berberine supplements
without berberine, and black co-
hosh supplements that instead
contained a cheaper plant substi-
tute. In addition to flagging
products with unpredictable vita-
min doses or undeclared plant
ingredients, the FDA has identi-
fied more than 1000 supplements
that contained prohibited pre-
scription or experimental drugs.
One inevitable outcome of the
bill would therefore be to compel
the FDA to post inaccurate ingre-
dient lists on its website.
The legislation also wouldn’t
regulate misleading health claims
made by supplement manufac-
turers. It would continue to allow
labels to include claims about a
product’s benefits without re-
quiring manufacturers to provide
related evidence to the FDA, so
long as these claims are phrased
in terms of effects on the struc-
ture or function of the human
body, such as “supporting a
healthy immune system” or “main­
taining normal sugar levels,” and
don’t mention a specific disease.
Ingredients could also still be
marketed as effective after clini-
cal trials have demonstrated the
opposite. Ginkgo biloba, for ex-
ample, wasn’t shown to prevent
cognitive decline or dementia
when studied in a large, well-
conducted clinical trial, but these
products can be described on the
label as “supporting healthy mem-
ory” or “supporting healthy brain
function.”
The bill wouldn’t stop the
promotion and sale of supple-
ments that contain dangerous in-
gredients, are poorly manufac-
tured, or are promoted using
prohibited disease claims. The
FDA would remain unable to
stop a supplement from being
sold — and listed in the agency’s
database — even if its label lists
an ingredient banned for use in
supplements, such as the stimu-
lant ephedra or the unapproved
drug phenibut, or if advertising
for the product includes false
and illegal claims, such as that
it’s a “cure for coronavirus.”
The proposed law is unlikely
to improve the quality, effective-
ness, or safety of marketed sup-
plements, but it could be a boon
for manufacturers. Not only does
it decline to place any new re-
strictions on the industry, but its
requirements could distract the
FDA’s Office of Dietary Supple-
ments, which has fewer than
three dozen employees, from en-
forcing the authority it has under
DSHEA to inspect supplement
facilities, issue import alerts, and
recall hazardous supplements.
From manufacturers’ perspec-
tive, the bill could also help re-
solve a long-standing public-
perception challenge. In the
mainstream media, the supple-
ment industry is often described
as operating in the 19th century,
free from government oversight.
It’s therefore in the industry’s in-
terest for consumers to believe
that the FDA is now overseeing
its products. Listing ingredients
and specious claims about a
product’s benefits on the FDA’s
website would implicitly give the
 PE R S PE C T IV E
agency’s imprimatur to dietary
supplements, even though the
agency would have no new pow-
ers to ensure their quality, effi-
cacy, or safety.
Public health could be better
served by the creation of a high-
quality registry of all lawfully
marketed dietary supplements.
We believe the new bill should be
extensively revised to introduce
basic safeguards. Congress could
give the FDA the authority to
read a supplement’s label before
registering the product and not
register the product if the label
lists unlawful ingredients or
claims. The bill could also be re-
vised to permit the FDA to swift-
ly remove products from the reg-
istry if the agency determines
that they are hazardous — for
example, if a supplement con-
tains toxic levels of selenium or
has been adulterated with a new
designer drug. The legislation
could require manufacturers to
submit a certificate of analysis to
ensure that labels are accurate
representations of products’ in-
gredients. In addition, to avoid
misleading consumers, health
claims submitted to the FDA
shouldn’t be posted publicly on
its website unless the agency
confirms that they are supported
The Portal
The Portal
Suzanne Koven, M.D.​​
I am a primary care physician
who, for many years, did not
have a primary care physician.
Instead, I presented myself annu-
ally and grudgingly to the Ob/Gyn
who had delivered my babies,
even long after those babies were
in high school. He checked my
n engl j med 387;1  nejm.org  July 7, 2022
The New England Journal of Medicine
Downloaded from nejm.org on July 20, 2022. For personal use only. No other uses without permission.
Copyright © 2022 Massachusetts Medical Society. All rights reserved.
The Dietary Supplement Listing Act of 2022
by high-quality clinical trials.
These revisions would benefit
consumers only if members of
the public could easily confirm
that a product was properly reg-
istered with the FDA. The pro-
posed bill requires that each reg-
istered product be assigned a
unique identifier. If this identifier
were incorporated into a quick
response (QR) code that could be
scanned before purchase, whether
in stores or on the Internet, con-
sumers could confirm that no
prohibited ingredients or disease
claims appeared on the label —
although such registration still
wouldn’t provide information
about the product’s efficacy or
safety.5
If advocates of the new legis-
lation, including the leading sup-
plement trade association, succeed
in maneuvering the bill through
Congress and into law, it will
give supplement manufacturers a
new channel for broadcasting
misinformation: the FDA’s own
website. By contrast, a thought-
ful revision of the bill could cre-
ate a useful resource for regula-
tors, clinicians, and consumers
to confirm that — at a minimum
— the ingredients listed on a
supplement’s label are compliant
with current law. Ensuring that
blood pressure and cholesterol, or-
dered mammograms, and placed
a stethoscope over my heart and
lungs, about which I teased him
— though no doubt his skills in
auscultation were at least as ad-
vanced as mine in performing
pelvic exams.
all dietary supplements are safe
and accurately promoted, how-
ever, will require much bolder
legislation that comprehensively
reforms DSHEA.
Disclosure forms provided by the authors
are available at NEJM.org.
From Cambridge Health Alliance, Somer-
ville (P.A.C.), and Harvard Medical School
(P.A.C., J.A., A.S.K.) and the Program on
Regulation, Therapeutics, and Law, Divi-
sion of Pharmacoepidemiology and Phar-
macoeconomics, Department of Medicine,
Brigham and Women’s Hospital (J.A.,
A.S.K.), Boston — all in Massachusetts.
This article was published on May 18, 2022,
at NEJM.org.
1. Mishra S, Stierman B, Gahche JJ, Po-
tischman N. Dietary supplement use among
adults: United States, 2017–2018. NCHS
Data Brief 2021;​399:​1-8.
2. Geller AI, Shehab N, Weidle NJ, et al.
Emergency department visits for adverse
events related to dietary supplements. N Engl
J Med 2015;​373:​1531-40.
3. Ghabril M, Ma J, Patidar KR, et al. Eight-
fold increase in dietary supplement-related
liver failure leading to transplant waitlisting
over the last quarter century in the United
States. Liver Transpl 2022;​28:​169-79.
4. Department of Health and Human Ser-
vices, Food and Drug Administration. Fiscal
year 2023 justification of estimates for ap-
propriations committees. 2022 (https://www​
.­fda​.­gov/​­media/​­157192/​­download).
5. Kapoor A, Sharfstein JM. Breaking the
gridlock: regulation of dietary supplements
in the United States. Drug Test Anal 2016;​8:​
424-30.
DOI: 10.1056/NEJMp2205675
Copyright © 2022 Massachusetts Medical Society.
The Dietary Supplement Listing Act of 2022
Then, when I hit 50, I decided
it was time to get serious about
my own medical care. This is how
I got serious about my own med-
ical care: I enlisted a colleague in
my internal medicine group to
serve as my doctor and then ig-
nored most of what she advised
5