The 1999 FDA regulation governing labels for over-the-counter drugs won a “No Gobbledygook” award. But the regulation doesn’t ban gobbledygook. It merely allows plain English.
As a matter of fact, the regulation, which was issued in March 1999 and will be phased in over the next few years, specifically allows gobbledygook. Perhaps the “No Gobbledygook” award, from Vice President Al Gore and the National Partnership for Reinventing Government, should be renamed the “Some Gobbledygook” award.
For example, the regulation doesn’t ban “aggravate” from labels or require the phrase “make worse.” It allows both.
The regulation explicitly allows “application” or “applying.” It does not require “putting on” or “rubbing in” – although it implicitly allows them.
The regulation bars only one major gobbledygook word on nonprescription labels and inserts: “contraindications.”
Here is a list of common label and package-insert jargon; simpler substitutions that the FDA approves; and simpler substitutions that the FDA is silent on.
The first column is the jargon. The second column explains what the FDA says in its1999 regulation. If there’s an entry in the row, rather than “NA,” the jargon is always acceptable to the FDA. The last column recommends one of the FDA’s choices. Or it recommends words that the FDA doesn’t mention but are in the spirit of the 1999 regulation.
Why should your company do more than the FDA requires? If both “aggravates” and “makes worse” are acceptable to the FDA, why aggravate yourself with “makes worse”?
If the FDA says that “application” and “applying” are both acceptable, and says nothing about “putting on,” why should your company use the phrase “putting on”?
Because you want people to use your product. You want them to use it right. You want to be a consumer-friendly company. You want to be the company whose products the pharmacist recommends to consumers, because the directions are clear.
Can any label or insert use any of these simpler substitutions, no matter what the drug or product? Not necessarily. Ask a lawyer. Or as a jargon aficionado would say, “Seek the expert advice from a duly experienced legal practitioner.”
There’s some stuffiness that a decongestant just won’t help. Even some of the FDA regulation is stuffy. The FDA, referring to itself, wrote: “The agency endeavors to require the least amount of information possible to assure proper self-selection and use.” The agency won’t win an award for that sentence. That doesn’t prove that the agency is hypocritical. It proves how hard it is to write simply. This list should help.
Jargon |
The
FDA’s 1999 regulation |
Ken
Bresler’s Recommendation |
abdominal |
Use
“abdominal” or “stomach” (in context only). The FDA does not explain
which context it means. |
Use
“stomach” or “near the stomach.” |
accompanied
by |
Use
“accompanied by,” “you also have,” or “that occurs with.” |
Use
“you also have.” |
administer |
Use
“administer” or “give.” |
Use
“give.” It is a simple
one-syllable word, as opposed to “administer,” which has four
syllables. |
aggravate |
Use
“aggravate” or “make worse.” |
Use
“make worse.” It’s
simpler than “aggravate.” |
application |
Use
“application” or “applying.” |
Use
“putting on” or “rubbing in.”
They’re simpler phrases.
Don’t use “application,”
which also has means “job application.”
Why use a same word that is more common in a different
context? |
apply |
NA |
Use
“put on” or “rub in.” Don’t
use “apply.” The
local drugstore is full of products with “apply” in the directions.
The same drugstore may have a sign in the window, “Now
Hiring. Apply Within.” Why risk confusing consumers, who are more familiar with
the second usage? |
area |
NA |
Use
“skin” if that is what you mean. |
are
uncertain |
Use
“are uncertain” or “do not know.” |
Use
“do not know,” “are unsure,” or “are not sure.” |
assistance |
Use
“assistance,” “help,” or “aid.” |
Use
“help” or “aid.” They
are simple single-syllable words.
“Assistance” has three syllables.
If you’re shipwrecked and you spell out a message on the
beach in coconuts, what are you going to say?
“Help.” Not
“assistance.” Not
“aid.” |
assist |
NA |
Use
“help.” |
associated
with |
Use
“associated with,” “due to,” or “caused by” |
Use
“due to” or “caused by.”
They’re shorter, simpler, and clearer than “associated
with.” When you read
in the newspaper that someone is “associated” with organized crime,
is he a mobster or not?
Newspapers are sometimes vague on purpose, but labels should
not be. |
avoid |
NA |
Use
the phrases “don’t,” “as little as possible,” or “keep away from.” |
avoid
contact with eyes |
Use
“avoid contact with eyes” or “do not get into eyes.” |
Use
“do not get into eyes” or “keep away from eyes.” Don’t use “avoid contact with eyes,” for three reasons. One,
the package label might advise the consumer to contact a doctor. That
means “contact” will be used on the same label in two different
senses. Two, consumers
should do more than avoid getting this stuff in their eyes; they should not do so. Three,
in the context of eyes, "contact" can mean"contact
lenses." Why risk confusion, even momentarily? |
avoid
excess handling |
NA |
Use
the phrase “handle this as little as possible.” |
avoid
contamination |
Use
“avoid contamination” or “avoid contaminating.” |
This
is a hard one, because “contaminate” doesn’t have a commonly used
synonym. Recommendation:
“Don’t get dirt / anything else / [name of contaminant] in this
product.” |
avoid
inhaling |
Use
“avoid inhaling” or “do not inhale.” |
Use
“do not breathe this product,” or, if appropriate, “do not breathe
the fumes.” |
before
a doctor is consulted |
Use
the phrases “before a doctor is consulted,” “without first consulting
your doctor,” or “consult your doctor before.” |
Use
“ask” or “talk with,” whichever is appropriate. Use the phrases,
“before asking your doctor” or “before talking with your doctor”;
or “ask your doctor before” or “talk with your doctor before”;
or “ask your doctor first” or “talk with your doctor” first. |
beverages |
Use
“beverages” or “drinks.” |
Use
“drinks.” Even people
who know what “beverages” means hardly use the word in conversation.
One common context for “beverages” is “alcoholic beverages.”
If that’s what you mean, just say, “alcoholic drinks.” |
broken
skin |
NA |
Use
“cuts and scrapes” if that’s what you mean.
Use “cuts, scrapes, rashes, and burns” if that’s what you
mean. |
cleanse |
Use
“cleanse” or “clean.” |
Use
“clean.” It is simpler,
conversational, and easier to pronounce. |
consecutive |
NA |
Use
“in a row.” |
consult |
At
one point in the regulation, the FDA recommends using “consult,”
“contact,” or “ask.” Elsewhere,
it recommends using “consult” or “advise.” |
Use
“contact” or “ask.” They’re
simpler words than consult.
“Ask” has the additional advantage of being a single syllable. |
develops |
Use
“develops,” “begins,” or “occurs.” |
Use
“starts,” “happens,” or “comes.” |
difficulty |
Use
“difficulty” or “trouble.” |
Use
“trouble.” It has
two syllables; “difficulty” has four. |
difficulty
in urination |
Use
“difficulty in urination” or “trouble urinating.” |
Use
“trouble urinating.”
Not only is “trouble” shorter and more conversational than
“difficulty,” but “urinating” is a verb, which is preferable to
the noun “urination.” See
“urinating.” |
direct
(as a verb) |
NA |
Use
“tell.” |
directly |
Use
“directly,” “immediately,” or “right away.” |
Use
“immediately” or “right away.”
Don’t use “directly,” which is an obscure synonym for “immediately.” |
discard |
Use
“discard” or “throw away.” |
Use
“throw away.” It’s
more conversational. |
discontinue |
Use
“discontinue,” “stop,” or “quit.” |
Use
“stop” or “quit.” They
are more conversational and both have a single syllable. “Discontinue” has four syllables and is pretentious. |
dosage |
NA |
Use
“dose.” It’s shorter
and easier to understand. |
drowsiness |
Use
“drowsiness” or “the drowsiness effect.” |
Use
the phrases “may make you drowsy” or “may make you sleepy.” |
enlargement
of |
Use
“enlargement of” or “an enlarged.” |
Use
“get bigger” or “make...bigger.” |
except
under the advice of a doctor |
Use
“except under the advice of a doctor,” “unless directed by a doctor,”
or “unless told to do so by a doctor.” |
Use
“unless a doctor tells you to do so.”
The other phrases are in the passive voice, which is harder
to understand than the active voice.
The phrase “except under the advice of a doctor” is also
hard to understand because it uses a noun (“advice”) instead of
a verb (“tells”). |
exceed |
Use
“exceed,” “use more than,” or “go beyond.” |
Use
the phrases “use more than,” or “go beyond.” |
exceed
recommended dosage |
Use
“exceed recommended dosage” or “use more than directed.” |
Use
the phrases “use / take more than a doctor / the directions tell
you to” or “use / take more than the dose you’re supposed to.” |
excessive |
Use
“excessive” or “too much.” |
Use
the phrase “too much.” |
excitability
may occur |
Use
“excitability may occur” or “you may get excited.” |
Use
“you may get excited” or “you may get jumpy.” Don’t use “excitability may occur.” It’s in the passive voice, and doesn’t reveal where or in
whom this excitability may happen (not “occur”). |
exposure
to the sun |
NA |
Use
“go out in the sun,” “in the sun,” or “while outside in the sun.” |
experience |
Use
“experience” or “feel.” |
Use
“feel.” It’s one
syllable, as opposed to four. |
external
use |
NA |
Use
the phrase “use on the outside of your body.” |
following
(as in “after”) |
NA |
Use
“after.” “Following
means “after,” but it’s also a verb, as in “following the leader.” Why risk confusion with the verb, even momentarily? |
for
relief of |
Use
“for relief of” or “relieves.” |
Use
“relieves” or “makes better.” |
for
temporary reduction of |
Use
“for temporary reduction of” or “temporarily reduces.” |
Use
“temporarily makes smaller” or “temporarily makes better” (as
in “temporarily reduces swelling”). |
for
temporary relief of |
Use
“for temporary relief of” or “temporarily relieves.” |
Use
“temporarily relieves” or “temporarily makes better.” |
for
treatment of |
Use
“for treatment of” or “treats.” |
Use
“treats.” It’s a
single word with a single syllable, and is a verb.
Don’t use “for treatment of,” which is three words, with
a total of four syllables, and relies on a noun, “treatment.” |
frequently |
Use
“frequently” or “often.” |
Use
“often.” It’s shorter
and more conversational. |
if
contact occurs |
NA |
Use
“if you get this in / on.” |
if
practical |
Use
“when practical” or “if possible.” |
Use
“if possible” or “if you can.” |
immediately |
Use
“immediately,” or “as soon as.” |
Use
“as soon as,” “right away,” “quickly,” or “now” (as in “Call a
doctor now”). |
immediately
following |
Use
“immediately following” or “right after.” |
Use
“right after.” It
has three syllables, as opposed to eight syllables for
“immediately following.” |
improve |
Use
“improve,” “get better,” or “make better.” |
Use
“get better” or “make better.”
A consumer may understand “improve” when it is spoken,
but it’s a hard word to read. |
increased |
Use
“increased” or “more.” |
Use
“more.” |
increase
your risk of |
Use
“increase your risk of” or “cause.” |
Use
“cause” or “make…more likely.” |
indications |
Use
“indications” or “uses.” |
Use
the word “uses.” It
is shorter and more conversational.
And “indications” is not a synonym for “uses” in everyday
language. |
ingest |
NA |
Use
“eat” or “swallow.” |
ingestion
(as in “not intended for ingestion”) |
NA |
Use
“Don’t eat or swallow” or “Use only on the outside of your body.” |
inhalation |
Use
“inhalation” or “puff.” |
Use
“puff” or “breathe in.” |
insert |
NA |
Use
“put in.” |
instill |
Use
“instill” or “put.” |
Use
“put.” |
instruct |
NA |
Use
“tell.” |
intended
(as in “not intended for ingestion”) |
NA |
Use
the phrase “Don’t use.”
Don’t use the word “intended.”
Whether a product is intended for a certain use is irrelevant if your true aim is that people don’t use it a certain way. |
liberally
(as in “apply liberally”) |
NA |
Use
“a lot” or “generously,” as in the phrases, “use generously” or
“put on a lot.” |
minimize |
Use
“minimize” or “reduce.” |
Use
“make less” or “make less likely.” |
mucous
membranes |
NA |
Use
“nose, eyes, mouth, ears,” and if applicable, “vagina and anus.” |
nervousness,
dizziness, sleeplessness occurs |
Use
“nervousness, dizziness, sleeplessness occurs,” or “you get nervous,
dizzy, or sleepless.” |
Use
“you get nervous or dizzy, or you lose sleep.” Don’t use “nervousness, dizziness, sleeplessness occurs.”
That phrase doesn’t say in whom the conditions occur.
And that phrase depends on nouns.
These particular nouns are longer and harder to understand
that the corresponding adjectives (“nervous” and “dizzy”) and
verb (“lose sleep”). |
not
to exceed |
Use
“not to exceed,” “do not exceed,” or “not more than.” |
Use
“not more than.” |
not
to be swallowed |
NA |
Use
“Don’t swallow this.” |
obtain |
Use
“obtain” or “get.” |
Use
“get.” |
occur |
NA |
Use
“happen.” |
over-apply |
NA |
Use
the phrases “put too much on” or “put on too much.” |
per
day |
Use
“per day” or “daily.” |
Use
"daily." |
perforation
of |
Use
“perforation of” or “hole in.” |
Use
“hole in.” |
persists |
Use
“persists,” “persistent,” “continues,” “does not go away,” or
“lasts.” |
Use
“continues,” “does not go away,” “lasts,” “stays,” or “still have.” |
persistent |
Use
“persistent,” “that does not go away,” “that continues,” or “that
lasts.” |
Use
“that continues,” “that does not go away,” “that lasts,” “that
stays,” or “that you still have.”
Don’t use “persistent.”
It is more complex word than the other phrases.
It is also an adjective, which is harder to understand
than a verb. |
physician |
Use
“physician” or “doctor.” |
Use
“doctor.” It’s shorter,
more conversational, and easier to read for people who have trouble
reading English, including non-native English speakers.
Readers must know how to pronounce “ph”; the “s,” which
sounds like a “z”; the “y”; and the “ci,” which sounds like “sh.” |
present
(as in “redness is present”) |
NA |
Use
“you have redness” or “the child has redness.” |
presently |
Use
“presently” or “now.” |
Use
“now.” Don’t use
“presently”! It is
three syllables and a less common word than “now.”
More importantly, “presently”
means both “now” and “soon”! Do you want the consumer to call a doctor now or soon?
If now, say “now.”
If soon, say “soon.” |
prior |
NA |
Use
“before.” |
produce |
Use
“produce” or “cause.” |
Use
“cause,” “lead to,” or "make."
Don’t use “produce.”
It has a common
homograph (as in “fresh produce”) that can cause (not “produce”)
confusion. |
promptly |
Use
“promptly,” “quickly,” or “right away.” |
Don’t
use “promptly,” which is an imprecise word.
Does it mean “now” or “soon”?
Use, as appropriate, “quickly,” “right away,” “as soon
as,” or “now.” |
pulmonary |
Use
“pulmonary” or “lung.” |
Use
“lung.” It’s not
long. |
reapply |
NA |
Use
“put on again.” Don’t
use “reapply.” That’s
people do when they
don’t get the job they want. |
recur |
Use
“recur,” “reoccur,” “return,” or “come back.” |
Use
“return” or “come back.”
They’re more common. |
reduce |
Use
“reduce” or “minimize.” |
Use
“make less” or “make less likely.” |
seek
professional assistance |
NA |
Use
“get medical help” or “contact a doctor.”
Don’t use “seek professional assistance.” What kind of professional assistance? Certainly not an accountant.
So just say “medical” or “doctor.” |
sensation |
Use
“sensation” or “feeling” |
Use
“feeling.” It’s shorter,
easier to read, and more conversational. |
solution |
Use
“solution” or “liquid.” |
Use
“liquid.” Don’t use
“solution,” which people use more commonly in the context of solving
problems. |
rectal
use |
NA |
Use
the phrase “use on your rectum.”
The noun “rectum” is unfamiliar enough to people. The adjective “rectal” is less familiar. |
tends |
NA |
Use
“is likely to.” |
topical
use |
NA |
Use
the phrase “use only on your skin.” |
uncertain |
Use
“uncertain” or “do not know.” |
Use
“do not know,” “are
unsure,” or “are not sure.” |
unless
directed by a doctor |
Use
“unless directed by a doctor,” “except under the advice of a doctor,”
or “unless told to do so by a doctor.” |
Use
“unless a doctor tells you to do so.”
The other phrases are in the passive voice, which is harder
to understand than the active voice.
The phrase “except under the advice of a doctor” is also
hard to understand because it uses a noun (“advice”) instead of
a verb (“tells”). |
use
caution |
Use
the phrase “use caution” or “be careful. |
Use
“be careful.” It’s
easier to read and more conversational.
When you went outside to play as a child, your mother said,
“Be careful,” not “Use caution.” |
vaginal
use |
NA |
Use
the phrase “use on your vagina.”
Don’t use the phrase “vaginal use,” which is a concept.
The phrase “use on your vagina” is concrete. |
when
practical |
Use
“when practical” or “if possible.” |
Use
“if you can.” |
worsens |
Use
“worsens,” “gets worse,” or “makes worse.” |
Use
“gets worse” or “makes worse.” |