Reading Labels Can be Hazardous to Your Health 

by Ken Bresler

Legal Times, September 18, 2000. Reprinted with permission. © 2000 NLP IP Company. A version of this article also appeared in The National Law Journal, November 13, 2000.

As a parent, I thank the FDA for issuing regulations last year allowing over-the-counter drugs to use plain English in their future labels.

My baby recently had a fever, making it necessary for her to receive a suppository of acetaminophen. (That’s generic Tylenol.) Then I realized just how necessary plain English on product labels is.

The very first sentence of the suppository directions – not written under the new regulation – offended plain English in at least five ways: “When practical, cleanse area around rectum with mild soap and warm water and rinse thoroughly.”

“When practical”? Nope, the common phrase is “If you can.”

“Cleanse”? Nope, the word is “clean.”

“Area around”? The directions mean “skin,” right? If so, they should say so.

“Rectum.” Is that the same as “anal opening” four paragraphs later? Why are we playing the synonym game when my baby has a temperature of 104 degrees?

Why use “thoroughly” when “well” is a one-syllable word, easy to read and pronounce? And “Rinse well” should be a separate sentence. That would obey the principle of placing only one thought or instruction per sentence.

You may laugh. You may say, “I can follow it, so what’s the big deal?” The big deal is that half of the people in America could be illiterate. (The exact figures depend on who’s counting and how literacy is defined.) A fifth of literate people can read rudimentary text with difficulty. The figures are imprecise, but we’re talking about millions of Americans for whom “cleanse” and “thoroughly” are too hard to read.

The big deal is that about 10 percent of people in America were born outside America. Unless they’re from English-speaking countries such as Ireland, or English-speaking communities such as in South Africa, they’re not native speakers of English.

The big deal is that health illiteracy is rampant. A 1999 article in The Journal of the American Medical Association reported that 27 to 44 percent of English-speaking Americans had inadequate or marginal health literacy — the ability to understand health information.

Finally, here’s the big deal for us overeducated lawyers: Health literacy goes down as we age. When we’re 85, we won’t understand package labels as they’re now written.

Fortunately, in March 1999, the Food and Drug Administration issued its regulation requiring that the labels on nonprescription drugs and the inserts in their boxes have a standard easy-to-understand format. Think about the easy-to-read nutritional labels on the junk food in your office vending machine. Now imagine a comparable format for over-the-counter drugs and products, listing active and inactive ingredients, what to use the drugs and products for, warnings, and directions. The regulation will be phased in over the next five years. Most, if not all, of the products you see in the drugstore now don’t have the new labels; I have yet to see one.

As part of its regulation requiring the easy-to-read format, the FDA allows some plain-English instructions. The unfortunate thing is that the FDA regulation didn’t go quite far enough. The regulation allows plain English in future labels, but doesn’t require it.

The regulation explicitly allows some of the jargon in the suppository instructions, such as “when practical” and “cleanse.” It also allows other pharmaceutical jargon, such as “administer” (as in “give”), “application” (as in “put on” or “rub in”), and “solution” (as in “liquid”).

I don’t want to be glib or gross, but package labels will never truly be in plain English until they are in the vernacular. The FDA skirted the issue by declaring that “difficulty in urination” is the same as “trouble urinating.” Let’s not be squeamish here. The required phrase should be “trouble urinating (peeing).”

Plain English won’t be completely effective unless it’s accompanied by effective graphics. The suppository directions depict a baby’s bottom, but – this is not surprising – no rectum or arrow. An adult hand, holding a suppository, is poised in the vicinity of the baby’s bottom. Just where exactly is that suppository supposed to go?

We can joke about suppositories – bodily parts and functions have been both funny and embarrassing since we were about six years old – but I’m serious. A baby’s health, and possibly life, is at stake. If a baby sitter (whose first language may not be English) can’t understand the package insert’s pompous euphemisms and prudish graphics, then a baby’s 104-degree temperature could rise to 105 degrees, and then 106. And it could be your baby.

Pharmaceutical companies are only beginning to implement the FDA regulation. But can we start thinking about the next step? How about requiring, not merely allowing, plain English on over-the-counter products? That’s what the Securities and Exchange Commission did in 1998 with financial prospectuses.

Luckily, technology might solve my objections to the FDA’s limited regulation. Twenty-five years ago, the debate over package inserts was whether consumers and patients should even get them. Ten years from now, drug containers might come with voice chips and video clips. “Push here for Espanol.” “Push here for a demonstration.” And even, “Push here if you want euphemisms for bodily parts and functions.”