News - Making Lice Treatments Clearer

Making Lice Treatments Clearer, If Not Less Embarrassing

By Cindy Skrzycki
Tuesday, January 20, 2004; Page E01

Lice. It's one of those four-letter words that every parent dreads hearing.

And seeking treatment is as bad as the infestation. The embarrassment of asking for lice shampoo (in the lowest whisper possible) from the pharmacist or hoping no one sees you reading the labels on the over-the-counter products to get the bugs out of your child's hair is one of the lower points of the parenting experience.

The Food and Drug Administration says it is here to help.

At the end of last month, the agency issued a final rule changing and amplifying some of the warnings, directions and other statements that parents and caregivers will encounter when they buy popular lice treatments such as Rid, Nix or the dozens of other brands (including private label ones) that are available at the drugstore. The rule goes into effect in 18 to 24 months, depending on the size of the manufacturer.

"Part of our concern was that the directions were not explicit enough," said David Hilfiker of the FDA's Division of Over-the-Counter Drug Products. "We are under the assumption that most people don't read through the label before they use the product."

The agency began work on the revision in May 2002. The idea was to synchronize the labels on over-the-counter lice treatment products with a design change that is supposed to make packaging more readable, direct and easy to understand.

The label that now appears on lice-killing products dates to 1994 and is in text format. The new label will point out warnings with bullets, and the directions on how to inspect, treat and remove the bugs will be extensive. For the first time, the agency will instruct consumers in how to actually do the job of combing out nits, or eggs, and disposing of them (Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.) Another change is that manufacturers will no longer be required to call the products "pediculicides," or lice killers. Instead, "lice treatment" will suffice.

The agency said it also was motivated to make the change, in part "to increase the probability of treatment success with these products."

"Back in the 1990s there was an epidemic of head lice and parents were very frustrated because schools adopted no-nit policies. After treatment, if there were nits, kids had to go home. We got lack-of-efficacy reports," said Marina Chang, an interdisciplinary scientist at the FDA who worked on the label change.

Some caregivers have tended to overuse the preparations, which has resulted in some bugs becoming resistant to the over-the-counter treatments. This then leads parents to turn to even stronger prescription chemical killers, which some safety advocates say must be used carefully if at all.

This may seem like nit-picking in the vast scope of federal regulatory activity, but lice are a big business and a burden to parents who have kids with stubborn infestations.

No-nit policies result in lost school days for the child, lost productivity for parents and employers, and expenditures on the expanding line of pricey products that are purchased. The National Pediculosis Association estimates that there are as many as 12 million cases of lice each year.

Doing this revision will cost makers of the preparations money.

The FDA estimated in the rule that relabeling would cost some $300,000. Qualis Inc., the largest private label manufacturer of pediculicide products in the United States, said it will have to redesign far more package labels than private brands -- at higher cost than the agency estimated.

Whatever the cost, those on the front line of battling lice, including some of the manufacturers, support more information on the label, figuring that clearer directions might help people use them more effectively. They know that the Internet is replete with home remedies (smother them with mayonnaise), names of professional nit-pickers, and statements cautioning parents about the use of preparations that have chemicals in them.

MarketResearch.com shows that sales of lice treatment were $130 million in 2002, but sales fell by 9.2 percent from the previous year and have been declining over the past few years. Data provided by ACNielsen showed that, measured by ounces, the use of lice preparations dropped to 20.4 million at the end of last year, from 31.6 million in 2000.

Some of the decline may be directly related to reading directions, but not fully paying attention to them.

Daniel Sheridan, systems manager with the National Pediculosis Association, said that when he gets calls from frantic parents who can't eradicate an infestation it sometimes reveals that they follow directions initially -- but then overtreat if they don't get immediate results. That then leads people to stop using the product out of frustration and turn to some other remedy.

"People do generally follow the directions. If anything, they use the products too much. If they still see bugs roaming around, they conclude they have to put more on or leave it on longer. Because it's over-the-counter, they think it's harmless," Sheridan said.

Richard Pollack, public health entomologist at the Harvard School of Public Health, read the fine print of the rule and pronounced it well-intentioned, but wanting and backward in some respects.

Pollack, who has done extensive research on lice infestations and let them live on his body, said eliminating the word "pediculicide" is a mistake because "lice treatment" will be used on a variety of products that are not intended to kill lice. "If there is evidence it kills, say kill," Pollack said.

He applauds the notion of unambiguous instructions, especially since "more than half the applications are on people without lice in the first place."

Other criticisms: He said there is no basis for "bagging anything for any period of time," as the rule suggests, or disinfecting hats, helmets or hair ribbons. Picked lice, he said, can go into the garbage can; they do not have to be sealed in a plastic bag.

"There are some positive things, but I was a little horrified," he said. "Hopefully, they will reconsider this in the future."