FDA and JAMA raise eyebrows at efficacy of head lice remedies – OTC/Natural Health

FDA and JAMA raise eyebrows at efficacy of head lice remedies – OTC/Natural Health – Brief Article

Labeling for lice-removing treatments may soon be getting a makeover, as the Food and Drug Administration dresses up its pediculicide monograph in an effort to improve the efficacy of over-the-counter lice remedies.

The FDA is proposing to revise its statement of identity, warnings, directions and certain other required statements with regard to the lice-ridding solutions. For one thing, the agency wants to instruct parents that thorough combing, use of a fine-tooth or special nit comb, in conjunction with the use of OTC pediculicides is absolutely necessary in removing lice. In addition, the agency is proposing that proper lice and nit disposal procedures be included? in usage instructions, as lice can live up to two days without a host. What’s more, flits (or lice eggs) can survive away from a host up to 10 days. Keeping old lice combs lying around–even in the bathroom wastepaper basket–keeps the parasites present, and the possibility of reinfestation open.

Other changes recommended by the FDA include removing the word “pediculicide” from labels.

The costs to change the labels should total no more than $4,000 per SKU, according to DA estimates. The entire cost to the industry shouldn’t exceed $300,000, the agency expects.

JAMA raises questions

The monograph change comes on the heels of an article published in the February 2002 Journal of the American Medical Association, which may actually serve to louse up the pediculicide business. The category certainly doesn’t need any bad press–it’s experienced a steady decline in at least the last three years.

The JAMA report supported the theory that lice in the United States are becoming increasingly resistant to several popular lice-removal treatments. There were statistically significant differences in efficacy in all the lice-ridding solutions available over the counter that were tested.

The sole exception was prescription-only Ovide lotion (malathion 0.5 percent), which did not prove any less effective in killing lice in Florida than it did in a similar study of Pediculicide treatments on a “treatment-sensitive population of head lice” in Panama. However, lice may have become most resistant to another popular prescription remedy, 1 percent lindane shampoo, study results showed.

According to a variety of estimates, lice infestations in a typical year can affect more than 12 million people in the United States. Most of those who become lice hosts are under the age of 12, which makes lice-ridding products ideal for the back-to-school season. Fortunately, mothers frantically seeking a solution for their children s lice infestation don’t generally read JAMA, and therefore, still are likely to turn to their drug chains for their lice-ridding solutions.

Hogil Pharmaceuticals took the JAMA report in stride, as it introduced its A200 lineup at the National Association of Chain Drug Stores’ Marketplace Conference as the “most effective” OTC pediculicide solution. The company’s lice treatment kit includes a nit comb, lice- killing shampoo and a control spray to be applied to carpets, upholstery and bedding. Both A200 and Del Laboratories’ Pronto lice shampoo for-mulations contain the active ingredients piperonyl butoxide 4 percent and pyrethrum extract equivalent to 0.33 percent.

Del touted its line extension Pronto Plus pediculicide at NACDS Marketplace, pitching retailers in time for this year’s back-to-school season. In addition to killing lice, Pronto Plus also includes a nit comb and household spray for eliminating lice from clothing, bedding and other items.

Del will support the Pronto Plus launch with a $6 million advertising campaign running August through November.

Bayer also has introduced a kit concept for its Rid brand in the category. And retailers are into the act, as well. CVS is one chain that had a similar private label lice treatment kit in time for the back-to-school season.

Top brands in drug

Brand $ sales + Percentage change

Rid $18.3 -3.0%

Nix 13.2 -22.5

Pronto 4.1 -28.8

Acumed 2.4 -12.6

Clear 2.2 -31.2

Source: Information Resources Inc. for the 52 weeks ended June 16.

* Excludes private labels

+ All sales in millions

Lice category struggles across all channels

Food/drug/mass * Percentage Drug $ Percentage

$ sales + change sales + change

Lice treatments $92.4 -11.9% $67.1 -11.9%

Source: Information Resources Inc. for the 52 weeks ended June 16

* Excludes sales in Wal-Mart stores

+ All sales in millions

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COPYRIGHT 2002 Gale Group