9723084
B248939

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION

In the Matter of

DEL PHARMACEUTICALS, INC. and DEL LABORATORIES, INC., corporations.

DOCKET NO. C-3837

COMPLAINT

The Federal Trade Commission, having reason to believe that Del Pharmaceuticals, Inc. and Del Laboratories, Inc., corporations (“respondents”), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:

1. Respondent Del Pharmaceuticals, Inc. is a Delaware corporation with its principal office or place of business at 178 EAB Plaza, Uniondale, New York 11556. Del Pharmaceuticals is a wholly owned subsidiary of Del Laboratories, Inc.

2. Respondent Del Laboratories, Inc. is a Delaware corporation with its principal office or place of business at 178 EAB Plaza, Uniondale, New York 11556.

3. Respondents have manufactured, advertised, labeled, offered for sale, sold, and distributed cosmetics and over-the-counter pharmaceuticals to the public, including “Pronto Lice Treatment” and “Baby Orajel Tooth & Gum Cleanser.” Pronto Lice Treatment is a pediculicide, which contains the active ingredients of 0.33 percent pyrethrum extract and 4 percent piperonyl butoxide. Baby Orajel Tooth & Gum Cleanser is a topically applied oral cleansing product, which is designed to clean the teeth and gums of infants and toddlers. Pronto Lice Treatment is a “drug” and Baby Orajel Tooth & Gum Cleanser is a “drug” and/or “cosmetic” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

4. The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act.

Pronto Lice Treatment

5. Respondents have disseminated or have caused to be disseminated advertisements for Pronto Lice Treatment, including but not necessarily limited to the attached Exhibits A through G. These advertisements contain the following statements:

A. “100% Effective In Laboratory Testing In Killing Lice And Eggs. 0% Lasting Chemical Pesticide Residue Left in Your Child’s Hair. Only One Lice Treatment Can Make These Claims.
...
Pronto is the only lice shampoo that’s laboratory-tested 100% effective in killing lice and eggs*...Plus Pronto actually helps prevent reinfestation.
Breakthrough Formula Pronto. 100% effective in laboratory testing in killing lice and their eggs. While leaving nothing behind but clean, healthy hair.
...
*Data on file. Use as directed.”
(Exhibit A).
 
B. “What parents should know about head lice infestations.
Fallacy & Fact
...
Fact
While it’s true that all lice killing shampoos can kill adult lice, they don’t all have the same effectiveness in killing lice eggs (nits) which can hatch later and cause reinfestation. Pronto Shampoo- and-Conditioner-in-One is laboratory proven to kill ALL lice and eggs.”
(Exhibit B).
 
C. “...brought to you by Pronto
The only lice shampoo laboratory tested 100% effective in killing lice and eggs without leaving a lasting pesticide residue. Pronto. So your child’s hair is clean and healthy.”
(Exhibit C).
 
D. “Announcer: Raulito is not going to school today because his mother found out he has lice.
Teacher: There isn’t a better treatment than Pronto shampoo. It’s the only one 100% effective against lice and eggs without leaving a lasting pesticide residue. Laboratory test show that it’s more effective than Rid.
Pronto is so effective that it guarantees it or your money back. Use Pronto! There is nothing more effective against lice.
Student (Raulito): And dead lice!”
(Exhibit D, translated from Spanish).
 
E. “Kills all the lice and their nits on contact.”
(Exhibit E, translated from Spanish).
 
F. “Get Lice Out of Your Hair and Home!
Fast Acting Pronto
Lice Killing Shampoo Kit
One Treatment Kills Lice & Their Eggs on Contact.”
(Exhibit F).
 
G. “Medical Update for Pharmacists.
. . .
Recommend Breakthrough Formula Pronto
Pronto represents a true breakthrough in pediculicide efficacy.
Pronto is Laboratory-Tested 100% Effective in Killing Lice and Eggs
Pronto is the first and only lice shampoo proven in single treatment laboratory tests to be 100% effective in killing lice and eggs.”
(Exhibit G).

6. Through the means described in Paragraph 5, respondents have represented, expressly or by implication, that:

A. Pronto Lice Treatment kills one hundred percent of lice eggs.
 
B. Pronto Lice Treatment is one hundred percent effective in killing lice and their eggs in a single treatment.
 
C. Pronto Lice Treatment helps prevent reinfestation.

7. In truth and in fact:

A. Pronto Lice Treatment does not kill one hundred percent of lice eggs. Pronto Lice Treatment is based on a pesticide which is not one hundred percent effective against lice eggs. As a result, purchasers are provided with an egg-removing comb, and are instructed to apply a second treatment in seven to ten days to kill any newly hatched lice.
 
B. Pronto Lice Treatment is not one hundred percent effective in killing lice and their eggs in a single treatment. In most cases, it must be reapplied in seven to ten days.
 
C. In many cases, Pronto Lice Treatment does not help prevent reinfestation. It does not leave a lasting pesticidal residue that would help prevent reinfestation from post-treatment contacts with other lice-infested people or things.

Therefore, the representations set forth in Paragraph 6 were, and are, false or misleading.

8. Through the means described in Paragraph 5, respondents have represented, expressly or by implication, that laboratory tests prove that Pronto Lice Treatment is one hundred percent effective in killing lice and their eggs.

9. In truth and in fact, laboratory tests do not prove that Pronto Lice Treatment is one hundred percent effective in killing lice and their eggs. Therefore, the representation set forth in Paragraph 8 was, and is, false or misleading.

10. Through the means described in Paragraph 5, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 6, at the time the representations were made.

11. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 6, at the time the representations were made. Therefore, the representation set forth in Paragraph 10 was, and is, false or misleading.

Baby Orajel Tooth & Gum Cleanser

12. Respondents have disseminated or have caused to be disseminated advertisements for Baby Orajel Tooth & Gum Cleanser, including but not necessarily limited to the attached Exhibits H and I. These advertisements contain the following statements:

A. “Baby teeth have special needs.
Pediatricians recommend Baby Orajel Tooth & Gum Cleanser.
...
·Pediatrician recommended.
Nine out of every ten pediatricians surveyed would recommend Baby Orajel Tooth & Gum Cleanser.”
(Exhibit H)
 
B. “Ordinary toothpastes are great for older kids, but baby teeth have special needs.
Discover why pediatricians recommend Baby Orajel Tooth & Gum Cleanser.
...
·Pediatrician recommended.
Nine out of every ten pediatricians surveyed would recommend Baby Orajel Tooth & Gum Cleanser.”
(Exhibit I)

13. Through the means described in Paragraph 12, respondents have represented, expressly or by implication, that competent and reliable surveys show that nine out of ten pediatricians would recommend Baby Orajel Tooth & Gum Cleanser.

14. In truth and in fact, competent and reliable surveys do not show that nine out of ten pediatricians surveyed would recommend Baby Orajel Tooth & Gum Cleanser. Among other reasons, the survey relied upon by respondents is methodologically flawed and the greatest number of respondents to that survey said they were only “somewhat likely” to recommend Baby Orajel Tooth & Gum Cleanser. Therefore, the representation set forth in Paragraph 13 was, and is, false or misleading.

15. Through the means described in Paragraph 12, respondents have represented, expressly or by implication, that nine out of ten pediatricians recommend Baby Orajel Tooth & Gum Cleanser.

16. Through the means described in Paragraph 12, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraphs 13 and 15, at the time the representations were made.

17. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraphs 13 and 15, at the time the representations were made. In addition to the reasons stated in Paragraph 14, the survey relied upon by respondents was not designed to elicit whether pediatricians actually do recommend Baby Orajel Tooth & Gum Cleanser to their patients. The survey merely asked pediatricians how likely they would be to recommend the product. Therefore, the representation set forth in Paragraph 16 was, and is, false or misleading.

18. The acts and practices of respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

THEREFORE, the Federal Trade Commission this eighth day of December, 1998, has issued this complaint against respondents.

By the Commission.

Donald S. Clark
Secretary

SEAL: