To the Editor,

Sheldon Wagner’s report¹ of fatal asthma in a child after use of a pyrethrin-based animal shampoo raises several matters that bear further clarification. Under current federal regulatory practices, the Environmental Protection Agency regulates various pyrethrin-containing products used to control insect infestations on animals, and other pyrethrin-containing products applied to inanimate objects (e.g., furniture and carpets) for control of insects. However, shampoos intended for use on humans, which may have even higher concentrations of pyrethrins than the product involved in the reported fatality, are regulated by the Food and Drug Administration. There are significant differences in the way in which these products are regulated by the two agencies.

EPA regulations specifically prohibit any claim of safety on the product label,² and federal law limits the nature of claims made for a pesticide “as a part of its distribution or sale.”³ On the other hand, FDA’s final regulatory review of over-the-counter pediculicide products includes a specific finding that they are “safe,” even though the products must bear precautionary labeling.⁴ Thus while manufacturers of products intended for use on animals and inanimate objects cannot label them as “safe” or “non-toxic,” manufacturers of over-the-counter shampoos intended for use on humans have claimed that they may be labeled as “safe,” citing the FDA document.

Using provisions of New York’s General Business Law, which prohibit deceptive advertising, the New York State Attorney General’s office has succeeded in eliminating false and misleading safety claims from the advertising of well over a hundred pesticide manufacturers and pest control services in New York State. However, the dilemma created by inconsistent EPA and FDA regulatory practices is apparent in two cases we recently prosecuted. While each respondent agreed to cease and desist from any safety claims for EPA-regulated sprays intended for use on pets and inanimate objects, they asserted a right to make such claims on their OTC shampoos for human use. They did, however, agree to accompany any such shampoo advertising claims with disclaimers that the label contained important health-related precautions.⁵ Because of jurisdictional limits, the advertising restrictions we obtained are only enforceable in New York State, so safety claims may be being made for OTC shampoos in other states.

Although FDA allows label claims of safety provided the specified precautions and other information are listed, acute allergic reactions to pyrethrin insecticides may occur from the use of any of these products, including those intended for use on humans. Physicians should not only be mindful of the fact that these reactions may occur, but that the labels that inform the choices of their patients are subject to inconsistent regulations. Physicians should warn patients about the potential consequences of the use of these products and be alert to the full spectrum of potential exposures when evaluating cases.

References

1. Wagner, S. “Fatal asthma in a child after use of an animal shampoo containing pyrethrin” WJM 2000; 173:86-87.
2. USEPA “Labeling requirements for pesticides and devices,” 40 C.F.R. 156.10(a)(5).
3. Federal Insecticide, Fungicide and Rodenticide Act, 7 USC136j(a)(1)(B).
4. USFDA, “Pediculicide Drug Products for Over-The-Counter Human Use; Final Monograph,” 58 Fed. Reg. 65452 (Dec. 14, 1993).
5. Assurances of Discontinuance in the Matter of Pfizer Inc., Respondent (in re: RID products) and in the Matter of Hogil Pharmaceutical Corp. (in re: A-200 products).

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