Michael H Surgan
Environmental Protection Bureau,
NY State Attorney General’s Office
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.
- Wagner, S. “Fatal asthma in a child after use of an
animal shampoo containing pyrethrin” WJM 2000; 173:86-87.
- USEPA “Labeling requirements for pesticides and
devices,” 40 C.F.R. 156.10(a)(5).
- Federal Insecticide, Fungicide and Rodenticide Act, 7
- USFDA, “Pediculicide Drug Products for Over-The-Counter
Human Use; Final Monograph,” 58 Fed. Reg. 65452 (Dec. 14, 1993).
- 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).