Kitty odor product seized; "Scent-Free' would only mask, not cure, infection

Kitty Odor Product Seized

"Scent-Free' Would Only Mask, Not Cure, Infection

"Whew! Ammonia! You open thewindows, and I'll clean the litter box,' she said.

"And then,' he said, "I'm off to thedrugstore to get some anti-ammonia-odor medicine we can give this cat.'

Wrong move. The right move wouldhave been a trip to a veterinarian--with the cat. Ammonia odor in a cat's urine is a sign of infection, and that calls for a doctor's care.

Here are more wrong moves. ForestPharmaceuticals, Inc., of Maryland Heights, Mo., not only broke the law by distributing its illegally labeled, anti-ammonia-odor product, SCENT-FREE, it also ignored FDA's warning to stop. Giving the mislabeled medicine to a sick kitty in lieu of a visit to the vet could be costly to the kitty's health. Selling the product was certainly costly to Forest Pharmaceuticals: Last October, as requested by FDA's St. Louis office, a U.S. marshal seized nearly $17,000 worth of SCENT-FREE capsules.

FDA's investigation began with an inspectionof the firm in April 1984, shortly before Forest Laboratories, Inc., of New York City bought the company. The St. Louis office investigator collected samples of all the labels for the company's products and sent them to FDA's Center for Veterinary Medicine for evaluation. Several were deemed illegal. In particular, said center experts, SCENT-FREE was an unapproved animal drug, since FDA knew of no scientific evidence showing that the product's active ingredient, methionine, was safe and effective for the use claimed in the label: controlling odor in cat urine. In a regulatory letter dated June 12, 1985, the St. Louis office spelled out FDA's problems with SCENT-FREE and the firm's other products, as well as the corrections the firm was to make.

The firm responded with promises tomake nearly all the changes FDA required, except with regard to SCENT-FREE.

The firm claimed that the productwasn't a drug but a food supplement, since the product's active ingredient, methionine, was an amino acid essential to the diet.

The firm also defended the packagestatement, "The major cause of the bad odor . . . is ammonia in the urine, which SCENT-FREE eliminates by acidifying the cat's urine.' It argued that the statement was consistent with labeling for a food supplement. The basis for the "acidifying' effect was this: When methionine is absorbed, sulfuric acid results, and that neutralizes the ammonia (which is alkaline) in the cat's urine, the company contended.

That's wrong information, said FDA'sveterinary drug experts last March. The facts are:

While it's true that methionine is anessential amino acid, the claim of controlling odor in cat urine is a medical claim, and that makes the product a drug, not a food supplement.

Normal cat urine is already acid, so"acidifying' it isn't sensible.

Normal cat urine doesn't contain ammonia.

If cat urine does have an ammoniaodor, it's because an infection has produced a substance that can cause urea (a component of urine) to change into carbon dioxide and ammonia.

The FDA investigator paid a follow-upvisit to the firm early last August. Labeling corrections were still needed for some products, including SCENT-FREE. Again, officials agreed to make changes for the other products, but not for SCENT-FREE. The investigator collected samples of SCENT-FREE as evidence for a possible sizure, which the St. Louis office recommended on Aug. 26. A complaint was filed against the drug on Oct. 12 in the U.S. District Court in St. Louis. The U.S. attorney charged that SCENT-FREE was a new animal drug and was illegal since there was no FDA-approved New Drug Application for it. On Oct. 23, some 709 cases of SCENT-FREE were seized by a U.S. marshal and slated for destruction. A recall wasn't needed because the expiration date for the drugs was March 27, 1987.

Soup to Bugs

The "White Rabbit Brand * * * ChingPo Leung Soup Mix' that resided in a warehouse in lower Manhattan last January had the wrong name. It should have been called "bug soup.'

An investigator with FDA's New Yorkoffice was inspecting International Oriental Food Corp., a dealer in Oriental foods, when he came upon 30 cardboard cartons of dried soup mix imported from Hong Kong that had a definite bug problem. Insects of various species and sizes were crawling over the cartons. A look inside one carton disclosed 100 plastic bags filled with both dehydrated soup and insects.

Analysis of samples collected by theinspector found literally thousands of insects in each bag. It was, in fact, difficult to say whether some bags contained more soup or insects.

At FDA's request, the New York Departmentof Agriculture and Markets embargoed the 30 cartons of soup, valued at approximately $1,500. They were subsequently seized by a U.S. marshal and destroyed.

Strong Medicine

"Effective Strength!' said the labelon a bottle of cough syrup that a woman purchased last December at a drugstore in Camden, S.C. . . . and strong it surely was.