Inspections, Compliance, Enforcement, and Criminal Investigations
Animal Magnetism Inc 30-Jan-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
January 30, 2008
Mrs. Ellen F. Greenberg, Co-Owner
Mr. Larry S. Greenberg, Co-Owner
Animal Magnetism Inc.
2038 Tamiami Trail N.
Naples, Florida 34102-4817
Dear Mr. and Mrs. Greenberg:
An investigation of your business, Animal Magnetism Inc., located in the Coastland Mall in Naples, Florida, conducted by representatives of the Food and Drug Administration on September 7, 2007, confirmed that you offer live turtles with a carapace length of less than four inches for sale to retail customers as pets. Your practice of selling turtles with a carapace of less than 4 inches is not in conformance with Title 21, Code of Federal Regulations, section 1240.62 [21 CFR 1240.62]. This regulation was enacted under the Public Health Service (PHS) Act, Section 361 [42 U.S.C. § 264]. You may find this regulation and other information regarding the sale of turtles through links on the Food and Drug Administration's home page at www.fda.gov.
The regulation specifies that viable turtle eggs and live turtles with a carapace length of less than four inches shall not be sold, held for sale, or offered for any other type of commercial or public distribution. Turtles of this size may carry Salmonella bacteria and transmit these bacteria to humans, causing salmonellosis. Salmonellosis is characterized by severe gastrointestinal symptoms (abdominal pain, nausea, fever, and diarrhea) and occasionally results in death.
Specifically, our investigation followed-up on a complaint involving a young child exhibiting clinical symptoms of salmonellosis after playing with a turtle with a carapace of less than 4 inches purchased from Animal Magnetism. The child's symptoms, which included fever and bloody diarrhea, required urgent medical care and hospitalization. Laboratory samples taken by the hospital confirmed the presence of Salmonella bacteria.
The regulations exempt certain sales of viable turtle eggs and turtles with a carapace length of less than 4 inches. These exemptions include the sale of such turtles and viable turtle eggs for bona fide scientific, educational, or exhibitional purposes, other than for use as pets. We are aware that your store, which is located in a retail shopping mall, routinely adds a notation to your customers' sales receipts stating that the turtles are being sold to them for educational or research purposes. Even with. such a notation, it is clear from our investigation that your firm has been selling, holding for sale, and/or offering for distribution undersized turtles as pets.
We request that you immediately cease the selling or further distribution of turtles with a carapace length of less than four inches at your store or any retail location. It is your responsibility to ensure that your operations are in compliance with the law. Selling, holding for sale, and/or offering for any other type of commercial or public distribution turtles with a carapace length of less than four inches in violation of the PHS Act and 21 CFR 1240.62 may result in further regulatory action being initiated against your firm without further notice.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to. correct this violation, including an explanation of each step taken to prevent reoccurrence. If corrective action cannot be completed within 15 working days, your response should state the reason for the delay and the time frame within which the correction will be completed.
Your reply relating to these concerns should be directed to the Food and Drug Administration, Attention: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, you may contact Ms. Shambaugh by telephone at (407) 475-4730.
Emma R. Singleton
Director, Florida District