Import Alert 33-04
-
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 33-04
Published Date: 12/05/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Candy Pacifiers"
Reason for Alert:
The revision of this Import Alert, dated 2/16/2011, updates the alert to the current format and terminology and updates the charge code. Changes bracketed by ***
*** Review of gummy pacifier products conducted in 1989 by Health Hazard Evaluation Board (HEE No. 2144) concluded that the size and the shape of such products tended to increase the likelihood of it lodging in the upper airway and producing partial or complete obstruction. In addition, when these types of products become wet, they can become very slippery, enhancing the chance of asphyxiation. It was the Board's opinion that candy pacifiers present a potential choking hazard to infants and small children.
Importation of these potentially dangerous products continues to be a concern. ***
*** Review of gummy pacifier products conducted in 1989 by Health Hazard Evaluation Board (HEE No. 2144) concluded that the size and the shape of such products tended to increase the likelihood of it lodging in the upper airway and producing partial or complete obstruction. In addition, when these types of products become wet, they can become very slippery, enhancing the chance of asphyxiation. It was the Board's opinion that candy pacifiers present a potential choking hazard to infants and small children.
Importation of these potentially dangerous products continues to be a concern. ***
Guidance:
Districts may detain, without physical examination, all candy pacifiers, including product labeled as "Gummy Pacifiers", from all countries and all manufacturers/shippers.
Product Description:
Candy Pacifiers (gummy pacifiers)
Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food, because it contains a foreign object which may pose a choking hazard [Adulteration 402(a)(3)]."
***OASIS charge code: CHOKE HZRD***
***OASIS charge code: CHOKE HZRD***
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(33 L - - 07) Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), without Nuts and Fruit (without Chocolate)
Desc:Candy Pacifiers (Gummy pacifiers)
-
