Import Alert 36-04

"Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones"

Fluoroquinolone antibiotics, including ciprofloxacin and enrofloxacin, have been used in the treatment of diseases. Enrofloxacin is approved for use in cattle (21 CFR 522.812)but there are no other approvals for use in other food animals. The use of fluoroquinolones in honey bees or their environment can result in residues in honey. Fluoroquinolones are not generally recognized as safe to treat any honey bee diseases nor are they approved for such use. In addition, fluoroquinolones have been prohibited from extra label use in food producing animals as per 21 CFR
530.41 because of concerns about the threat to public health. Fluoroquinolones used to treat any honey bee disease is considered to be an unapproved new animal drug use within the meaning of Section 512.

Furthermore, fluoroquinolones are not generally recognized as safe for any use in a manner that could reasonably be expected to result in their becoming a component of honey nor are they approved for this use. Therefore, fluoroquinolones in honey are considered to be unsafe food
additives within the meaning of Section 409 of the Food, Drug, and Cosmetic Act.

In February 2006, the Florida Department of Agriculture and Consumer Services (FDACS) became aware of a problem concerning adulteration of honey with fluoroquinolones. FDACS collected and analyzed samples of honey for residues of two of the fluoroquinolones of concern, ciprofloxacin and enrofloxacin. The state reported that residues of these antibiotics were found in honey that was traced back to a
firm from the People's Republic of China.

Because of concerns about the presence of fluoroquinolones in the food supply, the U.S. is continuing to develop methods and strategies to detect illegal residues and prevent their introduction into the U.S. food supply.

In 2007, two shipments of products declared and labeled as "blended syrups" were analyzed and found to contain ciprofloxacin. For that reason, in December, 2007, blended syrups were added to this import alert as a product of concern.

Districts may detain without physical examination (DWPE) all shipments of honey, honey products and blended syrups from the firms listed in the attachment for this Import Alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

All honey products (comb honey, strained honey, whipped honey, honey), Blended Syrups

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a food additive, namely, fluoroquinolone(s), that is unsafe within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)(i)";

(OASIS Charge Code = UNSAFE ADD]

OR

"The article is subject to refusal of admission pursuant to Section 8Ol(a)(3) in that it appears to be adulterated in that it bears or contains a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512 [Adulteration, 402(a)(2)(C) [ii)"

(OASIS Charge code = VETDRUGS]