Missouriwatcher
Editor, Senior Moderator
10/11/2011:
Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones
Reason for Alert:
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.
Product Description:
All honey products (comb honey, strained honey, whipped honey, honey), Blended Syrups from: List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List) on website
http://www.accessdata.fda.gov/cms_ia/importalert_111.html
Detention Without Physical Examination of Honey Due to Chloramphenicol
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals, including bees (21CFR 530.41). Use of the antibiotic in humans is reserved for treatment of certain serious infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious or even fatal blood disorders, such as idiosyncratic aplastic anemia. Therapeutic doses are from one thousand to one million times the levels typically found in these products. However, since the adverse reactions are not dose related, it is not possible to identify a safe level of exposure to chloramphenicol.
Analysis of honey samples collected by FDA and others continues to reveal the presence of chloramphenicol in honey.
Product Description:
All honey products (comb honey, strained honey, whipped honey, honey):
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List) on website
http://www.accessdata.fda.gov/CMS_IA/importalert_110.html
According to an FDA article published Mar/April 1998: (US approved method to treat) two parasites causing the death of bee colonies...For tracheal mites, menthol is used once a year...For Varroa mites, a twice-a-year treatment with fluvalinate-impregnated plastic is used...
The only other medication used for bees is oxytetracycline...is a useful method of control, but does not provide a cure for this devastating disease of honey bees.
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm089053.htm
May 2001 FDA: Confirmation of Multiple Phenicol Residues in Honey
http://www.fda.gov/Food/ScienceRese...DrugChemicalResiduesMethodology/ucm113250.htm
July 1, 2011 FDA announced: ...use of lincomycin hydrochloride water soluble powder for the control of American foulbrood (Paenibacillus larvae) in honey bees
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm261709.htm
Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones
Reason for Alert:
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.
Product Description:
All honey products (comb honey, strained honey, whipped honey, honey), Blended Syrups from: List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List) on website
http://www.accessdata.fda.gov/cms_ia/importalert_111.html
Detention Without Physical Examination of Honey Due to Chloramphenicol
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals, including bees (21CFR 530.41). Use of the antibiotic in humans is reserved for treatment of certain serious infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious or even fatal blood disorders, such as idiosyncratic aplastic anemia. Therapeutic doses are from one thousand to one million times the levels typically found in these products. However, since the adverse reactions are not dose related, it is not possible to identify a safe level of exposure to chloramphenicol.
Analysis of honey samples collected by FDA and others continues to reveal the presence of chloramphenicol in honey.
Product Description:
All honey products (comb honey, strained honey, whipped honey, honey):
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List) on website
http://www.accessdata.fda.gov/CMS_IA/importalert_110.html
According to an FDA article published Mar/April 1998: (US approved method to treat) two parasites causing the death of bee colonies...For tracheal mites, menthol is used once a year...For Varroa mites, a twice-a-year treatment with fluvalinate-impregnated plastic is used...
The only other medication used for bees is oxytetracycline...is a useful method of control, but does not provide a cure for this devastating disease of honey bees.
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm089053.htm
May 2001 FDA: Confirmation of Multiple Phenicol Residues in Honey
http://www.fda.gov/Food/ScienceRese...DrugChemicalResiduesMethodology/ucm113250.htm
July 1, 2011 FDA announced: ...use of lincomycin hydrochloride water soluble powder for the control of American foulbrood (Paenibacillus larvae) in honey bees
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm261709.htm