Products Containing Lactose and Lactose Derivatives‏ Will Not Require a USDA Import Permit

On September 12, 2016, The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services (VS) announced that products containing lactose, galactose or lactulose as the ONLY animal origin ingredient may enter into United States without a USDA APHIS VS import permit.

The decision to remove import permit requirements for lactose derived products comes as a result of the USDA APHIS’ determination that lactose (i.e., milk sugar) and several lactose derivatives (galactose and lactulose) do not pose a viable risk for Foot and Mouth Disease (FMD).

A USDA APHIS VS import permit (VS Form 16-6), will not be required for commodities for human and/or animal consumption or use if lactose, or its derivatives: galactose or lactulose, are the ONLY animal origin ingredient. USDA will publish this exemption to VS import permit requirements under newly created USDA Guideline #1107 (effective September 30, 2016).

Commodities that may be imported under USDA Guideline #1107 include:

  • Pharmaceuticals
  • Nutraceuticals
  • Dietary/nutritional supplements
  • Culture media
  • Medical devices
  • Placebos
  • Investigational Pharmaceuticals.

Imports of lactose and lactose derived products must be accompanied by the documents listed below and must be presented for review by the Department of Homeland Security, Customs and Border Protection (CBP) Agriculture Specialists/Officers at the U.S. port of arrival:

  • A document on company letterhead prepared by the producer/manufacturer, shipper, or seller identifying lactose, or its derivatives: galactose or lactulose, as the only animal origin ingredient; or
  • An official government certificate identifying lactose or galactose or lactulose as the only animal derived ingredient.

Questions regarding this update may be forwarded to

Daniel J. Bell
VP, Regulatory Compliance & Technical Affairs  

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