Medicinal Animal Feed Ingredients Are Classifiable as 'Antibiotics,' CBP Says

CBP found that the antibiotic effects of the three products, chlortetracycline hydrochloride (CTC-HCI), chlortetracycline feed-grade concentrate (CTC-FG) and neomycin sulfate, "dominate their chemical makeup, function and purpose," necessitating a classification as antibiotics.

The decision came in response to an internal advice request, originally initiated on behalf of importer Pharmgate, which described the products as intended for use in treating various animal diseases and infections. CTC-HCI and CTG-FG are broad-spectrum substances used in manufacturing of veterinary drugs, while neomycin sulfate is an antibacterial substance, Pharmgate said. All three products were imported into the U.S. and made into finished products at Pharmgate's facilities. The finished products are sold to licensed feed mills, farmers and manufacturers of medicated feed articles for use in livestock feeds to treat and control various infections and diseases that occur in livestock. The medicated feed products are administered in dosage forms that are added to the animal’s drinking water or added to animal feed.

Pharmgate argued that the products were drug substances, noting the FDA's Center for Veterinary Medicine approved CTC-FG, while CTC-HCI and neomycin sulfate are both listed under the FDA's definition of "purified drug substances." While CBP noted that FDA regulations were not binding on its decisions, the definitions provided in the Code of Federal Regulations are often instructive in determining commercial definitions, including the definition of "animal feed" as articles "intended for use for food for animals" and "a substantial source of nutrients," the agency said.

CBP first contemplated classification with heading 2309 as feeds. CBP found that animal feed preparation of heading 2309 "must fall under the category of either a complete feed, a supplementary feed, or a product used in making either." The agency said the items couldn't be considered “complete feed” preparations because they were not similar to those put up for retail sale as animal food.

CBP also considered the “supplementary feed” preparation. Additional U.S. Note 1 to Chapter 23 defines the term “mixed feeds and mixed-feed ingredients” as including products that are "admixtures of grains with molasses, oilcake, oil-cake meal or feedstuffs, and which consist of not less than 6 percent by weight of grain or grain products.” The products also didn't fall within the definition of mixed feeds or ingredients because they are not admixtures of grains and don't contain grains, CBP said. The agency found the products could be classified under heading 2309 only if they were a preparation used in making a complete or supplementary feed.

The explanatory notes to heading 2309 say that preparations (premixes) may include active substances such as antibiotics. Various ENs explain that such antibiotics are “obtained by simply drying the mass,” with the resulting dry substances having an antibiotic content of 8% to 16%. The notes also say that complete and supplemental feeds “should not be confused with certain preparations for veterinary uses. The latter are generally identifiable by the medicinal nature and much higher concentration of active substances.”

CBP said it has previously classified products under the category of “animal food preparations” and “animal feed premixes," including a similar CTC feed grade material under heading 2309. However, that product supplemented the nutritional value of the animal feed because it contained ingredients that provided nutritional value and sustenance.