new infant formula
(2) For purposes of paragraph (1), the term “new infant formula” includes— (A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and (B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. For purposes of this paragraph, the term “major change” has the meaning given to such term in section 106.30 (c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986 ), and guidelines issued thereunder.