(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable concentration is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million (ppm or mg/kg) or more of the sulfite in the finished food. The concentration of sulfite in the finished food will be determined using either:
(1) Determination of Sulfite in Food by Liquid Chromatography Tandem Mass Spectrometry; or
(2) AOAC Official Method 990.28.
(b) Any standardized food that, as a result of actions that are consistent with current good manufacturing practice, contains an indirectly added sulfiting agent that has no functional effect in the food and that would, in the absence of § 101.100(a)(4) of this chapter, be considered to be an incidental additive for purposes of § 130.8, conforms to the applicable definition and standard of identity if the presence of the sulfiting agent is declared on the label of the food.
(c) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and available from AOAC International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) AOAC Official Method 990.28, Sulfites in Foods, Optimized Monier-Williams Method, Section 47.3.43, Official Methods of Analysis, 21st edition, 2019.
(2) Determination of Sulfite in Food by Liquid Chromatography Tandem Mass Spectrometry: Collaborative Study, Katherine S. Carlos and Lowri S. De Jager; Journal of AOAC International, Vol. 100, No. 6, 2017, pp. 1785-1794.
[58 FR 2876, Jan. 6, 1993, as amended at 63 FR 14035, Mar. 24, 1998; 87 FR 2547, Jan. 18, 2022]
Notes of Decisions
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009).
· cites it 2× “30, 1965) (later codified at 21 C.F.R. § 130.9 (d)(1) (1965)). To effect this goal, the FDA announced in the rule a policy “to take no action against a drug or applicant solely because changes of [this] kind .”
Sidney Roginsky v. Richardson-Merrell, Inc., 378 F.2d 832 (2d Cir. 1967).
· cites it 2× “12595 (1960), 21 C.F.R. § 130.9 (1963 ed.). Believing defendant’s proposed letter to be too weak, the FDA withheld permission and insisted on a much stronger one which was approved on November 27 and mailed on December 1 to every doctor in the country and also to defendant’s…”
McEwen v. Ortho Pharm. Corp., 528 P.2d 522 (Or. 1974).
· cites it 2× “"* * * * * “ (e) It will be the policy of the Food and Drug Administration to take no action against a drug or applicant solely because changes of the kinds described in paragraph (d) of this section are placed in effect by the applicant prior to his receipt of a written notice…”
Feldman v. Lederle Labs., 561 A.2d 288 (N.J. Super. Ct. App. Div. 1989).
· cites it 3× “" 21 C.F.R. § 130.9 (a), 25 Fed.Reg. 12595 (December 9, 1960).”
Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 (D. Minnesota 2005).
“The regulation was originally codified at 21 C.F.R. § 130.9 (d); it then became 21 C.”
Cambiano v. Am. Cyanamid Co., 747 F. Supp. 543 (E.D. Mo. 1989).
“In 1965, about two years after the warning label was required, the FDA regulations were amended to insert 21 C.F.R. §§ 130.9 (d) and (e) which provide: (d) Changes of the following kinds proposed in supplemental new drug applications should be placed into effect at the earliest…”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009).
· cites it 2× “3 0 , 1965) (later codified at 21 C.F.R. § 130.9 (d)(1) (1965)). To effect this goal, the FDA announced in the rule a policy “to take no action against a drug or applicant solely because changes of [this] kind .”
In Re Tetracycline Cases, 747 F. Supp. 543 (W.D. Mo. 1989).
“In 1965, about two years after the warning label was required, the FDA regulations were amended to insert 21 C.F.R. §§ 130.9 (d) and (e) which provide: (d) Changes of the following kinds proposed in supplemental new drug applications should be placed into effect at the earliest…”
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