21 C.F.R. 170.3 - Definitions

Cite as21 C.F.R. 170.3
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138 practice notes
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Food facilities registration,
    • United States
    • Federal Register October 10, 2003
    • October 10, 2003
    ...for the facility; [sbull] FDA also may require each registration to include the general food category (as identified under Sec. 170.3 (21 CFR 170.3)) of the food manufactured, processed, packed, or held at the facility, if FDA determines through guidance that this submission is necessary. F......
  • Separate Parts In This Issue Part VI Health and Human Services Department, Food and Drug Administration,
    • United States
    • Federal Register October 10, 2003
    • October 10, 2003
    ...for the facility; [sbull] FDA also may require each registration to include the general food category (as identified under Sec. 170.3 (21 CFR 170.3)) of the food manufactured, processed, packed, or held at the facility, if FDA determines through guidance that this submission is necessary. F......
  • Part II
    • United States
    • Federal Register June 25, 2007
    • June 25, 2007
    ...Authorized for use as a food additive under section 409 of the act; or (2) authorized by a prior sanction consistent with Sec. 170.3(l) (21 CFR 170.3(l)); or (3) if used as a color additive, subject to a listing that, by the terms of that listing (including a listing for use in coloring foo......
  • Food for human consumption: Current good manufacturing practice— Dietary supplements; manufacturing, packaging, labeling, or holding operations,
    • United States
    • Federal Register June 25, 2007
    • June 25, 2007
    ...Authorized for use as a food additive under section 409 of the act; or (2) authorized by a prior sanction consistent with Sec. 170.3(l) (21 CFR 170.3(l)); or (3) if used as a color additive, subject to a listing that, by the terms of that listing (including a listing for use in coloring foo......
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24 cases
  • Viggiano v. Hansen Natural Corp., Case No. CV 12–10747 MMM (JCGx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • May 13, 2013
    ...enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.” 21 C.F.R. § 170.3( o ) (11) (emphasis added). By definition, therefore, neither sucralose nor ace-k are “flavors,” as they do not give the product an original taste—r......
  • Nemphos v. Nestle Waters N. Am., Inc., No. 13–2146.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • January 8, 2015
    ...“a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” 21 C.F.R. § 170.3(i). Establishing “complete certainty” of “absolute harmlessness” is not required. Id. Although the NLEA's preemption provisions sweep broad......
  • Nemphos v. Nestle Waters N. Am., Inc., No. 13–2146.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • January 8, 2015
    ...“a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” 21 C.F.R. § 170.3(i). Establishing “complete certainty” of “absolute harmlessness” is not required. Id. Although the NLEA's preemption provisions sweep broad......
  • Nemphos ex rel. C.G.N. v. Nestle Waters N. Am., Inc., No. 13–2146.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • January 8, 2015
    ...“a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” 21 C.F.R. § 170.3(i). Establishing “complete certainty” of “absolute harmlessness” is not required. Id. Although the NLEA's preemption provisions sweep broad......
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8 firm's commentaries
1 books & journal articles
  • Safety and Health Regulation
    • United States
    • Torts, Volume Two
    • March 12, 2016
    ...170 define “scientific procedures” and establish eligibility criteria for classification as GRAS through scientific procedures. Under 21 CFR 170.3(h), scientific procedures “include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate ......

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