21 CFR 101.70 - Petitions for health claims
| Cite as | 21 CFR 101.70 |
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43 practice notes
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Food Labeling: Revision of the Nutrition and Supplement Facts Labels
...could use to request an amendment to the definition of dietary fiber and the petition process for the authorization of a health claim (21 CFR 101.70) where a fiber that is the subject of an authorized claim would be considered a dietary fiber that we could add to the list of fibers in the d......
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Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...interested person may submit a petition to FDA requesting the agency to issue a regulation authorizing the health claim (see Sec. 101.70 (21 CFR 101.70)). The petitioner must demonstrate, among other things, that the use of the substance at levels necessary to justify the claim is safe and ......
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Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...authorized under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. ......
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Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...authorized under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. ......
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10 cases
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Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...authorized under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. ......
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Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...authorized under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. ......
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Pearson v. Shalala, No. 98-5043
...21 C.F.R. § 101.14(c) (1998). The FDA's authorization comes by an informal rulemaking under the Administrative Procedure Act. See 21 C.F.R. § 101.70 (1998); 5 U.S.C. § 553 (1994). This choice of a rulemaking rather than an adjudication--which would seem a more natural fit for this individua......
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Whitaker v. Thompson, No. 99-3247 GK.
...sections of the statute, including 21 U.S.C. § 343(r)(5)(D). In 1993, the FDA responded to the NLEA by promulgating 21 C.F.R. §§ 101.14 and 101.70, which explained the standards and procedures for FDA consideration of nutrient-disease claims. The FDA chose the same standard for authorizing ......
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3 firm's commentaries
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Is the FDA rule prohibiting the use of disclaimers, and instead outright prohibiting product labeling that is not supported by significant scientific research, an unconstitutional prior restraint...
...21 C.F.R. § 101.14(c) (1998). The FDA's authorization comes by an informal rulemaking under the Administrative Procedure Act. See 21 C.F.R. § 101.70 (1998); 5 U.S.C. § 553 (1994). This choice of a rulemaking rather than an adjudication--which would seem a more natural fit for this individua......
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
...interested person may submit a petition to FDA requesting the agency to issue a regulation authorizing the health claim (see Sec. 101.70 (21 CFR 101.70)). The petitioner must demonstrate, among other things, that the use of the substance at levels necessary to justify the claim is safe and ......
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FDA Announces Qualified Health Claim for Consuming Oils with High Levels of Oleic Acid to Reduce Coronary Heart Disease Risk
...12/ Qualified Health Claims Questions & Answers; FDA Response at 12. The requirements for submitting a petition are set out in 21 C.F.R. 101.70. 13/ FDA Response at 2. \\DC - 700999/000501 - 13366498 v5 - 3 - focuses its review on reports of human intervention and observational studies.......