21 CFR 101.14 - Health claims: general requirements
| Cite as | 21 CFR 101.14 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
142 practice notes
-
Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...a new definition of disease, FDA will use the preexisting definition of ``disease or health-related condition'' in Sec. 101.14(a)(5) (21 CFR 101.14(a)(5)) (formerly Sec. 101.14(a)(6)), which was issued as part of the implementation of the health claims provisions of the Nutrition Labeling a......
-
Bruton v. Gerber Prods. Co., Case No.: 12–CV–02412–LHK
...claims, 21 U.S.C. § 343(r)(1)(A); the FDA's “natural” policy, see21 C.F.R. § 101.22; 58 Fed. Reg. at 2407; the “health” claims, see21 C.F.R. § 101.14; and the “sugar-related” claims, see21 C.F.R. § 101.60. According to Defendants, “there is no label element Plaintiff challenges that FDA reg......
-
Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...outlines requirements for when a party may or may not use "nutrient content claims" or "health claims" on food labels.Specifically, 21 C.F.R. §§ 101.14 and 101.65 regulate when nutrient content claims or health claims can be made in the presence of other harmful nutrients. If fats, saturate......
-
In re Conagra Foods Inc., Case No. CV 11–05379 MMM (AGRx).
...21 C.F.R § 101.13 (limits on claims that can be made about the nutritional content of food, such as labeling a product “low sodium”); 21 C.F.R § 101.14 (health claims). Indeed, as ConAgra notes, 38 the FDA has regulated use of the term “natural.” 21 C.F.R § 101.22.39 While, as explained in ......
Request a trial to view additional results
66 cases
-
Bruton v. Gerber Prods. Co., Case No.: 12–CV–02412–LHK
...claims, 21 U.S.C. § 343(r)(1)(A); the FDA's “natural” policy, see21 C.F.R. § 101.22; 58 Fed. Reg. at 2407; the “health” claims, see21 C.F.R. § 101.14; and the “sugar-related” claims, see21 C.F.R. § 101.60. According to Defendants, “there is no label element Plaintiff challenges that FDA reg......
-
Pearson v. Shalala, No. 98-5043
...that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants' Page 652 four claims links the consumption of a particular supplement to the reduction in risk of a particular......
-
Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
...outlines requirements for when a party may or may not use "nutrient content claims" or "health claims" on food labels.Specifically, 21 C.F.R. §§ 101.14 and 101.65 regulate when nutrient content claims or health claims can be made in the presence of other harmful nutrients. If fats, saturate......
-
In re Conagra Foods Inc., Case No. CV 11–05379 MMM (AGRx).
...21 C.F.R § 101.13 (limits on claims that can be made about the nutritional content of food, such as labeling a product “low sodium”); 21 C.F.R § 101.14 (health claims). Indeed, as ConAgra notes, 38 the FDA has regulated use of the term “natural.” 21 C.F.R § 101.22.39 While, as explained in ......
Request a trial to view additional results
18 firm's commentaries
-
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...
...that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants' four claims links the consumption of a particular supplement to the reduction in risk of a particular [*3] dis......
-
Finger Lickin’ Good
...from the perils of poultry would not quit. No, they argued, these statements amount to “actionable health claims in violation of 21 C.F.R. §101.14.” 2007 U.S. Dist. Lexis 32041, at *8. They claimed they could enforce §101.14 as “negligence per se” and under certain state statutes allowing f......
-
Food and Beverage Law Update: April 2016
...federal requirements for "health claims" are contained in the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. §343 et seq. and 21 C.F.R. Part 101 (see §101.14), and for "organic" food labeling in 7 C.F.R. Part 205. A "health claim" is defined, in short, as any claim made on the label......
-
Food And Beverage Law Update: April 2016
...federal requirements for "health claims" are contained in the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. §343 et seq. and 21 C.F.R. Part 101 (see §101.14), and for "organic" food labeling in 7 C.F.R. Part 205. A "health claim" is defined, in short, as any claim made on the label......
Request a trial to view additional results
1 books & journal articles
-
The First Amendment and Disclosure Regulations: Compelled Speech or Corporate Opportunism?
...supports the claim.”See id. at 197; Nutrition Labeling and Education Act of 1990, 21 U.S.C. § 343 (r)(3)(B)(i)(2012); see also 21 C.F.R. § 101.14(c) (2012) (adopting the “significant scientific agreement”standard for health claims relating to dietary supplements). The FDA rejected the petitio......