21 CFR 201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil
| Cite as | 21 CFR 201.302 |
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4 practice notes
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Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some unique effectiveness or composition); 21 CFR 201.302(c) (prohibiting implied claims that drugs for internal use that contain mineral oil are for administration to infants). The agency has also regul......
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In re Amarin Corp. PLC Sec. Litig., Case No. 3:19-cv-06601 (BRM) (TJB)
...the placebo arm in the REDUCE-IT trial, the allegations in the Sklar Action regarding the use of mineral oil as a placebo, Regulation 21 C.F.R. 201.302(G)(a) (2018), and recent failed cardiovascular studies of omega-3 products. (Id. ¶ 83.) Plaintiffs allege these statements were misleading ......
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Ex parte Shlieout, Appeal 2020-005326
...products and have provided advice concerning specific pharmaceutical excipients (see e.g. U.S. Code of Federal Regulations, 21 CFR §201.302), such mineral oil. It is recommended today that mineral oil not be provided indiscriminately to either pregnant women or infants. (Spec. 1:19-26.) We ......
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
...of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some unique effectiveness or composition); 21 CFR 201.302(c) (prohibiting implied claims that drugs for internal use that contain mineral oil are for administration to infants). The agency has also regul......
2 cases
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In re Amarin Corp. PLC Sec. Litig., Case No. 3:19-cv-06601 (BRM) (TJB)
...the placebo arm in the REDUCE-IT trial, the allegations in the Sklar Action regarding the use of mineral oil as a placebo, Regulation 21 C.F.R. 201.302(G)(a) (2018), and recent failed cardiovascular studies of omega-3 products. (Id. ¶ 83.) Plaintiffs allege these statements were misleading ......
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Ex parte Shlieout, Appeal 2020-005326
...products and have provided advice concerning specific pharmaceutical excipients (see e.g. U.S. Code of Federal Regulations, 21 CFR §201.302), such mineral oil. It is recommended today that mineral oil not be provided indiscriminately to either pregnant women or infants. (Spec. 1:19-26.) We ......
1 firm's commentaries
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
...of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some unique effectiveness or composition); 21 CFR 201.302(c) (prohibiting implied claims that drugs for internal use that contain mineral oil are for administration to infants). The agency has also regul......