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Search for firms, violations, and import refusal records
| Code | Charge Code | Description | Legal Section |
|---|---|---|---|
| 274 | COLOR LBLG | The article appears to contain an artificial coloring and it fails to bear labeling stating that fact. | 403(k), 801(a)(3); MISBRANDING |
| 487 | SACCHARIN | The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement. | 403(o); 801(a)(3) Misbranded |
| 2680 | SACCHARLBL | The article contains Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient | 403(i); 803(a)(3) Misbranding |
| 2300 | DIETARYLBL | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient. | 403(s)(2)(B), 801(a)(3), misbranded |
| 3362 | NUTR UNIT | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10. | 403(f), 801(a)(3); MISBRANDED |
| 3858 | TPFDA4ALBL | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its regulation or inspection by the FDA. | 903(a)(1); 801(a)(3); 301(tt)(4)(A); MISBRANDING |
| 256 | INCONSPICU | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). | 403(f), 801(a)(3); MISBRANDING |
| 324 | NO ENGLISH | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). | 403(f), 801(a)(3); MISBRANDING |
| 223 | FALSE | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading. | 502(a), 801(a)(3); MISBRANDING |
| 3862 | DIETARYING | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. | 403(s)(2)(A),801(a)(3); MISBRANDING |
| 2020 | LBLG ADVER | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual. | 502(a), 201(n) and 801(a)(3) Misbranding |
| 3500 | RXLABEL | The labeling fails to bear, at a minimum, the symbol "RX Only". | 503(b)(4)(A), 801(a)(3); MISBRANDING |
| 336 | INCONSPICU | Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. | 502(c), 801(a)(3); MISBRANDING |
| 3859 | TPFDA4BLBL | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its compliance with regulatory requirements set by the FDA. | 903(a)(1); 801(a)(3); 301(tt)(4)(B); MISBRANDING |
| 471 | CSTIC LBLG | The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701. | 602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING |
| 472 | NO ENGLISH | Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1). | 502(c); 801(a)(3) ;MISBRANDING |
| 3801 | FALSERXLBL | The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 503(b)(4)(B) of the FD&C Act. The labeling falsely bears the symbol "RX Only". | 503(b)(4)(B), 801(a)(3) |
| 3857 | TPFDA3LBLG | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is endorsed by the FDA for use by consumers. | 903(a)(1); 801(a)(3); 301(tt)(3); MISBRANDING |
| 3844 | SACCHARLBL | The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient. | 403(i), 801(a)(3); Misbranding |
| 3863 | PLANT PART | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. | 403(s)(2)(C), 801(a)(3); MISBRANDING |