# Olnatura, S. A. de C. V. · 99-39 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Olnatura, S. A. de C. V. · 99-39 · MEXICO, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is MEXICO; product is Biofiberex | Dietgenix Shake (Chocolate) | Biogaxtric | Dietgenix Shake (Chocolate) | Dietgenix Shake (Chocolate); product code is 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 I - - -- Fiber | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C; date published is 11/16/2015; address is Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO, verified against its source on 2026-09-16.

- **Firm:** Olnatura, S. A. de C. V. _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** MEXICO _(verified: appears in the quote below)_
- **Address:** Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO _(verified: appears in the quote below)_
- **Date published:** 11/16/2015 _(verified: appears in the quote below)_
- **Product code:** 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 I - - -- Fiber | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Biofiberex | Dietgenix Shake (Chocolate) | Biogaxtric | Dietgenix Shake (Chocolate) | Dietgenix Shake (Chocolate) _(verified: each item appears in the quote below)_
- **FDA notes:** "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)). [Misbranded; Section 403 (f)]" | "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]" | "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)). [Misbranded; Section 403 (f)]" | "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]" | "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]" _(verified: each item appears in the quote below)_

## What the source says

> Olnatura, S. A. de C. V. Date Published : 11/16/2015 Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 11/16/2015 Desc: Biofiberex Notes: "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)). [Misbranded; Section 403 (f)]" 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 11/16/2015 Desc: Dietgenix Shake (Chocolate) Notes: "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]" 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 11/16/2015 Desc: Biogaxtric Notes: "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)). [Misbranded; Section 403 (f)]" 54 I - - -- Fiber Date Published: 11/16/2015 Desc: Dietgenix Shake (Chocolate) Notes: "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]" 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 11/16/2015 Desc: Dietgenix Shake (Chocolate) Notes: "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(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "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)). [Misbranded; Section 403 (f)]"

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).