# INDUSTRIAS UNIDAS, S.A. · 99-39 · GUATEMALA — FDA import alert red lists: firms subject to detention without physical examination

For INDUSTRIAS UNIDAS, S.A. · 99-39 · GUATEMALA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is GUATEMALA; product is Oak Flakes | Oak Flakes; product code is 05 A - - 02 Oat Flakes, Rolled Oats,Puffs,Krispies,Loops Ready To Eat | 05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C; date published is 10/02/2015; address is Km. 14.8 Carretera A Villa Canales , Boca Del Monte, Guatemala GUATEMALA, verified against its source on 2026-09-16.

- **Firm:** INDUSTRIAS UNIDAS, S.A. _(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:** GUATEMALA _(verified: appears in the quote below)_
- **Address:** Km. 14.8 Carretera A Villa Canales , Boca Del Monte, Guatemala GUATEMALA _(verified: appears in the quote below)_
- **Date published:** 10/02/2015 _(verified: appears in the quote below)_
- **Product code:** 05 A - - 02 Oat Flakes, Rolled Oats,Puffs,Krispies,Loops Ready To Eat | 05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Oak Flakes | Oak Flakes _(verified: each item appears in the quote below)_
- **FDA notes:** VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d); | VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d); _(verified: each item appears in the quote below)_

## What the source says

> INDUSTRIAS UNIDAS, S.A. Date Published : 10/02/2015 Km. 14.8 Carretera A Villa Canales , Boca Del Monte, Guatemala GUATEMALA 05 A - - 02 Oat Flakes, Rolled Oats,Puffs,Krispies,Loops Ready To Eat Date Published: 10/02/2015 Desc: Oak Flakes Notes: VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d); 05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C. Date Published: 10/02/2015 Desc: Oak Flakes Notes: VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);

## 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/).