INDUSTRIAS UNIDAS, S.A. · 99-39 · GUATEMALA
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
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- GUATEMALA verified
- Address
- Km. 14.8 Carretera A Villa Canales , Boca Del Monte, Guatemala GUATEMALA verified
- Date published
- 10/02/2015 verified
- 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. each item verified
- Product
- Oak Flakes | Oak Flakes each item verified
- 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); each item verified
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);
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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