Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda · 99-39 · BRAZIL

For Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda · 99-39 · BRAZIL, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is BRAZIL; product is Compound of Honey Propolis Extract and Ginger Spray | Compound of Honey Propolis Mint and Mallow Spray | Compound of Honey Propolis Mint and Pomegranate Spray | Brazilian Guarana Supplement in capsules | Compound of Honey Propolis Extract and Ginger Spray | Compound of Honey Propolis Mint and Pomegranate Spray | Brazilian Guarana Supplement in powder (50g and 100g) | Compound of Honey Propolis Mint and Mallow Spray; product code is 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 04 Honey | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 05/14/2020; address is Rua Alcidio Paganelli, 412 , Bebedouro, Sao Paulo BRAZIL, verified against its source on 2026-09-16.

What the source says

Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda Date Published : 05/14/2020 Rua Alcidio Paganelli, 412 , Bebedouro, Sao Paulo BRAZIL 36 C - - 04 Honey Date Published: 05/14/2020 Desc: Compound of Honey Propolis Extract and Ginger Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 36 C - - 04 Honey Date Published: 05/14/2020 Desc: Compound of Honey Propolis Mint and Mallow Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 36 C - - 04 Honey Date Published: 05/14/2020 Desc: Compound of Honey Propolis Mint and Pomegranate Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/14/2020 Desc: Brazilian Guarana Supplement in capsules Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g). Your Brazilian Guarana Supplement in capsules product label includes a statement of identity as a "Supplement." The term "dietary supplement" may be modified by replacing the term "dietary" with the name of a dietary ingredient or ingredients or an appropriately descriptive term indicating the type of dietary ingredients that are in the product. However, the term "Supplement" is not appropriate because it does not identify or describe the dietary ingredients or combination of ingredients that the dietary supplement product supplies (see 62 FR 49826, 49827). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/14/2020 Desc: Compound of Honey Propolis Extract and Ginger Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/14/2020 Desc: Compound of Honey Propolis Mint and Pomegranate Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/14/2020 Desc: Brazilian Guarana Supplement in powder (50g and 100g) Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). ; 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/14/2020 Desc: Compound of Honey Propolis Mint and Mallow Spray Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.