Reference Source

Eu Yan Sang (Hong Kong) Ltd. · 99-39 · HONG KONG SAR

For Eu Yan Sang (Hong Kong) Ltd. · 99-39 · HONG KONG SAR, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is HONG KONG SAR; product is Bak Foong Pills | Bak Foong Pills | Bak Foong Pills | Bak Foong Pills; product code is 54 A - - 99 Vitamin, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 09/27/2024; address is Yuen Long Industrial Estate Yuen Long , 10-12 Wang Lee Street , Yuen Long, New Territories HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Eu Yan Sang (Hong Kong) Ltd. verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
HONG KONG SAR verified
Address
Yuen Long Industrial Estate Yuen Long , 10-12 Wang Lee Street , Yuen Long, New Territories HONG KONG SAR verified
Date published
09/27/2024 verified
Product code
54 A - - 99 Vitamin, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
Product
Bak Foong Pills | Bak Foong Pills | Bak Foong Pills | Bak Foong Pills each item verified
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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. | 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. | 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. | 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Eu Yan Sang (Hong Kong) Ltd. Date Published : 09/27/2024 Yuen Long Industrial Estate Yuen Long , 10-12 Wang Lee Street , Yuen Long, New Territories HONG KONG SAR 54 A - - 99 Vitamin, N.E.C. Date Published: 09/27/2024 Desc: Bak Foong Pills 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 09/27/2024 Desc: Bak Foong Pills 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/27/2024 Desc: Bak Foong Pills 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2. 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 09/27/2024 Desc: Bak Foong Pills 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: Sections 403(e)(1), 403(i)(2), 403(q)(5)(F), 403(s)(2)(B), and 403(y) of the Act [21 U.S.C 343(e)(1), 343(i)(2), 343(q)(5)(F), 343(s)(2)(B), and 343(y)] because the inner product label does not bear: (1) the name and place of business of the manufacturer, packer, or distributor, (2) the common or usual name of each ingredient, (3) nutrition information, (4) the statement of identity of the product, (5) a domestic address or phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement, and (6) any required warning statement. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the Supplement Facts label (SFL) does not include all intended groups as noted in the label directions. Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 101.2.

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

Source

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

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.