THE GREAT PHYSICIAN INTERNATIONAL · 99-39 · SAINT LUCIA
For THE GREAT PHYSICIAN INTERNATIONAL · 99-39 · SAINT LUCIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is SAINT LUCIA; product is The Answer; product code is 54 F - - -- Herbal & Botanicals(other than teas); date published is 08/09/2019; address is Jeremie Street , Castries, SAINT LUCIA, verified against its source on 2026-09-16.
- Firm
- THE GREAT PHYSICIAN INTERNATIONAL verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- SAINT LUCIA verified
- Address
- Jeremie Street , Castries, SAINT LUCIA verified
- Date published
- 08/09/2019 verified
- Product code
- 54 F - - -- Herbal & Botanicals(other than teas) verified
- Product
- The Answer verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that it does not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §343(s)(2)(A) and 343(q)(5)(F)] in that the LBL fails to list the name of each dietary ingredient of the supplement described in sections 201(ff) and the quantity of each ingredient. Section 403(q)(1)(B) of the Act [21 U.S.C. §343(q)(1)(B)] in that the LBL fails to list the servings per container in accordance with 21 CFR 101.36(b)(1)(ii). Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer or distributor in accordance with 21CFR101.5. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the LBL by the common/usual name, in accordance with 21CFR101.4 and 21CFR101.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size on the LBL is incomplete. Specifically, the LBL fails to declare the equivalent metric quantity in parenthesis following the "capful". Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the FDA disclaimer statement is incomplete and not linked to the structure function claim made on the LBL, per 21 CFR 101.93(c)-(d) verified
What the source says
THE GREAT PHYSICIAN INTERNATIONAL Date Published : 08/09/2019 Jeremie Street , Castries, SAINT LUCIA 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 08/09/2019 Desc: The Answer Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that it does not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §343(s)(2)(A) and 343(q)(5)(F)] in that the LBL fails to list the name of each dietary ingredient of the supplement described in sections 201(ff) and the quantity of each ingredient. Section 403(q)(1)(B) of the Act [21 U.S.C. §343(q)(1)(B)] in that the LBL fails to list the servings per container in accordance with 21 CFR 101.36(b)(1)(ii). Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer or distributor in accordance with 21CFR101.5. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the LBL by the common/usual name, in accordance with 21CFR101.4 and 21CFR101.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size on the LBL is incomplete. Specifically, the LBL fails to declare the equivalent metric quantity in parenthesis following the "capful". Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the FDA disclaimer statement is incomplete and not linked to the structure function claim made on the LBL, per 21 CFR 101.93(c)-(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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