Fengjia Biotechnology Ltd · 99-39 · TAIWAN

Product code, Product and FDA notes

41 E - - 99 Meal Replacements (Not labeled for treatment of disease) Date Published: 01/18/2024 Desc: Collagen Glow Berries Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n). 54 A - - 99 Vitamin, N.E.C. Date Published: 01/18/2024 Desc: Collagen Glow Berries Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n). 54 A - - 99 Vitamin, N.E.C. Date Published: 01/18/2024 Desc: Sicilian Orange Slimming Elixir Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n). 54 E - - 12 Ginseng (Herbal & Botanical Teas) Date Published: 01/18/2024 Desc: Ginseng Turmeric Superjuice Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/18/2024 Desc: Sicilian Orange Slimming Elixir Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n).