TAANE · 99-39 · JAPAN
For TAANE · 99-39 · JAPAN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is JAPAN; product is Active Hydride Plasma; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C; date published is 12/10/2015; address is Nakano Miyagino , 5chome-7-15; Nakano; Miyagino , Sendai, Miyagi JAPAN, verified against its source on 2026-09-16.
- Firm
- TAANE verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- JAPAN verified
- Address
- Nakano Miyagino , 5chome-7-15; Nakano; Miyagino , Sendai, Miyagi JAPAN verified
- Date published
- 12/10/2015 verified
- Product code
- 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. verified
- Product
- Active Hydride Plasma verified
- FDA notes
- The article is subject to refusal of admission pursuant to section 801(a)(3)for the following: It appears to be misbranded within the meaning of section 403(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 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The "Suggested use" states to take 2-6 capsules daily and the Serving Size is identified as 3 capsules. It appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, the label lists a "Proprietary blend" but fails to list all of the ingredients of the blend. It appears to be misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count on the principal display panel as required by 21 CPR 101.105. It appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. It appears to be 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 does not repeat all the required information in both languages, as required by 21 CFR 101.15(c). verified
What the source says
TAANE Date Published : 12/10/2015 Nakano Miyagino , 5chome-7-15; Nakano; Miyagino , Sendai, Miyagi JAPAN 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/10/2015 Desc: Active Hydride Plasma Notes: The article is subject to refusal of admission pursuant to section 801(a)(3)for the following: It appears to be misbranded within the meaning of section 403(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 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The "Suggested use" states to take 2-6 capsules daily and the Serving Size is identified as 3 capsules. It appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, the label lists a "Proprietary blend" but fails to list all of the ingredients of the blend. It appears to be misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count on the principal display panel as required by 21 CPR 101.105. It appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. It appears to be 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 does not repeat all the required information in both languages, as required by 21 CFR 101.15(c).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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