Reference Source

Aquanova AG · 99-39 · GERMANY

For Aquanova AG · 99-39 · GERMANY, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is GERMANY; product is Nanofy; product code is 41 E - - 99 Meal Replacements (Not labeled for treatment of disease); date published is 08/21/2023; address is Birkenweg 8-10 , Darmstadt, Hesse GERMANY, verified against its source on 2026-09-16.

Firm
Aquanova AG verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
GERMANY verified
Address
Birkenweg 8-10 , Darmstadt, Hesse GERMANY verified
Date published
08/21/2023 verified
Product code
41 E - - 99 Meal Replacements (Not labeled for treatment of disease) verified
Product
Nanofy verified
FDA notes
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear 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 the article is not in accordance with 21 CFR 101.36 and 101.9. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the labeling fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR 101.9(b)(7). Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the inner bottle 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. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Aquanova AG Date Published : 08/21/2023 Birkenweg 8-10 , Darmstadt, Hesse GERMANY 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) Date Published: 08/21/2023 Desc: Nanofy Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear 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 the article is not in accordance with 21 CFR 101.36 and 101.9. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the labeling fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR 101.9(b)(7). Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the inner bottle 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.

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

Source

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