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FDA Warning Letter Explorer
Drugs · Letter issue date: Oct 26, 2026

Natuzem

4 extracted findings

FDA source excerpt, selected passage

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
02
Based on a review of your website, “Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
03
“Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
04
Previous FDA lab analyses of products similarly named to “Reumofan Plus,”***1*** “Artrifan King,”***2*** “RMSOL Gracian,”***3*** “Kuka Flex Forte,”***4*** and “Reuma King”***5*** sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 201.128

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