Drugs · Oct 13, 2021

Organa International Corp.

15 extracted findings

FDA source excerpt, selected passage

Your Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, MSM (Methylsulfonylmethane), Silver, Relieve Progesterone Cream, and Silver Gel products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].

FDA published a close-out letter on Oct 4, 2024. The findings below are from the original warning letter.

Findings and supporting evidence

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Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Iron, Magnesium, Manganese, Molybdenum, MSM, Vanadium, Silver, Relieve Progesterone Cream, and Silver Gel products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

the labels fail to identify your products using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity

the serving size on the labels are incorrect. The terms “serving” or “serving size” for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. The labels state the serving size is “1 tsp” while the directions indicate to “Take 2 tsp. once or twice daily as needed.” Furthermore, your “Silver” product is also misbranded because its label fails to include a serving size.

the labels fail to declare the number of servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).

the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36.

fail to enclose the nutrition information (Supplement Facts label) in a box using hairlines and titled with bolded “Supplement Facts” (not “Supplemental Facts” as incorrectly noted on your product labels) set full width, as required by 21 CFR 101.36(e)(1) and (2). Furthermore, all nutrition information within the nutrition label (Supplement Facts label) must utilize all black or one color type, as required by 21 CFR 101.36(e)(3)(ii)

Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).

fail to include the subheading “Servings Per Container” as required by 21 CFR 101.36(b)(ii) and 101.36(e)(6)(i). A heavy bar must be placed beneath the subheading “Servings Per Container”

fail to include a heavy bar beneath the last (b)(3)-dietary ingredient (other dietary ingredient), as required by 21 CFR 101.36(e)(6)(iii).

fail to list “Other ingredients” in a separate “Other ingredients” list outside and immediately below the Supplement Facts label in accordance with 21 CFR 101.4(g)

bear the following or similar statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).

If a product is for persons within more than one group, the percent of Daily Value for each group must be presented in separate columns, as required in 21 CFR 101.36(b)(2)(iii)(E).

The Essiac Tea product label lacks a declaration of % Daily Value. Furthermore, on several of your product labels the statement *“Percentage Daily Value not established” is not linked to a symbol elsewhere in the nutrition information label, as required by 21 101.36 (b)(3)(iv).

the label fails to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act.

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Organa International Corp.

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