H2 Beverages, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your website establish that your products Hydro Shot, Silver Bullet Green Tea with Zinc, and Hydro Brew Unsweetened Green Tea are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Accordingly, your Hydro Shot, Silver Bullet Green Tea with Zinc, and Hydro Brew Unsweetened Green Tea products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)].

Passage 3

Your Hydro Shot product is misbranded within the meaning of section 403(i)(1) of the FD&C Act [21 U.S.C. 343(i)(1)] in that the product label fails to bear the common or usual name of the food in the statement of identity on the principal display panel, as required by 21 CFR 101.3.

Passage 4

Your Hydro Brew Unsweetened Green Tea, Silver Bullet Green Tea with Zinc, and Hydro Shot products are misbranded within the meaning of section 403(e)(1) of the FD&C Act [21 U.S.C. 343(e)(1)] in that the product labels fail to include the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

Passage 5

Your Hydro Brew Unsweetened Green Tea, Silver Bullet Green Tea with Zinc, and Hydro Shot products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)] in that the product label fails to list each ingredient of the product by its common or usual name, as required by 21 CFR 101.4.

Passage 6

For the Hydro Brew Unsweetened Green Tea and Silver Bullet Green Tea with Zinc products, “hydrogen infused RO water” and “hydrogen enriched RO water” are not common or usual names as required by 21 CFR 101.4 because “RO” is not a widely used abbreviation established by common usage.

Passage 7

For the Silver Bullet Green Tea with Zinc and Hydro Shot products, “stevia” does not meet the ingredient declaration requirements of 21 CFR 101.4 because it is not specific or descriptive enough to be a common or usual name.

Passage 8

Please check all physical and electronic labels for this product and ensure that you are declaring the sugar content of the product accurately on all of them (see 21 CFR 101.9(c)(6)(ii)-(iii)).

Passage 9

Therefore, if the water ingredient you use in all three products is the same, it should be declared by the same name on the label of each product.

Passage 10

We discourage use of defined nutrient content claims for nutrients not covered by the nutrient content claim regulation to avoid any consumer confusion as to whether the food bearing the claim meets the nutritional criteria in the regulation.

Passage 11

The Nutrition Facts labels do not meet the requirements in 21 CFR 101.9. Examples include, but are not limited to: the labels use the full vertical format but fail to declare cholesterol and dietary fiber, as required by 21 CFR 101.9(d)(7); the quantitative amounts for some nutrients are not declared correctly (order of listing, rounding, and/or other errors), as required by 21 CFR 101.9(c); the serving size is not declared in accordance with 21 CFR 101.9(b)(5)(iv), which requires a description of the individual container or package for single serving containers; “EGCG” is not one of the nutrients that may be declared in Nutrition Facts (see 21 CFR 101.9(c)).

Passage 12

Failure to provide a complete list of ingredients on the label of a product misbrands the product under sections 403(a)(1) and 403(i)(2) of the FD&C Act [21 U.S.C. 343(a)(1) and 343(i)(2)].

Passage 13

Your use of vitamin D2 and vitamin D3 in beverages such as your Hydro Brew Unsweetened Green Tea and Silver Bullet Green Tea with Zinc is not authorized under either FDA’s GRAS regulations or FDA’s food additive regulations.

Passage 14

Additionally, 21 CFR 172.345 provides for the safe use of folic acid under certain specified conditions, which do not include its use in beverages such as your Hydro Brew Unsweetened Green Tea product.