WARNING LETTER
H2 Beverages, Inc.
MARCS-CMS 622917 —
June 14, 2022
Delivery Method:
UPS Overnight
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Kurt H. Ruppman, Sr.
Recipient Title
President / Chief Executive Officer
H2 Beverages, Inc.
1601 Summit Ave Ste 100
Plano
,
TX
75074-8109
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
June 14, 2022
WARNING LETTER
Ref: CMS # 622917
Dear Mr. Ruppman:
This letter concerns your hydrogen-infused water beverages “Hydro Shot,” “Silver Bullet Green Tea with Zinc,” and “Hydro Brew Unsweetened Green Tea,” which you offer for sale in the United States. From November 8 through November 10, 2021, the U.S. Food and Drug Administration (the FDA) inspected your beverage manufacturing and distribution facility, located at 1601 Summit Ave Ste. 100, Plano, TX 75074-8109. During the inspection, we collected copies of your product labels and other labeling. In March 2022, FDA reviewed your website at https://h2bev.com, where you take orders for your hydrogen-infused water beverages. We also reviewed your social media account on Facebook at https://www.facebook.com/h2bev, which directs consumers to your website to purchase these products. In addition, we observed that your product Silver Bullet Green Tea with Zinc is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
in people.
Unapproved New Drugs and Misbranded Drugs
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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act through links on FDA’s website at
www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
and the FDA regulations at
http://www.ecfr.gov/current/title-21
.
Examples of some of the website claims that provide evidence that your H2 Bev products are intended for use as drugs include:
Website Claims about Hydrogen-Infused Water
These claims apply to all three of your H2 Bev products because each of them contains hydrogen-infused water.
https://h2bev.com/
“Hydrogen water has been shown to stabilize cholesterol, … fight inflammation, protect against radiation damage, ameliorate gastrointestinal disorders …”
“Molecular hydrogen … This anti-inflammatory little beast stabilizes cholesterol levels …”
Website Claims about Silver Bullet Green Tea with Zinc
https://h2bev.com/pages/silver-bullet
“Studies have shown green tea and zinc can help naturally lower LDL cholesterol.”
“Fight against disease Studies show zinc fights the replication of diseases like COVID-19.”
“Green tea has been shown in research to lower the chances of heart disease and stroke.”
Website Claims about Hydro Brew Unsweetened Green Tea
https://h2bev.com/pages/hydro-brew
“Green tea has been shown in studies to naturally lower blood presure [sic].”
“Lower LDL cholesterol Research shows antioxidants in teas can lower cholesterol levels.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Hydro Shot, Silver Bullet Green Tea with Zinc, and Hydro Brew Unsweetened Green Tea products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. 331(a)].
Misbranding Violations
Even if your products “Hydro Shot,” “Silver Bullet Green Tea with Zinc,” and “Hydro Brew Unsweetened Green Tea” (your H2Bev products) did not have therapeutic claims that make them misbranded and unapproved new drugs, these products would be misbranded under section 403 of the FD&C Act [21 U.S.C. 343]:
1. 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. "Hydro Shot" is not a name established by common usage among consumers and therefore is not the common or usual name of the food. In the absence of a common or usual name, the statement of identity regulation permits a food to bear an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food; however, “Hydro Shot” is not an appropriately descriptive term, nor is it a fanciful name commonly used by the public for a product whose nature is obvious.
2. 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.
3. 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. Specifically,
The manufacturing process for these products involves infusing hydrogen gas into the water. Therefore, hydrogen must be declared as an ingredient in accordance with 21 CFR 101.4(b)(2).
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. In addition, as explained above, hydrogen must be declared as a separate ingredient of these beverages, rather than as part of the name of the water ingredient.
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. Simply declaring “stevia” does not identify whether the ingredient is stevia leaf, crude stevia extract, or purified steviol glycosides. Disclosing which of these ingredients the product contains is important because of safety concerns about stevia leaf and crude stevia extract (extracts containing < 95% steviol glycosides). Specifically, FDA considers stevia leaf and crude stevia extracts to be unsafe food additives for use in conventional foods, including beverages. For more information, see
https://www.fda.gov/food/food-additives-petitions/additionalinformation-about-high-intensity-sweeteners-permitted-use-food-united-states
.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also offer the following comments regarding your products:
On your website, the product page for your Hydro Brew Unsweetened Green Tea (https://h2bev.com/products/unsweetened-green-tea-12-ct-case-free-shipping) includes an image of the product’s Nutrition Facts panel showing that it contains 10 mg CBD per serving, although the product label does not declare CBD or any source of CBD as an ingredient. 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)]. In addition, falsely claiming that a product contains an ingredient misbrands the product under section 403(a)(1) of the FD&C Act. As defined in section 201(s) of the FD&C Act [21 U.S.C. 321(s)], the term "food additive" means, in relevant part, any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use (or unless the substance meets one of the other listed exceptions to the food additive definition, none of which is relevant here). Based on FDA’s review of published scientific literature on CBD, the agency does not consider CBD to be GRAS for use in conventional foods, including beverages.
2
Under section 409(a) of the FD&C Act [21 U.S.C. 348(a)], a food additive that is directly added to food is considered unsafe unless it is used in conformity with a food additive regulation prescribing the conditions under which the additive may be safely used. As there is no food additive regulation establishing safe conditions of use for CBD in food for humans or animals, CBD is an unsafe food additive. You can find more information about how FDA regulates CBD at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
As discussed above in the misbranding section of this letter, we cannot determine what stevia-derived ingredient is used in your products Silver Bullet Green Tea with Zinc and Hydro Shot because the term “stevia” is too general to distinguish among different stevia-derived ingredients such as stevia leaf, crude stevia extract, and steviol glycosides. Please note that FDA considers stevia leaf and crude stevia extract (< 95% steviol glycosides) to be unsafe food additives when used in conventional foods, including beverages. Food containing an unsafe food additive is adulterated under section 402(a)(2)(C) of the FD&C Act [21 U.S.C. 342(a)(2)(C)]. For more information, see
https://www.fda.gov/food/foodadditives-petitions/additional-information-about-high-intensity-sweeteners-permitteduse-food-united-states
.
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. Vitamin D is affirmed as GRAS with specific limitations set forth in 21 CFR 184.1950, which means that only the uses specified under that regulation or under a food additive regulation are authorized (21 CFR 184.1(b)(2)). However, neither 21 CFR 184.1950 nor the food additive regulations prescribing safe conditions for the use of vitamin D2 and vitamin D3 in food (21 CFR 172.379 and CFR 172.380) provide for the use of vitamin D2 or D3 in beverages such as your Hydro Brew Unsweetened Green Tea and Silver Bullet Green Tea with Zinc. Therefore, your use of vitamin D2 or D3 in these beverages requires approval by FDA through a food additive petition. Food containing an unapproved food additive is adulterated under section 402(a)(2)(C) of the FD&C Act.
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. Food containing an unapproved food additive is adulterated under section 402(a)(2)(C) of the FD&C Act. You are responsible for ensuring that the use of folic acid in your product does not require approval as a food additive (e.g., that this use is generally recognized as safe).
On your website, the product page for your Hydro Brew Unsweetened Green Tea (https://h2bev.com/products/unsweetened-green-tea-12-ct-case-free-shipping) includes an image of its Nutrition Facts panel showing that the product contains 9 grams of sugar per serving. However, the physical label collected for this product during our inspection declares 0 grams of sugar per serving on the Nutrition Facts panel. 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)). False or misleading labeling misbrands a product under section 403(a)(1) of the FD&C Act.
Your products Hydro Shot, Silver Bullet Green Tea with Zinc, and Hydro Brew Unsweetened Green Tea all contain water as an ingredient; however, this ingredient is referred to as “purified water” in the ingredient list on the Hydro Shot label, but the Silver Bullet Green Tea with Zinc and Hydro Brew Unsweetened Green Tea labels refer to it as “RO water.” To prevent consumers from being confused or otherwise misled, the common or usual name of a food should be uniform among identical products. 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. The name should accurately describe the nature of the ingredient; for example, purified water processed by reverse osmosis may be called either “purified water” or “reverse osmosis water” (see 21 CFR 165.110(a)(2)(iv)). As discussed above in the misbranding section of this letter, the abbreviation “RO” may not be used because it has not been established by common usage.
The Silver Bullet Green Tea with Zinc and Hydro Shot labels bear the claim “hydrogen enriched.” Although 21 CFR 101.54(e) authorizes the use of the nutrient content claim “enriched” for certain nutrients (e.g., vitamins) and defines nutritional criteria for using the claim in the labeling of food containing those nutrients, this regulation does not cover “enriched” claims for hydrogen because there is no Daily Value for hydrogen. 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.
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)). For additional information, see
https://www.fda.gov/food/food-labeling-nutrition/industry-resources-changes-nutrition-facts-label#Compliance
.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, by email at chad.whitwell@fda.hhs.gov (preferred) or by mail at U.S. Food and Drug Administration, 1201 Main Street North Central Expressway, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, please contact Mr. Whitwell by email or telephone at 214-253-5328.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director, HAF West 3
Dallas District Director
Cc:
Lori Woznicki, Food and Drug Inspections Branch
Manager Division of Regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756
___________________________________
1
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described in the body of this letter, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
2
For an explanation of FDA’s basis for concluding that CBD is not GRAS for use in conventional foods, see
FDA Warning Letter to NextL3vel Services Group, LLC
(12/22/2020) and
FDA Warning Letter to KOI CBD LLC
(11/22/2019).
Content current as of:
07/19/2022
Regulated Product(s)
Drugs
Food & Beverages