WARNING LETTER
Genesis Partnership Company SA
MARCS-CMS 618953 —
December 29, 2021
Product:
Drugs
Recipient:
Recipient Name
Elmar Giovanni Cardona Quintana
Recipient Title
President
Genesis Partnership Company SA
Km 19.5 Carrtera Al Pacifico, Bodega 28
01064
-
Villa Nueva
Guatemala
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
December 29, 2021
FEI: 3016785739
Dear Mr. Elmar Giovanni Cardona Quintana:
This letter concerns your firm’s marketing of Bathletix HAND SANITIZER, bearing the trademarked logo of the Baltimore Orioles or other team logos of Major League Baseball and the National Basketball Association, as an alcohol based over-the-counter (OTC) hand sanitizer sold in various sizes and package configurations. Your Bathletix HAND SANITIZER is packaged in 8 ounce bottles and entered into interstate commerce within the U.S. in June of 2020.
The United States Food and Drug Administration (FDA) reviewed your Bathletix HAND SANITIZER product, including the product labels and containers. Based on our review, Bathletix HAND SANITIZER is misbranded under section 502(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). This violation is described in more detail below.
Misbranding Violation
Bathletix HAND SANITIZER is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a topical consumer antiseptic.
Examples of claims observed on the product label for Bathletix HAND SANITIZER that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product includes, but may not be limited to, the following:
“
Drug Fact
. . .
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.”
“
Directions
. . . Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.”
Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” On August 27, 2020, FDA published a news release titled, “COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers,” see https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers. This news release warns consumers about alcohol-based hand sanitizers packaged in containers that resemble food or drink containers customarily purchased by U.S. consumers and may put consumers at risk of serious injury or death if ingested.
Your Bathletix HAND SANITIZER product is packaged in containers that resemble drinking water bottles customarily purchased by U.S. consumers. OTC hand sanitizer drug products packaged in containers that resemble beverage containers commonly used by adults and children may mislead consumers into believing the products are food and, thereby, increase the risk of accidental ingestion. As such, your OTC hand sanitizer, packaged in 8 ounce bottle containers that have a similar shape, size, and function as a plastic bottle ordinarily used to package drinking water, is misbranded under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violation cited in this letter is not intended to be an all-inclusive list of violations that may exist in connection with your product. 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 and 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.
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.
Direct your email response to the Office of Unapproved New Drugs and Labeling Compliance at the following email address, fdaadvisory@fda.hhs.gov.
Sincerely,
/s/
for Carolyn Becker, Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
01/18/2022
Regulated Product(s)
Drugs