WARNING LETTER
Vitamin Vape, Inc.
MARCS-CMS 617787 —
December 01, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
George Michalopoulos
Vitamin Vape, Inc.
6320 S. Sandhill Road, Suite 5
Las Vegas
,
NV
89120
United States
support@vitaminvape.co
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December 1, 2021
Vitamin Vape, LLC
George Michalopoulos
2483 Albert Street North
Roseville, MN 55113
Vitamin Vape, Inc.
901 Marquette Ave., Suite 1500
Minneapolis, MN 55402
RE: 617787
Dear Mr. Michalopoulos:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.vitaminvape.co in September 2021 and has determined that you take orders there for the “B
12
VITAMINVAPE” product. We have also reviewed your social media website at https://www.facebook.com/VitaminVape. This social media website directs consumers to your websites https://www.vitaminvape.co and https://www.vitaminvape.com (which redirects to https://www.vitaminvape.co) to purchase your product. The claims on your website and social media website establish that your product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). As explained further below, introducing or delivering this product for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Furthermore, the use of your “B
12
VITAMINVAPE” product raises safety concerns for the agency because the ingredients or the impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity.
We note that you market your “B
12
VITAMINVAPE” product with a Nutrition Facts label, but your product does not meet the definition of “food” under section 201(f) of the FD&C Act, 21 U.S.C. 321(f).
Based on our review of your website and social media website, your “B
12
VITAMINVAPE” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the cure, mitigation, treatment, or prevention of disease and/ or intended to affect the structure or any function of the body.
Examples of some of the claims observed on your website, https://www.vitaminvape.co and your social media website https://www.facebook.com/VitaminVape, that provide evidence that this product is intended for use as a drug include, but may not be limited to, the following:
On the website https://www.vitaminvape.co:
“Better Than Shots & Pills”
“The Benefits of B12
Nerve Function
B12 plays a key role in healthy nerve function.
Cell Health
B12 plays a key role in cell health and DNA creation.”
“Going to get B12 shots can cost hundreds of dollars, not to mention the pain and inconvenience. Each vaporizer contains 4 times that amount of B12 you’d find in a shot.”
“More effective than pills
Studies have shown that inhaling B12 can be 100s of times more effectively absorbed than pills.”
“Take 5-10 puffs whenever desired. There is no upper-limit on the amount of B12 you can have in any given day.”
“Is it safe?
According to the existing research on B12 inhalation…
‘This simple form of therapy is not only effective, but safe and economical’”
“Why is vitamin B12 so important?
According to the National Institute of Health:
‘Vitamin B12 is a nutrient that helps keep the body’s nerve and blood cells healthy and helps make DNA, the genetic material in all cells. Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.’”
“But I read on the Internet you can’t vape vitamins, is this a scam?
…vitamin B12 is an ideal candidate for vaporizing, and the inhalation science goes back a half century.
Those studies found that inhaling B12 was both safe and very effective.”
“VitaminVape contains vitamin B12. On top of offering a healthier buzz, the all natural ingredient has numerous health benefits, especially for the nervous system and cell development.”
On your social media Facebook page https://www.facebook.com/VitaminVape:
On your January 26, 2021 post: “Why Vape Vitamin B12? Many people, our founders included, have a difficult time properly absorbing vitamin B12. B12 is a tricky little vitamin that is essential (This means that the body requires vitamin B12 to work properly) playing essential roles in red blood cell formation, cell metabolism, nerve function and the production of DNA . . . www.vitaminvape.com”
Your “B
12
VITAMINVAPE” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” 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 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved application is in effect for your product.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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, including FDA regulations. You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.
Your written reply should be directed to the U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
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:
12/07/2021
Regulated Product(s)
Drugs