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  1. Warning Letters

WARNING LETTER

VitaCig, Inc. MARCS-CMS 617847 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Paul Rosenberg
VitaCig, Inc.

2375 Watermill Dr.
Orange Park, FL 32073
United States

[email protected]
[email protected]
[email protected]
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

December 1, 2021

4720 Salisbury Rd.
Jacksonville, FL 32256

RE: 617847

Dear Mr. Rosenberg:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.vitaciggroup.com in September 2021 and has determined that you take orders there for your “VitaCig products,” which include a variety of flavors available as “Classic edition” and “S-edition” inhalers as well as capsules for use in your rechargeable “Excalibur” inhaler. The claims on your website establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products 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 VitaCig products raises safety concerns for the agency because the ingredients and/or 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.

Based on our review of your website, your VitaCig products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, 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.vitaciggroup.com that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:

On the website https://www.vitaciggroup.com/:

  • “VitaCig® is a unique NICOTINE & TOBACCO FREE personal aromatherapy device, pre-filled with vitamin-enhanced liquids and diluted natural essential oils. Its formulation is based on the knowledge and centuries-old experience of using herbs and natural extracts to assist our wellbeing, to balance our mental, emotional and physical levels of energy. Each VitaCig® is bursting with flavors and mood enhancing effects. Let yourself feel your emotions with every VitaCig® blend.”
  • From your “VitaCig® Cool Citrus” product webpage: “The Lemon Essential Oil has a clarifying quality, good for mental fatigue and emotional confusion, stimulates the mind and increase the ability to [sic] memorise.”
  • From your “VitaCig® Watermelon Wave” product webpage:

    o “Watermelons are loaded with antioxidants and have been associated with a wide range of health benefits — such as better heart health, enhanced immunity and increased weight loss.”
    o “Lychee is a wonderful fruit with plenty of health benefits, including its ability to aid in weight loss, protect the skin, boost the immune system prevent cancer, improve digestion, build strong bones, lower blood pressure, defend the body against viruses, improve circulation, and optimize metabolic activities.”

  • From your “VitaCig® Vintage Vanilla” product webpage: “The Valerian Oil can lessen anxiety as well as improve both the quality and duration of sleep”
  • From your “VitaCig® Focus” product webpage:

    o “Asian ginseng is prescribed for those with low energy, tendency to feel cold, and a lack of sex drive. Studies have shown ginseng improves erectile dysfunction in men”1
    o “VitaCig® FOCUS . . . is an inhalable natural cognitive booster. . . . It has a stimulation effect, improves your concentration, helps support optimal cognition and acute focus, bringing clarity of mind.”

  • From your “VitaCig® Rejuvenate” product webpage: “Both calming and uplifting, geranium makes a natural antidepressant and helps to relieve anxiety.”
  • From your “VitaCig® Sleep” product webpage:

    o “Lack of sleep weakens the immune system, slows reaction times and makes you more prone to depression, anxiety and a low mood.”
    o “Neroli Oil …has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”

  • From your “VitaCig® Slim” product webpage: “Hoodia is used as a weight loss aid.”

Your VitaCig 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 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) and 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 applications are in effect for your products.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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. 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 products are 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 [email protected].

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

_________________________

1 This claim also appears on your “VitaCig® Surge” product webpage.

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