---

---

---

WARNING LETTER

December 1, 2021

RE: 617979

Dear Mr. Matzkin:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.nutrovape.com and https://nutriair.com/ in October 2021 and has determined that you take orders there for numerous “vaporizer” products, including but not limited to the products named “nutrovape B-Complex,” “nutrovape Diet,” “nutrovape Energy,” “nutrovape Focus,” and “nutrovape Recover” (hereinafter referred to as your “nutrovape vaporizer products”) and “diffuser” products, including but not limited to products named “nutriair Energy,” “nutriair Focus,” “nutriair Immune,” “nutriair Relax,” “nutriair Recover,” and “nutriair Sleep” (hereinafter referred to as your “nutriair diffuser products”)¹. We have also reviewed your social media websites at www.facebook.com/nutriair, www.facebook.com/trynutrovape, www.instagram.com/nutri.air, www.instagram.com/nutrovape, www.twitter.com/nutriair, www.twitter.com/nutrovape. These social media websites direct consumers to www.nutrovape.com or https://nutriair.com/, respectively, to purchase your products. The claims on your websites, social media websites, and product packaging, establish that your nutrovape vaporizer products and nutriair diffuser 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 nutrovape vaporizer products and nutriair diffuser 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.

You appear to be marketing your nutrovape vaporizer products and nutriair diffuser products as dietary supplements. For example, the labeling for your “Relax” and “Sleep” products in your nutriair and nutrovape product lines include Supplement Facts panels. However, the products’ labeling also states that they are intended for inhalation. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your nutrovape vaporizer products and nutriair diffuser products are not intended for ingestion. Therefore, your products do not meet the definition of a dietary supplement under the FD&C Act.

Based on our review of your websites, social media websites, and product packaging, your nutrovape vaporizer products and nutriair diffuser 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 cure, mitigation, treatment, or prevention of disease and/ or intended to affect the structure or any function of the body.

Some examples of claims observed on your websites and social media websites that established the intended use of your products as drugs include, but may not be limited to, the following:

On your website, www.nutriair.com:

On the webpage titled, “Sleep”²:

• “Melatonin has been shown to be effective in managing the symptoms of insomnia”
• “Passion Flower Extract: Many pharmacological investigations confirm the sedative effects of Passion Flower, and the short-term subjective sleep benefits. . . additional studies also show anti-anxiety effects.”

On the webpages titled, “Relax” and “Relax XL”:

• “Chamomile Extract: . . . may produce a sedative or relaxant effect by affecting certain brain chemicals, such as serotonin.”
• “Valerian Root Extract: . . . well known for its sedative qualities and its ability to relax the central nervous system and the smooth muscle groups.”

On the webpages titled, “Recover” and “Recover XL”

• “Milk Thistle Extract: Research on Milk Thistle suggests various beneficial effects on the liver. Many take it as a natural supplement for liver issues, aiding its connection with the term ‘hangover cure’ . . . to help protect the liver from toxins, including the effects of alcohol.”
• “Turmeric Root: Turmeric is mainly recognized as an anti-inflammatory; this calms the digestive system and strengthens the liver to better process the alcohol. It is known as one of the most popular hangover prevention supplements in Japan.”

On the webpages titled, “Immune” and “Immune XL”:

• “Astragulas. . . is known to be a powerful immune-building plant. . . and can even fight off tumors and alleviate symptoms of chemotherapy!”
• “Elderberry Extract: In folk medicine, the dried berries or juice are used to treat influenza, infections, sciatica, headaches, dental pain, heart pain and nerve pain.”

On the webpages titled, “Focus” and “Focus XL”:

• “Nutriair Focus. . . full of nootropics, which may improve cognitive function.”
• “Guarana Extract: . . . is well known for its powerful effect of . . . reduced fatigue.”
• “Vitamin B-12 is one of the most important vitamins for concentration and memory. When you lack sufficient vitamin B-12, the nerves' myelin sheath . . . is disturbed, resulting in problems with concentration, memory loss, disorientation, and dementia.”

On the webpage titled, “BENEFITS OF TAKING L-THEANINE WITH CAFFEINE” which includes the product image and a link to purchase your “Energy” product:

• “Stress and Anxiety Relief: . . . [R]eduction in anxiety is observed with theanine.”
• “Improved Immune Function . . . theanine supplementation could improve the functionality of your immune system by supporting gut health, reducing inflammation and decreasing the rate of respiratory infection.”

On your website www.nutrovape.com:

On the webpage titled, “Nutrovape Introduces New Inhalable Hangover Recovery Aid,” which includes the product image to your “Recover” product:

• “Hangovers! Does anybody like them? Not a soul, but how can we stop ourselves from encountering one after a long night? Nutrovape now has the answer. With the new Nutrovape recover, you can make sure your hangovers don't ruin your days after a night of drinking.”

On your Facebook social media website at www.facebook.com/nutriar:

• On your April 9, 2020 post: “Nutriair Diffuser, Relax contains natural herbs and nutrients known for relieving stress, combating anxiety, and overall mood support.”

On your Facebook social media website at www.facebook.com/trynutrovape:

• On your April 30, 2021 post: “Your diet is about to get a whole lot easier! Introducing New Nutrovape Diet XL! Double the servings in every device, Nutrovape Diet XL . . . help you resist that cheat meal just a little bit longer!”
• On your October 11, 2021 post: “Thinking about buying Focus? Read our latest review of the product by Parker H. . . . Genuinely helps with my focus cause i [sic] have ADHD.”

On your Instagram social media website at www.instagram.com/nutri.air:

• On your April 10, 2020 post: “Recover is an at home must-have . . . #hangoverprevention #hangovercure . . . #antiinflammatory . . . #liverdetox”

On your Instagram social media website at https://www.instagram.com/nutrovape/:

• On your June 28, 2019 post: “Need help sticking to your summer diet? Nutrovape Diet can help! . . . regulate appetite! . . . #inhaleyoursupplements . . . #supplementsthatwork #diet”
• On your June 14, 2021 post: “Nutrovape B-Complex with CoQ10 is a combination of essential B vitamins and antioxidants that help support the production of cellular energy! Also available in Nutrovape XL!”
• On your June 30, 2021 post: “Whether you tying [sic] to make it through your to do list, or just resist that second cup of coffee, Nutrovape Energy is a daily essential that's ready to help get you through the week!. . . #antianxiety . . . #anxietymanagement . . . #caffeine #coffeealternative”

On your Twitter social media website at www.twitter.com/nutriair:

• On your May 2, 2018 tweet: “Aren't hangovers the worst? Using Nutriair Recover will help you to avoid the dreaded morning after.”

On your Twitter social media website at www.twitter.com/nutrovape:

• On your April 26, 2019 tweet: “Make Nutrovape Recover your best friend and say adios to a #hangover!”

Your nutrovape vaporizer products and nutriair diffuser 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 We note that many of nutrovape vaporizer products and nutriair diffuser products are also available in “XL” versions.

2 Similar claims appear on the “Sleep” product webpage of your www.nutrovape.com website.