NV Nutrition, LLC
FDA issued a warning letter to NV Nutrition, LLC (operating nutrovape.com and nutriair.com) in December 2021, finding that its inhaled 'vaporizer' and 'diffuser' products—marketed under the nutrovape and nutriair brands—were unapproved new drugs sold in violation of the FD&C Act. The agency cited numerous disease-treatment and structure/function claims on the company's websites, social media, and product packaging that established drug intent, including claims about treating insomnia, anxiety, hangovers, ADHD, and immune function. Because the products are intended for inhalation rather than ingestion, they also do not qualify as dietary supplements under the FD&C Act. FDA warned that failure to promptly correct violations could result in seizure and/or injunction.
Flagged claims (17)
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.
Recover is an at home must-have . . . #hangoverprevention #hangovercure . . . #antiinflammatory . . . #liverdetox
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.
Nutriair Diffuser, Relax contains natural herbs and nutrients known for relieving stress, combating anxiety, and overall mood support.
Chamomile Extract: . . . may produce a sedative or relaxant effect by affecting certain brain chemicals, such as serotonin.
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.
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.
Thinking about buying Focus? Read our latest review of the product by Parker H. . . . Genuinely helps with my focus cause i [sic] have ADHD.
Stress and Anxiety Relief: . . . [R]eduction in anxiety is observed with theanine.
Melatonin has been shown to be effective in managing the symptoms of insomnia
Valerian Root Extract: . . . well known for its sedative qualities and its ability to relax the central nervous system and the smooth muscle groups.
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.
Nutriair Focus. . . full of nootropics, which may improve cognitive function.
Astragulas. . . is known to be a powerful immune-building plant. . . and can even fight off tumors and alleviate symptoms of chemotherapy!
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.
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.
Make Nutrovape Recover your best friend and say adios to a #hangover!
Required actions (3)
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.
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.
Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
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