FDA Cracking Down On Vape Products Making Health, Wellness Claims 12/09/2021 – MediaPost Communications

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Having linked a nationwide lung disorder to vaping devices containing THC and vitamin E acetate, the U.S. Food and Drug Administration is turning its focus to vape marketers that make erroneous health or wellness claims.
Yesterday, the FDA issued an alert saying that vaping products containing vitamins and/or essential oils are being illegally marketed to adults and minors with unproven claims and could be harmful if used.
“Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases,” the agency said.
The claims in question range from improving mental clarity to treating tumors or asthma, and supposed remedies for ADHD and dementia.
“These claims are unproven and the products may be ineffective, a waste of money, unsafe and may prevent or delay you from seeking an appropriate diagnosis and treatment from a health care professional,” the agency said.
On Dec. 1, the FDA issued warning letters to five companies whose vape products are sold mainly online and promoted on websites and social media platforms.
In one example, the FDA sent a 1,550-word missive to Montana-based Eagle Energy USA Inc. regarding its Caffeine Pen vape devices, which are touted as a “healthy caffeine alternative.”
On its website, Eagle Energy calls the Caffeine Pen the first and only “inhalable energy supplement.” Its natural, plant-based ingredients include guarana—which contains caffeine—ginseng and vitamin B12.
“Safe, effective, and easy to use—welcome to the future of caffeine,” the website states.
According to the FDA, claims on Eagle Energy’s website, social media and packaging establish that its products are “unapproved new drugs” being sold in violation of the Federal Food, Drug and Cosmetic Act.
The FDA noted that Eagle Energy appears to be marketing Caffeine Pen as a dietary supplement. Under federal law, dietary supplements are legal only when ingested.
“However, your products’ labeling states that they are intended for inhalation. Therefore, your ‘Caffeine Pen’ products do not meet the definition of a dietary supplement under the FD&C Act.”
Marketing Daily reached out to Eagle Energy for comment but had not heard back by deadline.
The FDA is generating public awareness of potentially illegal health-related vape product claims with posts on social media and emails to people who sign up for its newsletters.
In 2019, a mysterious lung disorder began to spread across all 50 U.S. states. Eventually tied largely to black-market THC vape products and dubbed EVALI, the outbreak had caused approximately 3,000 hospitalizations and 70 deaths by February of 2020.
According to the FDA, vitamin E acetate—an additive in some TCH vape products—was “strongly linked to the EVALI outbreak.”


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