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June 8, 2020

FDA Warns Vape Company for Bizarre Medical Claims

If you wanted to design a vaping product that was likely to get the FDA’s attention, you probably couldn’t do a better job than the folks who make STEMJUICE. The Southern California-based e-liquid manufacturer just received a warning letter from the federal regulators, citing its “false and misleading” claims.

STEMJUICE is an e-liquid line with four flavors, each available in 25 and 50 mg/mL nic salt and 0, 3 or 6 mg/mL freebase nicotine versions. The prices range (based on nicotine content) from $23.90 to $27.90 for a 30 mL bottle. The manufacturer, with little else to stand out from the crowd, decided to set themselves apart by making some rather…unusual claims about its product. And that’s what landed STEMJUICE in hot water with the lawyers at the FDA Center for Tobacco Products.

According to the FDA complaint, STEMJUICE and its parent company stemSTIX, Inc. have made a series of claims that are false or misleading, and that makes its products “adulterated or misbranded” per the Food Drug & Cosmetic Act (or which the Tobacco Control Act is a part).

And the FDA is correct—the marketers at STEMJUICE make some spectacular claims—equal to anything seen in the early wild west days of the vaping industry:

  • “STEMJUICE is the least toxic vape on the market”
  • “Lose the toxic chemicals, not the flavor”
  • “#STEMJUICE is Made in the USA us [sic] We removed toxic chemicals to give you a cleaner vape experience…Revitalize your lungs with STEMJUICE.”
  • “We replaced the bad stuff with the good”
  • “Breathe easy, with STEMJUICE”
  • “MADE WITHOUT…Aldehyde, Formaldehyde, Diacetyl, Propylene Glycol, Hydrogen Cyanide, Vitamin E Acetate”
  • “We use plant stem cell extracts from fresh green apples grown in Switzerland, providing a natural source for our e-juices. These are not only safe to include in e-juices, but can even improve your lung vitality.”
  • “Our e-liquid has undergone tests with the Food and Drug Administration, ensuring its quality and safety. We [have] begun the PMTA process, so you can be assured that our product is safe for consumption and use.”

“Vaping has had a tough time in the news lately and illegal vapes have given the industry a bad rap,” says the company’s website. “As we innovate, we want to clearly show everyone right down to our labels what we do not contain. No propylene glycol, No heavy metals, No aldehydes, No diacetyl and No vitamin e acetate.”

How did propylene glycol make it onto the STEMJUICE naughty list? Your guess is as good as mine. By the way, there’s nothing on the website—which is still active, even after the FDA warning—that explains how stem cells from Swiss green apples improve the user’s “lung vitality.” Do the apples have to be Swiss and green?

The stem cell idea may come from the CEO of the company—the same person who received the warning letter. Maryam Rahimi is an osteopathic physician whose Orange County Pain & Rehab Clinic in Huntington Beach, California is listed at the same address as the Maryam Rahimi on the FDA warning letter. She is also listed as an officer of the company on its incorporation documents, and the CEO on an SEC filing.

The OC clinic website says that she “uses the latest, cutting-edge regenerative therapies, such as Platelet Rich Plasma (PRP) and Stem Cell therapy, found at elite universities.” Stem cells, eh? Oh, doctor, why couldn’t you have just gone into the dietary supplement or CBD business like everyone else who wants to make unproven medical claims? Oh wait, stemSTIX has also applied for a trademark for the name stemCBD, so that probably means we can expect to see “lung-revitalizing” Swiss green apple CBD juice soon.

The company also makes a pod device called stemSTIX, but there’s no mention of it on the STEMJUICE website. There is, however, a Facebook page showing the device in a marketing photo with some green apples. The company also makes some extraordinary claims about the stemSTIX device (which presumably contains STEMJUICE):

  • Detox lung tissue
  • Provide natural respiratory support
  • Strengthen respiration ability

Those are outright medical claims, which require FDA drug approval. Sanjay Dhar, described on LinkedIn as stemSTIX’ chief scientific officer, should have known that. He describes his job as “Leading and guiding the company with all aspects of biosciences and regulatory requirements.” Dhar has a PhD in Parasitology from the Indian Veterinary Research Institute, so at least we can be confident that STEMJUICE is free of ticks, mites and fleas.

The stemSTIX Facebook page shows pictures of the device, being held by celebrating people in stemSTIX t-shirts, and displayed at the company’s booth at the 2019 ECC event. The FDA probably found stemSTIX at ECC. For the price of admission, the agency can see questionable products up close, and hear the marketing claims from the manufacturers’ own mouths.

Of course, all the marketing and medical claims are beside the point. Any product introduced after Aug. 8, 2016 is de facto illegal anyway. That date was the cutoff for products to escape enforcement of the FDA’s Premarket Tobacco Application (PMTA) requirement until the final deadline. (Products introduced before that date have until Sept. 9, 2020 to file their applications.)

“STEMJUICE is committed to working with the FDA and submission of the PMTA due in September,” says their website. “As to the constant changing regulatory landscape we are adapting to meet necessary requirements and testing.” Or they may just sell actual snake oil.

The agency’s warning letter, as usual, gives the company 15 days to respond and describe its “corrective actions,” or face FDA enforcement, “including, but not limited to, civil money penalties, seizure, and/or injunction.” But there’s no correcting the mistakes STEMJUICE and stemSTIX have made. The only way they’ll satisfy the regulators is to shut down, which they should do immediately.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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