FDA's continuing focus on tobacco sellers results in 3 new official warning letters.

In recent weeks the U.S. Food and Drug Administration, or FDA, has released a stack of formal warning letters to online sellers of tobacco and tobacco-related products who the agency alleges violate current FDA regulations. This week saw the release of 3 more official warnings.

FDA warning letter sent to The Briar Shoppe, Bill Scoggins and Diane Grace.

The Briar Shoppe, Bill Scoggins and Diane Grace

Bill Scoggins and Diane Grace were warned earlier this month when their website, briarshoppe.squarespace.com, was warned for neglecting to carry FDA-required health warnings about smokeless tobacco’s addictive qualities, the fact that it is not a safe alternative to cigarettes and its known link to gum disease, tooth loss and oral cancers.

FDA warning letter to Abdul Wakeel and Ravenstorm AUA-Father Christmas Group.

Abdul Wakeel and Ravenstorm AUA-Father Christmas Group

Abdul Wakeel was warned after his website, ravenstormaua.org, allegedly filled an order for a customer under the age of 18.

FDA warning letter to Southern Cloud Cartel, Travis Karasek and Nakomah Hanson.

Southern Cloud Cartel LLC, Travis Karasek and Nakomah Hanson

Travis Karasek and Nakomah Hanson are also accused of selling to a minor. Their website is southerncloudcartel.com.

All the warned sellers were given the normal 15 working days to answer the FDA’s accusations and present a written plan detailing how they will avoid repeating the alleged violations in the future.

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Beater sticks for toy xylophones are recalled for potential choking risk.

The U.S. Consumer Product Safety Commission, or CPSC, along with Health Canada, has announced a recall of toy xylophones made in China and distributed by Wild & Wolf. The toys, say child safety experts, pose a potential choking risk because the balls at the ends of the beater sticks can detach.

A company-provided photo of the recalled Petit Collage toy xylophone in and out of its packaging.

Wild & Wolf says it has logged one report of a ball loosening and another of a ball coming completely off its handle. There have been no injuries and no reports of any children swallowing or choking on them.

If you think you might have one of these, you’ll need to turn yours over, the company says, and look for this code:

• TT.1902.0617

In this CPSC-provided photo you can see an example of where to find your toy’s production code.

Only xylophones bearing this exact code are recalled, says Wild & Wolf. But if you do find that your toy is covered in this recall, you should remove the beater sticks immediately. Then, when you contact Petit Collage or Wild & Wolf, you’ll be sent a free replacement beater.

All retailers offering the toy xylophones have already been notified, says the company. The toys were on store shelves as recently as January. Around 2900 were sold in the U.S.; about 240 were sold in Canada.

All the recalled toys were made in China.

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No, qii isn’t actually “the world’s first functional drink for oral health” but it is expanding its line of plaque-fighting beverages with the addition of 3 new flavors. The company announced the […]

No, qii isn’t actually “the world’s first functional drink for oral health” but it is expanding its line of plaque-fighting beverages with the addition of 3 new flavors. The company announced the new flavors in a press release yesterday.

New oral health drink qii is fibbing when it calls itself the world’s first oral health drink but it’s serious about having new flavors.

The new flavors are:

• White Peach
• Pomegranate
• Lychee Tea

Are “Oral Health” Drinks A Real Thing?

Qii, and products like it, are made with xylitol, which is a sugar alcohol widely used as an artificial sweetener. Xylitol is thought to “fight” tooth decay both by “starving” the bacteria that produce dental plaque and by increasing salivation.

But qii also has another trick up its sleeve. Soft drinks, coffee and sports drinks tend to be acidic; qii was specially formulated to be pH-neutral. The drink’s creator claims it is proven to reduce plaque by more than 50%. (We were unable to find that study ourselves.)

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This story was inspired by a press release distributed to media. No one at LisaBarger.com was compensated directly or indirectly for writing it. No one at LisaBarger.com received free samples of qii to review. Image of qii were provided by the company.

FDA continues to go after websites that sell e-cigs to kids.

The U.S. Food and Drug Administration, or FDA, is continuing its crackdown on web-based sellers of e-cigarettes, and other tobacco-related products, who sell those items to kids. Recently, the agency released another batch of formal warning letters sent to e-cig sellers allegedly caught selling to kids online.

Accused in March and April are:

• Kassim Al-Derzi and The Sub Ohm Syndicate (thesubohmsyndicate.com)
• YaJing Yang (cigarettes-mart.com)
• Nevin Dowling and Oglesby & Butler Limited d/b/a Iolite (iolite.com)
• David Tomes and Jam Vapes (jamvapes.com)
• Ahsan Qadir and Atom Vapes LLC/Atom Vapes USA, LLC (atomvapes.com)
• Lynsey Green and Quit Easy Ltd (quit-easy.co.uk)
• David Taylor (ecigretail.com)
• Victoria Vasconcellos and Cignot Inc. (cignot.com)
• Chris Hill and Reedhill Ventures LLC d/b/a Vape On Liquids (vapeonliquids.com)

Each website owner has 15 working days to provide the agency with a plan that will prevent sales to minors, and other violations of FDA regs, in the future.

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Photo by Davide Sibilio on Unsplash

The folks behind PowerUp and PowerDown get FDA warning letter for shoddy labeling and bogus claims.

Amerigo Laboratories’ owners Ralph Maser and Carol Maser have found themselves in hot water with health officials for hawking supplements the U.S. Food and Drug Administration, or FDA, says are unproven and shoddily labeled.

The supplements, PowerUp and PowerDown, are nootropics, or brain enhancers. PowerUp, for example, is peddled as an all-natural way to enhance memory, sharpen focus and improve attention. Its companion product, PowerDown, promises to lower anxiety, deepen concentration and improve sleep. Together, the two products offer “full brain support” for “maximizing your brain potential”.

But it’s the Masers’ claims about narcolepsy, cataplexy, ADHD an other serious medical issues that got the FDA’s hackles up.

Screengrab with FDA-warned claims for Amerigo’s PowerUp supplement still visible as of this morning.

FDA says that neither product has been formally greenlit for claims about Alzheimer’s disease, attention deficit hyperactivity disorder, heart disease prevention or a host of other serious medical issues mentioned in the products’ marketing. And both products are further misbranded because they’re marketed for conditions that cannot be accurately self-diagnosed or effectively self-treated at home with over-the-counter supplements.

The agency also takes issue with the way Amerigo is labeling its products. The products lack contact information a customer could use to report an adverse event, for example, and do not disclose their nutrition facts, among other things.

Ralph Maser and Carol Maser were given the normal 15 working days to respond. The letter was dated April 04, 2018; as you can see from the screengrab above, it appears they have not yet removed the allegedly bogus health claims.

It does not appear that either owner has publicly addressed the release of the FDA’s letter.

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A new study finds that 45% of women taking prescribed medications are also taking herbal supplements.

New research from Scotland found that of the 889 pregnant or post-partum women surveyed at the Royal Aberdeen Maternity Hospital, more than 45% of them reported using at least one prescription medication (not including vitamins) while pregnant. And of those, 45% also admitted to taking at least one herbal product, many doing so without their doctors’ knowledge or recommendation.

How serious a problem is this? Well, in this study, the researchers identified 32 herb/medicine combinations used by 23 women that pose what doctors deem a “moderate” risk for complications. And in another example, the combination of ginger and nifedipine was rated “potentially major”. (Combining ginger and nifedipine is well known to increase the blood-thinning effect of nifedipine.)

So why are so many women risking harm to themselves and their babies? The researchers behind this study say that most of the women did not appear to recognize the herbal products as real medications.

The study appears at the website for BMC Complementary and Alternative Medicine.

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Photo by Hermes Rivera on Unsplash