U.S. Customs seizes 102,000 banned pills in Cincinnati
The pills were shipped by the same entity in Mexico and were destined for the same residence in California, CBP officials said Tuesday in a news release.
The customs declaration for six packages containing the pills describes them as "Nutritional Supplement Natural INGR," according to the CBP.
"Most people hear about CBP seizing narcotics shipments," CBP Chicago Field Office director of operations LaFonda Sutton-Burke said. "Shipments of unapproved pills are very dangerous, too."
Sutton-Burke said the U.S. Food and Drug Administration has not approved the potentially dangerous pills.
The pills "contain harmful chemicals which can lead to medical emergencies or even death," Simon-Burke said.
The Artri King pills are promoted as treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions and are sold through some retail stores and websites, such as Amazon.com, Walmart.com and latinfoodsmarket.com.
FDA lab analyses show the pills contain undeclared ingredients and are associated with liver toxicity and deaths.
The FDA in April 2022 issued a warning saying the pills contain diclofenac and dexamethasone, neither of which are listed among its ingredients.
"Consumers taking Artri King should immediately consult with their health care professional to safely discontinue use of this product," the FDA warning says.
Dexamethasone is a corticosteroid that FDA officials say commonly is used to treat inflammatory conditions.
Corticosteroids can impair a person's ability to fight infections and could cause high blood sugar levels, muscle injuries and psychiatric problems, according to the FDA.
When taken over an extended periods or in high doses, they can suppress the adrenal gland, cause withdrawal symptoms and cause serious side effects when combined with other medications.
Diclofenac is a non-steroidal and anti-inflammatory drug commonly referred to as "NSAIDs" that could increase users' risks of heart attack, stroke and other cardiovascular medical events.
The drug also could cause serious gastrointestinal damage, including bleeding, ulcers and fatal perforations of the stomach and intestines.
It also might interact with other medications and significantly increase the risk of harmful medical reactions.
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Bloomberg
33 minutes ago
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00:00 What's your view that the FDA does not have authority in this moment, your wellness, not medical device? Well, thanks for having me on. You know, you've spent the last three years developing a very innovative feature called Blood Pressure Insights, and this takes our wrist worn wearable alongside a calibration with a cuff and is allowed to provide you with a daily estimate of your blood pressure. And in turn, it also then gives you insights how your blood pressure may be affecting other things in your wellness. This could be sleep, stress, nutrition, a variety of different wellness factors. And the FDA is coming forward saying that they believe that this should be regulated. Now, the 21st Century Cures Act makes it very clear that wellness intended features are not supposed to be regulated by the FDA, and the FDA is intended to actually just regulate medical devices that are diagnosing something. So there's this key question of intended use. And you can see this with other physiological metrics like heart rate monitoring, for example, where Hari monitoring has wellness applications and medical applications. The wellness applications might be things like exercise or stress monitoring or sleep monitoring. And we do all that right. And alternatively, there could be, you know, a diagnosis for AFib, and that would be an example where the say, well, well, that's what the FDA misinterpreted of. Right. But you're a smart guy and you employ lots of smart people. Why not just go through the FDA process in the first place kind of foreseeing that this might come up? Well, you have to understand, there's different use cases, right? One use case for blood pressure is around wellness. And there's other use cases that might be a medical diagnosis. And we're certainly looking at, you know, cleared products as well and a longer term horizon. But we're providing a lot of value today and we're following the law again. The 21st Century Cures Act makes it very clear if a product is intended for a wellness use case, it's not supposed to be regulated by the FDA. So then the fundamental question becomes, does blood pressure have wellness intended use cases? We believe it does, right? There's an avalanche of peer reviewed research that shows that blood pressure, not surprisingly, is influenced and influences other aspects of your well, well, why call it medical grade? Why market it that way? Well, we recently came out with the WOOP five data and the BMJ and a key distinguishing factor between the five data and the M.G. is that the M.G. has a medically cleared feature on it. Now, both of those products have a number of wellness features associated with it. The WU PMG happens to have an EKG monitor as part of that that can detect A-fib. And by the way, we spent two and a half years working with the FDA to have that be a cleared feature. So that is the distinguishing factor between those two hardware's. 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Ultimately, I think that, you know, innovation needs to be able to thrive in the United States. WOOP is one of the first wearables in the world that can measure blood pressure accurately from the wrist. That's a really big deal. And it's also being accepted in 50 other markets around the world. So, you know, we want to make sure that there's policies that are consistent here in the U.S. that really allow companies to innovate and to operate. It's also worth noting, you know, we have a lot of people using this every single day. And overwhelmingly, if you look at the feedback from our members, they absolutely love this feature and they talk about how accurate is and how it's helping them understand their wellness. So we feel like we're on the right side of history and we're going to continue educating the FDA on what we're doing. Well well, I'm very quickly I'm not a we use it, but I'm very conscious that in the Premier League and other international football players, it's it's very in the public conscience. I just wonder like is this a good PR moment for you to fight America's regulator? I think in the long run will be on the right side of history and that maybe in a very short period of time, too. I think that fighting for innovation, fighting for Americans access to health data is the right thing to do. And, you know, I've spent 13 years building this company. When I first started, the idea that you could measure sleep or heart rate accurately from the wrist seemed impossible. And now we're able to do blood pressure accurately from the wrist. That's a really big deal. And I think it should be celebrated as long as there's the right guidelines in place and the right education in place for members to understand how to use. And that's what we've done with this feature, and that's why we're proud of it.