fda

biofilms,-unwashed-hands:-fda-found-violations-at-mcdonald’s-ex-onion-supplier

Biofilms, unwashed hands: FDA found violations at McDonald’s ex-onion supplier

E. coli, fda, food safety, health, inspection, mcdonalds, onions, outbreak, taylor farms / /

Perhaps most concerning, FDA inspectors noted that employees were never seen washing their hands. Instead, they wore gloves, and if they touched dirty surfaces or items, they would simply put hand sanitizer on their dirty gloves and carry on. What they should have been doing was removing their dirty gloves, washing their hands, and getting clean gloves. However, the FDA inspectors never saw this happen, and managers confirmed that hand sanitizing gloves was common practice.

The inspectors also noted that the facility’s equipment was always wet. Employees applied sanitizing solutions on knives and other equipment used to dice and chop fresh produce. The sanitizing solution is meant to be air-dried before use, but Taylor Farms employees immediately used the equipment—still dripping with sanitizing solution—to cut RTE produce.

On one day of the inspection, FDA agents saw employees chop RTE lettuce with equipment that was wet with sanitizing solution at the maximum concentration, which was 200 ppm. In another instance, the inspectors saw an employee mix cleaning chemicals together to make a sanitizing solution, which the employee said was done “routinely.” When inspectors asked about the mixture, Taylor Farms “could not find the source of this recipe,” nor could they find the manufacturer label or other information stating the mixture was designed for use.

“Highest expectations”

In a statement to CBS, Taylor Farms said that it “immediately took steps to address” the problems found in the FDA’s inspection, which resulted in no “administrative or regulatory action” against the company.

“Taylor Farms is confident in our best-in-class food safety processes, and in turn, the quality and safety of our products,” the company said in the statement. “As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities.” The company added that “no illnesses or public health threat has been linked to these observations” in the inspection.

McDonald’s, meanwhile, said it had stopped getting onions from the facility.

“We hold our suppliers to the highest expectations and standards of food safety. Prior to this inspection, and unrelated to its findings, McDonald’s stopped sourcing from Taylor Farms’ Colorado Springs facility,” McDonald’s said in a statement.

Biofilms, unwashed hands: FDA found violations at McDonald’s ex-onion supplier Read More »

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After decades, FDA finally moves to pull ineffective decongestant off shelves

decongestant, fda, health, phenylephrine, Science, sudafed / /

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.

Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drug makers will no longer be able to include phenylephrine in products for the temporary relief nasal congestion.

“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA’s previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.

Reviewed reviews

The slow-moving abandonment of phenylephrine is years in the making. The decongestant was originally approved by the FDA back in 1976, but it came to prominence after 2006. That was the year when the “Combat Methamphetamine Epidemic Act of 2005” came into effect, and pseudoephedrine—the main component of Sudafed—moved behind the pharmacy counter to keep it from being used to make methamphetamine. With pseudoephedrine out of easy reach at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.

In 2007, an FDA panel reevaluated the drug, which allegedly works by shrinking blood vessels in the nasal passage, opening up the airway. While the panel upheld the drug’s approval, it concluded that more studies were needed for a full assessment. After that, three large, carefully designed studies were conducted—two by Merck for the treatment of seasonal allergies and one by Johnson & Johnson for the treatment of the common cold. All three found no significant difference between phenylephrine and a placebo.

After decades, FDA finally moves to pull ineffective decongestant off shelves Read More »

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“Havard”-trained spa owner injected clients with bogus Botox, prosecutors say

botox, counterfeit, fda, fraud, health, Science, skin fillers, spa / /

Mounting evidence

Multiple clients and employees told investigators that Fadanelli also said she is a registered nurse, which is false. Though she is a registered aesthetician, aestheticians are not permitted to administer injections or prescription drugs.

Investigators set up an undercover operation where an agent went in for a consultation, and Fadanelli provided a quote for a $450 Botox treatment. Investigators also obtained videos and images of Fadanelli performing injections. And the evidence points to those injections being counterfeit, prosecutors allege. Sales records from the spa indicate that Fadanelli performed 1,631 “Botox” injections, 95 “Sculptra” injections, and 990 injections of unspecified “filler,” all totaling over $933,000. But sales records from the manufacturers of the brand name drugs failed to turn up any record of Fadanelli or anyone else from her spa ever purchasing legitimate versions of the drugs.

Despite the mounting evidence against her, Fadanelli reportedly stuck to her story, denying that she ever told anyone she was a nurse and denying ever administering any injections. “When agents asked Fadanelli if she would like to retract or modify that claim if she knew there was evidence showing that she was in fact administering such products, she reiterated that she does not administer injections.”

Ars has reached to Fadanelli’s spa for comment and will update this story if we get a response. According to the affidavit, clients who received the allegedly bogus injections complained of bumps, tingling, and poor appearances, but no infections or other adverse health outcomes.

In a press release announcing her arrest, Acting United States Attorney for Massachusetts Joshua Levy said: “For years, Ms. Fadanelli allegedly put unsuspecting patients at risk by representing herself to be a nurse and then administering thousands of illegal, counterfeit injections. … The type of deception alleged here is illegal, reckless, and potentially life-threatening.”

For a charge of illegal importation, Fadanelli faces up to 20 years in prison and a $250,000 fine. For each of two charges of knowingly selling or dispensing a counterfeit drug or counterfeit device, she faces up to 10 years in prison and a fine of $250,000.

“Havard”-trained spa owner injected clients with bogus Botox, prosecutors say Read More »

drugmaker-shut-down-after-black-schmutz-found-in-injectable-weight-loss-drug

Drugmaker shut down after black schmutz found in injectable weight-loss drug

compounding pharmacies, eli lilly, fda, health, mounjaro, Novo Nordisk, Ozempic, safety, Science, wegovy, weight loss drugs, zepbound / /

It’s unclear how widely the pharmacy’s drugs were distributed. Fullerton Wellness could not be reached for comment.

Bigger battles

This is just the latest warning on weight-loss drugs from the FDA, which has repeatedly cautioned about quality and safety problems related to compounded versions of the drugs. The compounded drugs are intended to be essentially copycat versions of the blockbuster brand-name drugs. Compounding pharmacies can make copycat versions only as long as the drugs are in short supply, acting as a stopgap for patient access. But, with the popularity of the drugs and the high prices of the brand name versions, compounded formulations have become seen as affordable alternatives for many patients.

The situation has become a legal quagmire, with less-than-scrupulous compounding facilities drawing the ire of the FDA, and the big pharmaceutical companies fighting with their compounding competition. Eli Lilly, maker of Zepbound and Mounjaro (tirzepatide), and Novo Nordisk, maker of Wegovy and Ozempic (semaglutide), have both sued multiple compounding pharmacies over copycat versions of their lucrative drugs, which they claim are unsafe and fraudulent.

Meanwhile, in October, a trade organization for large-scale compounding pharmacies sued the FDA after the regulator removed tirzepatide from the drug shortage list, a move that blocks compounders from making copycat versions of the drug. But, the FDA quickly backpedaled in court, saying it would reconsider the removal and would allow compounders to keep producing off-brand versions in the meantime.

Also in October, Novo Nordisk asked the FDA to stop letting compounders make copycat versions of semaglutide, arguing that the drug is too complex for compounders to make and poses too many safety risks to patients. In response, the trade organization for compounders, the Outsourcing Facilities Association, submitted a letter to the FDA asking it to require Novo Nordisk to provide an economic impact statement to assess the cost and price increases that could occur if semaglutide were no longer available through compounding pharmacies.

Drugmaker shut down after black schmutz found in injectable weight-loss drug Read More »

guy-makes-“dodgy-e-bike”-from-130-used-vapes-to-make-point-about-e-waste

Guy makes “dodgy e-bike” from 130 used vapes to make point about e-waste

disposable vapes, e-bike, e-bikes, e-waste, elf bar, fda, Tech, vape / /

Disposable vapes are indefensible. Many, or maybe most, of them contain rechargeable lithium-ion batteries, but manufacturers prefer to sell new ones. More than 260 million vape batteries are estimated to enter the trash stream every year in the UK alone. Vapers and vape makers are simply leaving an e-waste epidemic to the planet’s future residents to sort out.

To make a point about how wasteful this practice is—and to also make a pretty rad project and video—Chris Doel took 130 disposable vape batteries (the bigger “3,500 puff” types with model 20400 cells) found littered at a music festival and converted them into a 48-volt, 1,500-watt e-bike battery, one that powered an e-bike with almost no pedaling more than 20 miles. You can see the whole build and watch Doel zoom along trails on his YouTube video.

A pile of empty aluminum vape shells, and the juice and batteries that came out of them, on Chris Doel’s workstation. A pile of empty aluminum

To be clear: Do not do this. Do not put disposable vape cartridges in a vise clamp to “pop out” their components. Do not desolder them from vape cartridges that have a surprising amount of concentration still in them. Do not wire them together using a balance board, group them using 3D-printed cell holders, and then wire them in series. Heck, do not put that much power into a rear hub on a standard bike frame, at least more than once. Doel has a fire extinguisher present and visible on his workbench, and he shows you what happens when two of the wrong batteries happen to make momentary contact—smoke, coughing, and strong warnings.

And yet, when you see Doel get 33 kilometers (about 20.5 miles) on his vape-powered ride, almost entirely without pedaling, hitting 32 miles per hour once, the point is made. We are tossing out a lot of battery materials that could be doing a lot of other things. Doel estimates his “dodgy bike” cost about $60 in filament and materials to piece together. Most of the cells are rated for a minimum of 300 cycles, which is both not a lot, but also more than some bikes and scooters actually take on.

Guy makes “dodgy e-bike” from 130 used vapes to make point about e-waste Read More »

shady-drugmaker-used-code-words-to-sell-knockoff-weight-loss-drug:-lawsuit

Shady drugmaker used code words to sell knockoff weight-loss drug: lawsuit

eli lilly, fda, GLP-1, health, mounjaro, Pharmaceutical industry, Science, Tirzepatide, weight loss, zepbound / /

Starts with a T

Pivotal Peptides—which is not a licensed pharmacy or dispensary—did not respond to the letter. Instead, its website was modified to indicate that it was “down for maintenance,” and the company instructed customers to email directly. About 10 days later, Pivotal Peptides’ registered agent, Elizabeth Gately, then sent an email (which Lilly obtained) instructing customers to place tirzepatide orders using coded language.

“Good News,” the email read, “Pivotal Peptides … is still in business!”

“If a favorite product (starting with T) was your go-to, that name can’t be used in any correspondence with me or listed on my price sheet anymore,” Gately allegedly wrote. “Therefore, I need another identifier and decided (for now) to call this peptide ’11mg.'”

Gately went on to say that the codenamed product “is Pivotal Peptide’s [sic] bestseller,” and “it is the only T size available from PP right now except by special order.” The letter ended with: “Remember to order ’11 mg’ with the latest price to identify the product you want, if applicable, and no longer use T in our communication.”

Pivotal Peptides did not respond to Ars’ request for comment.

In a statement emailed to Ars, a Lilly spokesperson said Pivotal Peptides and the other companies Lilly is suing are engaging in “conduct that poses serious risks to patient safety.” In the lawsuit, Lilly notes that even children could be ordering this DIY, research-grade drug.

“No one should ever be allowed to sell these untested, non-human grade or manipulated drugs to American consumers,” the statement continued.

Lilly’s lawsuits come amid a legal storm over compounded versions of the tirzepatide, which can be legally made by licensed pharmacies as long as tirzepatide is in shortage. On October 2, the Food and Drug Administration announced that the shortage had ended but then decided to reconsider the decision after being sued by compounding pharmacies.

On several occasions, the FDA has warned of safety concerns related to compounded versions of GLP-1 weight-loss drugs.

Shady drugmaker used code words to sell knockoff weight-loss drug: lawsuit Read More »

drugmakers-can-keep-making-off-brand-weight-loss-drugs-as-fda-backpedals

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

compounding pharmacies, diabetes, fda, GLP-1, health, lilly, mounjaro, OFA, outsourcing facilities, Science, Tirzepatide, weight loss, zepbound / /

The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21.

Drugmakers respond

The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.

“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off of the list at a time when the agency has acknowledged ‘supply disruptions,’ which immediately created a major access issue for patients everywhere,” OFA Chairperson Lee Rosebush said in a statement. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”

The move is also likely to please patients who have come to rely on cheaper, more readily available compounded versions of the drugs. For some, compounded products may have been their only access to tirzepatide.  Still, those drugs are not without risk. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not go through the same safety, efficacy, and quality reviews. And the agency has warned of dosing errors and other safety concerns with compounded versions.

The one party that is certainly unhappy with the FDA’s move is Eli Lilly, which had reportedly sent cease-and-desist letters to compounders. In an emailed statement to Ars, a spokesperson for Lilly said that there was sufficient supply of the company’s drug and continued use of compounded versions is unwarranted. “Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.

Lilly also noted the FDA’s safety concerns about the compounded versions, adding that its own examination of some compounded products found impurities, bacteria, strange coloring, incorrect potency, puzzling chemical structures, and, in one case, a product that was just sugar alcohol.

“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.

In terms of the supply “disruptions” the FDA mentioned and that some patients and pharmacies have reportedly experienced, Lilly said that the supply chain was complex and there are many reasons why a given pharmacy may not have a specific dose at hand, such as limited refrigerated storage space.

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals Read More »

over-86%-of-surveyed-health-care-providers-are-short-on-iv-fluids

Over 86% of surveyed health care providers are short on IV fluids

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Trucks and Gatorade

Federal officials, meanwhile, are working with Baxter to help support increasing supplies, setting up temporary imports, and expediting consideration of any shelf-life extension requests.

In a letter earlier this week, Department of Health and Human Services Secretary Xavier Becerra told health care leaders that the department is “working tirelessly to mitigate the sterile solutions supply chain disruptions” and, beyond the current crisis, is also working to diversify the supply chain so it is less reliant on a single plant.

For now, though, “HHS is encouraging all providers and health systems, regardless of whether they have experienced a disruption in their supply, to take measures to conserve these critical products,” the letter read. Some hospitals have already reported giving patients Gatorade and Pedialyte to conserve IV fluid supplies.

In one bright spot in the current disruptions, fears that Hurricane Milton would disrupt another IV fluid manufacturing plant in Florida were not realized this week. B. Braun Medical’s manufacturing site in Daytona Beach was not seriously impacted by the storm, the company announced, and production resumed normally Friday. Prior to the storm, with the help of the federal government, B. Braun reportedly moved more than 60 truckloads of IV fluid inventory north of Florida for safekeeping. That inventory will be returned to the Daytona facility, according to reporting by the Associated Press.

Over 86% of surveyed health care providers are short on IV fluids Read More »

drug-makers-can’t-make-knockoff-weight-loss-drugs-anymore—and-they’re-mad

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

compounding pharmacy, fda, GLP-1, health, lilly, outsourcing facility, Science, semaglutide, Tirzepatide, weight loss / /

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad Read More »

homeopathic-company-refuses-to-recall-life-threatening-nasal-spray,-fda-says

Homeopathic company refuses to recall life-threatening nasal spray, FDA says

fda, homeopathy, nasal spray, Science, snorestop / /

Dangerous —

Consumers should stop using SnoreStop, FDA says.

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Homeopathic company refuses to recall life-threatening nasal spray, FDA says

The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and Drug Administration once again found evidence of dangerous microbial contamination.

In a warning Thursday, the FDA advised consumers to immediately stop using SnoreStop nasal spray—made by Green Pharmaceuticals—because it may contain microbes that, when sprayed directly into nasal cavities, can cause life-threatening infections. The FDA highlighted the risk to people with compromised immune systems and also children, since SnoreStop is marketed to kids as young as age 5.

According to the regulator, an FDA inspection in April uncovered laboratory test results showing that a batch of SnoreStop contained “significant microbial contamination.” But, instead of discarding the batch, FDA inspectors found evidence that Green Pharmaceuticals had repackaged some of the contaminated lot and distributed it as single spray bottles or as part of a starter kit.

In response, Green Pharmaceuticals destroyed the remainder of the tainted lot and stopped selling the nasal spray on its website. (It is still selling its SnoreStop throat spray, chewable tablets, and pet products, which includes a nasal spray.) But, according to the FDA, it refused to recall products that may contain product from the tainted lot. The agency said it “reiterated its recall recommendation multiple times” in August and September. But, “To date, the company has not taken action to recall this potentially dangerous product from the market.”

Ars has reached out to Green Pharmaceuticals for comment but has not received a response.

Tainted history

SnoreStop.

Enlarge / SnoreStop.

This isn’t new territory for the company. In 2022, Green Pharmaceuticals got warnings from the FDA and issued a recall due to microbial contamination in its SnoreStop nasal spray. In June 2022, the FDA held a conference with the company over findings of bacteria and fungi in the spray. Some of the results suggested high levels of microbial contamination. “The individual sample results varied between 420 and up to 6,200 colony forming units (CFU)/mL for total aerobic microbial count… and between 30 and up to 3,800 CFU/mL for total yeast and mold counts,” the FDA reported in a December 2022 warning letter sent after the fact.

The FDA also noted finding the specific bacterial pathogen Providencia rettgeri, an opportunistic germ that can lurk in health care settings. It’s most often linked to urinary tract infections, but it can also cause pneumonia, brain and spinal cord infections, heart infections, and wound and bloodstream infections in vulnerable people, according to a 2018 review.

“The high bioburden in conjunction with the route of administration with this drug product poses a high risk of harm to vulnerable patients, including children,” the FDA wrote in its warning letter. Green Pharmaceuticals recalled SnoreStop in June 2022, after its meeting with the FDA.

Dangerous dilutions

Aside from the gross microbial contamination, the FDA also noted in its letter that SnoreStop appears to be an unapproved new drug, illegally claiming to treat a disease without FDA approval. SnoreStop is a homeopathic product, meaning it is based on pseudoscience. Homeopaths falsely believe that if substances, including poisons, cause the same symptoms as illnesses, the substance can cure those illnesses (“like cures like”). The reason the products don’t poison users is because homeopaths also believe that diluting substances into oblivion enhances their curative properties (“law of infinitesimals”). Some dilutions are so extreme that not a single molecule of the starting substance is present in homeopathic products. And some homeopaths have argued that water molecules can have a “memory” of the substance, which, they contend, explains how the products work.

SnoreStop is said to contain dilutions of: nux vomica (a natural source of strychnine), belladonna (deadly nightshade), Ephedra vulgaris (a source of the drug ephedrine), hydrastis canadensis (a toxic herb), Kali Bichromicum (potassium dichromate, which is considered toxic and carcinogenic), Teucrium marum (similar to catnip), and Histaminum hydrochloricum (Histamine dihydrochloride).

Consumer advocates have worked for years to try to get homeopathic products off of store shelves, where they’re sometimes sold alongside evidence-based, FDA-approved over-the-counter medicines. While homeopathic products are mostly harmless and ineffective—offering placebo effects at best—they can turn deadly when manufacturers mishandle the dilutions. For instance, in 2016, the FDA linked improperly diluted belladonna in homeopathic teething products to the deaths of 10 infants and the poisonings of more than 400 others.

Homeopathic company refuses to recall life-threatening nasal spray, FDA says Read More »

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ADHD med shortages push DEA to up drug allotment by 23.5%

adderall, ADHD, controlled substances, DEA, drug shortages, fda, health, Science, Vyvanse / /

drug boost —

The DEA’s quota increase is for Vyvanse and its generic forms.

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ADHD med shortages push DEA to up drug allotment by 23.5%

While supplies of Adderall and its generic versions are finally recovering after a yearslong shortage, the Drug Enforcement Administration is now working to curb the short supply of another drug for attention-deficit/hyperactivity disorder: Vyvanse (lisdexamfetamine) and its generic versions.

This week, the DEA said it will increase the allowed production amount of lisdexamfetamine by roughly 23.5 percent, increasing the current 26,500 kg quota by 6,236 kg, for a new total of 32,736 kg. The DEA also allowed for a corresponding increase in d-amphetamine, which is needed for production of lisdexamfetamine.

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA said.

Quotas

Just like Adderall (amphetamine/dextroamphetamine salts), Vyvanse (lisdexamfetamine) is an amphetamine-class stimulant classified by the DEA as a Schedule II drug. As such, the DEA controls its production levels to ensure demand is met while preventing excess supply that could find its way to the black market. The administration does this by setting an “aggregate production quota”—which is what the DEA adjusted for lisdexamfetamine this week—and doling out undisclosed allotments to drug manufacturers.

While various factors have contributed to the shortages of ADHD medications, some medical and industry groups have placed blame on the DEA’s quota system for underestimating demand and choking supply. For instance, the Adderall shortage began in 2022 following a labor shortage on the product’s production line at Teva, Adderall’s maker. But, while that production snag was resolved, prescription rates increased significantly, in part due to increased awareness of ADHD, broadening diagnosis criteria, and an increase in access with the rise of telehealth services, which boomed during the COVID-19 pandemic. In a report earlier this year, the American Society of Health-System Pharmacists pointed to the DEA’s quotas, saying they’re “exacerbating” shortages.

In an August 2023 joint letter, the DEA and the FDA responded to such criticism, suggesting that the quotas aren’t to blame. Rather, it’s that some manufacturers are not using up their allotment of controlled drugs.

“Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products [which include the two ADHD drugs], manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend,” the FDA and DEA wrote.

The FDA and DEA said they would work with manufacturers to ensure they would ramp up production of drugs in short supply or relinquish their remaining allotments.

Vyvanse shortage

A similarly complicated situation is seen with the current shortfall of Vyvanse and its generics. The DEA raised the quota after prodding from the Food and Drug Administration. In July, the FDA sent the DEA a letter requesting a quota increase. However, the shortage had actually begun in June 2023. At that time, Vyvanse’s maker, Takeda, said that a “manufacturing delay compounded by increased demand” had led to low inventory.

In August 2023, the FDA approved multiple generic versions of Vyvanse after Takeda’s patent exclusivity expired, raising hopes that the shortage would ease with the injection of new generics. But supply problems have persisted. In November, the Association for Accessible Medicines, which represents generic drugmakers, sent a letter to the DEA saying that generic manufacturers weren’t able to obtain enough raw material to “launch their products at full commercial scale,” because the quotas were standing in the way, according to reporting by Bloomberg.

FiercePharma reported another potential factor raised by lawmakers and industry watchers. Those onlookers took note of the timing of Takeda’s “manufacturing delays” just months before generics entered the market. With the significantly thinner profit margin of generic and off-patent drugs, there’s concern that manufacturers may de-prioritize production.

Last, the DEA flagged yet another factor in the supply chain: exports to foreign markets. While the FDA estimated a 6 percent increase in the domestic need for lisdexamfetamine between 2023 and 2024, the DEA’s export data showed a 34 percent increase in exports of lisdexamfetamine between 2022 and 2023, with expectations that exports would continue to increase this year and beyond. As such, the current 23.5 percent quota increase for lisdexamfetamine is only partly for domestic production. In fact, only a quarter of the 6,236 kg is intended for the US. Of the increased allotment, 1,558 kg is for domestic drug production, while the other 4,678 kg addresses increases in foreign demand, the DEA said.

ADHD med shortages push DEA to up drug allotment by 23.5% Read More »

tattoo-ink-sold-on-amazon-has-high-levels-of-weird-and-rare-bacteria

Tattoo ink sold on Amazon has high levels of weird and rare bacteria

bacteria, contamination, fda, health, microbiology, pathogens, recall, Science, Tattoo, tattoo ink / /

Infectious ink —

The recall announcement noted that the germs “present a health concern.”

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BARCELONA, SPAIN - 2021/10/02: Spanish tattoo artist Oscar Garcia works on a man, during the Expo. Fira de Barcelona hosts the XXIV edition of the Barcelona Tattoo Expo where tattoo artists from Spain and other countries exhibit tattoos and tattoo material such as ink, needles and special machinery for tattoo work. (Photo by Ramon Costa/SOPA Images/LightRocket via Getty Images)

Enlarge / BARCELONA, SPAIN – 2021/10/02: Spanish tattoo artist Oscar Garcia works on a man, during the Expo. Fira de Barcelona hosts the XXIV edition of the Barcelona Tattoo Expo where tattoo artists from Spain and other countries exhibit tattoos and tattoo material such as ink, needles and special machinery for tattoo work. (Photo by Ramon Costa/SOPA Images/LightRocket via Getty Images)

The Food and Drug Administration has been warning for years that some tattoo inks are brimming with bacteria—a large assortment that, when injected into your skin, can cause inflammatory reactions, allergic hypersensitivity, toxic responses, and, of course, straight-up infections. And, worse yet, the labels that say the inks are sterile are not reliable.

But, a recent recall of three tattoo pigments from the same manufacturer does a good job of illustrating the FDA’s concerns. The water-based inks, all from Sierra Stain, had a bizarre array of bacteria, which were found at high levels, according to FDA testing.

One ink product—described as “Carolina Blue”—offered a microbial menagerie, with six odd species identified. They included a bacterium that often dwells in the gastrointestinal system and can inflame the mucosal lining of the intestines (Citrobacter braakii), a water-borne bacterium (Cupriavidus pauculus), and several that cause opportunistic infections (Citrobacter farmer, Achromobacter xylosoxidans, Ochrobactrum anthropi, and Pseudomonas fluorescens). These are bacteria that don’t typically go about attacking humans but will if the conditions are right, including when they find themselves inside a human with a compromised immune system.

An ink called “UV China Pink” contained an unusual soil bacterium (Curtobacterium citreum/pusillum). And an “All Purpose Black” ink puzzlingly contained Acetobacter senegalensis, a bacterium first isolated from mangos in Senegal and used for industrial vinegar production in low-income countries.

The three inks were sold nationwide through Amazon. To date, there have been no reported infections or adverse reactions linked to these inks. But the FDA notes that reactions to contaminated inks can be difficult to accurately diagnose. The infections and skin responses can look like generic rashes and allergic responses, sometimes including lesions with red papules in areas where the ink was injected, the FDA notes. However, infections from tattoo ink can leave permanent scarring.

In a study published in July in Applied and Environmental Microbiology, FDA researchers tested 75 samples of tattoo and permanent makeup inks from 14 manufacturers. Of the 75 inks, 26 (35 percent) were contaminated with a total of 34 types of bacteria, many that were possibly disease-causing. Some of the bacteria were anaerobic, meaning they don’t need oxygen to grow, suggesting they could thrive in the low-oxygen environment of skin layers. Of the 40 tattoo inks specifically, nine (22 percent) were contaminated. Among all the ink samples, 49 were labeled “sterile” and, of those, 16 (33 percent) were contaminated.

The recall announcement noted that Sierra Stain is no longer in business. While the company lists a remaining email address, it did not immediately respond to a comment request from Ars on the bacteria found in their inks.

The FDA recommends that consumers be vigilant about the quality and safety of tattoo supplies and techniques. It also encourages tattoo artists to work in professional environments that can reduce the risk of contamination.

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