FDA is warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine -- a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions. FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. Neptune Fix’s labels state the product contains tianeptine, but may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine.

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CVM Antimicrobial Stewardship in FY 2023 and Beyond

By Bill Flynn, DVM, MS, Deputy Director of FDA’s Center for Veterinary Medicine

Today, we kick off Antimicrobial Awareness Week, held every year from November 18-24. This recognition is a great opportunity to reflect upon what we at FDA’s Center for Veterinary Medicine (CVM) are doing to address antimicrobial resistance (AMR) and preserve the effectiveness of these critical and life-saving drugs. In this post, I’m mainly going to focus on what we accomplished in FY 2023.

 

Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps

FDA’s Center for Veterinary Medicine is sharing news of this recall to alert veterinarians who may be using this product.

In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health Monoject syringes.” These new syringes differ from the previously branded “Covidien Monoject syringes” as they have different dimensions.

The affected Cardinal Health Monoject syringes should not be used with syringe pumps. The dimensional changes made to the affected Cardinal Health Monoject syringes when used with syringe pumps may result in pump performance issues such as overdose, underdose, delay in therapy, and delays in occlusion alarms.

Cardinal Health has received 15 reports of delayed therapy due to syringe infusion pumps not recognizing syringes, and 13 reports of inaccurate volume/rate dispensing, including some injuries. Cardinal Health has not received any reports of patient death.

 

FDA Approves Pregabalin Oral Solution for Alleviating Anxiety Associated with Transportation and Veterinary Visits in Cats

Today the U.S. Food and Drug Administration approved Bonqat (pregabalin oral solution) for the alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. The drug is administered orally approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days. Bonqat is the first FDA-approved animal drug containing pregabalin.

 

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection

Today’s Action also Opens the 510(k) Pathway for Other Tests for These Infections with At-Home Sample Collection

Today, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. Prior to today’s authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office. The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.
 
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.” 
 
According to the Centers for Disease Control and Prevention’s Sexually Transmitted Infections Surveillance Report, chlamydia and gonorrhea are the first and second most common bacterial sexually transmitted infections (STI) in the United States, and the rate of these STIs is steadily increasing, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea, in 2021 alone. Typically, both infections can be easily treated, but if left untreated, both infections can cause serious health complications for patients, including infertility. Expanding the availability of STI testing can help patients get quicker results and access to the most appropriate treatment, ultimately helping to curb the rising rates of STIs. 

The Simple 2 Test which uses vaginal swabs or urine specimens, as appropriate, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively. The test is a direct-to-consumer test that can be purchased without a prescription. The user activates the collection kit online and fills out a health questionnaire for a health care provider to evaluate. The individual collects the specimen at home using the provided collection kit, which is then sent back to the designated laboratory for testing. Results are delivered online, with follow-up from a health care provider in cases of positive or invalid test results.  

The Simple 2 Test includes the Simple 2 Home Collection Kits that were validated for use with the cleared Hologic Aptima 2 Combo Assay. The FDA also evaluated data from LetsGetChecked demonstrating lay users can safely use the kit and have a general understanding of the results and any necessary follow up actions and validated their home collection kits with the intended test.  

The risks associated with the test are mainly the possibility of false positive and false negative test results. False negative test results can result in delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout your community. If exposed to a person with either gonorrhea or chlamydia, CDC guidelines indicate that you should be treated by a healthcare provider with antibiotics, regardless of the test result. False positive results could lead to an inappropriate diagnosis of, and unnecessary treatment for chlamydia and gonorrhea, respectively. This could lead to psychological distress, delay in receiving a correct diagnosis as well as the expense and risk for side effects from unnecessary treatment.   

The FDA reviewed the Simple 2 Test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.

 

Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its chief executive officer, to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the consent decree. According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women’s Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace. “Americans expect and deserve drugs that have been scientifically proven to be safe, effective and of high quality,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law.”  The FDA has not approved Smart Women’s Choice’s drug, a vaginal cream the company has marketed as a safe and effective contraceptive. Smart Women’s Choice has disseminated these claims on its website and social media accounts, among other sources. According to the complaint, despite the FDA’s issuance of a warning letter in 2021 advising Smart Women’s Choice that the distribution of its contraceptive drug product is unlawful under the FD&C Act, the company and Richard continued to violate the law.   The consent decree prohibits Smart Women’s Choice, Richard, and any persons or entities in active concert or participation with them who receive notice of the decree, from directly or indirectly manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug at or from their facilities unless and until they meet certain requirements to ensure they are operating in compliance with the FD&C Act, the FDA’s regulations and the decree, and they receive written notice from the FDA that they appear to be in compliance with these requirements.

 

FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder

Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.

“The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.”

The very rare, inherited blood clotting disorder called cTTP is caused by a disease-causing mutation in the ADAMTS13 gene, which is responsible for making an enzyme, also named ADAMTS13, that regulates blood clotting. A deficiency in this enzyme causes blood clots to form in the small blood vessels throughout the body. It is estimated that cTTP affects fewer than one thousand people in the United States. Symptoms typically develop in infancy or early childhood, but in some cases may develop in adulthood and may first manifest during pregnancy. Individuals with cTTP may experience severe bleeding episodes, strokes and damage to vital organs. If left untreated, the disease can be fatal. Treatment for cTTP typically involves prophylactic plasma-based therapy for individuals with chronic disease to reduce the risk of clotting/bleeding by replenishing the absent/low ADAMTS13 enzyme.

Adzynma is a purified recombinant form of the ADAMTS13 enzyme that works by providing a replacement for the low levels of the deficient enzyme in patients with cTTP. For prophylactic ERT, Adyznma is administered to help reduce the risk of disease symptoms. The product may also be administered as an on-demand ERT for treatment when the patient is experiencing an acute event. Adzynma is administered intravenously once every other week for prophylactic ERT, and once daily for on-demand ERT. 

The safety and effectiveness of Adzynma were demonstrated in a global study evaluating prophylactic and on-demand ERT with Adzynma compared to plasma-based therapies in patients with cTTP.

The efficacy of Adzynma in the prophylactic treatment of patients with cTTP was evaluated in 46 patients who were randomized to receive 6 months of treatment with either Adzynma or plasma based therapies (Period 1), then crossed over to the other treatment for 6 months (Period 2). The efficacy was demonstrated based on the incidence of thrombotic thrombocytopenic purpura (TTP) events, and TTP manifestations, as well as the incidence of the need for supplemental doses. 

The efficacy of on demand ERT was evaluated based on the proportion of acute TTP events responding to Adzynma in both the prophylactic and the on-demand cohorts throughout the duration of the study. All acute and subacute TTP events resolved after treatment with either Adzynma or plasma based therapies. 

The most common side effects associated with Adzynma include headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness and vomiting. During the clinical studies, no adverse events, including allergic reactions, were observed during the administration of Adzynma.

The application was awarded a Rare Pediatric Disease Priority Review Voucher, and granted Priority Review, Fast Track and Orphan designations.

The FDA granted approval of Adzynma to Takeda Pharmaceuticals U.S.A. In

 

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products

Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act. 

The U.S. District Court for the District of Utah, Central Division has entered two consent decrees of permanent injunction against Evig LLC, of St. George Utah, and the company’s CEO, Douglas Lex Howard, as well as Premium Production LLC, of St. George, Utah, and its Manager, Ryan Petersen. 

Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. The FDA has not approved Balance of Nature products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. In addition, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements. Evig distributes Balance of Nature dietary supplement products through Amazon, Walmart, and its own online store at www.balanceofnature.com. 

Premium Production LLC and Mr. Petersen manufactured Balance of Nature products in violation of multiple CGMP requirements, such as failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements. 

“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured, and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” said Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs. “We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be. The FDA will continue to protect the U.S. public health by taking appropriate actions when companies violate the law.”

In 2019, the FDA issued warning letters to Evig LLC and Premium Production LLC after facility inspections identified CGMP violations at both companies’ facilities. The warning letter to Evig LLC also informed the company that a review of its Balance of Nature website revealed that its products as labeled were unapproved new and misbranded drugs because they were intended to cure, mitigate, treat, or prevent disease. Following the 2019 warning letters, FDA inspections showed that the firms failed to address the deviations and come into compliance with the FDA’s requirements. Based on the firms’ continued violations, the FDA pursued injunctions against the firms. 

“Products intended to treat or cure diseases require FDA approval,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Dietary supplement makers also must abide by federal health and safety requirements. The Department will continue to work closely with FDA to stop the distribution of unapproved, adulterated, and misbranded dietary supplements.”

The consent decrees prohibit Evig LLC and Premium Production LLC from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. Under the consent decrees, both firms must hire CGMP experts, submit documents demonstrating compliance, and receive the FDA’s approval to resume operations. In addition, Evig LLC must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs. 

The U.S. Department of Justice filed the complaints on behalf of the FDA.

 

11/07/2023	10/30/2023	Dexterity Health, LLC DBA Zazzee Naturals	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug
11/07/2023	10/23/2023	ADM Animal Nutrition	Division of Human and Animal Food Operations East VI	CGMP/Animal Food/Adulterated
11/07/2023	08/04/2023	Biorica International Corp.	Center for Food Safety and Applied Nutrition (CFSAN)	New Drug/Misbranded
11/07/2023	10/27/2023	Neurotris, Inc. dba A1 Engineering	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
11/07/2023	09/01/2023	InnoMark, Inc.	Division of Human and Animal Food Operations West IV	CGMP/Dietary Supplement/Misbranded

 

11/14/2023	11/06/2023	Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
11/14/2023	11/08/2023	Wello Inc.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Misbranded
11/14/2023	10/18/2023	Natural Relief Inc.	Division of Human and Animal Food Operations East V	Unapproved New Drugs/Misbranded
11/14/2023	10/12/2023	American Distribution and Manufacturing Co., LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
11/14/2023	11/13/2023	Amazon.com, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
11/14/2023	10/20/2023	Global Pharma Healthcare Private Limited	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded