Thursday, July 21, 2022
| Swan Brothers Dairy Inc | Office of Human and Animal Food Operations West Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | ||||
| H2 Beverages, Inc. | Division of Human and Animal Food Operations West III | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
| Jap Inc. dba Intercontinental Foods | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Regino Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Free Range Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| USA Vapor Trails | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Imprimis Rx LLC | Division of Pharmaceutical Quality Operations IV | False & Misleading Claims/Misbranded | ||||
| Living Foods LLC | Office of Human and Animal Food- West Division II | Unapproved New Drugs/Misbranded |
| Rockwall Vaporstop LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Young Living Essential Oils Corporate | Office of Human and Animal Food Operations – West Division 4 | New Drug/Misbranded | ||||
| Genlabs Corporation | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| New Sun Inc. | Office of Human and Animal Foods- East Division 3 | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| Bioiberica, SAU | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| Greenfield Produce Imports | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Brad Grate Dairy Farm | Office of Human and Animal Food Operations East Division 6 | New Animal Drug/Adulterated | ||||
| Dara Food LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Flores Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| North30 LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
Monday, July 18, 2022
- Adam's Secret Extra Strength Blue contains hidden drug ingredient
- Adam’s Secret Extra Strength Purple contains hidden drug ingredients
- Adam’s Secret Extra Strength Amazing Black contains hidden drug ingredient
- Adam’s Secret Extra Strength 3000 Platinum (White Packaging) contains hidden drug ingredient
- Dr. Reade Slim Sense contains hidden drug ingredient
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Wednesday, July 13, 2022
"After Roe, Autoimmune Patients Lose Access to "Gold-Standard" Treatment
Patients with rheumatic illnesses may lose access to methotrexate, a cheap drug prescribed to millions of Americans each year, since the Supreme Court overturned Roe v. Wade, according to an investigation by the Los Angeles Times."
quoting Med Page Today, July 13, 2022
Tuesday, July 12, 2022
Horse Doping Drug Supplier Sentenced To 11 Years In Prison
Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant SETH FISHMAN, DVM, received a sentence of 11 years in prison today for his role at the helm of an approximately twenty-year scheme to manufacture, market, and sell to racehorse trainers and others in the racehorse industry “untestable” performance enhancing drugs for use in professional horseracing. FISHMAN was one of over thirty defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs.
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FDA Warns Four Companies for Selling Tainted Honey-based Products with Hidden Active Drug Ingredients
Today, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments.”
Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
The warning letters were issued to:
- Thirstyrun LLC (also known as US Royal Honey LLC),
- MKS Enterprise LLC,
- Shopaax.com,
- 1am USA Incorporated dba Pleasure Products USA
Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.
The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
Department of Justice
District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA
A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce. According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Compounding pharmacies must ensure that their products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance. “While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”
The defendants did not admit or deny the allegations in the government’s complaint, but agreed to settle the suit and be bound by a consent decree of permanent injunction. The consent decree requires, among other things, that the defendants stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to the FDA that they will comply with federal law. Judge Chief Judge Geoffrey W. Crawford of the U.S. District Court for the District of Vermont entered the order against the defendants.
The government was represented by Trial Attorney David G. Crockett of the Civil Division’s Consumer Protection Branch, with the assistance of Claudia Zuckerman of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Vermont provided valuable assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.