Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, June 8, 2022
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter |
|---|---|---|---|---|---|---|
| Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Chrimar Enterprises LLC d/b/a VapeGeek | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Hainan Golden Spring Foods Co. Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Zhoushan Haichang Co. Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Valley View Milling LLC | Office of Human and Animal Food- West Division II | CGMP/Medicated Feeds/Adulterated | ||||
| BonZer BrandZ LLC d/b/a BonZer VapeZ, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Aire-Master of America, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Zerocig dba Aristo Electronic Cigars | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Thursday, June 2, 2022
FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals
Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume.
“Dietary supplements can be valuable to your health but taking some supplements can also involve health risks. It’s important for consumers to have a comprehensive understanding about dietary supplements as well as the ability to identify and safely use supplements that are beneficial to their health,” said Douglas Stearn, Deputy Director for Regulatory Affairs in the FDA’s Center for Food Safety and Applied Nutrition. “These Supplement Your Knowledge resources will help provide consumers and healthcare professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”
Every day, millions of Americans take dietary supplements for a variety of reasons, whether recommended by their healthcare professional or on their own. Some supplements can help consumers meet their daily requirements of essential nutrients or help improve or maintain their overall health. But dietary supplements may also come with health risks, so it’s important to stay informed. As part of the FDA’s ongoing efforts to build awareness around dietary supplements, Supplement Your Knowledge includes the following materials:
- For consumers: Public education videos and fact sheets with important information about dietary supplements, including how they are regulated and potential benefits and risks. These materials are also a helpful resource when talking to a physician, nurse, dietitian, pharmacist, or other healthcare professional before taking a dietary supplement.
- For educators: Teenagers can be particularly vulnerable targets for misunderstanding what dietary supplements are, and they are often unaware of the potential benefits and adverse effects dietary supplements can have on their bodies. To help high school students evaluate the accuracy and credibility of information they may see and hear about dietary supplements, the FDA has developed Science and Our Food Supply: Examining Dietary Supplements (2021 Edition). This curriculum aligns with current national education standards and supports educators seeking Science, Technology, Engineering, and Mathematics (STEM) activities for their classrooms. This curriculum can be customized to science, health, and other related classes.
- For healthcare professionals: The FDA, in collaboration with the American Medical Association (AMA), has developed a continuing medical education (CME) program to help physicians and other healthcare professionals understand how dietary supplements are regulated, provide information to patients on their use, and recognize and report adverse events to the FDA. This free CME program includes three videos and companion education materials and is available on the FDA’s Healthcare Professionals website. Interested physicians can also access these materials at no cost and earn 1 AMA PRA Category 1 Credit on the AMA Ed HubExternal Link Disclaimer.
The FDA advises consumers to talk to their doctor, pharmacist, or other healthcare professional before deciding to purchase or use any dietary supplement. One reason for this recommendation is because some supplements might interact with medicines or other supplements. 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 healthcare professional. The FDA also encourages consumers and healthcare professionals to report adverse reactions associated with FDA-regulated products to the agency using the Safety Reporting Portal.
Public health and safety regarding dietary supplement use are matters of great importance to the FDA. Supplement Your Knowledge is part of the agency’s plan of action to arm individuals with helpful information to make informed decisions about the use of dietary supplements. Help spread the word about this important initiative by using the FDA’s Dietary Supplements Social Media Toolkit and find additional information on dietary supplements at www.fda.gov/
FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients
FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA urges consumers taking these products to immediately talk to their health care professional (e.g., doctor) to safely discontinue use of the product because suddenly stopping these drugs may be dangerous.
These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions and are sold on various websites and in some retail stores.
FDA laboratory analyses revealed certain Artri and Ortiga products contain the undeclared drug ingredients:
- Dexamethasone (a corticosteroid) that can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction;
- Diclofenac sodium (an anti-inflammatory drug) that can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death
- Methocarbamol (a muscle relaxant) that can cause sedation, dizziness, and low blood pressure.
These drug ingredients, which are not listed on the product label, can also interact with other drugs a consumer is taking.
FDA has received adverse event reports, including of liver toxicity and death, associated with the use of Artri King products, since the agency issued its first warning about an Artri Ajo King product on January 5, 2022.
Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath. These risks depend on several factors that a health care professional must assess. Medical intervention may be necessary.
Health care professionals should evaluate patients who have used Artri and Ortiga products for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and treat accordingly.
FDA has identified the following Artri and Ortiga products containing hidden drug ingredients:
Wednesday, June 1, 2022
| Haniel Concepts, Inc. DBA Free State Oils, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| Grimann S.A. de C.V. | Center for Drug Evaluation and Research | CDER | Failure to Comply with Drug Registration and Listing Requirements | ||||
| Yippee Farms, LLC | Division of Human and Animal Food Operations East II | Illegal Drug Residue Animal Tissue/Adulterated | ||||
| OsteoLife Biomedical I LLC | Office of Biological Products Operations – Division I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
| New Vitalis, LLC dba New Vitalis Pharmacy | Division of Pharmaceutical Quality Operations III | Compounding Pharmacy/Adulterated Drug Products | ||||
| CAJ Food Products Inc. | Office of Human and Animal Food Operations East Division 6 | New Drug/Misbranded | ||||
| Russ Davis Wholesale Inc | Office of Human and Animal Food Operations - West Division 1 | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Freeman and Biddy, LLC d/b/a Freedom Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Wick ‘N’ Vape, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Hope Botanicals, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| Plantacea, LLC dba Kahm | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
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