Wednesday, March 9, 2022

 

Tuesday, March 8, 2022

 

  • On March 7, a consent decree of permanent injunction was signed by a judge requiring Salud Natural Entrepreneur, Inc. of Illinois not to engage in any distribution operations until it completes corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company distributed adulterated and misbranded dietary supplements and unapproved new drugs that it claimed would cure, mitigate, treat or prevent diseases such as cancer, diabetes, high blood pressure and heart disease. The FDA will continue to hold manufacturers responsible for the sale of mislabeled dietary supplements and for unlawful claims to cure, treat, and mitigate diseases, as this can be potentially harmful to consumers.

Monday, March 7, 2022

Public Notification: Wonderful Honey contains hidden drug ingredient

 The Food and Drug Administration is advising consumers not to purchase or use Wonderful Honey, a product promoted for sexual enhancement on various websites and possibly in some retail stores. This product was discovered during an examination of imported goods.

FDA laboratory analysis confirmed that Wonderful Honey contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient 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.

Health care professionals and consumers should report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, or body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

More information:

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FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use

Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use.

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Saturday, March 5, 2022

Brazen fraud or playing by the rules? How a pharma rep made millions marketing medical cream for $27,000 a tube Patrick Lakamp Feb 27, 2022 Updated 23 hrs ago

https://buffalonews.com/news/local/brazen-fraud-or-playing-by-the-rules-how-a-pharma-rep-made-millions-marketing-medical/article_baee310c-963f-11ec-b0b1-db44bcc15892.html 

 

5 days ago — “Even when executions are botched because of quality failings from compounded drugs, secrecy laws prevent the FDA and (U.S. Drug Enforcement Agency)

 

201 KAR 2:311.Compounding drugs for veterinary use.

3 days ago — compounded drug containing a controlled substance shall only be compounded for patient specific dispensation from the pharmacy to the ultimate user. Section 3 ...

 

Preserving Patient Access to Compounded Medications Act of ...

4 days ago — 2871 - Preserving Patient Access to Compounded Medications Act of 2017115th Congress (2017-2018). Bill. Hide Overview. Sponsor: Rep. Griffith, H. Morgan [R-VA- ..

 

2 days ago — The FDA has had a long and troubled history with compounding pharmacies, which create tailor-made versions of doctor-prescribed drugs.

 

The FDA Will Make New Rules for Drug Compounding

21 hours ago — The FDA plans to undertake administrative rulemaking governing pharmacy compounding. In October 2020, the FDA had issued a memorandum of understanding .