I remember when I was at the FDA and presenting at a meeting discussing a guidance that industry had been waiting for the FDA to publish for a year or so. I noted that it would be released soon! Immediately someone from the audience asked, “what’s the FDA’s definition of soon?” I thought for a […]
The Food and Drug Administration is advising consumers not to purchase or use the following products that are marketed as dietary supplements as they contain undeclared drug products that could be harmful: VITAFER-L Gold 10 ml may be harmful due to hidden drug ingredient tadalafil VITAFER-L Gold 20 ml may be harmful due to hidden drug ingredient […]
Well, there is bad, then there is worse! In this case, the FDA warns us about a product that is being marketed as all natural and promoted as a dietary supplement for joint and muscle pain. The product, called Trinity Gold, actually contains three undeclared drug ingredients, acetaminophen, diclofenac, and phenylbutazone (which was removed from […]
We have written a lot about fraudulent drugs over the years. Some examples of these include counterfeit drugs, dietary ingredients that are unsafe, dietary drugs that contain undeclared prescription drugs in them, and the list goes on and on. In his presentation titled “Fraudulent Drugs: You’re Taking What?” (here), Brad Pace, Associate Director, Office of […]
Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here). The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]
While most of you are aware of these facts published by FDA last week, I found this article quite interesting, and it may teach us a thing or two! And because many of our readers come from different backgrounds than us in regulatory, the FDA, or the healthcare industry, it may provide some prospective on […]
Just like the FDA says on its warnings and notifications page (here): “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]
Jim Jones was appointed Deputy Commissioner for Human Foods in August 2023. Through the leadership of FDA Commissioner Robert M. Califf, M.D., the overhaul of the FDA’s food program is getting well-deserved additional attention as it protects our food supply and dietary supplements. Under the new unified Human Foods Program (HFP) to be led by Jones, […]
Today FDA has warned consumers (here) that the products listed below that are offered for sale in the US contain undeclared active ingredients that can be dangerous for some users. This is not really a surprise as unscrupulous manufacturers and distributors try to cash in on patients with erectile disfunction or on users that merely […]
The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]
