The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
Over the last week, the FDA issued a series of seven warnings about supplements that contain undeclared drugs. Six of the products contain numerous undeclared active drug ingredients including the usual suspects sildenafil, tadalafil, and testosterone propionate on the erectile dysfunction side of the house and piroxicam for relieving pain/arthritis. The seventh product, Tawon Liar, […]
This month, April 2026, the Center for Drugs Evaluation and Research’s (CDER’s) Office of Compliance (OC) issued its yearly report, highlighting many of its goals, new programs, and accomplishments. First, let’s take a look at the report by the numbers. According to the report (here), the OC lists the following workload figures: Office of Compliance […]
In this blog, I often rail about how unapproved drugs and illegal dietary supplements find their way into the U.S. market through the internet or mail outlets. I’ve wondered why the FDA is not doing more to stop the game of whack-a-mole where, as soon as the FDA makes an enforcement action against one supplier, […]
Today, the FDA issued yet another health warning regarding an unapproved sexual enhancement product marketed as an over-the-counter drug and, boy, is this one a doozy. It contains sildenafil and tadalafil, the active ingredients in approved Viagra and Cialis, while also containing, flibanserin, which “is the active ingredient in Addyi, an FDA-approved prescription drug used […]
Today, the FDA again advised consumers to avoid purchasing and using Umary, a product marketed as a dietary supplement to treat pain; it contains the undeclared prescription drug ingredients diclofenac and omeprazole. The Agency first warned consumers about this product and another, similar product marketed as Amazy in June 2024 and reissued that warning in […]
For those of you who regularly read our blog posts, we are often harping about dietary supplements that contain undeclared prescription drug ingredients or unapproved and potentially dangerous ingredients. While we only highlight some of the more egregious products that have received FDA attention, there are many, many more that we do not address. According […]
Earlier this week, the Agency issued a statement warning consumers not to use or purchase Pain Flex, sold as a dietary supplement for joint pain, as it contains undeclared dexamethasone and methocarbamol. Both ingredients have the potential to cause significant serious adverse events in some users. The Agency says that dexamethasone is a “corticosteroid commonly […]
Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
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 […]
