With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
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, […]
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 […]
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 […]
Over the course of the last few decades, the FDA has chipped away at removing unapproved prescription drug products from the market. In most cases, the drugs have been marketed for a long time, sometimes referred to as so-called “grandfathered drugs.” However, the FDA’s goal has been to bring all products under the regulatory umbrella […]
Today, the FDA issued warnings (here) for four male-enhancement products that contain undeclared prescription drug products. All of the products on the list in the FDA’s warning contain both sildenafil and tadalafil (the active ingredients in Viagra and Cialis, respectively), while the first three also contain undeclared acetaminophen. Versace Real Honey for Men may be […]
Yesterday, the FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products” (here). We all know that removing or partially removing a color from a product was an easy annual reportable change, and this remains unchanged in the draft guidance. However, changing a color by replacing it with another color […]
Ingestible fluoride products used to prevent dental caries have a long and twisted regulatory history relative to their permitted marketing status. After searching the web for an explanation, I found an interesting article (here) published by the Fluoride Action Network. I provide this article as it gives a reasonable historical account of the avenues along which the […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
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 […]
