The dietary supplement market is notorious for issues associated with the inclusion of not-permitted ingredients in marketed supplements. Kratom is a recent poster child for this issue, but the erectile disfunction and weight loss markets both seem to have extraordinarily bad compliance and enforcement histories. These two disease states comprise the lion’s share of Warning […]
I must admit that the explosion in the CBD market surprised me. The Warning Letters have also been flying off of the computers at FDA with most addressing drug claims for such products. Maybe I have not seen this before in a Warning Letter, but the argument made in recent FDA Warning Letters regarding CBD […]
So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over? This is not a new problem. We have posted about it numerous times here, here, […]
Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here). The FDA had warned consumers about the dangers […]
CBD products are available just about everywhere – you see them show up in gas stations, supermarkets, the internet, convenience stores, farm markets, and just about any place where things are sold. CBD appears in drinks, pastry, candy, as an oil, and is infused in just about anything that can be orally ingested, or in […]
The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their […]
In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar. Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) . The Dietary Supplement Health and […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]