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 […]
In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.” The Agency noted that […]