Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]
The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog. The most recent post on this topic was on June 17, 2020 (here). That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters. […]
Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market. In the release, the FDA announces that it issued Warning Letters to four […]
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 […]
The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products. This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017. The document […]
In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products. The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in […]
