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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on July 16, 2024, to five companies for illegally selling and introducing into the market copycat food products...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
Earlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19. In warning letters...more
In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel...more
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more
On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more
The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more
For the first time in 25 years, the Food and Drug Administration (FDA) announced a plan to modernize dietary supplement regulation and oversight. The announcement sets lofty goals and articulates the following priorities: ...more
Recognizing the rapid growth and penetration of dietary supplements into all demographics of American consumers, the Food and Drug Administration (FDA) is viewing at least some dietary supplements as belonging to “the Wild...more
Dietary supplements are big business. Three out of four Americans take a dietary supplement, and the rate rises to four out of five among older Americans. Dietary supplements are a $40 billion dollar industry, with between...more
In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more