Kristen R. Klesh

Latest Articles

There is no denying that, at times, the express claims made on dietary supplement labels may seem to convey a broader implied claim to the consumer regarding the supplement’s performance benefits. While that may be true, last month the Ninth Circuit confirmed that plaintiffs cannot successfully allege that a lawful “structure/function” claim misleadingly implies that a dietary supplement will treat, cure, or prevent a disease under state law. In so deciding, the court found that…
A change in administration inevitably raises questions regarding the priorities and direction of federal agencies. To help set the record straight, Lesley Fair, a Senior Attorney with the Federal Trade Commission’s (FTC or Commission), Bureau of Consumer Protection, reminded us during last week’s NAD Annual Conference that the FTC has kept quite busy over the last year or so, with numerous enforcement cases arising out of the FTC’s Bureau of Consumer Protection. Ms. Fair also…
FDA finalizes rule to revise Nutrition Facts panels for foods and Supplement Facts panels for Dietary Supplements On May 20, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a final rule (Rule) that overhauls the design and content of nutrition labeling for foods and dietary supplements (known as the Nutrition Facts label for packaged foods and the Supplement Facts label for dietary supplements). These changes are largely consistent with those proposed…
3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process. Perhaps this…
Since we are now fully comfortable with “smart” everything, it should be no surprise that 3D printing has taken center stage in the tech world. It’s easy to imagine 3D-printed machine parts, prototype models, or even toys, but it might be harder to accept 3D-printed foods, implantable medical devices, cosmetics, drugs, and even human tissue.  Too futuristic? Not really. The technology to 3D-print, U.S. Food and Drug Administration (“FDA”)-regulated products is, in…
As expected, NASA recently successfully completed the first hot-fire tests on an advanced rocket engine thrust chamber assembly using copper alloy materials.  This was the first time a series of rigorous tests confirmed that 3D manufactured copper parts could withstand the heat and pressure required of combustion engines used in space launches. In all, 19 hot-fire tests on four injector and thrust chamber assembly configurations were conducted. These successful tests represent a milestone in NASA’s use…
We are entering a brave new world of food design and regulation brought to us through the mechanical development and visual artistry of 3D printing. As with any new medium, understanding what we confront and its regulation lag behind the medium’s implementation. 3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which…
We agree – the Jetsons era has indeed arrived. Beyond the days of “smart” everything, now 3D printing has taken center stage in the tech world. While it is not so farfetched to imagine 3D-printed machine parts, prototype models, or even toys, it is might be harder to watch it printing foods, implantable medical devices, cosmetics, drugs and even human tissue. All too futuristic? Not really. The technology of 3D-print FDA-regulated products is, in…