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…e.g., letter from the National Alliance on Mental Illness). Multiple concerns were expressed, including interference with the practice of medicine; impeding dissemination of information of clinical value (as recognized by…
…Sweeteners provide less than 4 calories per gram and include all low and non-calorie sweeteners including high-intensity sweeteners, artificial sweeteners, and sweeteners used for bulking purposes such as sugar alcohols.”…
…“more accurately understood as a voluntary, intentional violation of a known legal duty…the mens rea element goes no further” (internal quotations omitted). Consistent with the district court, the Second Circuit…
…of phosphorus would be the calculated equivalent amount of elemental phosphorus from all the phosphorus-containing components. (FDA stresses that it should not be the amount of phosphate). As is the…
…for women. We also heard from Dr. Suzanne Baron, Director of Interventional Cardiology Research at Lahey Hospital and Medical Center. Dr. Baron spoke to specific actions sponsors can take to…
…CBD by consuming meat, milk, and eggs from animals that ingest CBD. For that reason, FDA also does not intend to pursue rulemaking that would allow CBD in animal food…
…how a person functions or feels about a health condition or its treatment. The instruments can capture significant clinical information that traditional evaluations by health care professionals cannot, such as…
…charges the defendants with criminal conspiracy, mail fraud, wire fraud and violations of the Federal Food, Drug, and Cosmetic Act. In plain English the defendants are alleged to have falsified…
…Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. For FTC, a continuing priority is advertising substantiation. Mr. Vladeck, in his speech, stressed that it is…
…of “athletic, musical, artistic, or other social or cultural event[s]” and FDA must reissue regulations that prohibit the sponsorship of athletic, social, and cultural events “in the brand name” of…
…more immediate and aggressive enforcement action by FDA. Against traditional pharmaceutical manufacturers, FDA has, in its armamentarium, civil (e.g., TRO, seizure) and criminal (FD&C Act prosecution) judicial actions that can…
…to all. Due to limited spacing, new registrants must attend virtually. More information on the Scientific Workshop can be found here and registration for the live-stream can be found here….
…be misbranded unless its principal display panel (“PDP”) bears “summary nutrition information that reflects the overall nutritional value of the food or specified ingredients” as required in regulations that would…
…agencies to collaborate on enforcement actions. Here’s a list of the star-studded cast of government presenters: Gary Cantrell, Deputy Inspector General for Investigations, Office of Inspector General, HHS Mary E….
…Disposal Ordinance. Both measures require brand-name and generic drug manufacturers to shoulder the financial burden of local take-back obligations, including collection, transportation, disposal, public outreach, and administrative expenses. But the…