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…interstate commerce. U.S. Const. art. I, § 8, cl. 3; see, e.g., Philadelphia v. New Jersey, 437 U.S. 617, 623-624 (1978). PhRMA and BIO argue that the “extraterritorial effects of…
Buried in the 2,124-page Consolidated Appropriations Act, 2021 (the Act), which was signed by Donald Trump yesterday, was a brief provision requiring the reporting of average sales price (ASP) by…
…the difference between the Federal Ceiling Price and either (a) the most recent annual non-Federal average manufacturer price (“Non-FAMP”) reported to the VA, or (b), at the manufacturer’s option, “direct…
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and…
…i.e., whether the WAC disclosure rule compelled speech in violation of the First Amendment. Certain states, such as New Hampshire, Oregon, and Vermont, have enacted statutes and issued implementing regulations…
…Ipsen Biopharmaceuticals, Inc. v. Azar, Ipsen had obtained approval in 2007 for Somatuline Depot for the treatment of acromegaly. In 2014, FDA approved two supplemental NDAs (sNDAs), one for changes…
…hope these (clever) mash-ups grab readers’ attention and keep you interested in things that can, at times, seem boring or hypertechnical, or that may not be in your bailiwick, but…
As we previously reported, about two years ago, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for…
…in your submission, it is possible that a recently enacted law may affect the legal status of dietary supplements containing [the NDI]. Section 301(ll) of the Federal Food, Drug, and…
By Riëtte van Laack & Wes Siegner – In recent consent decrees against Nestle, discussed here, and Iovate, discussed here, the Federal Trade Commission (“FTC”) appeared to be tightening its substantiation…
…implementing regulations require food labels to bear nutrition information on the amount of dietary fiber present in a food, specify how dietary fiber must be disclosed, authorize nutrient content claims…
…initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators.” The vast majority of submissions are so-called “subsequent reports,” meaning…
…to customers upon request, state on menus that written nutrition information is available, and, for self-service foods (e.g., buffets), include calorie disclosures next to each food. The Secretary must pass regulations that…
…scientific information. The report describes the U.S. legal framework that governs substances intentionally or inadvertently added to food, relevant standards and guidance of the Codex Alimentarius Commission, applicable European Union…
…action against the food, drug and medical device industries. As with some foods, the bill provides a “standard of identity” for cigarettes that would, among other things, prohibit the addition…