First Amendment Lawsuit Against FDA Over Labeling of Skim Milk with No Vitamins A and D Added

Dairy Co. Sues FDA Over ‘Imitation’ Skim Milk Labeling Rule  (subscription to Law360 required) South Mountain Creamery, a family-owned dairy in Maryland, sued the Food and Drug Administration (FDA) in federal court on Thursday (April 5, 2018) claiming its free-speech rights under the First Amendment of the U.S. Constitution are violated by FDA’s regulations requiring the company’s product be … Continue Reading

Pharma and the First Amendment

Amarin settlement paves way for “off-label” promotion of omega-3 product. As previously covered on this blog, the pharmaceutical industry has been awaiting the resolution of the groundbreaking Amarin case.  At the heart of the case is Amarin’s marketing of Vascepa, an omega-3 drug product, as effective in treating patients with “persistently high” triglyceride levels, as compared to … Continue Reading


GMA continues its fight in the GM labeling arena. The effective date for Vermont’s GM labeling law is July 1, 2016.  Absent a federal legislative solution or a victory in the Grocery Manufacturers Association (GMA) challenge to the Vermont law in federal court, the food industry must decide how to comply with the new GM … Continue Reading

State Support

States support Vermont’s position in GM labeling lawsuit. As previously covered on this blog, the lawsuit brought by the Grocery Manufacturers Association (GMA) and other trade associations to challenge Vermont’s labeling mandate for Genetically Modified (GM) food products is ongoing.  Following the Vermont district court’s denial in April of the plaintiffs’ motion for a preliminary injunction, GMA filed … Continue Reading

Fish Oil and the First Amendment

Federal court ruling paves the way for off-label promotion of fish oil product. FDA’s historical position is that “off-label promotion” — the promotion of pharmaceutical products for unapproved uses — violates the Federal Food, Drug, and Cosmetic Act.  The underlying logic is that:  (1) drugs are misbranded when they fail to bear adequate directions for … Continue Reading

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