FDA & FTC Law

Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.

False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.

According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]

FDA's tobacco products Deeming rule imposes many regulatory requirements on tobacco products retailers, manufacturers, distributors, importers,including establishment registration and product listing.

FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]

If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

FTC Big Data regulation tells companies how to use big data legally and responsibly, in FTC’s report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues,

FTC tackles native advertising and sponsored content in an Enforcement Policy Statement on Deceptively Formatted Advertisements.