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No Password Required: A Senior Product Manager at GitLab With an Instagram Alter Ego That Puts Her in Privacy Superhero Territory
PODCAST: Williams Mullen's Trending Now: An IP Podcast - False and Misleading Advertising, Label Review
More CBD Certainty: Clearing Confusion over Hemp in New York State
Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more
On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) opened a comment period in advance of a proposed rule on labeling requirements for meat and poultry products comprised...more
The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more
On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a...more
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more
On May 31, 2019, the Food and Drug Administration (FDA) held its first public hearing concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food,...more
The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more
One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more