On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
A new law in New York expands retail sales channels for many craft alcoholic beverage producers across the country. S.2852A/A.3132A, recently signed into law by Governor Kathy Hochul, introduces significant changes to the...more
Navigating the virtual marketplace has become an integral part of the consumer experience in the digital age. Lurking behind the convenience and accessibility of e-commerce websites, however, lies a subtle yet pervasive...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
With 2024 underway, we highlight some of the most pressing legal issues facing the automotive industry this year, including a surprise Federal Trade Commission (FTC) rule, changes to manufacturer direct-to-consumer sales, and...more
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more
In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC)...more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more
FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on...more
As we previously reported, most states authorize direct-to-consumer (DTC) shipments of wine if the shipper has obtained the correct license, but this area of law has continued to evolve through litigation. Recently, the...more
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more
Responding to incidents impacting consumer health and wellness technologies, including apps, will be more complex under proposed breach notice rules by the U.S. Federal Trade Commission (“FTC”). Businesses have until August...more
The North Carolina General Assembly recently passed Senate Bill 91, which included a technical correction to again allow breweries, wineries, and distilleries in North Carolina to obtain and hold private bar permits to sell...more
On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more
“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more
The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more
On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more
The Food and Drug Administration (FDA) recently conducted two online studies concerning comprehension of direct-to-consumer (DTC) prescription oncology drug advertising. The research suggests that consumers may have...more
Breweries outside of Oregon can sell and ship malt beverages directly to Oregon retailers if they obtain a newly created direct-to-retailer self-distribution permit. In addition, out-of-state breweries may obtain a Direct...more
We know there has been an ongoing slowdown in venture capital funding for startups - this has been the case since 2022 and it continues to impact startups at all stages of growth. The slowdown appears to be leveling from...more
In 2022, the alcohol industry saw significant developments in the regulatory space. As we look to 2023, industry leaders continue to adapt to the changing needs of consumers, driving more innovation than we’ve seen in years...more
A year ago we wrote about Alabama’s then-new alcohol laws, which allowed (1) ABC Board-licensed businesses in the state to deliver wine, beer, and spirits to customers’ homes and (2) wineries anywhere in the country to ship...more