Summary: FDA marketing rules draw a clear line: you sell the benefit, but you don’t rewrite the label. Product names, taglines, and claims all signal “intended use,” and reviewers read between every line. Teams that anchor copy to approved language, build an internal claim grid, and pressure-test campaigns before launch protect both revenue and reputation. In the 80s and 90s, pharmaceutical brand names tried to tell Read More
When Marketing Outruns Approval: What Regulated Industries Can Learn From Pharma
Summary: Pharmaceutical marketing operates at the edge of federal regulation, competitor scrutiny, and scientific proof. Recent Lanham Act disputes, including Section 43(a) claims tied to product labeling and advertising, show how quickly ambition can outpace compliance. The lessons extend far beyond pharma. Any regulated industry making performance or safety claims faces similar exposure when substantiation lags Read More
Contractors and Employees: The Differences and When to Transition
When companies first start up, it’s common, and often efficient, for them to rely on independent contractors. Contractors bring flexibility, lower overhead, and minimal compliance burdens. That works when you’re small. But when contractors end up working exclusively for your company, with you deciding what they do, when they work, and how they operate, you’re risking misclassification, and that opens a legal can of Read More
An Effective Employee Handbook is Crucial for Your Business
Managing employees is one of the most difficult parts of running a business. Ironically, the cornerstone of personnel management, an employee handbook, is a critical task that is too often overlooked. This document serves as a comprehensive guide, establishing clear policies and procedures within the workplace. The handbook’s vital role in operations and dispute resolution cannot be overstated, establishing Read More
Navigating Regulatory and Business Challenges in Highly Regulated Industries
Before 2018, Elizabeth Holmes and Theranos, the company she founded, were lauded nationally and internationally for a magic box that promised a new era in democratized healthcare. On that promise, Theranos attracted some $700 Million in funding, signed a deal with Walgreens, and reached the dizzying heights of a $10 Billion valuation – all without turning a profit. The truth, however, was that Theranos’ magic box Read More
BAKER JENNER ALERT: FTC Proposes New Rule Banning Noncompete Clauses
In our August 2021 BAKER JENNER ALERT, we advised our clients and colleagues about the Biden Administration’s new policy initiative, centered on eliminating noncompete restrictions applicable to many aspects of the American workplace. Following, on January 5 and 19, 2023, the Federal Trade Commission (FTC) unrolled its sweeping new proposed rule that would ban noncompete restrictions on workers and others. A copy of Read More
Harnessing a Diverse Workforce – a Short Reference Guide on Avoiding Religious Discrimination
Freedom of religion has deep roots in American history, stemming from the great diversity of peoples, faiths, practices and philosophies that have helped define our civic culture and values. But in application, freedom of religion–and from religion–have proven subtle and more thorny questions, especially when applied to private modes of business, association, and conduct. In short, what can a private employer be Read More
Force Majeure in a Time of COVID
The COVID-19 pandemic and its shadow continue to loom over businesses, supply chains, and more. The true scope of the challenges and changes imposed by COVID-19 continues to be learned as the economy and society adjust. But one immediate consequence is known: for the first time in a long time, businesses are having to seriously read and implement force majeure clauses to determine their respective rights and defenses Read More
