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2024 CPSC and FDA Enforcement Trends

The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more

FDA: The Effects of Loper on the Regulatory Agenda

The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more

LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements

On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more

FDA Continues to Take Stance That it Will Not Issue CBD Rules

The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more

Trademark Primer: Proactive Strategies for Avoiding Disputes and Consumer Confusion

Trademark disputes can be time-consuming and costly. By proactively assessing risks and taking steps to avoid infringement, emerging companies save time and money. At the crux of most trademark disputes is the claim that...more

My Healthy Food Product is Ready to Go to Market – What About its Packaging?

After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought.  It should not be.   Food packaging has become an increasingly hot topic among federal and state regulators,...more

Understanding the Risks Associated with Social Media Marketing

Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more

Primer on Navigating VC for Growth in the Healthy F&B (Food & Beverage) Space

Venture capital can be a vital source of funding and support for emerging companies in the healthy food and beverage space. In addition to providing capital, venture capitalists may offer strategic guidance, networking...more

Bringing a New Healthy Food Ingredient to Market: Understanding the Regulatory Pathways

Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market.  This...more

Contract Manufacturing Primer for Emerging Healthy F&B Companies

A contract manufacturer (also known as a “co-man” or “co-packer” and for brevity, we’ll use “co-man” from here on out) is a critical partner for most emerging companies in the healthy food and beverage (F&B) space. The...more

Brand Selection Primer for Emerging Healthy F&B Companies

Branding is critical for emerging companies in the healthy food and beverage (“F&B”) space. Strong brands can help companies stand out from competitors and build trust and loyalty with customers. For emerging companies, a...more

M&A Primer for Emerging Healthy F&B Companies  

As an emerging growth company in the healthy food & beverage (F&B) space, you might rightfully think, “My company is too young to consider either buying another company or selling to another company.” And depending on what...more

FDA Issues Tip Sheet to Shore-up the Supply Chain for Infant Formula and Critical Food

In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents...more

Who Regulates My Product?

In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not...more

IP Primer for Emerging Healthy F&B Companies

Intellectual property protection is essential for emerging companies in the healthy food and beverage (“F&B”) space to attract investors and stand out from competitors. To gain a competitive edge, companies should understand...more

FDA Issues New Warning Regarding Compounded Ketamine

On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications: Second Time is the Charm

On October 6, 2023, the Drug Enforcement Administration (DEA) released a second temporary rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This second extension, issued...more

Key Contractual Considerations for Health AI and Hospital Collaborations

If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

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

DEA: Potential New Telemedicine Special Registration for Controlled Substances Prescribing to be Discussed in Special Listening...

At long last, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination. On August 4,...more

Top Legal Issues Facing the Manufacturing Sector in 2023

Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the...more

Regulation of Digital Health Products by FDA

Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more

Decentralized Clinical Trials Blog Series: Introduction

Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more

FDA and SAMHSA Issue Joint Statement in Support of Reducing Barriers to Evidence Based Treatments

On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based...more

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