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
8/30/2024
/ Consumer Product Safety Commission (CPSC) ,
Consumer Product Safety Improvement Act (CPSIA) ,
E-Commerce ,
Enforcement ,
Food and Drug Administration (FDA) ,
Inspections ,
Litigation Strategies ,
Policies and Procedures ,
Regulatory Agenda ,
Regulatory Requirements ,
Reporting Requirements
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
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
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 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
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
3/15/2024
/ Beverage Manufacturers ,
Code of Federal Regulations (CFR) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GRAS ,
Green Guides ,
PFAS ,
Product Packaging ,
Recycling ,
Sustainability
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
2/29/2024
/ Advertising ,
Corporate Branding ,
Disclosure Requirements ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Endorsement Guidelines ,
Influencers ,
Marketing ,
Popular ,
Risk Management ,
Scientific Evidence ,
Social Media ,
Targeted Digital Advertising ,
Transparency
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
2/15/2024
/ Beverage Manufacturers ,
Business Plans ,
Corporate Governance ,
Early Stage Companies ,
Emerging Growth Companies ,
Food Manufacturers ,
Intellectual Property Protection ,
Investors ,
Private Equity ,
Restaurant Industry ,
Seed Financing ,
Startups ,
Venture Capital
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
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
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
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
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
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
11/30/2023
/ Advertising ,
Alcohol Beverage Control ,
Beverage Manufacturers ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Meat Inspection Act (FMIA) ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Organic ,
TTB ,
USDA
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
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
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
10/11/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
Shareholders
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
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
9/15/2023
/ Artificial Intelligence ,
Change of Control ,
Collaboration ,
Contract Term ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Hospitals ,
License Renewals ,
Medical Devices ,
Pharmaceutical Industry ,
Pricing ,
Regulatory Requirements ,
Startups
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
9/12/2023
/ Advertising ,
Compliance ,
Direct to Consumer Sales ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Factors
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
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
7/11/2023
/ Artificial Intelligence ,
Best Practices ,
Clawbacks ,
Compensation ,
Compliance ,
Customs and Border Protection ,
Cyber Threats ,
Cybersecurity ,
Enforcement ,
Environmental Protection Agency (EPA) ,
Final Rules ,
Intellectual Property Protection ,
Machine Learning ,
Manufacturers ,
Securities and Exchange Commission (SEC) ,
Supply Chain
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 (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
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