Is Your Business Structure Holding You Back?

By: Carlos Arce

As companies grow, revenue increases, teams expand, and the vision of success becomes reality. However, this success can also expose foundational issues if the original legal and operational structure no longer aligns with the evolving needs of the business. Many founders discover that what once worked is now creating friction, limiting opportunities, and introducing new risks.

This is a common crossroads in a business’s development: realizing that the initial setup is now a barrier to achieving future goals. At this point, corporate restructuring becomes not just prudent, but essential. This process should not be viewed as a sign of failure, but as a strategic evolution to meet both current challenges and long-term aspirations. Whether planning an exit, managing the complexities of rapid growth, or bringing on new partners, adapting the business structure is critical for securing future success.

For many entrepreneurs, building a scalable and sellable company is a key objective. Planning for an exit should influence strategic decisions from the earliest stages. Yet, founders often become so immersed in the daily demands of the business that the corporate structure is overlooked, making the eventual sale more challenging.

Buyers are drawn to businesses with clear, transparent structures. Assets, liabilities, ownership interests, and intellectual property should all be straightforward and well documented. A tangled or outdated structure can delay or even derail negotiations, frequently resulting in a reduced valuation. For instance, companies operating as sole proprietorships or simple LLCs with commingled personal and business finances present unnecessary risk to acquirers.

Working with a healthcare business attorney, founders can prepare by creating a “clean room” environment: organizing financials, clarifying ownership, ensuring contracts are current, and securing intellectual property within the right entity. Taking these actions early not only streamlines the exit process, but also significantly enhances the value and appeal of the business.

Fast-growing businesses often start with the simplest legal structures to minimize costs and move quickly. While practical in the beginning, this approach can become unsustainable as an organization’s size and complexity increase.

Lack of clarity around roles, responsibilities, and ownership can result in serious operational headaches. Ambiguity regarding the ownership of intellectual property or decision-making authority leads to internal friction and inefficiencies as companies expand. Formal structures that define these relationships are essential for maintaining control and operational excellence.

Emerging healthcare and life sciences sectors, such as peptides, present additional regulatory challenges. Changing regulations can introduce significant risk to companies not structured to isolate liabilities. In these cases, a thoughtful restructuring plan—such as “siloing” business units into separate legal entities under a parent company—can provide crucial protection. With expert legal guidance, risk is contained so that setbacks in one unit do not threaten the entire enterprise. This approach enhances resilience and supports agile responses to shifting legal or market landscapes.

The original choice of corporate entity directly affects the ability to attract capital and add key partners. Structures that once served the business well may now limit fundraising and collaboration opportunities.

For example, the S Corporation (S-corp) is popular for small business tax advantages but imposes strict limits on the number and type of shareholders. Only one class of stock is permitted, and ownership is limited largely to U.S. citizens or residents. This restricts the ability to create varied investment opportunities, such as preferred stock for venture capitalists or equity incentives for executives.

Restructuring, often through conversion to a C Corporation, opens the door to a wider range of investors and partners. C-corps allow multiple classes of shares, facilitating the participation of venture capital, strategic partners, and top-tier talent. Legal professionals specializing in healthcare business law can guide founders through the process, ensuring the transition aligns with strategic growth plans and industry regulations.

Corporate restructuring is a natural stage in a company’s journey. Early decisions made for speed or simplicity often require reexamination as the business matures. Ongoing assessment and adjustment of the corporate framework allow organizations to capitalize on opportunity, minimize risk, and pave the way for sustainable growth.

Engaging a healthcare business attorney can make the process smoother and more effective. Expert guidance helps founders anticipate challenges, avoid common pitfalls, and position businesses for both immediate needs and long-term goals.

For founders who recognize their structure may be holding the company back, now is the time to seek professional guidance. A proactive approach to corporate restructuring will not only resolve current limitations but also prepare the organization to seize future opportunities in a dynamic healthcare market.

FDA’s Expanding Focus: From RUO Platforms to Mainstream Oversight

By: Caitlin Koppenhaver

FDA’s “Green List” for GLP-1 Ingredients

On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced a new “green list” import alert for active pharmaceutical ingredients (APIs) used in GLP-1 medications such as semaglutide and tirzepatide. The green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards, standards applicable to all APIs manufactured in the U.S. APIs from other sources are subject to detention without physical examination. The policy reflects FDA’s heightened concern over compounded GLP-1 products sourced from unverified suppliers, which is not to be confused with compounding pharmacies who are already committed to supply chain transparency, safety and quality for specific patient needs. The agency has warned that some products involve unapproved chemical forms or inconsistent potency, with adverse events including hospitalizations already reported. For compounding pharmacies, distributors, and providers, the expectation is now clear that sourcing must be transparent, quality must be documented, and regulatory compliance must be demonstrable.

Crackdown on Deceptive Drug Advertising

Just four days later, on September 9, 2025, FDA announced a parallel initiative: a nationwide crackdown on deceptive drug advertising. Thousands of warning letters and nearly one hundred cease-and-desist notices are being issued to companies whose promotional materials emphasize benefits while minimizing or omitting risks. The agency is also moving to close the long-standing 1997 “adequate provision” loophole in broadcast advertising, which permitted companies to reference safety information indirectly rather than disclose it directly in the advertisement. Going forward, FDA expects risks to be presented clearly and prominently alongside benefits.

Further, enforcement extends beyond preventing false or exaggerated claims. Omitting material facts such as contraindications, warnings, or key limitations can render an otherwise accurate statement misleading under the Federal Food, Drug, and Cosmetic Act. Digital and social media advertising are particular priorities, with FDA deploying AI-powered monitoring tools to review influencer content and other online promotions.

Broader Enforcement Trends

These back-to-back actions reflect a significant broadening of FDA’s enforcement posture. Historically, the agency’s most visible interventions in this space centered on Research Use Only (RUO) peptide platforms, particularly where websites implied human use. That focus has now expanded to include global supply chain practices for high-demand therapies and mainstream pharmaceutical advertising. Enforcement is no longer narrow or reactive. FDA is proactively targeting both manufacturing integrity and the accuracy of consumer-facing communications.

The Bottom Line and What This Means for Industry Stakeholders

For companies across the healthcare and life sciences sectors, the implications are immediate: sourcing arrangements for GLP-1 APIs must be confirmed against FDA’s new green list to avoid shipment detention, and all promotional materials, including digital and influencer campaigns, should be reviewed to confirm that risks are presented as clearly as benefits and that no omissions make statements misleading. In this heightened enforcement environment, businesses that proactively strengthen compliance, documentation, and transparency will be best positioned to withstand scrutiny and maintain long-term credibility as the enforcement landscape continues to evolve.

Texas Now Regulates Elective IV Therapy: Key Takeaways for Healthcare Providers

By: Caitlin A. Koppenhaver

On June 20, 2025, Governor Abbott signed House Bill 3749, known as Jenifer’s Law, into law. Effective September 1, 2025, this legislation amends the Texas Occupations Code to regulate, for the first time, elective intravenous (IV) therapy performed outside of hospitals and physician offices (Full text here: 89(R) HB 3749 – Enrolled version – Bill Text).

The bill was passed unanimously following the tragic 2023 death of Jenifer Cleveland, who received an IV infusion at a med spa administered by an unlicensed individual without adequate physician oversight. Her case exposed the lack of clear regulatory safeguards in rapidly expanding wellness sectors such as elective IV therapy.

The statute provides a clear definition of “elective intravenous therapy” as a procedure in which fluids, nutrients, medications, or blood are administered directly into a patient’s vein. It applies when a patient seeks treatment to relieve temporary discomfort or to promote temporary wellness, rather than to treat a specific illness or injury. The statute further clarifies that elective IV therapy does not include treatments administered in a physician’s office, a licensed hospital, a licensed mental health facility, or a Texas state-operated hospital. This language is significant because it squarely situates elective IV therapy within the wellness and medspa context.

HB 3749 also establishes who may prescribe or order elective IV therapy. A physician may delegate this authority to a physician assistant (PA) or an advanced practice registered nurse (APRN), provided the delegation occurs under a prescriptive authority agreement or facility-based protocol authorized by Chapter 157 of the Occupations Code. Further, this delegation remains subject to the statutory cap on prescriptive authority, which limits physicians to supervising the equivalent of seven full-time delegates. Nothing in the new law diminishes the physician’s ongoing supervisory responsibility.

The law is equally clear on administration. Elective IV therapy may be administered only by a physician, PA, APRN, or registered nurse (RN), and always under “adequate physician supervision.” The Act does not define ‘adequate supervision,’ leaving the term subject to interpretation by the Texas Medical Board. In practice, providers should anticipate that the Board may look to its existing delegation rules which emphasize physician accessibility, written protocols, good faith exams, emergency procedures, and chart review as the baseline for compliance.

Because Jenifer’s Law integrates elective IV therapy into Texas’s broader prescriptive authority structure, compliance requires careful attention to delegation agreements and supervisory practices. Physicians must make sure that delegation is properly documented in writing, that prescriptive authority agreements are registered with the Texas Medical Board, and that chart review and supervision requirements are satisfied. Providers should also update screening, consent, and emergency protocols to reflect the elective nature of these services and the supervisory standard imposed by the statute.

Jenifer’s Law defines physician responsibility and delegation under Texas law and provides that elective IV therapy is to be regulated within a medical oversight framework. For an industry that has expanded rapidly in recent years, this is a legislative reset that establishes patient safety as the cornerstone of continued growth.