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Oral Health Products Inclusion Act: Expanding Access to Preventive Oral Care
The Oral Health Products Inclusion Act represents a significant bipartisan step toward improving Americans’ access to essential oral...
Evan Howard
May 277 min read
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FDA’s Action on Ingestible Fluoride Supplements: Legal, Regulatory, and Public Health Perspectives for the Oral Care Industry
In May 2025, the U.S. Food and Drug Administration (FDA) announced its intention to remove ingestible fluoride prescription drug products such as tablets and drops for children from the market, pending the completion of a safety review by October 2025.
Evan Howard
May 276 min read
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Chapter IV: Food of the FD&C Act – A Comprehensive Guide
Whether you’re a food business seeking to navigate regulatory requirements or a consumer wanting to understand how your food is regulated, Chapter IV is the key to understanding how food safety, labeling, and quality are maintained in the U.S. market.
Evan Howard
May 268 min read
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Mouthwashes: How Ingredients and Marketing Claims Can Trigger Clinical Trials and NDA Requirements
Behind the minty freshness and bold marketing claims lies a complex regulatory landscape, where both the ingredients used and the promises made can determine whether a product glides smoothly to market or faces the rigorous scrutiny of clinical trials and New Drug Applications (NDAs).
Evan Howard
May 245 min read
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Understanding Allowable Antiplaque and Antigingivitis Marketing Claims in OTC Oral Care Products
The 21 CFR 356 monograph for antiplaque and antigingivitis drug products represents a comprehensive, evidence-based approach to regulating OTC oral health products in the United States. By clearly defining which active ingredients are safe and effective, specifying allowable claims, and outlining the circumstances under which a New Drug Application is required, the monograph provides a transparent framework for manufacturers, clinicians, and consumers alike.
Evan Howard
May 207 min read
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The National Advertising Division: Its Role in OTC Drug Advertising, FDA Collaboration, and the Regulatory Process
The National Advertising Division plays a pivotal role in the world of OTC drug advertising, working alongside the FDA and FTC to ensure that advertising claims are truthful, substantiated, and not misleading.
Evan Howard
May 197 min read
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Federal Regulations of New Toothbrush Development
Whether you’re launching a classic manual brush, a high-tech powered model, or an innovative new design, compliance is your key to building trust with consumers, dental professionals, and regulators alike. Stay informed, stay compliant, and you’ll be well-positioned to make a positive impact in the world of oral care.
Evan Howard
May 188 min read
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IRC Section 721: Guide to Nonrecognition of Gain or Loss on Contribution to a Partnership
IRC Section 721 is a provision in the U.S. Internal Revenue Code that governs the tax treatment of property contributed to a partnership in exchange for an interest in that partnership.
Evan Howard
May 157 min read
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NAD Fast Track SWIFT: Speedy Advertising Dispute Resolution
The National Advertising Division (NAD) has fulfilled this need and introduced the Fast-Track SWIFT process - a streamlined path to tackle advertising allegations.
Evan Howard
May 146 min read
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The Anticaries OTC Monograph: Foundation of Cavity Prevention in the U.S.
Dental caries-commonly known as tooth decay or cavities-remains one of the most prevalent chronic diseases globally. In the United States, the fight against cavities has been revolutionized by the widespread use of fluoride-containing products, especially toothpastes and mouth rinses.
Evan Howard
May 138 min read
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The Rise and Fall of Seller-Financed Notes in SBA Transactions
The rise and fall of seller-financed notes in SBA transactions is a story of innovation, flexibility, and, ultimately, regulatory tightening that has dramatically reshaped how small business acquisitions are financed in the United States.
Evan Howard
May 127 min read
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Tax Implications of an Acquisition from the Buyer Side: How Structured Asset Purchase Agreements Benefit New Owners Through Depreciation and Amortization
When businesses change hands, the structure of the acquisition has profound tax consequences for both buyer and seller. From the buyer’s perspective, the choice between an asset purchase and a stock purchase is not merely a technical distinction-it can dramatically affect the after-tax value of the deal.
Evan Howard
May 117 min read
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The Antiplaque and Antigingivitis OTC Monograph: Science, Regulation, and the Future of Gum Health
Gum health is a vital, yet often overlooked, component of overall well-being. While much public attention is given to cavity prevention, the fight against plaque and gingivitis is just as crucial.
Evan Howard
May 108 min read
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Chapter III: Prohibited Acts and Penalties of the FD&C Act
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the cornerstone of food and drug law in the United States. Chapter III of the FD&C...
Evan Howard
May 86 min read
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Understanding the Anticaries, Antiplaque Antigingivitis, and Hypersensitivity OTC Monographs: Creation, Status, and Impact
Oral health is a cornerstone of overall well-being, and millions of people rely on over-the-counter (OTC) products every day to prevent cavities, fight plaque and gingivitis, and manage tooth sensitivity.
Evan Howard
May 78 min read
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FTC Process Before Filing a Lawsuit Over Marketing Claims
When the Federal Trade Commission (FTC) identifies potentially deceptive marketing claims, they follow a structured enforcement process designed to protect consumers while encouraging voluntary compliance.
Evan Howard
May 53 min read
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Exposing the Truth: Recent Lawsuits Over False and Misleading Claims in Oral Care Product Advertising
The oral care industry is extremely competitive, with brands vying for consumer trust through bold claims about whiter teeth, cavity protection, and even broader health benefits.
Evan Howard
May 15 min read
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The Removal of Loan Contingency in NC Real Estate Form 580-T: A Consumer's Nightmare
he North Carolina Association of REALTORS® (NCAR) has made a significant change to Standard Form 580-T, the Offer to Purchase and Contract form, by removing the agent commission contingent on financing.
Evan Howard
Apr 305 min read
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The FDA Cosmetic Act: In-Depth Analysis of the Federal Food, Drug, and Cosmetic Act and Its Modern Impact on Cosmetic Regulation
The FDA Cosmetic Act, formally known as the Federal Food, Drug, and Cosmetic Act (FD&C Act), is the foundation of modern cosmetic regulation in the United States.
Evan Howard
Apr 299 min read
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Toothpaste Regulation: How Ingredients and Marketing Claims Can Trigger Clinical Trial Requirement
Toothpaste is a product almost every American uses daily, but few consumers realize the regulatory complexity behind that familiar tube.
Evan Howard
Apr 286 min read
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