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.

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).

A frequent misunderstanding is that “LLCs cannot own S corporations.” In reality, the rule is that entities taxed as partnerships or corporations cannot be S corporation shareholders. A single-member LLC, if disregarded for tax purposes and owned by an individual or other eligible person, is not treated as a separate entity and thus does not violate the rule.

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.

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.

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.

A typical buyout provision specifies the triggering events that require or permit a buyout, such as voluntary withdrawal, death, disability, or expulsion for cause. It also outlines who has the right or obligation to purchase the departing owner’s interest, often the company itself or the remaining owners, and the method for valuing that interest, which may be based on book value, fair market value, or an independent appraisal.

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.

The National Advertising Division (NAD) has fulfilled this need and introduced the Fast-Track SWIFT process - a streamlined path to tackle advertising allegations.

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.

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.

A Section 338(h)(10) election is a nuanced and powerful provision within the Internal Revenue Code, designed to provide flexibility in the tax treatment of certain corporate acquisitions.

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.

Phantom employee fraud is a serious threat to organizations of all sizes, with profound legal, tax, and governance consequences. Whether perpetrated by a rogue executive or a business owner seeking to enrich family members, these schemes can result in criminal prosecution, civil liability, tax penalties, and lasting reputational damage.

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.

While the concept of one company buying another seems straightforward on the surface, the reality is far more intricate. Many M&A deals, especially those involving public companies or complex ownership structures, require a series of coordinated legal and financial steps to achieve the desired outcome.

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...

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.

The S-Corporation, or S-Corp, is a fixture in American business, prized for its tax efficiency and liability protections. Yet, confusion abounds-one of the most common errors is thinking of the S-Corp as a type of business entity, like an LLC or a C-Corporation.

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.