Tag: US FDA consultancy
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Cosmetic Adverse Events: US FDA Requirements, MoCRA Rules, and Compliance Obligations
Cosmetic safety does not end once a product reaches the market. Under United States law, cosmetic companies are legally responsible for monitoring, documenting, and reporting cosmetic adverse events. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), adverse event reporting has become a mandatory and enforceable requirement under the authority of the US…
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Cosmeceutical FDA Meaning: What the Term Really Means Under US Law
The word “cosmeceutical” is widely used in marketing, product development, and consumer communication. It is often intended to describe cosmetic products that appear to deliver therapeutic or medical-like benefits. However, from a regulatory standpoint, the term cosmeceutical has no legal meaning under US FDA law. Understanding how the US FDA views the term “cosmeceutical” is…
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OTC Cosmetic Products: How US FDA Regulates Cosmetics With Drug Functions
Many personal care products in the US marketplace appear to be simple cosmetics, yet they also perform therapeutic functions. These products are commonly referred to as OTC cosmetic products, meaning they have both cosmetic and over-the-counter (OTC) drug characteristics. Under the authority of the US FDA, products that both beautify and treat or prevent certain…
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Drug vs Cosmetic Intent: How US FDA Determines Product Classification
One of the most critical regulatory questions for any personal care product is whether it is legally considered a cosmetic, a drug, or a combination product. This determination is driven primarily by product intent, which is evaluated based on claims, labeling, marketing, and consumer perception. Under the authority of the US FDA, product intent defines…
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Imported Cosmetics FDA Requirements: Complete Compliance Guide for Foreign Brands
Selling cosmetics in the United States is a major business opportunity—but it comes with strict regulatory obligations. Imported cosmetic products must fully comply with laws enforced by the US FDA, just like domestically manufactured products. There are no relaxed standards for foreign manufacturers. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), the…
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Trade Secret Ingredients in Cosmetics: US FDA Rules, MoCRA Expectations, and Compliance Strategy
Cosmetic formulations often represent years of research, development, and significant financial investment. For this reason, many cosmetic companies seek to protect certain ingredients as trade secrets. At the same time, cosmetic products sold in the United States must comply with strict ingredient disclosure and safety requirements enforced by the US FDA. The Modernization of Cosmetics…
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Cosmetic Product Claims: How US FDA Regulates What You Can and Cannot Say
Cosmetic product claims are one of the most common sources of regulatory violations in the United States. While cosmetic labels and marketing materials are powerful tools for attracting consumers, they are also closely regulated by the US FDA. Claims that overstep legal boundaries can cause a cosmetic to be misbranded, reclassified as a drug, or…
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Warning Statements in Cosmetic Labeling: US FDA Requirements and Compliance Obligations
Warning statements are a critical component of cosmetic labeling in the United States. Their purpose is to alert consumers to potential hazards associated with product use and to provide instructions that reduce the risk of injury or misuse. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA),…
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Net Quantity of Contents on Cosmetic Labels: US FDA Requirements Explained
The net quantity of contents statement is one of the most fundamental and strictly enforced cosmetic labeling requirements in the United States. It tells consumers exactly how much product they are purchasing and allows fair comparison between products. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA),…
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Statement of Identity for Cosmetics: US FDA Labeling Requirement Explained
Every cosmetic product sold in the United States must clearly tell consumers what the product is. This simple concept is known in regulatory terms as the Statement of Identity. The Statement of Identity is one of the most fundamental labeling requirements enforced by the US FDA, and it appears on the cosmetic’s Principal Display Panel…