Drug Labeling Requirements

All drugs distributed in the United States must comply with the Federal Food Drug and Cosmetic Act (FDCA), regardless of where they are made. The FDCA and FDA regulations require that drugs meet manufacturing standards to assure quality and compliance with drug label requirements.

Because the FDCA defines the term drugs and FDA regulations define the requirements for drugs based upon an article’s intended use, it is critical to understand what the drug label, the drug labeling, the internet marketing, and other promotional materials say (or imply) an article is intended to be used for. The intended use of a drug article will determine many of the FDA regulatory requirements that will apply.

The primary way FDA determines an article’s intended use is through the FDA label regulations and advertising or marketing on the Internet, or in other promotional materials. Internet sites where an FDA regulated product can be purchased is considered “labeling” for FDA purposes and “advertising” for Federal Trade Commission (FTC) purposes.

FDAImports provides comprehensive advice to clients regarding their drug labels, drug labeling, and internet marketing and advertising to ensure their products in U.S. distribution comply with all FDA drug regulations and FTC advertising regulations.

What FDA regulation requires to appear on a drug label depends upon the regulatory classification of the drug. Prescription (Rx) finished drugs have very different (and much more comprehensive) drug label requirements than active pharmaceutical ingredients (APIs). Similarly, there are very different requirements for OTC drug labels when compared to Homeopathic drug labels or prescription (Rx) drug labels. Topical drugs have specific drug labeling requirements, as do injectable drug labels and oral dosage drug labels.

Drugs that bear incorrect drug labels are subject to FDA import detention, FDA Import Alerts, and FDA import refusal of admission at the port of entry. If an imported drug shipment is refused admission by FDA, the refused drug must be exported or destroyed. FDA will not permit it to be imported for distribution. FDA or Customs may seize unapproved drugs imported into the U.S. Articles can become unapproved drugs if their drug labels, drug labeling or drug Internet marketing materials contain illegal, exaggerated, or impermissible claims or intended uses. Therefore, getting the drug label and Internet site right is critical to successfully importing drugs into the U.S.

Navigating the many drug regulatory requirements can seem impossible to a new company. But these complex requirements present challenges even to drug companies that have been marketing in the U.S. for many years. FDAImports spends much of its time evaluating drug labels to ensure they comply with FDA drug labeling regulations, OTC monographs and Homeopathic monographs. FDAImports helps make the confusing clear and the complex understandable, finding The Way Through for its drug clients on a regular basis.

Certain label claims may cause a product to be regulated by FDA as a drug, even if the manufacturer or distributed intended the product to be regulated as a cosmetic. Getting the label and labeling (Internet marketing) claims right is critical for FDA regulation compliance and FTC regulation compliance. Articles that meet both the cosmetic and the drug FDCA definitions are regulated under both the FDA cosmetic regulations and the FDA drug regulations. This means they must meet both the cosmetic label and the drug label requirements. Such products include creams or lotions (cosmetics) that contain or claim to have sun protection factor (SPF) benefits, dandruff shampoos, antiperspirants, hand sanitizers, toothpastes, mouthwashes, and others. These products are both drugs and cosmetics.

Labeling claims for cosmetic products that contain no active drug ingredients can cause the cosmetic to be regulated as unapproved drugs and misbranded drugs. Such product labeling or marketing claims include those that imply or explicitly state the product is beneficial for treating, mitigating, or preventing disease or otherwise affecting the structure or functions of the human body. Some examples are claims that products will restore hair growth (hair restoration products), reduce cellulite (cellulite reduction products), and anti-wrinkle or wrinkle removal or wrinkle reduction claims.

FDAImports assists companies in developing product claims for their cosmetic labels and drug labels and in developing marketing strategies for cosmetics and drugs that ensure FDA will regulate their products as intended. Failing to meet the FDA and FTC requirements can create significant business risks to Internet distribution companies selling drugs and cosmetics. Therefore, it is important to find The Way Through the regulatory maze and FDAImports is there to ensure FDA regulation and FTC regulation compliance for cosmetic and drug companies.

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At FDAImports we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States.

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