Cosmetic and OTC Drug
Cosmetic and OTC Drug
Approval and Enforcement Overview
Prescription, OTC, and Homeopathic Drugs
Drug products distributed in the U.S, including cosmetic and OTC drugs, must comply with the Federal Food, Drug and Cosmetic Act. This is the case for both domestic and imported products. Unless exempted by law or regulation, drug products must be approved by the FDA before they can be marketed. To obtain product approval, a firm must submit a New Drug Application (NDA), or an Abbreviated New Drug Application (ANDA) to the FDA. Each of these must contain, among other things, research data and manufacturing information about the drug. The ultimate goal of the NDA/ANDA is to provide enough information to permit an FDA reviewer to determine that the drug is safe and effective for its intended use(s).
Over-the-counter (OTC) drugs (i.e. non-prescription drugs) that comply with the FDA’s OTC monograph regulations do not require FDA approval before they are marketed. The OTC monograph serves as a “recipe book” specifying what active ingredients may be used, at what level, and for what intended uses. These OTC drugs are classified: “as generally recognized as safe and effective” (GRASE) for use and do not require further pre-market approval by the FDA. OTC monographed drugs must still be registered and listed.
Homeopathic drugs that comply with the FDA’s homeopathic drug Compliance Policy Guide (CPG) also do not require FDA approval before they are marketed. The CPG specifies conditions under which a homeopathic drug may be marketed without prior approval. Drug products that fail to meet these conditions are subject to enforcement actions. Homeopathic drugs must also be registered and listed.
Labeling and Advertising Review: We provide regulatory counseling to help you determine whether your product can be marketed as an OTC drug under the OTC monograph, a homeopathic drug, or require a New Drug Application. Our firm also assists clients with labeling and advertising review to help ensure compliance with applicable federal regulations.
Facility Registration and Product Listing: All drug manufacturers, processors, packers, repackers, labelers, and relabelers who offer drugs for sale or distribution in the U.S. are required to register their drug establishments with the FDA. Every drug establishment registered with FDA must submit a list of every drug they have in commercial distribution to obtain NDC (National Drug Code) numbers. This is also known as a NDC relabeler code. Our firm can help register your drug establishment, list your drug products, and can act as the U.S. Agent for foreign drug manufacturers.
Adverse Event Reporting & Record Keeping: Drug firms are required to report to the FDA certain adverse events associated with their products and maintain reports of adverse events. We assist clients in developing process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance
Export Certificates: Struggling to determine whether you need an Export Certificate to Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for OTC or Rx pharmaceutical. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on forms and what attachments to include. Whether you’re already selling the product in the US, or only looking to export; we can help.
Cosmetics and Cosmeceuticals
Cosmetics marketed in the U.S. must comply with the Federal Food, Drug and Cosmetic Act, Fair Packaging and Labeling Act and other federal regulations. With the exceptions of certain color additives, cosmetics and their ingredients do not require cosmetics FDA approval for marketing.
Federal law defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Most firms run into trouble when their product labeling makes drug or disease claims. Examples include claims that their products will restore hair growth, reduce cellulite, or remove wrinkle. The differences between a cosmetic claim and a drug claim can be subtle, and failure to appreciate the subtleties can result in enforcement actions by the FDA.
We conduct ingredient and labeling review of your cosmetics as well as an analysis of any claims made on your website to help ensure compliance with FDA regulations. When you want to market your product for areas covered by OTC drugs we can guide you through the application process.