In the European Union (EU), the classification of cosmetics and drugs is pretty clear, but it's not the case everywhere. Indeed, in the United States of America (USA), a hybrid status exists, the OTC product, which follows a specific regulation. Getting into the US market with cosmetics implies one knows and understands this regulation, to prevent any unpleasant surprises.

What is an OTC product? 

The OTC ("over the counter") product is a product that falls into both drugs and cosmetics definition following the American regulation (Picture). The FDA (Food and Drug Administration) considers an OTC a prescription-free drug that can be purchased without a prescription of a doctor (hence its name "over the counter"). It may be surprising, but several cosmetic product categories, regulated as such in the EU, fall into the OTC category in the USA.   
OTC products both cosmetic and drug

The Federal Food, Drug & Cosmetics (FD&C) Act states that a cosmetic product is applied to the human body for "cleansing, beautifying, promoting attractiveness, or altering the appearance". Drugs are meant to be used  in the diagnosis, cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body". But how does a cosmetic fall into the OTC category? It's the intended use that defines which category the product is categorized. Indeed, if a product has several intended uses, let's say two, and one matches the definition of a cosmetic product, and the other matches a drug, the product is an OTC! The FDA gives the example of an anti-dandruff shampoo:   
  • One of its intended use is to wash hair: it is a cosmetic product.  
  • Its other intended use is to fight dandruff: it is a drug.  
Other categories match this scenario, like sunscreen (prevention), antiperspirants, anti-acne products, or skincare cream with an SPF.   

The FDA defines the intended use by several facts: 
  • Claims: beware, in the USA, all communication around the product (including advertisements, website, etc.) is addressed. It is possible, for example, to have a packaging labeling compliant to the cosmetic category for a skincare cream, but if a claim like "regenerates the skin" occurs in an advertisement or other support, the FDA considers the product as an OTC. So, it is very important to be cautious with every claim around the product.  
  • Consumer's perception established through the product's reputation.  
  • Ingredients that have a well-known therapeutic effect, like fluoride in toothpaste.  
Once a product is identified as an OTC, appropriate steps are required to launch it on the American market.   

How to put an OTC product on the American market?  

  • Cosmetic products do not need any registration or approbation by the FDA to be put on the market in the USA (except if they contain color additives, or voluntarily *not sure what this means*). For an OTC product, it must be proven that it is "Generally Recognized As Safe and Effective" (GRASE). There are two possible ways:  
  • The product fits in the frame of an OTC monograph: the FDA's approval is not necessary (info box).  
  • There is no OTC monograph matching the product: an NDA (New drug application) must be submitted to the FDA.   
In the case of an NDA, a complete file is necessary to ensure that the ingredients, especially OTC active ingredients, and the finished product are safe and effective. This authorization file is a combination of all the elements that prove that ingredients are safe and effective, like clinical trials. The FDA itself states that "The documentation required in an NDA is supposed to tell the drug's whole story".  
What is an OTC monograph?  

Considering the significant number of OTC products launched, the FDA created the monograph system to organize categories of products instead of individual products. An OTC monograph is like a recipe book that specifies the authorized ingredients, their concentrations, the formulas, and the appropriate labeling (see below). Be aware that to avoid the NDA process, the product must precisely follow the appropriate monograph.   
  • Regardless of the method chosen, an agent in the USA (US agent) is mandatory: a natural person or an enterprise, the US agent is the link between the brand and the FDA, and must be able to answer the FDA's questions, including questions about Good manufacturing practices (GMP). Indeed, the FDA requires, for drugs and OTC, compliance with the GMP as describes in the Code of Federal Regulations (210 and 211 parts). 
 The launch of an OTC product on the market also requires the following steps submitted to the FDA (including when a monograph exists) :  
  • A request of establishment registration (manufacturing, repacking, or labeling establishments of drug products for the USA) ;  
  • A request of labeler code to obtain an NDC (National Drug Code) code ;  
  • The registration of the drug / OTC products list of each establishment.   
Specific attention must be made to the labeling of OTC products to avoid sanctions from the FDA.   

What are the labeling obligations for OTC in the USA?  

The labeling requirements for OTC products are close to those for cosmetic products in the USA (lien article etiquetage), but they have their own characteristics. The labeling of an OTC product must not only follow the labeling requirements for drugs but also OTC products. One of their characteristics is the drug facts table (picture), which is on the secondary packaging (or on the primary packaging if there is no secondary packaging). Its format is regulated, and its features: 
  • The title "Drug facts".  
  • The OTC active substances section with their quantity.  
  • The purpose of the product.  
  • The indications of the product (uses).  
  • The warnings required for an OTC product and those specific to the OTC monograph, if applicable.  
  • The directions of use.  
  • The inactive ingredients, that means the ingredients in the formula that are not active substances.  
  • Any other necessary information.  
  • A phone number for the consumer questions.   

If an OTC product follows an existing monograph, some labeling requirements specific to each category exists. They are specified in the monograph.  
The Drug facts table of an OTC product
 The Drug facts table of an OTC product (example of a sunscreen) 


Both a cosmetic product and a drug for the FDA, an OTC product implies specific regulatory requirements. They must be kept in mind during the cosmetic product development process if a launch on the American market is considered. It is quite easy for a cosmetic product under the European regulation to fall into the more complex OTC status in the USA. Qualified support should be sought to avoid any mistakes.