An Over-the-Counter (OTC) drug is a product that is generally safe and effective for use without seeking help from a health professional. There can be a fine line between when a product is considered a Cosmetic, an Over-the-Counter drug, or both. Unlike Cosmetic products, an OTC must have pre-approval before entering the market. We enlighten you on the registration process of an OTC drug, in the United States of America.

Enregistrer des produits OTC aux États-Unis

What is the difference between an OTC drug and a cosmetic in the US?

A cosmetic is any product “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 appearance” (FD&C Act, 201(i)).

A drug is any product “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease,” or any product “intended to affect the structure or any function of the body of man or other animals” (FD&C Act, 201 (g)(1)).

Which products should be registered in the US as OTC instead of as cosmetics?

An OTC or Cosmetic product is classified based on its intended use. The intended use can be established by:

  • The claims stated on the product labelling, in promotional material, or in the Internet
  • The consumer's perception and the product's reputation
  • The ingredients having a well-known therapeutic use

If, based on any of these categories, a product is determined to be intended to affect the structure or function of the body, or intended to treat or prevent disease, then it must be registered as a drug.

How are OTC products registered?

OTC products are registered using one of two pathways:

  1. New Drug Application: The active ingredients unknown or not recognised as generally safe and effective for its indication. The product requires FDA approval prior to marketing. This pathway requires a full drug application dossier, including clinical trials, to prove safety and efficacy.

  2. OTC Monograph: The active ingredients are Generally Recognized as Safe and Effective (GRASE) for their indication. The restrictions for these products are outlined in Monographs that can be found in 21 CFR 330. The product does not require pre-approval by the FDA if it complies with the restrictions outlined in its Monograph. (Exception: Colour additives may require batch certification). EcoMundo can assist you in preparing and filling your registrations.

Examples of OTC Monographs

The following are some examples of OTC Monograph categories:

  • CFR 21, 333.310: Acne Active Ingredients (ex. salicylic acid, benzoyl peroxide)
  • CFR 21, 347.10: Skin Protectant Active Ingredients (ex. aluminium hydroxide, glycerin)
  • CFR 21, 352.10: Sunscreen Active Ingredients (ex. octinoxate, titanium dioxide)

What is the role of a US Agent?

Foreign sponsors who want to market a drug product in the US require a US Agent. The US Agent is an individual or a company who interacts with the Food and Drug Administration (FDA) on behalf of the sponsor. The US Agent must reside and maintain a place of business in the US and cannot be just a P.O. Box or an email address. EcoMundo is able to connect you with a US Agent and ensure that you are equipped for effective communication with the FDA.

The FDA considers communication with the US agent to be indistinguishable from communication with the sponsor. As a result, a US Agent must be readily available to participate in urgent agency queries. In addition, a US Agent should be knowledgeable in regulatory requirements, including Good Manufacturing Practices (GMP).

What needs to be filed with the FDA?

The registration of an OTC product involves filing an Establishment Registration, a Labeler Code Request, and a Drug Listing. These forms are filed in an XML format known as SPL (Structured Product Labeling). EcoMundo can prepare and file your registrations with the FDA.

  1. Establishment Registration: Any domestic or foreign establishment that manufactures, repacks, or re-labels drug products for the United States must be registered with the FDA. Please note that an annual renewal is required between October 1 and December 31 of each year.

  2. Labeler Code Request: Allows the FDA to assign a unique NDC labeler code. It does not represent FDA approval.

  3. Drug Listing: Registered establishments must list all their drug products with the FDA. The listing includes the product’s identifiers, description, and labelling/artwork.

Wish to know more about the difference between OTCs and cosmetics?

For more information on cosmetic regulation in the North American continent, do not hesitate to contact our expert, Mr. Michaël Sommeil by phone at : +1 (514) 575-6085 or even send him an email at [email protected]

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