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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
COSMETICS

Conventional or Over-the-Counter (OTC)

COSMETICS

Are defined as cosmetics:

  • skin moisturizers
  • perfumes
  • lipsticks
  • fingernail polishes
  • eye and facial makeup
  • cleansing shampoos
  • permanent waves
  • hair colors
  • deodorants
  • sunscreens
  • any substance intended for use as a component of a cosmetic product

Soap is not included.

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

MoCRA exempts certain small businesses from GMP, registration, and product listing requirements. But there are some limitations.

MoCRA establishes the following new requirements for industry:

Adverse Event Reporting is required for serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days after receiving the report and certain additional information, such as new medical information, within one year of the initial report. The FDA will also have access to adverse event reports during an inspection.

Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew their registration every two years.

FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the U.S. has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the U.S. cosmetic products from the facility.

Product Listing: Manufacturers must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.

Safety Substantiation: Manufacturers are required to ensure and maintain records supporting adequate safety for their products.

MoCRA also requires that industry comply with regulations that will be established by the FDA for:

  • Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products.
  • Fragrance allergen labeling requirements.
  • Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

The Responsible Person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.

BOTH COSMETICS AND DRUGS

Whether a product is a cosmetic or a drug is determined by a product’s intended use.

The following products require a drug establishment registration:

  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Deodorant that is also antiperspirant
  • Moisturizer and makeup marketed with sun-protection claims
  • Sunscreens.
OTC COSMETIC OR CONVENTIONAL COSMETIC?

Need help determining whether your product is a  conventional or over-the-counter cosmetic before manufacturing, exporting or importing?

COSMETIC ESTABLISHMENT REGISTRATION

Here are the options for your company:

OTC (Over-the-Counter) Cosmetics

Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Also, the use of specific active ingredients may result in a product being regulated as a drug.

No OTC Cosmetic Establishment Registration is possible without the payment of MDF Facility Fees ($26,153), or CMO Facility Fees ($17,435) to the U.S. Treasury, first.

Manufacturers, Exporters and Importers are expected to know whether their products are conventional cosmetics or OTC cosmetics.

Voluntary Cosmetic Registration Program (VCRP)

Conventional Cosmetics

Your product does not meet the definition of an OTC cosmetic, as indicated.

In this case, your company’s registration was not required, and the listing of related products, as well. However, VCRP is requested by most wholesale distributors and Amazon.com, Inc.

Registration of a cosmetic establishment, assignment of an establishment registration number, filing a cosmetic product, or assignment of a Filing Cosmetic Product Ingredient Statements (CPIS) number, does not mean that FDA has approved the firm or its products.

A cosmetic manufacturer, packer, or distributor can file a statement for each product entering into commercial distribution in the United States.

Conventional cosmetic establishment registration is exempt from the annual User Fee. Only a Service Fee is required.

Update

The FDA stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products. The FDA is developing a program for submission of the facility registrations and product listings mandated by MoCRA and will provide further updates on its forthcoming availability.

COSMETIC ESTABLISHMENT REGISTRATION SERVICE
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Please Provide

Company’s DUNS Number

FDA Compliant Label

U.S. Toll Free Number.

U.S. Toll Free Number is preferred on OTC Cosmetics labels, to report health related issues.

Need Label Review or Update? Simply contact ITB HOLDINGS LLC.

FDA COMPLIANCE
Avoid the U.S. Customs Detention of your cargo.