Selling Cosmetics in the U.S. & FDA Cosmetic registration

It’s not a secret to anyone that the cosmetic market is growing tremendously. Current projections estimate a considerable growth in the U.S. market. With the growing trend of e-commerce, a decent size of cosmetic products is being sold through online channels like Amazon. 

US FDA Cosmetic Registration

U.S. Food and Drug Administration (FDA) oversees the regulations over the cosmetics and personal care products sold in the U.S. market.  Under current regulations of the FDA, cosmetic registration is not mandatory. However, cosmetic and personal care product companies can voluntarily register with FDA through a program called Voluntary Cosmetic Registration Program (VCRP). Through VCRP program manufacturers, packers, labelers and retailers can voluntarily register with the FDA. Even though cosmetic retailers and business offices can participate in the cosmetic registration, only the owners or operators of cosmetic manufacturing or packing establishments will obtain the FDA registration number after the cosmetic registration submission.

In addition, after the cosmetic product has entered the commercial distribution (sold a minimum of $1000), the cosmetic manufacturer, packer, or distributor can file a statement for each product entered the U.S. market. Through this program, that is called Cosmetic Product Ingredient Statements (CPIS), cosmetic companies can file an statement for each cosmetic formulation. Through CPIS filling process, companies have the chance to cross-reference their product ingredients with the FDA cosmetic ingredient dictionary. A CPIS filling can be amended later if the product formulation is changed.

Selling Cosmetics on Amazon

Amazon sales of cosmetic and personal care products for (FY) 2018 was estimated to be over $16 Billion, close to 40% increase compare to the (FY) 2017. According to Amazon Seller Central forum, cosmetic resellers and distributors are required to present an invoice from the manufacturer as well as  proof of FDA registration or Good Manufacturing Practice (GPM) certificate or Certificate of analysis for certain cosmetic products.

FDA Listing Inc. is a New York based corporation that assists companies from around the world to comply with U.S. FDA Regulations. FDA Listing Inc. can assist with cosmetic manufacturers and packers with FDA cosmetic establishments registration and product formulation fillings as well as FDA Cosmetic Labeling Requirements and will provide a certificate of FDA registration after completion or registration.

How to Get FDA Registration for Your Medical Devices?

Businesses engaged with the manufacturing, relabeling, repacking or export of the medical devices to the U.S. are required by FDA law to register with FDA and comply with FDA regulations. A foreign company working at offshore location or outside the US must appoint an FDA US agent who will help in the FDA device registration process and compliance with FDA rules.  

Selecting an experienced company or an independent US agent who is well-versed with FDA regulations and requirements can help you get registered or renew your device registration in a timely manner. This will ensure that your business gets registered with FDA and you can smoothly carry out the business transactions and promotion without any legal complication posed by US FDA.

If you are the manager of a company engaged in manufacturing and distribution of medical devices for commercial purposes in the US, you would require FDA Device Registration annually. You would require registering and mentioning the types of devices and their functionalities or ways in which they are used at that establishment to get proper FDA registration. 

Here is a checklist of ways through which you can get registered in a proper way.

• Pay fee for annual registration

As per the Food and Drug Administration Amendments Act (FDAAA) of 2007 every company engaged in the manufacturing, relabeling, repacking or export of the medical devices sold in the U.S. are required to pay a registration fee and provide listing information electronically unless a waiver granted by the FDA. For the payment, they can pay via FDA online platform and obtain a Payment Confirmation Number (PCN). Once the payment has been made, as this process may take one week or more, one needs to make payment in advance for timely registration.

• Submit your registration and listing information online

After a PCN has been received, the owner/operator of the medical device establishment needs to use FDA online platform to complete the FDA device registration process and list their devices on FDA. For this, they need to create an online account ID and password. Hiring an FDA US agent requires that a sub-account for the official correspondent should be created with a separate account ID and password for the same. Renewal of registration requires that the owner uses the same User ID and password that has been created earlier at the time of registration.

• Get e-mail confirmation from FDA that you have met all requirements.

Once you pay the annual fee and submit your business listing info and registration electronically you will get the confirmation through mail that all requirements for FDA registration have been met.  This will help you complete the registration process and thus gain peace of mind.