Cosmetics are one of the least regulated product categories by the FDA, but that does not mean you can skip on compliance. There are still very good reasons to register even when voluntary that can greatly affect a business. One such optional program is known as the Voluntary Cosmetic Registration Program or VCRP. There are many benefits to completing this process, even though it is not a strict requirement of the Food and Drug Administration.
The VCRP is broken into two parts: establishment registration and cosmetic product ingredient statement or formulation filing. Although they are voluntary when it comes to submission to the FDA, there are some very good reasons to participate.
Benefits for the Cosmetic Industry
The VCRP is primarily utilized by the FDA to gather information on cosmetics marketed and sold in the U.S. It provides information such as their frequency of use, business engagement, etc. It also provides ingredient information to the Cosmetic Ingredient Review (CIR) for assessing the safety of ingredients used in the formulation of cosmetic products.
The registration of your establishment and issuance of a certificate confirming registration can legitimize your manufacturing operations and be used by customers to demonstrate transparency in your operations. Although the certification does not mean the FDA has reviewed your product or facility specifically, it demonstrates your company’s willingness to submit this information. It may also be helpful when importing product from other countries.
Amazon and Other Sellers
Additionally, certain distribution companies may require proof of registration as a prerequisite to selling on their site. Amazon is well-known for this requirement.
Some VERY Important Notes
The VCRP is a great opportunity to legitimize your company and provide documentation to distributors. However, it is important to understand that there are some very strict requirements in order to register your establishment and submit a product formulation filing.
Cosmetic establishments are facilities where cosmetics are manufactured and/or packaged, not locations that house only business operations. Only owners or operators of cosmetic manufacturing or packing facilities can register their establishments, using a separate Form FDA 2511 for each facility location.
Distributors cannot register an establishment (21 CFR 710.1).
Domestic firms that have begun operations can register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers.
Foreign firms may voluntarily register their establishments after their products are exported for sale in the U.S. FDA assigns a registration number to each establishment location.
A cosmetic manufacturer, packer, or distributor can file a statement for each product the firm has entered into commercial distribution in the United States.
VCRP does not apply to products like sunscreen which are regulated as drugs. Those must meet strict drug regulations and fall outside the category of cosmetics.
Changes to a brand name or ingredients should be submitted within 60 days after the product enters commercial distribution. A CPIS should be discontinued within 180 days after discontinuance of commercial distribution becomes known to you.
Should you decide to move forward with this process, it is important to ensure that you meet all of the requirements listed above first. Gather all information and documentation in advance of filing to ensure a smooth process.
Bustos Law Group can assist with this process and issue certificates verifying establishment registration. Our experienced registration experts can make the process seamless and help you determine the best strategy for registering your firm.