‌ 

The FDA regulates a wide range of manufactured goods for consumers, including food, electronics, medications, medical devices, and more. In the United States, the FDA does not require cosmetic manufacturers to register their products. However, creators and businesses can register cosmetic products with the FDA as part of the Voluntary Cosmetic Registration Program (VCRP).

Even though the program is entirely voluntary, Companies should still consider registering. Joining the VCRP has many advantages, including:

  • The FDA will notify registered merchants of what cosmetic ingredients do not comply with FDA specifications.
  • Cosmetic Ingredient Review provides information for assessing the safety of ingredients used in the formulation.
  • Companies in the VCRP are promoted as part of running a responsible cosmetics business.
  • Those who join the voluntary registration program will enter the government database, which helps retail stores identify safety-conscious manufacturers if you’re looking to grow your business.
  • Program is likely to reduce the possibility of “violating customs clearance.”
  • It gives the FDA the best estimate of products, their frequency of use, and businesses engaged in their manufacture and distribution1.

As of July, there were 103,644 cosmetic stores in the US2. However, as of October 2021, there are only 4,914 active cosmetic establishments registered with the VCRP3. With the number of benefits companies receive when registering with the VCRP, it’s surprising more companies have not done so.

If you’re thinking about registering with the Voluntary Cosmetic Registration Program, or if you’re wondering if your products are considered cosmetics, EMMA International has experts to help. EMMA International’s team of experts can assist with everything from regulatory strategy to voluntary registration, post-market observance, and beyond. Give us a call at 248-987-4497 or email info@emmainternational.com to find out more!

References:

  1. Center for Food Safety and Applied Nutrition. (2020, August 24). Voluntary Cosmetic Registration Program. U.S. Food and Drug Administration. Retrieved November 8, 2021, from https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This