Decoding MoCRA: Small Business Exemptions and What They Entail
The Modernization of Cosmetics Regulation Act (MoCRA) has introduced a range of requirements that cosmetic businesses must navigate. However, small businesses might breathe a sigh of relief knowing there are certain exemptions they can benefit from. Here's a breakdown of what small cosmetic brands need to understand about MoCRA's small business exclusions.
Understanding the Threshold
The key to qualifying for a small business exemption under MoCRA lies in the annual gross sales. If your cosmetic business's average gross annual sales in the United States over a three-year period are less than $1 million, you may be eligible for specific exemptions.
Exemptions for Small Businesses
The exemptions for small businesses earning less than $1 million annually include:
Product Listing and Registration: Small businesses are exempt from the requirement to list and register their products with the FDA.
Adverse Event Record Keeping: While they must maintain records of adverse events, they only need to retain them for three years.
It’s crucial to note that these are the only exemptions. Other requirements, such as labeling, adverse event reporting, and listing allergens, remain in place for all businesses, regardless of size.
Important Exclusions from the Exemptions
Despite these exemptions, if your small business is involved in manufacturing or processing certain types of cosmetics, you will not be exempt. These include:
Cosmetics that come into contact with the mucous membranes of the eye.
Injected cosmetics.
Cosmetics intended for internal use.
Cosmetics that alter appearance for more than 24 hours.
These categories reflect the FDA's focus on products with a higher risk profile.
What This Means for Your Small Business
If your brand falls under the small business category, it's essential to determine if you qualify for these exemptions. You must assess your products, their intended use, and your gross sales to understand your obligations under MoCRA. Remember, while these exemptions can offer some relief, it’s vital to stay informed and compliant with all other aspects of the legislation. Small businesses should not underestimate the importance of adhering to the non-exempted requirements, as they play a crucial role in consumer safety and product integrity.
Navigating MoCRA can be daunting, especially for small businesses that might lack the resources of larger corporations. This is where EWC steps in – as your compliance partner, we specialize in clarifying the nuances of MoCRA's small business exemptions and guiding you through the compliance process. EWC can help you assess whether your business qualifies for exemptions, understand the range of requirements that apply to you, and develop a compliance strategy that ensures you meet FDA standards without compromising your business's efficiency. With EWC’s expertise, small cosmetic businesses can confidently adapt to new regulations and maintain a focus on growth and innovation.
