The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. With the registration and listing deadline of July 1 fast approaching, Venable's Food and Drug Law team hosted a webinar to review key information and answer last-minute questions on the practical aspects of complying with the law.
Joining partners Todd Harrison and Claudia Lewis was counsel Laura Rich, who brought the perspective of someone who worked at the FDA for 17 years. The following is a summary of the webinar's highlights.
Deadlines
The tables below contain some key MoCRA deadlines. They also note where we anticipate there will be delays.
MoCRA Requirement |
Current Deadline |
|
Safety Substantiation |
In Effect |
|
Adverse Events Reporting (and related recordkeeping and follow-up reporting) |
In Effect |
|
Labeling - Professional Use |
In Effect |
|
Register (covered cosmetic manufacturing or processing facilities and renew/update as appropriate) |
July 1, 2024 |
|
List (covered cosmetic products, including their ingredients, and update annually) |
July 1, 2024 |
|
Labeling - Contact Information (certain contact information for the responsible person must be on the label) |
December 29, 2024 |
Required Rulemaking |
Publication Deadline for Proposed Rule |
Publication Deadline for Final Rule |
|
Good Manufacturing Practice (GMP) regulations |
December 29, 2024 |
December 29, 2025 |
|
Establishing and requiring standardized testing methods for detecting asbestos in talc-containing cosmetic products |
December 29, 2023 |
180 days after the proposed rulemaking's public comment period closes |
|
The identification of fragrance allergens to be listed on cosmetic products labels |
June 29, 2024 |
180 days after the proposed rulemaking's public comment period closes |
Registration and Listing
It is important to remember that registration and listing is not a one-time requirement. You have an ongoing obligation to update as appropriate and renew as required. For example, every person who is required to register must update their registration within 60 days of any changes to the information required for registration. Updates to listing must be provided annually. This includes an update that a product was discontinued. Your anniversary date will be the date you originally registered and listed.
Adverse Events
The requirement to report adverse events is already effective. Be aware that the definition of "serious adverse event" has been broadened under MoCRA, and you have a tight deadline for reporting a serious adverse event.
Things you need to be doing in this area if you have not already include:
- Reviewing your current safety and reporting procedures to determine whether they are adequate or need updating
- Ensuring you have the right level of recall insurance, because MoCRA gives the FDA mandatory recall authority over cosmetics
- Paying attention to the plaintiffs' bar, which is already active in this space and will become more so moving forward
Q&A
What will happen if I don't get my registration and listing information submitted by July 1?
"I think the FDA is going to be a bit surprised as to how much information they are going to be getting in July," said Laura. "With that in mind, it is unlikely they will be coming after people with a warning letter who aren't right on time. Still, if you can be on time, it will get you off on a good foot and establish a positive compliance pattern."
When the requirement to identify fragrance allergens takes effect, will we need to re-label our inventory or just use new labels moving forward?
This will most likely be addressed in the proposed and/or final rule, but the FDA tends to be reasonable about giving companies time to transition. Do read the proposed rule, though, and if anything seems unreasonable, this is the time to submit a comment about what could be a better approach.
What if we are using an ingredient that doesn't have an FDA Unique Ingredient Identifier (UNII) code?
The FDA website indicates that not everything has a UNII, so if you do not have one, do not fret. This is optional information.
We know the Federal Trade Commission (FTC) standard for safety substantiation, but what is FDA looking for?
Newly added Section 608 of the Federal Food, Drug, and Cosmetic Act requires "reasonable persons" to ensure and maintain records supporting "adequate substantiation" and showing that a cosmetic product is "safe," and establishes a safety standard that products must meet. This section also includes a definition of "adequate substantiation of safety" and "safe." You should read it over, then sit down with your team and discuss whether you think your records are adequate and whether your cosmetic products are safe, considering this new statutory language. Also be aware that the plaintiffs' bar is going to be looking closely at your safety claims and other claims like "natural," and they will be applying more scrutiny than the FDA.
Will inspections under MoCRA be only for manufacturers or also for distributors?
You should anticipate that the FDA will inspect both. The fact that you are outsourcing manufacturing does not mean you are not responsible for what is happening at the factory. There are good contracts with language in place to delineate responsibilities between manufacturer and distributor. But you must audit your contract manufacturers and ingredient suppliers and have testing done for what is supposed to be in the product and for what is not supposed to be in it.
For More Information
The Venable team is closely following everything related to MoCRA and will continue to provide updates. Reach out to Claudia, Laura, or Todd if you have additional questions.
You can also watch a recording of the entire webinar, "The Modernization of Cosmetics Regulation Act (MoCRA)," visit the All About Advertising Law blog to get more insights from Venable's Advertising and Marketing Group, listen to our Ad Law Podcast, and sign up to be among the first to know about upcoming events hosted by the group.