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Expanded FDA Cosmetic Regulations for Manufacturers | MoCRA

Intellex explains the 2022 Modernization of Cosmetic Regulations Act (MoCRA) and how it will affect cosmetic brands and manufacturers in the coming year.

Modernization of Cosmetic Regulations Act and its impact on manufacturers

We sat down with our very own Intellex cosmetics expert, Geoff Waby, a consultant and former Estee Lauder quality assurance executive, to get his perspective on how MoCRA will impact cosmetics manufacturers. His answers may surprise you.

Why did Congress pass MoCRA in 2022?

The last time Congress passed new regulations related to cosmetics was the food drug and cosmetic act of 1938. Given that most cosmetics companies today haven’t existed for 84 years, MoCRA represents a significant—and unfamiliar—regulatory shift.

This highly anticipated overhaul provides heightened regulatory oversight of cosmetic products and facilities. This law impacts all categories under the term cosmetics, including professional salon products, personal care products, and intimate care products. The new requirements will increase product safety, and provide greater reassurance to both individual consumers, beauty advisors, and salon workers that cosmetics are both healthy and safe while enhancing self-confidence and wellbeing.

As a cosmetic manufacturer, what should we be prepared to do?

The key word here is prepare. This will be a marathon, not a sprint, when it comes to complying with the new regulations.

Register with the Food & Drug Administration (FDA) by December 29, 2023

While that’s only about 10 months away, you don’t need to worry about the actual registration part just yet—the FDA is still in the process of preparing guidance on the use of their registration site, which could take weeks or months. Any company which is already participating in the FDA’s Voluntary Cosmetic Registration Program will be familiar with what the FDA may decide to make mandatory. In the meantime, there are other steps you can take to be ready with the required information.

Gather your cosmetic product information

  • For Brand Owners: this includes the name and contact number of a responsible person, the label names of cosmetics products and the applicable product category, a list of ingredients (including fragrances, flavors, and colors), and a facility registration number.
  • For Manufacturers: This includes name, address, email address, and telephone number for U.S.-based facilities; for foreign facilities, this includes U.S. agent name, brand names, and product categories.

Many major cosmetics manufacturers have a mixed portfolio, with about 15% of that being over-the-counter (OTC) products. If you’re one of these companies, you’re already familiar with FDA registration. If you’re a contractor whose sole focus has been on cosmetics, MoCRA will pose a greater operational shock.

Review your Supply Chain from cosmetic product filler to raw material supplier

One of the first requirements to come into force on December 29, 2023 is safety substantiation of your cosmetic product.  Companies who are placing their products onto the market in the European Union, will be familiar with the requirement to hold a Product Information File.  This document includes a Cosmetic Product Safety report confirming the safety of the product formulation during its intended use.  MoCRA brings the concept to products placed on the market in the United States.  Once again, expect the FDA to issue further guidance on this topic.

What if we miss the FDA registration deadline?

After December 29, 2023, the FDA can hold manufacturers accountable. Does this mean come January 1, citations and shutdowns are imminent? Probably not. I would expect that the FDA is working hard to get their own processes in order, decide on their enforcement priorities, and get training completed to align with MoCRA just as much as cosmetics companies. But make sure you’re compliant, all the same.  Showing the FDA that you are acting responsibly, and in the best interests of the people who buy your products, is always the best policy.

And here’s an interesting side note: within the FDA, cosmetics are aligned with food and not OTC drugs. So, the FDA will have to determine whether OTC drug inspectors will handle cosmetics inspections on behalf of food, or whether “food” inspectors will also now be performing inspections on the same sites as the drug inspectors.

Which cosmetic products could be under review first?

I suspect they will begin by prioritizing manufacturers of cosmetics products used or applied close to vulnerable areas of the body, like the eyes and mouth. Especially if there have been safety concerns raised about this type of product in the past.

For example, there are certain pigments not allowed to be used near sensitive areas. But some cosmetics companies get into trouble by using these pigments to create, say, an eye shadow. They then state on the label (in barely readable fine print) that the product is not to be used on or near the eyes. Consumers will now be better protected against these dangers because companies will no longer be able to fly under the FDA radar.

Should we be worried about these new cosmetic safety regulations?

Not at all. The truth is, most cosmetic manufacturers and facilities have nothing to fear, and even welcome the new regulations. Many companies welcome the opportunity to spotlight bad actors who tarnish the cosmetics industry.

It’s not uncommon for unscrupulous people to pass knock-off versions of a product as the real thing, using sub-par ingredients that hurt an honest brand’s reputation and the consumer who purchases it.

On a related note, according to the FDA website, the largest cause of product recalls across drugs, cosmetics, and dietary supplements is microbial contamination. The formulation, the preservative system, the way you operate, even the packaging and the cleanliness of the equipment–you can’t make one of these vulnerable without adjusting the rest. You have to bring everything back into balance. The recent growth of “natural” products and the loss of robust preservative systems, while understandable in today’s world, requires companies to revisit all of the components of manufacturing hygiene to minimize the risk of microbial contamination, which can have a negative impact on consumer health and safety.

A reputable personal care industry, providing benefits in terms of health and wellbeing, and avoiding safety risks is what MoCRA will help accomplish. The FDA expects manufacturers to provide safe, effective products. They are looking for companies to accept responsibility, and these regulations can now prevent them from profiting while causing adverse health events for consumers.

Will MoCRA be a catalyst for other changes in the cosmetics industry? 

I see two important developments emerging from this new regulation.

Identification of fragrance allergens

The FDA is required to develop a positive list of fragrance allergens, in part by looking at international standards and what other countries are doing.

Safety substantiation

While this has been present in OTC, it’s new to cosmetics. Manufacturers must produce studies, tests, analyses, or other data that supports a claim that a product is safe for the public.

As already mentioned, important conversations will be needed between brand owners and the contract manufacturers that supply cosmetic ingredients. It could be that ingredients used today don’t have studies to back them up. Some cosmetic products may need to be reformulated to replace unsubstantiated ingredients or, if that’s not possible, discontinued.

What is the cost of this new regulation for cosmetic companies?

There are a few different ways to look at and categorize the investment for companies in order to comply.

People & systems

The main investment will be in people and recording systems for product listings and registration maintenance, as well as technology to support better hygiene in the manufacturing process overall. This will drive the lion’s share of capital investment.

Registration management

The registration component is particularly important. Companies will need someone responsible for keeping their company’s registration up to date. Brand-new facilities will have 60 days to register. In the case where an existing product is transferred to a facility never before used, a registration update or change will also be required within 60 days. And registrations must be renewed biennially.

How can smaller cosmetics companies best handle the MoCRA regulations? 

The best thing they can do is turn to industry experts for help. Consultants can help perform a gap analysis to address where process remediation would be needed. And, as we move into the next phases of MoCRA in the coming years, consultants can help with everything from education, to corrective action, and disaster recovery if they were ever to be shut down by the FDA.

In the case of venture capital investors, they have a financial stake in their cosmetics investments and must fully understand the risks as well as what it takes to maintain compliance. They are growing fast and have a specific timetable to divest and make the money. Expert counsel will be key.

Connect with Intellex 

As a cosmetics company, you probably have many more questions about the impact of MoCRA on your future operations. We have experienced experts, like Geoff Waby, on hand and ready to partner with you to uncover your best path forward. Reach out to get started.

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