Everything to Know About FDA Regulations

A new year means new FDA regulations and requirements. For businesses to remain successful, they must be properly prepared for any changes to come.

In this blog, we’ll cover the most recent FDA regulations and trends, as well as explain how a 3PL like Jay Group can benefit your business in the long run.

New FDA Regulations for Cosmetics

While it wasn’t specifically implemented in 2024, the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, is an important piece of legislation that will significantly impact the cosmetic industry.

The MoCRA is the most significant (and recent) expansion of the FDA into cosmetics since 1938, making it imperative for companies to ensure they are upholding the new requirements.

Some of these requirements have been delayed until July 2024, but it’s recommended that companies remain aware of the changes and ensure they are complying in the upcoming year. Below, we will review the new regulations included in the MoCRA.

Good Manufacturing Practices (GMPs)

The FDA is authorized to develop GMPs for cosmetic products which would establish minimum standards for manufacturing, testing, and packaging.

Labeling Requirements

Cosmetic products are required to have a label with contact information. These labeling requirements are available to customers so they can report adverse events related to the product. This information will include:

Domestic address
Domestic phone number
Website and/or email address

In addition to the new contact information requirements, the FDA will also be releasing a list of fragrance allergens which will also need to be featured on the label of each product.

Keep in mind that the company present on the label (either manufacturer, distributor, or both) will be the responsible party and will be obligated to keep all contact information up to date.

Mandatory Adverse Reporting

A serious adverse event refers to any health-related incident associated with using a harmful cosmetic product.

These events must be reported to the FDA within 15 business days of the company receiving the initial report. This applies to whoever is listed on the label (manufacturer, distributor, or both).

FDA Facility Registration & Product Listing

Any manufacturers of cosmetics will have to register as an FDA-certified manufacturing facility within 60 days of starting their operations. The registration will be expected to be renewed every 2 years.

It is within these registrations that companies can find the Good Manufacturing Practices (GMPs), which the FDA will establish before enactment. It should be noted that these registrations do not apply to distributors.

All cosmetic products must be registered with the FDA. This applies to distributors as well if they have annual cosmetic sales above $1 million and/or they are listed on the label. Similar to the facilities, these products must be registered every 2 years.

Companies will also be required to have a list available featuring every product marketed, as well as the ingredients found in each product. These lists must be updated every year.

Enhanced Safety Substantiation

Manufacturers will be required to follow current product regulations and provide proof that their product is safe. This proof will include records and documentation with scientific data to support their product’s safety.

For example, tests, studies, and research. If distributors are featured on the label, this also applies to them. They should ask their manufacturers to provide these items to be FDA certified.

Mandatory Recall Authority

If the FDA has a reasonable probability that a product is adulterated, misbranded, or presents a risk of serious adverse health consequences, they can recall the product.

When this happens, the person or company responsible will have the opportunity to voluntarily cease distribution of the product. However, if they do not do this voluntarily, the FDA then has the authority to issue a mandatory recall.

Upcoming FDA Regulations & Changes

Currently, the FDA is still working on finalizing new regulations for 2024, but that doesn’t mean there aren’t noteworthy FDA regulations expected on the horizon.

The following section will discuss the proposed legislative changes we recommend keeping an eye on throughout the upcoming year.

Enhanced authority for managing shortages– includes manufacturers notifying the FDA about potential supply disruptions as well as providing the proper tools needed to address shortages of drugs, medical devices, and food.

Streamlined inspection processes– allows the FDA to continue having oversight over companies and products, even when in-person inspections are not feasible.

Improved information sharing– involves increased collaboration between the states and the FDA to enhance regulatory effectiveness.

Expanded authority– seeks broader powers that allow the FDA to recall all human and animal drugs that are deemed unsafe.

Dietary supplement oversight– proposes stricter regulations to protect consumers from potentially harmful supplements. This will include the following regulations:
- Enhanced safety requirements for new dietary ingredients (NDIs).
- Improved labeling requirements.
- Increased enforcement authority.

Modernization of tobacco user fees– aims to offer fair distribution fees across all FDA-certified tobacco products.

How Can FDA-Certified 3PLs Help?

After reading through the new and proposed FDA regulations to come, it’s natural for any business owner or company to feel overwhelmed, especially when taking into account the consequences they may face if they don’t comply.

Fortunately, no one has to do it on their own. Using an FDA-certified 3PL can have many advantages for businesses of any size. Below, we’ve provided a few benefits every company can expect when partnering with a 3PL.

1. Access to FDA-Registered Facility

As an FDA-registered facility, Jay Group is among one of the few 3PL providers qualified to work with highly regulated products and industries, including:

We have put into place procedures and policies that maintain strict quality control while storing, packaging, and shipping products.

2. Ensured cGMP Compliance

In addition to being an FDA-registered facility, we also ensure our company enforces all of the current Goods Manufacturing Practice regulations (cGMP) throughout every step of the manufacturing and delivery process.

This includes the monitoring and controlling of the manufacturing process as well as the storage and shipping of cGMP-related products.

Finally, Jay Group has an internal Quality & Compliance Department that supports several other services related to FDA regulations and requirements. These include:

Quarantine
Recalls
Climate control
Proper handling
Inventory management
Inspections
Repackaging and Relabeling

With some FDA 3PL guidance, companies can ensure their customers that their products will be delivered to their doorstep safely and securely every time.