US FDA Regulations
Attention Brand Owners, Manufacturers/Contract Manufacturers, for Cosmetics (MoCRA) & OTC Drugs:
MoCRA (Modernization of Cosmetics Regulation Act of 2022)
– the newest cosmetic regulation in the US since 1938.
- Requires Manufacturing Facility Registrations (Bi-Annually) otherwise products will be void if facility is not registered (let us register your facility)
- Requires Product Listing (annually) if facility is not registered or shut down products can not be registered (let us List your products)
- International companies are required to have a US Agent (let us be your US Agent)
- Other MoCRA requirements include;
- labeling, Safety Substantiation,
- Adverse Event Reporting and
- Responsible Person (separate from US Agent)
- Requires Manufacturing Facility Registrations (Bi-Annually) otherwise products will be void if facility is not registered (let us register your facility)
- Requires Product Listing (annually) if facility is not registered or shut down products can not be registered (let us List your products)
- International companies are required to have a US Agent (let us be your US Agent)
- Other MoCRA requirements include;
- labeling, Safety Substantiation,
- Adverse Event Reporting and
- Responsible Person (separate from US Agent)
Be sure you know and understand the classification of your product. Did you know Salicylic Acid, SPF or fluoride may change the classification of your product to an Over The Counter drug in the US?
There are other ingredients that can change the product classification, so let us know and we will help you confirm where you product fits.
OTC Drugs (Over The Counter Drugs)
We work with a number of common Over-The-Counter (OTC) drugs, including:
- Sunscreens (sun protection factor / SPF)
- Acne products
- Toothpaste (fluoride product)
- Antiperspirants
- Hand sanitizers
- Topical antiseptics
- Skin protectants
- Sunscreens (sun protection factor / SPF)
- Acne products
- Toothpaste (fluoride product)
- Antiperspirants
- Hand sanitizers
- Topical antiseptics
- Skin protectants
FDA registrations are required annually and van be quite confusing at times. We have been working with the FDA for over 25 years and know all of the “ins and outs” of these submissions. Our rates are among the lowest for these services.
FDA Facility Registrations
- Cosmetics (MoCRA)
- Bi-Annual for Manufacturer/Contract Manufacturer
- International facility requires USA Agent
- Starting October 2023
- OTC Drugs
- Annual for Manufacturer/Contract Manufacturer & Packager/Labelers/Repacker
- International facility requires USA Agent
- Annually October to December
- Cosmetics (MoCRA)
- Bi-Annual for Manufacturer/Contract Manufacturer
- International facility requires USA Agent
- Starting October 2023
- OTC Drugs
- Annual for Manufacturer/Contract Manufacturer & Packager/Labelers/Repacker
- International facility requires USA Agent
- Annually October to December
FDA Product Listing
- Cosmetics (MoCRA)
- Annual for Manufacturer/Contract Manufacturer
- International facility requires USA Agent
- Starting October 2023
- OTC Drugs
- Annual for Manufacturer/Contract Manufacturer & Packager/Labelers/Repacker
- International facility requires USA Agent
- Annually October to December
- Cosmetics (MoCRA)
- Annual for Manufacturer/Contract Manufacturer
- International facility requires USA Agent
- Starting October 2023
- OTC Drugs
- Annual for Manufacturer/Contract Manufacturer & Packager/Labelers/Repacker
- International facility requires USA Agent
- Annually October to December
Facility registrations as well as Product Registrations were due December 31, 2020 for the 2021 year. If you miss a deadline, the product will be out of compliance/illegal. Incoming product will be held at US Customs causing daily storage fees or destruction. And worse, the company may be Red Listed causing FDA inspections with every shipment before release. So avoid the rush and call us today!
Here are answers to some of the questions you may have about FDA registrations:
Annual FDA Registrations are required for the following:
- Manufacturers (if you make fill, or package the product)
- You must register both your facility AND any OTC product intended for the US market
- If you are a Brand Owner (identified by name and address on the package) you must register each OTC product and each size
- Distributor (identified by name and address on the package) – you must register each OTC product and each size
- Labeler and/or provide OTC kit assembly – you must register each OTC product and each size
- Manufacturers (if you make fill, or package the product)
- You must register both your facility AND any OTC product intended for the US market
- If you are a Brand Owner (identified by name and address on the package) you must register each OTC product and each size
- Distributor (identified by name and address on the package) – you must register each OTC product and each size
- Labeler and/or provide OTC kit assembly – you must register each OTC product and each size
Facility registrations as well as Product Registrations were due December 31, 2020 for the 2021 year. If you miss a deadline, the product will be out of compliance/illegal. Incoming product will be held at US Customs causing daily storage fees or destruction. And worse, the company may be Red Listed causing FDA inspections with every shipment before release. So avoid the rush and call us today!
Here are answers to some of the questions you may have about FDA registrations:
When should we start this registration?
- Annual facility registrations begin October through December for the following year
- Annual product registrations begin October through December for the following year
- If you are launching a US-made new OTC drug, it must be registered within 10 days of placing the product on the market
- Or you are importing an OTC drug, it must be fully registered before reaching US Customs to avoid detainment
- Annual facility registrations begin October through December for the following year
- Annual product registrations begin October through December for the following year
- If you are launching a US-made new OTC drug, it must be registered within 10 days of placing the product on the market
- Or you are importing an OTC drug, it must be fully registered before reaching US Customs to avoid detainment
How long does it take?
- Typical registration takes 1 to 2 weeks
- As December grows closer, it may take longer depending on work load and FDA response as needed.
- Typical registration takes 1 to 2 weeks
- As December grows closer, it may take longer depending on work load and FDA response as needed.
What happens if the deadline is missed?
- FDA will identify the product registration as expired in their system and the product will be out of compliance/illegal
- Incoming product will be held at US Customs causing daily storage fees or destruction
- Company may be Red Listed causing FDA inspections before release
- FDA will identify the product registration as expired in their system and the product will be out of compliance/illegal
- Incoming product will be held at US Customs causing daily storage fees or destruction
- Company may be Red Listed causing FDA inspections before release
Let us know how we can be of assistance with your OTC drug registrations.
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Latest news about the US FDA
The deadline for registering your OTC products is approaching. From October through December 31st you must register your over-the-counter products. International Cosmetics can take care of this for you, and don’t worry! If you miss the deadline, we can still help!
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An expert in the field of international Cosmetics, putting her best face and hair forward, Cheeky International is the newest member of International Cosmetics. As an expert spokesbrush of International Cosmetics & Regulatory Specialists, L.L.C. in the U.S. and International Cosmetics & Chemical Services, Ltd. in the UK & EU, she guides her clients through the complex maze of constantly changing regulatory laws. Cheeky’s extensive experience has given her unique expertise in worldwide regulatory systems, with a specific focus on the European, United States and Canadian cosmetic industries.
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