All businesses involved in the production, processing, storage, and packaging of food for sale in the United States must be registered as food manufacturers with the FDA.
Foodstuffs include food, beverages, nutritional and dietary supplements, as well as baby formula. Animal feed and additives are regulated by the same rules.
To successfully import food products into the USA, you need:
- Compliance of product labels and its ingredient list with FDA requirements and standards
- Registration of the manufacturer in DUNS
- Registration agent in the USA (for companies located outside the territory of the USA)
- Registration of a food manufacturer (Food Facility Registration) with the FDA
- Registration of a manufacturer of canned products (Food Canned Establishment) and registration of canned products with the FDA
- Sending Prior Notice (import notification)
In 2022, the FDA issued the Modernization of Cosmetics Regulation Act (MoCRA) and expanded the FDA’s powers to regulate cosmetics. This law requires all manufacturers of cosmetic products sold in the US to be registered with the FDA and to register their products. In addition, they must update product labels, which will help ensure the safety of cosmetic products that millions of people use every day.
According to the new FDA MoCRA bill, from July 1, 2024, all manufacturers of cosmetic products that produce and process products ready for sale in the US are required to be registered with the FDA and register their products there.
Cosmetics are all products, with the exception of pure soaps, that are intended to be applied to the body for the purpose of cleansing, enhancing attractiveness, or changing appearance. Examples include bath oil, eyebrow pencils, eau de toilette, hairspray, blush, and nail polish. Cosmeceuticals and cosmetics with medicinal effects are not considered cosmetic products.
However, small businesses, whose average annual gross sales of cosmetic products in the USA over the previous 3-year period are less than $1,000,000, adjusted for inflation, may be exempt from registering the manufacturer and cosmetic products with the FDA, although the labeling of their products must meet defined standards of FDA and MoCRA.
!!! Regardless of the annual gross sales, manufacturer and product registration remains mandatory for manufacturers of the following products:
– cosmetics that usually come into contact with the mucous membrane of the eye. For example: eye makeup removers, liquid eyeliner, or glue for false eyelashes;
– cosmetics that are injected. For example: tattooing and others;
– cosmetics intended for internal use;
– cosmetics intended to alter the appearance for more than 24 hours. For example: certain nail polishes (gel polishes), some hair products (dyes and colorants), some eyebrow dyes, and certain skincare products that are not rinsed off (SPF).
If a company produces one or more of the aforementioned products, it will be required to register the manufacturer and all products it plans to sell in the USA under any circumstances.
If you are required to register with the FDA (or wish to do so voluntarily), the procedure for exporting cosmetic products to the USA is as follows:
- Registration of the cosmetic manufacturer with an FDA agent
- Registration of cosmetic products
Additionally, we recommend conducting a product label analysis to check its compliance with FDA standards.
Domestic and foreign companies that manufacture, repackage, or relabel drugs in the United States must register with the FDA. Domestic and foreign medicine manufacturers, repackagers, or relabelers are also required to register all their drugs sold in the US market.
Additionally, new drugs must be approved through a New Drug Application (NDA).
Over-the-counter drugs that meet the requirements of FDA-mandated monographs do not need to obtain an NDA. Medicines that meet all the requirements of the monograph are considered safe and effective and can be sold without additional approval.
Medical device manufacturers involved in the production and distribution of medical devices intended for use in the United States are required to register with the FDA annually.
The FDA defines a medical device as an instrument, device, appliance, machine, implant, or other item that diagnoses, treats, mitigates, or prevents disease for humans or animals, or affects the structure or function of the body if this cannot be done with drugs.
Examples: laboratory tests, injection needles, hearing aids, endoscopes, etc.
To sell medical devices in the United States, you need to:
- Register the company with the FDA
- Submit a list of medical devices that are planned to be imported to the USA
- Apply for a 510k pre-market notice, if the product is not exempt from one, according to the product classification
Manufacturers of products that emit radiation are required to be registered with the FDA and submit electronic reports on the radiation safety of products.
These include various medical and non-medical products such as mammography devices, magnetic resonance imaging (MRI) devices, laser toys, laser pointers, liquid crystal displays (LCDs) and light emitting diodes (LEDs).
Every person who owns or operates a business that manufactures, prepares, prepares, or processes regulated tobacco products must register those enterprises with the FDA. A list of all tobacco products manufactured by the company for commercial distribution must also be submitted, along with certain supporting information, including all labeling.
Businesses must be registered with the FDA if they:
- involved in any or all steps related to the recovery, processing, storage, labeling, packaging or distribution of human cells and tissues;
- collect, produce, prepare, store under controlled conditions for further distribution or process blood and blood products;
- manufacture, repackage or relabel drugs and biological products, including vaccines.
Domestic and foreign manufacturers of drugs and biological preparations, repackagers or relabelers are also required to register all their medicinal and biological products sold on the market.
New biological products must go through a pre-market approval process called a Biological License Application (BLA), similar to a drug application.
