Food products include food, beverages, nutritional supplements and infant formula. The same rules govern animal feed and supplements.
To import these goods into the USA you need:
- To analyze product labels for compliance with FDA requirements
- To register all facilities (places where goods are processed in any way: produced, packaged, stored, recycled or labeled)
- Issue Prior Notice (import notice)
According to the FDA, 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.
The FDA does not require mandatory registration or certification for cosmetics producers.
However, there is an opportunity to register under the FDA VCRP voluntary program
, which offers sellers a competitive advantage. This procedure includes:
- Manufacturer registration
- Imported goods registration
To do this, it is necessary to analyze the product label for compliance with the FDA requirements in advance.
OTC drugs are over-the-counter (non-prescription) drugs.
If the characteristics of these products (ingredients, doses, and use) match the active ingredient monographs previously registered with the FDA, they may be legally sold in the United States without registration.
Otherwise, you need to:
- Register a new drug
- Submit an SPL (drug list)
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 premarket notice, if the product is not exempt from one, according to the product classification.
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).
For the sale of such products, it is required to obtain the obligatory safety certification of the product or its components.
The FDA Tobacco Product Center regulates the manufacture, marketing, and distribution of tobacco products in the US for the purpose of protecting public health.
For the sale of any tobacco products, it is obligatory to register a company and provide a full list of goods.
Vaccines, blood and tissue products, biological products
These products are regulated by an affiliate of the FDA, the Center for Drug Evaluation and Research. These include blood and blood products, vaccines, allergens, cell and tissue products, and gene therapy products.
New biological products must go through a pre-market approval process called a Biological License Application (BLA), similar to a drug application.