What happens if you violate FDA rules?

[metoc15411]

So far, we have written that it is important to comply with FDA rules when selling Japanese food and cosmetics. If you violate FDA rules, your products may not pass import customs and you may be subject to penalties from the FDA. The details of the penalties are as follows:

■ Sending a warning letter

If the FDA rules are violated, the FDA may first send a warning letter to the US agent of the manufacturing facility. The warning letter will indicate legal issues and areas that need improvement.
If there is a problem with the labeling, the labeling will be requested to be changed.

■ Seizure of products

Next, if a food or cosmetic product is deemed adulterous, such as if the labeling is false, the FDA may forcibly seize the product.

■ Prohibition order

In more severe cases, where violations of the rules have kuwait whatsapp data continued for a long time and there are no signs of improvement, the FDA can go to court and order a ban on the activity.

■ Criminal complaint

In the event of a violation of the U.S. Food, Drug, and Cosmetic Act or a violation involving injury or other injuries, the FDA can file criminal charges against the business operator at its discretion. Fines (approximately 11 million to 55 million yen) and even prison time may be imposed.



When is FDA approval not required?
Even if a food or cosmetic product is subject to FDA regulations, it is exempt from FDA regulations if it is sent from one person to another for non-commercial purposes.

Food items purchased by a traveler in an international destination and shipped by the traveler to his or her U.S. address are excluded.
Food and gifts purchased at a commercial establishment and shipped by the purchaser.
Food brought or carried by a person arriving in the United States that is intended for consumption by the person, family, or friends and is not for sale or distribution.
Food that is prepared by an individual in their private residence and sent by that individual as a personal gift (not for commercial use) to an individual in the United States.
Basically, even if it is food or cosmetics, if it is shipped from one person to another, it is not for sale, and it is for non-commercial purposes, i.e. souvenirs, it is not subject to FDA regulations. Only shipments from one person to another, that is, to retailers or delivery companies or to American consumers, are subject to FDA regulations.

summary
Care must be taken when shipping FDA products such as food, beverages, cosmetics, and supplements to the US via cross-border e-commerce. In order to ship FDA products to the US, it is necessary to ship and sell products that have obtained FDA approval.
Japanese products are highly regarded in the US for their high quality. Americans who visit Japan as tourists are often surprised by the high quality of Japanese food products and become repeat users of those foods. To sell these foods on Amazon.US, eBay, etc., it is necessary to follow the rules set by the FDA.
If you are selling food or medicines to US consumers, please comply with the rules regarding FDA registration, application, and certification.