Yellowstone

Some of our services include:

We conduct an in-depth study of the applicable regulations for the importation of your product or service in the United States. This includes identifying relevant federal and state regulations, tariffs, labeling reviews, and other legal requirements.

We assist in obtaining and managing registrations for applicable products, and documentation necessary to comply with import regulations.

We ease the process of obtaining licenses and permits that may be necessary for the importation of your product or service in the United States, as well as ensure that your company complies with all requirements to operate in the market.

We provide guidance on international trade sanctions compliance, including risk identification and assessment, and management of commercial transactions with sanctioned countries.

We assist in resolving commercial issues, such as good inspections, shipment holds, detentions or inclusion in red lists.

Products subjected to FDA Regulations

The Food and Drug Administration (FDA) is a federal agency of the United States responsible for protecting and promoting public health by ensuring the safety, effectiveness, and security of food, drugs, biological products, medical devices, cosmetics, and radiation-emitting products in the country..

The FDA regulates a wide range of products , and its scope extends to both domestic and international companies wishing to market their products in the United States. Among the main sectors regulated by the FDA are:

01Food and Beverage Imports

All companies that produce, process, store, package, or distribute food and beverages intended for human or animal consumption in the United States are subject to FDA regulations. This includes not only food manufacturers but also restaurants, grocery stores, and catering companies.

Our services include, among others:

Facility registration with the FDA;
Registration of acidified or low-acid products;
Support service in managing Prior Notice Notifications;
Resident Agent Service;
Labeling and ingredient review;
Review of products labeled as organic;
California Proposition 65.

02Importation of Dietary Supplements

Dietary supplements are defined as products intended to supplement the diet that contain one or more dietary ingredients, such as vitamins, minerals, herbs or other botanicals, amino acids, and other substances. They are classified as foods and, as such, are subject to specific regulations.

Our services include:

Registration of facilities with the Food & Drug Administration;
Resident Agent Service;
Labeling and ingredient review;
Review of Master Manufacturing Records (MMR).

03Cosmetic Products

The FDA regulates the safety of cosmetics and personal care products, including makeup, hair care products, skincare, and perfumes. Companies that manufacture or sell these products must comply with FDA regulations to ensure consumer safety.

Our services include, among others:

Facility registration;
Cosmetic product registration;
Resident Agent Service;
Labeling and ingredient review;
Cosmetic Product Listing;
Verification of ingredients, in accordance with the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) to import an endangered species;
California Proposition 65;
Import Alert Management.

04Medical Devices

Companies that manufacture, import, or distribute medical devices, such as diagnostic equipment, prosthetics, and medical equipment, are subject to FDA regulations. These regulations range from assessing the safety and efficiency of devices to obtaining FDA approval or authorization before marketing.

05Drugs and Pharmaceutical Products

Manufacturers of both over-the-counter and prescription drugs, as well as manufacturers of pharmaceutical and biological products, must comply with FDA's strict regulations before their products can be marketed in the US.

06Tobacco and Nicotine Products

The FDA also regulates tobacco and nicotine products, including electronic cigarettes and vaping products, with the aim of protecting public health and reducing tobacco consumption in the population.

Products subjected to TTB regulations

The importation of alcoholic beverages into the United States is regulated by several federal agencies, including the Food and Drug Administration (FDA), the United States Customs and Border Protection (US Customs and Border Protection), and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Here are some services we can help with:

1. Registration of facilities and products;
2. Assistance in complying with FDA requirements;
3. Resident Agent Service;
4. Assistance with obtaining federal and State licenses for importing and distributing activities;