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Food & Drug Administration

The FDA is responsible for protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled and also ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.

More info on FDA

FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. All FDA-regulated products are electronically screened before they enter the U.S.
Products regulated by the FDA are subject to review by the FDA when they are offered for entry into the U.S. The FDA electronically reviews all FDA-regulated entries submitted through the U.S. Customs and Border Protection (CBP). FDA-regulated products imported into the U.S. must comply with all of the FDA’s laws and regulations. The importer is responsible for making sure these products comply with all U.S. requirements. Products which do not comply with U.S. requirements at the time of importation are subject to refusal of admission.
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.

In general, FDA regulates:

Foods, including:

  • Dietary supplements, bottled water, food additives, infant formulas, other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products).

Drugs, including:

  • Prescription drugs (both brand-name and generic) and non-prescription (over-the-counter) drugs.

Medical Devices, including:

  • Simple items like tongue depressors and bedpans and complex technologies such as heart pacemakers, also dental devices and surgical implants and prosthetics.

Cosmetics, including:

  • Color additives found in makeup and other personal care products, from skin moisturizers and cleansers to nail polish and perfume.
  • Veterinary Products, including: livestock feeds, pet foods and veterinary drugs and devices.

Biologics, including:

  • Vaccines for human blood and blood products.
  • Electronic Products that give off radiation, including: microwave ovens or ultrasonic therapy equipment.

Tobacco Products, including:

  • Cigarettes or smokeless tobacco.

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Please select your industry

FOOD & BEVERAGES

COSMETICS

DRUGS

MEDICAL DEVICES

Food

Cosmetics

Drugs

Medical devices

Food & Beverages (Including Dietary Supplements, Ingredients and Food Additives)

Alcoholic Beverages

Animal FOOD

COMPLIANCE: Learn your requirements by activity

Labeling Review for Food , Beverage & Dietary Supplements

Ingredient Review for Food , Beverage & Dietary Supplements

FOOD SAFETY REQUIREMENTS

Are you a trader?

Do you manufacture, process, pack, label or warehouse in your facility a food or beverage product that will be consumed in the U.S.?

Do you manufacture, process or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (LACF)?

Do you need to send samples to the U.S.?

Do you repack or relabel or warehouse in your facility the product that will be consumed in the U.S.?

YES, I DO warehouse or repack.

NO, I do NOT warehouse or relabel or repack.

Are you a U.S. company or a U.S. subsidiary that manufactures, process, packs or warehouses foods to be distributed in the U.S.?

Are you a U.S. company or a U.S. subsidiary that imports and warehouses foods to be distributed in the U.S.?

Are you a foreign company that manufactures, process, pack, label or warehouses food or beverage products to be consumed in the U.S.?

YES , and I have a Facility registration number for my facility or my supplier's

Yes, but I do NOT have a Facility Registration number

Learn your requirements by activity

Are you a trader?
Do you repack or relabel or warehouse in your facility the product that will be consumed in the U.S.?

Do you manufacture, process, pack, label or warehouse in your facility the alcoholic beverage product that will be consumed in the U.S.?

Do you need to send samples to the U.S.?

YES, I DO warehouse, relabel or repack.

NO, I do NOT warehouse, relabel or repack.

YES , and I DO have a Facility registration number for my facility or my supplier's and the COLA Waiver from my importer.

Yes, but I do NOT have a Facility Registration number or an approved COLA or COLA WAIVER.

Learn your requirements by activity

LABEL & INGREDIENTS REVIEW

FOOD SAFETY REQUIREMENTS

Are you a trader?
Do you repack or relabel or warehouse in your facility the animal food in the U.S.?

Do you manufacture, process, pack, label or warehouse in your facility an animal food or beverage product that will be consumed in the U.S.?

Do you need to send samples to the U.S.?

Are you a U.S. company or a U.S. subsidiary that imports and warehouses foods to be distributed in the U.S.?

YES, I DO warehouse or repack.

NO, I do NOT warehouse or relabel or repack in my facility.

Yes, and I have a Facility registration number for my facility or my supplier's.

Yes, but I do NOT have a Facility registration number.

Learn your requirements by activity (Is your product a soap, cosmetic or a drug?)

I am not sure.

It’s a Cosmetic

It’s a Drug

Is your product a Medical Device?

It’s your product classified as Class 1?

I am not sure.

Yes, but I need to confirm its classification.

Yes, and I am a foreign establishment and I need an U.S.-Agent for registration and listing purposes.

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