WHAT DOES FDA REGULATES

The Food and Drug Administration (FDA) is in charge for protecting public health by assuring the safety and efficacy of human and animal drugs and biologics, medical devices, tobacco products, human food and animal food for consumption, cosmetics, and electronic products that emit radiation. It also provides precise science based health information to the public.

FDA regulates the following which is a list of traditionally-recognized products that comes under FDA’s regulatory authority.

Foods, which includes

  • Dietary Supplements
  • Bottled water
  • Vegetable and fruit products
  • Food additives
  • Infant formulas
  • Other food products (some of the food products are regulated by USDA such as meat, poultry and egg products).

Drugs, which includes

  • Over the counter (OTC) drugs
  • Prescription drugs( Brand name and generic)

Medical devices, which includes

  • Simple items from bed board and cane
  • Dental devices
  • Surgical devices, implants and prosthetics
  • Complex medical devices such as intraocular lens and pacemakers.

Vaccines, Blood & Biologics, which includes

  • Allergenics
  • Blood and Blood products
  • Tissue and it products
  • cellular and gene therapy products

Radiation emitting products, which includes

  • Laser products
  • X-ray equipment
  • Ultrasonic therapy equipment
  • Mercury Vapor lamps
  • Sunlamps

Cosmetics, which includes

  • skin moisturizers and cleansers
  • Color additives found in makeup and personal care products
  • Nail polish and perfumes

Animal & Veterinary, which includes

  • Pet foods
  • Livestock feeds
  • Animal drugs and devices

Tobacco Products, which includes

  • Cigarattes
  • cigarette tobacco
  • roll-your-own tobacco
  • smokeless tobacco

Alcohol products are regulated by The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) which monitors the production, importation, wholesale distribution, labeling and advertising.

Consumer Product Safety Commission(CPSC) ensure the safety of consumer goods such as children toys, power tools, cigarette lighters, household chemical products and products that cause a  fire, electrical, chemical or mechanical hazard.

Meats, Poultry and certain egg products are regulated by US Department of Agriculture (USDA).

The Environmental Protection Agency (EPA) regulates many traits of pesticides which determines the amount of pesticide used during cultivation, processing and how much can remain on the food we buy. EPA also regulates drinking water, which develops the national standards of drinking water from municipal tap water to limit the level of impurities.

Liberty Management Group, a leading FDA consulting firm provides assistance with registration of food, drug, medical devices and cosmetic companies and also provides assistance with US agent service to foreign companies.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us