Objective of FDA

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; ensuring that human and
veterinary drugs, and vaccines and other biological products and medical devices
intended for human use are safe and effective
• Protecting the public from electronic product radiation
• Assuring cosmetics and dietary supplements are safe and properly labeled
• Regulating tobacco products
• Advancing the public health by helping to speed product innovations.

Definition of medical devices

FDA defines a device as: An instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including a component part or accessory which
is:
– recognized in the official National Formulary, or the United States Pharmacopoeia, or any
supplement to them
– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease in man or other animals
– intended to affect the structure or any function of the body of man or other animals
– And does not achieve its primary intended purposes through chemical action within or on the
body of man or other animals and which is not dependent upon being metabolized for the
achievement of its primary intended purposes.
Rules and Regulations

FDA develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act
(FD&C Act) or other laws – including the Family Smoking Prevention and Tobacco Control Act
– under which FDA operates. FDA regulations have the full force of law.

FDA's traditional "safe and effective" standard for evaluating medical products does not apply to
tobacco products. FDA evaluates new tobacco products based on a public health standard that
considers the risks and benefits of the tobacco product to the population as a whole, including
users and nonusers. Similarly, when developing certain regulations, the law requires FDA to
apply a public health approach that considers the effect of the regulatory action on the population
as whole, not just on individual users, with respect to initiation and cessation of tobacco use.

FDA regulations are based on the laws set forth in the Tobacco Control Act and the Food, Drug,
and Cosmetic Act (FD&C Act). FDA regulations are also federal laws.
Rules and Regulations
Title Type Date

Premarket Tobacco Applications and Recordkeeping Final Rule 10/05/21

Requirements

Content and Format of Substantial Equivalence Reports; Final Rule 10/05/21

Food and Drug Administration Actions on Substantial
Equivalence Reports

Required Warnings for Cigarette Packages and Final Rule 03/18/20

Advertisements

Tobacco Products; Required Warnings for Cigarette Proposed Rule 08/15/19

Packages and Advertisements

Regulation of Premium Cigars Advance Notice of 03/26/18

Proposed Rulemaking
(ANPRM)

Regulation of Flavors in Tobacco Products Advance Notice of 03/21/18

Proposed Rulemaking
(ANPRM)

Tobacco Product Standard for Nicotine Level of Combusted Advance Notice of 03/16/18
Cigarettes Proposed Rulemaking
(ANPRM)

Tobacco Product Standard for N-nitrosonornicotine Level Proposed Rule 01/23/17

in Finished Smokeless Tobacco Products

Clarification of When Products Made or Derived From Final Rule 01/09/17

Tobacco Are Regulated as Drugs, Devices, or Combination
Products; Amendments to Regulations Regarding "Intended
Uses"
Title Type Date

Refuse to Accept Procedures for Premarket Tobacco Final Rule 12/29/16

Product Submissions

Deeming Tobacco Products To Be Subject to the Federal Final Rule 05/05/16

Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act

Requirements for the Submission of Data Needed to Final Rule 05/05/16

Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe Tobacco

National Environmental Policy Act; Environmental Final Rule 09/24/15

Assessments for Tobacco Products; Categorical Exclusions

Nicotine Exposure Warnings and Child-Resistant Advance Notice of 07/01/15

Packaging for Liquid Nicotine, Nicotine-Containing E- Proposed Rulemaking
Liquid(s), and Other Tobacco Products (ANPRM)

Tobacco Products, User Fees, Requirements for the Final Rule 07/10/14
Submission of Data Needed to Calculate User Fees for
Domestic Manufacturers and Importers of Tobacco
Products

Menthol in Cigarettes, Tobacco Products Advance Notice of 07/24/13

Proposed Rulemaking
(ANPRM)

Harmful and Potentially Harmful Constituents in Tobacco Established List 04/03/12

Products and Tobacco Smoke

Regulations Restricting the Sale and Distribution of Proposed Rule 11/10/11

Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents (Amends Brand Name Provision (1140.16(a))
Title Type Date

Non-Face-to-Face Sale and Distribution of Tobacco Advance Notice of 09/09/11

Products and Advertising, Promotion, and Marketing of Proposed Rulemaking
Tobacco Products (ANPRM)

Exemptions From Substantial Equivalence Requirements Final Rule 07/05/11

Required Warnings for Cigarette Packages and Final Rule 06/22/11

Advertisements

Amendments to General Regulations of the Food and Drug Final Rule 11/30/10
Administration

Promotion and Advertising Restrictions Enforcement Action 10/01/10

Plan

Request for Comment on Implementation of the Family Advance Notice of 03/19/10

Smoking Prevention and Tobacco Control Act Proposed Rulemaking
(ANPRM)

Regulations Restricting the Sale and Distribution of Final Rule 03/18/10

Cigarettes and Smokeless Tobacco