Food Regulation. Neal D. Fortin

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       FDA Modernization Act of 1997

      The FDA Modernization Act reformed many aspects of the regulation of food, medical products, and cosmetics. The most important food regulation aspect is that the act eliminated the requirement for FDA’s premarket approval for most packaging and other substances that come in contact with food and may migrate into it. The act also expanded the procedures under which FDA can authorize health claims and nutrient content claims on foods.

       Food Safety Modernization Act (FSMA) in 2011

      FSMA may be the most significant amendment of United States food law in history. The 1938 FD&C Act was broad in scope in amending the 1906 Pure Food and Drug Act. The 1958 Food Additive Amendment was detailed in its provisions. In comparison, the FSMA is both broader in scope than the 1938 Act and more detailed than the 1958 amendment.

      FSMA shifts the focus of the U.S. FDA from primarily reacting to food safety problems to prevention. FSMA empowers the FDA to order recalls, implement new standards on domestic producers, and to place restrictions on importers of food to make sure that imports meet these new standards.

      1.6.3 The Regulations

      Regulations are promulgated by federal agencies to implement and interpret the statutes that are passed by Congress. Regulations are codified in the C.F.R. Regulations typically have the same or similar title number as their corresponding enabling statute in the U.S.C. For example, the regulations which have been promulgated to interpret and implement Title 21 of the U.S.C. are, for the most part, located in Title 21 of the C.F.R.

      Regulations are first published in the Federal Register to order to comply with the requirement for notice and comment of the Administration Procedure Act. Titles 7, 9, and 21 contain most of the laws regulating foods. However, Titles 5, 15, 16, 19, 27, 42, and 49 contain other matters that may relate to food in a less direct manner.

Title 5	Governmental Organizations and Employees
Title 7	Agriculture
Title 9	Animal and Animal Products
Title 15	Commerce and Trade
Title 16	Conservation
Title 19	Customs
Title 21	Food and Drugs
Title 27	Alcohol, Tobacco Products, and Firearms
Title 42	Public Health and Welfare
Title 49	Transportation

1.7 INFORMATIONAL RESOURCES

      1.7.1 Government Agencies

      The government agencies provide a wealth of information on food regulations. Examples of gateway sites are as follows:

       The Food and Drug Administration welcome page: www.fda.gov

       Government food safety information: www.foodsafety.gov

       USDA FSIS website: www.fsis.usda.gov

      1.7.2 Associations and Trade Groups

      Trade and professional associations can provide important sources of information, particularly on law and policy issues. Some examples are:

       Association of Food and Drug Officials (AFDO): www.afdo.org

       Biotechnology Industry Organization (BIO): www.bio.org

       Institute of Food Technologists (IFT): www.ift.org

      1.7.3 Other Sources

      As you have learned, the local food laws and regulations can vary from state to state and even city to city. Therefore, you need develop skill at accessing this information. In particular, do not overlook your contacts and acquaintances. The Internet is a growing source of information, but some more traditional sources of information should not be forgotten:

       Colleagues

       Contacts and acquaintances

       Elected and nonelected officials

       Public interest groups

       Trade groups

       Public records

       State registers (similar to the Federal Register)

APPENDIX: CONSTITUTIONAL AMENDMENTS I THROUGH X (THE BILL OF RIGHTS)

       Amendment I

      Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

       Amendment II

      A well‐regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed.

       Amendment III

      No Soldier shall, in time of peace be quartered in any house, without the consent of the Owner, nor in time of war, but in a manner to be prescribed by law.

       Amendment IV

      The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.

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