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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 3.3 - STATE OPERATIONAL AUTHORITY

3.3 - STATE OPERATIONAL AUTHORITY
3.3.1 - STATE OPERATIONAL AUTHORITY
      3.3.1.1 - FDA Personnel with State Authority
      3.3.1.2 - Joint Inspections
      3.3.1.3 - FDA Commissioned State Personnel
3.3.2 - STATE MEMORANDA OF UNDERSTANDING
3.3.3 - STATE AUTHORITIES AND PHONE CONTACT NUMBERSHighlighted to denote updated text
      3.3.3.1 - Alabama (AL)
      3.3.3.2 - Alaska (AK)
      3.3.3.3 - Arizona (AZ)
      3.3.3.4 - Arkansas (AR)
      3.3.3.5 - California (CA)
      3.3.3.6 - Colorado (CO)
      3.3.3.7 - Connecticut (CT)
      3.3.3.8 - Delaware (DE)
      3.3.3.9 - Florida (FL)
      3.3.3.10 - Georgia (GA)
      3.3.3.11 - Hawaii (HI)
      3.3.3.12 - Idaho (ID)
      3.3.3.13 - Illinois (IL)
      3.3.3.14 - Indiana (IN)
      3.3.3.15 - Iowa (IA)
      3.3.3.16 - Kansas (KS)
      3.3.3.17 - Kentucky (KY)
      3.3.3.18 - Louisiana (LA)
      3.3.3.19 - Maine (ME)
      3.3.3.20 - Maryland (MD)
      3.3.3.21 - Massachusetts (MA)
      3.3.3.22 - Michigan (MI)
      3.3.3.23 - Minnesota (MN)
      3.3.3.24 - Mississippi (MS)
      3.3.3.25 - Missouri (MO)
      3.3.3.26 - Montana (MT)
      3.3.3.27 - Nebraska (NE)
      3.3.3.28 - Nevada (NV)
      3.3.3.29 - New Hampshire (NH)
      3.3.3.30 - New Jersey (NJ)
      3.3.3.31 - New Mexico (NM)
      3.3.3.32 - New York (NY)
      3.3.3.33 - North Carolina (NC)
      3.3.3.34 - North Dakota (ND)
      3.3.3.35 - Ohio (OH)
      3.3.3.36 - Oklahoma (OK)
      3.3.3.37 - Oregon (OR)
      3.3.3.38 - Pennsylvania (PA)
      3.3.3.39 - Rhode Island (RI)
      3.3.3.40 - South Carolina (SC)
      3.3.3.41 - South Dakota (SD)
      3.3.3.42 - Tennessee (TN)
      3.3.3.43 - Texas (TX)
      3.3.3.44 - Utah (UT)
      3.3.3.45 - Vermont (VT)
      3.3.3.46 - Virginia (VA)
      3.3.3.47 - Washington (WA)
      3.3.3.48 - West Virginia (WV)
      3.3.3.49 - Wisconsin (WI)
      3.3.3.50 - Wyoming

 3.3 - STATE OPERATIONAL AUTHORITY

3.3.1 - STATE OPERATIONAL AUTHORITY

Establishment Inspections - All state and local officials have some type of jurisdiction over the food and drug establishments located within their state or local boundaries, regardless of the interstate movement or origin of the products involved. Some states divide the responsibility for food, drugs, etc., among the various agencies within the state. See IOM 3.3.31.

Samples - All state laws provide authority to collect samples of food, drug, and other products within the state.

Embargoes - FDA does not have embargo authority. Some states have embargo and detention authorities, these authorities are specific within each state. FDA does have administrative detention authority for medical devices and food. Administrative detention for medical devices and food can be used when the Agency has reason to believe that the article is adulterated, misbranded, or presents a threat of serious adverse health consequences to humans or animals. See FD&C Act section 304(g) and (h), Highlighted to denote updated text IOM 3.2.1.3, 2.2.10, and Highlighted to denote updated text 2.7.1 for administrative detention information.Highlighted to denote updated text

Some state laws empower their inspectors to place an immediate embargo on products that are, or are suspected of being, adulterated or misbranded or otherwise in violation of their laws. As a cooperative measure most state agencies will have their inspectors place an embargo at the request of an FDA representative. Do not routinely request such embargo. District assignments may include instructions relative to cooperative embargoes.

In all instances, exercise care in requesting embargoes.In accordance with Field Management Directive 50 (FMD 50), the appropriate state agency should be notified of pending or recommended compliance/enforcement actions within five working days. When a state institutes an embargo at FDA’s request, the District must assure that cooperating officials are kept informed of the status of the resulting administrative or legal action. The District must promptly notify state officials when the resulting action is final so that the state can update records and issue required releases for the lot. This helps prevent inordinately long holding times by the state.

Embargoes should not be considered as a mere convenience to the Food and Drug Administration but as an important and effective cooperative measure to be applied only when circumstances indicate such action.

Disaster Operations - Following major disasters, FDA regional directors and district directors will arrange for close cooperation with local and state food and drug officials, Health Departments, the Public Health Service and other agencies engaged in comparable work. When requested to do so, FDA district personnel will assist local and state officials during such emergencies. At such times FDA personnel may be temporarily commissioned by local or state authorities and provided the authority to place embargoes (See IOM 8.5.5.1).

 3.3.1.1 - FDA Personnel with State Authority

Certain states have designated selected FDA employees as special representatives or agents of the particular state agency. In these cases, they have furnished the FDA individuals with official state credentials. The FDA representatives given this authority will receive instructions and training, by their district, in the proper exercise of the powers conferred on them and must operate within the guidelines established by their district to monitor this authority. This is particularly important whenever state embargo powers may be used.

 3.3.1.2 - Joint Inspections

Joint inspections with state or local inspectors are arranged by the district supervisory personnel. Joint inspections are conducted in the same manner as inspections by FDA alone and findings are discussed with the accompanying inspector. The cooperating inspector may wish to take action against the merchandise or the firm under pertinent local or state laws.

 3.3.1.3 - FDA Commissioned State Personnel

Qualified state regulatory officials may be commissioned under section 702(a)(1)(A) of the FD&C Act to conduct examinations and investigations, which can include conducting inspections, collecting samples, copying and verifying records and carrying out an administrative detention order (following approval by the FDA District Director) under the FD&C Act.

 3.3.2 - STATE MEMORANDA OF UNDERSTANDING

The FDA has entered into agreements with various state and local agencies covering a variety of issues and work sharing agreements. At the present time not all the states have entered into agreements with FDA. Complete text of the MOUs is in Federal Cooperative Agreements Manual. A listing of current MOUs for states, the District of Columbia, and the Commonwealth of Puerto Rico are on OE's intranet site.

 3.3.3 - STATE AUTHORITIES AND PHONE CONTACT NUMBERS

This section contains information regarding various state enforcement authorities. Some states operate under state laws patterned after the FD&C Act of 1906 or the current FD&C Act. However, most of the states operate under a "Uniform FD&C Act" which was developed by the Association of Food and Drug Officials (AFDO).

States that have adopted the Uniform FD&C Act as their legal guideline have in most cases adopted the entire act. The food authority in most cases includes among other things the adoption of the food and color additive provisions, pesticide residue amendments, enrichment guidance, etc. The Uniform FD&C Act also includes a provision for automatic adoption of changes in the FD&C Act. Some state legislatures have also included this provision in their laws. Some other provisions of the Uniform Act adopted by state include the new drug provisions, medical device laws, and cosmetic requirements.

Some states have also adopted the Association of American Feed Control Officials (AAFCO) model bill as their legal guideline for feed inspections.

In most cases the contact for "Consumer Protection Issues" would be located in the Office of the State Attorney General and would usually cover consumer fraud and other consumer protection issues. The State Attorney General's staff usually has mechanisms to deal with health fraud issues not efficiently dealt with by traditional FDA approaches. Contact your District Health Fraud Monitor for guidance in cooperative efforts with the State Attorney General's staff.

A complete listing of the personnel and programs at the state and local level may be found in the FDA Internet Directory of State and Local Officials which was prepared by the Office of PartnershipsHighlighted to denote updated text (HFC-150) at http://www.fda.gov/ora/fed_state/default.htm or http://www.afdo.org/.

 3.3.3.1 - Alabama (AL)

Alabama has adopted the FD&C Act of 1906 and the 1970 AAFCO as their legal guideline. The control agencies are Agriculture and Health. They have not adopted the new drug provisions, the medical device law, nor the automatic adoption provisions.

 3.3.3.2 - Alaska (AK)

Alaska has adopted the Uniform FD&C Act without the automatic adoption provision and have not adopted either AAFCO feed bill. The controlling agencies are Health, Social Services, and Environmental Conservation. Alaska has adopted the various provisions of the Uniform bill.

 3.3.3.3 - Arizona (AZ)

Arizona operates under the Uniform FD&C Act and the 1970 AAFCO Feed Bill. The controlling agencies are Health, Pharmacy and the State Chemist. They have not adopted the medical device law, cosmetics law, nor the automatic adoption provisions of the Uniform FD&C Act.

 3.3.3.4 - Arkansas (AR)

Arkansas operates under the Uniform FD&C Act and the 1970 AAFCO Feed Bill. The agencies in control are Health and the Plant Board. They have not adopted the new drug provisions or the automatic adoption provision.

 3.3.3.5 - California (CA)

California has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.6 - Colorado (CO)

Colorado has adopted the Uniform FD&C Act and the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted either version of the AAFCO Feed Bill.

 3.3.3.7 - Connecticut (CT)

Connecticut has adopted the FD&C Act, the Uniform FD&C Act and the 1958 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Consumer Protection.

 3.3.3.8 - Delaware (DE)

Delaware has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Health, and Pharmacy. They have not adopted the food and color additive amendments, the pesticide residue amendment, enrichment amendment, new drug provisions, medical device law, and the cosmetics law.

 3.3.3.9 - Florida (FL)

Florida has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.10 - Georgia (GA)

Georgia has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy. They have not adopted the food additive, color additive or pesticide residue amendments.

 3.3.3.11 - Hawaii (HI)

Hawaii has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Health and the Attorney General.

 3.3.3.12 - Idaho (ID)

Idaho has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill and has not adopted the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Health and Pharmacy. They have not adopted the food additive, color additive or pesticide residue amendments of the Act.

 3.3.3.13 - Illinois (IL)

Illinois has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the enrichment provisions of the Act.

 3.3.3.14 - Indiana (IN)

Indiana has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Health and the State Chemist.

 3.3.3.15 - Iowa (IA)

Iowa has adopted the 1906 FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the FD&C Act. The controlling agencies are Agriculture, Health and Appeals, and Pharmacy.

 3.3.3.16 - Kansas (KS)

Kansas has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill and has not adopted the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.17 - Kentucky (KY)

Kentucky has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Human Resources, Pharmacy, and the University of Kentucky Registration Services.

 3.3.3.18 - Louisiana (LA)

Louisiana has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the provisions of the medical device law.

 3.3.3.19 - Maine (ME)

Maine has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy. They have not adopted the food and color additive amendments nor the new drug provisions or the medical device law.

 3.3.3.20 - Maryland (MD)

Maryland has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the enrichment provisions of the Act.

 3.3.3.21 - Massachusetts (MA)

Massachusetts has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the new drug provisions of the Act.

 3.3.3.22 - Michigan (MI)

Michigan has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Commerce, Licensing and Registration. They have not adopted the enrichment provisions or the cosmetics law.

 3.3.3.23 - Minnesota (MN)

Minnesota has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy. They have not adopted the enrichment provisions, the new drug provisions, the medical device law, nor the cosmetic law.

 3.3.3.24 - Mississippi (MS)

Mississippi has adopted the 1906 FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Commerce and the State Chemistry Lab. They have not adopted the food additive, color additive, and pesticide residue amendments, nor the new drug provisions or cosmetic law.

 3.3.3.25 - Missouri (MO)

Missouri has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the enrichment provisions of the Act.

 3.3.3.26 - Montana (MT)

Montana has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.27 - Nebraska (NE)

Nebraska has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the new drug provisions nor the medical device and cosmetic laws.

 3.3.3.28 - Nevada (NV)

Nevada has adopted the Uniform FD&C Act but not the automatic adoption provisions of the Uniform FD&C Act. They have not adopted either version of the AAFCO Feed Bill. The controlling agencies are Agriculture and Health. They have not adopted the enrichment provisions of the Act.

 3.3.3.29 - New Hampshire (NH)

New Hampshire has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.30 - New Jersey (NJ)

New Jersey has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the pesticide residue amendment.

 3.3.3.31 - New Mexico (NM)

New Mexico has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Environment, Health and Pharmacy. They have not adopted the food additive or color additive amendments.

 3.3.3.32 - New York (NY)

New York has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Markets, Health, and Pharmacy. They have not adopted the cosmetics law.

 3.3.3.33 - North Carolina (NC)

North Carolina has adopted the Uniform FD&C Act and both versions of the AAFCO Feed Bills along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agency is Agriculture. They have not adopted the enrichment provisions of the Act.

 3.3.3.34 - North Dakota (ND)

North Dakota has adopted the Uniform FD&C Act and neither version of the AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Consolidated Laboratories, Health and Pharmacy.

 3.3.3.35 - Ohio (OH)

Ohio has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy.

 3.3.3.36 - Oklahoma (OK)

Oklahoma has adopted the Uniform FD&C Act but neither version of the AAFCO Feed Bills nor the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the food additive or color additive amendments, the enrichment provisions nor the new drug provisions.

 3.3.3.37 - Oregon (OR)

Oregon has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy. They have not adopted the cosmetics law.

 3.3.3.38 - Pennsylvania (PA)

Pennsylvania has adopted the 1906 FD&C Act and the 1958 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the food additive, color additive, and pesticide residue amendments nor the enrichment provisions.

 3.3.3.39 - Rhode Island (RI)

Rhode Island has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Environmental Management and Health.

 3.3.3.40 - South Carolina (SC)

South Carolina has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health.

 3.3.3.41 - South Dakota (SD)

South Dakota has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Commerce and Regulations. They have not adopted the new drug provisions, medical device law, nor the cosmetics law.

 3.3.3.42 - Tennessee (TN)

Tennessee has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agency is Agriculture.

 3.3.3.43 - Texas (TX)

Texas has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Health and the State Chemist.

 3.3.3.44 - Utah (UT)

Utah has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the new drug provisions.

 3.3.3.45 - Vermont (VT)

Vermont has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Health. They have not adopted the enrichment provisions.

 3.3.3.46 - Virginia (VA)

Virginia has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy.

 3.3.3.47 - Washington (WA)

Washington has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy.

 3.3.3.48 - West Virginia (WV)

West Virginia has adopted the 1906 FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture, Health and Pharmacy. They have not adopted the food additives or color additive amendments, the new drug provisions, the medical device law and the cosmetics law.

 3.3.3.49 - Wisconsin (WI)

Wisconsin has adopted the Uniform FD&C Act and the 1958 AAFCO Feed Bill along with the automatic adoption provisions of the Uniform FD&C Act. The controlling agencies are Agriculture and Pharmacy. They have not adopted the enrichment provisions, the new drug provisions, the medical device law, and the cosmetics law.

 3.3.3.50 - Wyoming

Wyoming has adopted the Uniform FD&C Act and the 1970 AAFCO Feed Bill but not the automatic adoption provisions of the Uniform FD&C Act. The controlling agency is Agriculture.