• The FDA's Regulatory Procedures Manual explains the basis for the agency's actions.livres image by papydiesel from Fotolia.com
  
  What happens if a food is found to be unsafe? Or a company becomes known for distributing mislabeled supplements? The Food and Drug Administration (FDA) is the government agency responsible for regulating all food and drugs, as well as animal feed and drugs and cosmetic labeling. One trillion dollars worth of consumer goods are regulated by the FDA yearly, and several procedures are in place to make sure products meet current standards and laws.
  
  

Warning Letter

• Depending on the nature of the violation, a warning letter is issued to achieve voluntary compliance. The letter provides advance notice for the recipient to correct the situation before any enforcement action is taken. Warning letters are given for violations that have regulatory significance; however, it is not a prerequisite for taking more serious corrective steps. The FDA can take enforcement action without first issuing a warning letter when there is a history of repeated similar conduct, the violation is intentional or the violation presents a reasonable possibility of injury or death.
  
  

Citation

• Citations are issued when the FDA has evidence that a law has been violated and the violation can significantly affect consumer protection. Prior notice is typically given, except in cases of fraud, potential health hazards or severe violations. The FDA must thoroughly review the evidence, as well as review the accused firms' regulatory history and review inspection reports to build solid support for a court case.
  
  

Section 305 Meeting

• A meeting allows a person to present his or her views to an FDA compliance officer before criminal prosecution is recommended. Section 305 refers to the issued citation. The meeting is not a trial, but rather an opportunity for discussion about extenuating circumstances or corrective actions possible. The FDA will consider the facts presented that are relevant before deciding whether to recommend prosecution to the Department of Justice.
  
  

Administrative Detention of Food

• The Bioterrorism Act of 2002 includes a provision allowing the administrative detention of food. The article of food will be detained if it is found during an inspection, examination or investigation to present a threat of serious adverse health effect or death to humans or animals. Detention is supposed to protect the public by allowing the FDA to investigate and take further action, if appropriate, while the food is off the market. Food can be detained for no longer than 20 days.
  
  

License Revocation or Suspension

• Biologic licenses can be revoked or suspended under the Public Health Service Act. Licenses of specific biologic products can be revoked if there is a danger to health and one or more grounds for revocation is present. There also must be evidence of violations of relevant statutes and regulations.