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What is an FDA Warning Letter?

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  • Written By: Marlene Garcia
  • Edited By: Daniel Lindley
  • Last Modified Date: 11 November 2016
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The U.S. Food and Drug Administration (FDA) sends warning letters to tell manufacturers they are violating federal laws that regulate a wide range of products. An FDA warning letter allows manufacturers to correct violations of the Food, Drug and Cosmetics Act within set time limits before further action is taken. All FDA warning letters are published online to make consumers aware of any health or safety issues that might exist.

The FDA regulates the safety of food, drugs, cosmetics, and medical devices in all states and U.S. territories. It also monitors devices that emit radiation, and the marketing and promotion of tobacco products. Veterinary medicine and food additives fed to animals used for human consumption also fall under FDA authority.

An FDA warning letter might dispute product labels, including claims made in a company's marketing material. For example, labels on a dietary supplement may not claim it cures or treats diseases or disorders, because supplements are not defined as drugs. All new drugs need FDA approval to ensure they are safe and effective for use. To comply with the law, an FDA warning letter might be sent asking the manufacturer to remove misleading advertising from promotional material.

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Drug products go through several stages of testing before they are approved by the FDA. The standards apply to prescription and over-the-counter medicine, which must be tested on animals and humans for their effectiveness and safety. Food and drug laws also apply to products like sunscreen, dandruff shampoos, and toothpaste fortified with fluoride, along with more traditional medication. Labels on drugs must outline the recommended dose and side effects, and explain the approved use of the medicine.

After an FDA warning letter is received, the recipient submits a corrective plan that includes strategies to prevent further violations. Failure to outline an acceptable plan of action may result in enforcement action by federal agents. The FDA can seize products deemed unsafe if the manufacturer does not address issues raised in a warning letter.

Federal law requires sanitary food production and storage procedures to protect the public from contamination. These requirements include food storage temperatures, how food is handled, and how equipment is used in production. The FDA also audits food labels to ensure consumers know the exact ingredients in products they eat. Specific rules apply to food labeled as organic, for example. FDA warning letters in the food industry are typically sent after an inspector finds violations.

The government’s regulation of cosmetics is limited to color additives, with the exception of those used in hair dyes. Cosmetic safety is monitored by manufacturers, which are prohibited from using ingredients that are banned or restricted. The regulation of tobacco products is limited to marketing efforts aimed at children. It forbids flavor additives that appeal to minors.

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