Submitting a Citizen Petition to the FDA

The FDA is one of the most common government agencies that receive petitions from citizens because it is one that often has an impact on the lives of US residents. However, before you start making a citizen petition, you do have to be aware of the regulation surrounding doing so to the Food and Drug Administration.

These regulations are put in place with the help of the public, most often through the petition process. Everyone has the right to comment on this process through making written statements on the proposed rules and through petitions.

Whenever the FDA has a proposal for a new regulation, it publicizes its intentions so that the public is made aware of changes. While you are able to make comments on this procedure online, it is important to know that the FDA does not accept an online citizen petition.

These petitions can be used to try to persuade the agency to change one or more of its regulations or to take some other action with regard to food and the medications available in pharmacies. On average, the FDA receives about 200 petitions annually.

When submitting a citizen petition to the FDA there are several things that must be included. These are:

• A description of the action you want addressed, such as a ruling or an order you want to have put in place, rewritten to include changes or revoked.

• The legal grounds on which you are making a petition and the facts to back up your claims. You do need to include all the supporting information that you can come up with.

• If your petition is one for which you are requesting approval of drugs, food additives, medical devices or for a food to be categorized as safe for consumption, you will have to provide information regarding the environmental impact of such a request.

• All petition letters must include the name, address and telephone number of the person initiating the petition.

Since the FDA does not accept any citizen petition that is emailed to them, you must mail the petition to the address provided by the agency. Once it is received, the staff of the agency will evaluate the petition - a process that could take anywhere from a few weeks to a year. The evaluation period depends on the complexity of the issues addressed in the petition.

Once it has been deemed worthy by the staff, it then has to go to the management, who will make the final decision as to whether or not your petition will gain results in having the changes you suggest put in place. Whether the decision is favorable or unfavorable to you, you will receive notification from the FDA.

The petition signatures you collect for a citizen petition to the FDA have to be collected in person and should include the signer's name and address, written legibly. Persons under the age of 18 are not permitted to sign petitions, which means when a young person asks to sign your petition you should ask for identification attesting to the fact that this person is over this age.

The petition must contain the exact wording of the regulation that you want to address. If you request a specific action, you must include suggestions for changes and realistic ways in which these changes can be brought about.

Sarah Martin is a freelance marketing writer from San Diego, CA. She specializes in leadership, motivation, and how to properly file a citizen petition. To learn more about gathering petition signatures or to browse online petitions, please visit http://www.thepetitionsite.com/.

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