FDA Regulations: Making Your Voice Heard

The FDA regulates the production and marketing of foods, drugs, medical devices, and other health products. One facet of their regulatory efforts is writing and issuing regulations in accordance with the Administrative Procedures Act.

When the FDA plans to issue a new regulation or revise an existing one, an announcement is placed in the Federal Register, and is also posted on www.fda.gov/ohrms/dockets/. The "notice of proposed rulemaking" describes the planned regulation and provides background information on the issue.

The FDA encourages public comment on their proposed rules because the public has a vested interest in the products it regulates, and because the public provides critical insight into the effects of their regulations on the public. The FDA carefully considers the public’s comments and recommendations. Their decisions are not based on the number of comments submitted, nor do they use a "majority rules" ideology. Any comments based on sound grounds are considered during FDA’s decision-making.

How do I submit a comment?
There is no special form to fill out or special format to follow for submitting comments. Comments may be mailed to the address given in the announcement, or emailed to fdadockets@oc.fda.gov. However, the easiest method for submitting comments is to go to their "Documents Open for Comment" page at www.fda.gov/dockets/ecomments. By submitting online, you are sure to include all the necessary information the FDA requires for accepting your comments.

How much time do I have to submit a comment?
Once a proposed regulation is announced, the "comment period" begins. Comments from the public are typically accepted for at least 60 days, though some comment periods are as short as 10 days or as long as 9 months. An extension of the comment period may be requested in writing by anyone if they do not think there is sufficient time to study the proposal and comment on it. If the extension is granted, a notice of the extension is published in the Federal Register.

What does the FDA do with my comment?
The FDA numbers and logs all the comments it receives. After the FDA reviews and carefully considers all comments on a proposed rule, they will usually publish the final rule, unless a decision is made that the proposal should not be finalized. The final rules are published in the Federal Register, issued Monday through Friday. Any pending matters can be found at www.regulations.gov.

Make your voice heard. Have a say in how the government regulates our food, drugs, medical devices, and other health products. You can make a difference!