New FDA Interim Final Rule
In an effort to better ensure the safety of the American food supply, President Obama passed the Food Safety Modernization Act (FSMA). FSMA increases the powers and activities of the Food and Drug Administration (FDA) with the goal of preventing food safety problems. FSMA also grants the FDA more enforcement authority to increase rates of FDA compliance.
FSMA section 101 amends the Bioterrorism Act and increases FDA access to company records. On February 23, the Food and Drug Administration (FDA) released an Interim Final Rule and draft guidance in the Code of Federal Regulations. This is in response to FSMA. FSMA expands FDA’s access to records to include records relating to any article of food that the Secretary of Health and Human Services “reasonably believes is likely to be affected” by suspect foods. FSMA also works to expand FDA access to records so as to help prevent adverse health consequences or death to humans or animals (source). These decisions are to be made on a case by case basis.
The new Interim Final Rule will directly affect food and beverage manufacturers. It allows the FDA to ask for any company record without being required to attain an injunction. The Interim Final Rule mandates that records and other information be given to the FDA as soon as possible and no later than 24 hours from the receipt of the request. FDA hopes the Interim Final Rule will increase the safety of the food supply.
The Interim Final Rule will be effective March 1, 2012. Since this is not a final ruling, the FDA will not take comments before it is in effect. FDA will accept comments from shareholders up through March 23, 2012 and take them into account when considering any revisions to the Interim Final Rule. FDA believes that the Interim Final Rule is necessary to ensure potentially harmful food will not reach consumers and to improve the safety of the food supply in the U.S.
For information about commenting on the Interim Final Rule or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.