Jun 24

FDA Publishes Overview of Regulatory Requirements for Food Businesses

On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA regulations. You can read the article here.

As the FDA explains, the Public Health Security and Bioterrorism Preparedness and Response Act amended the FDCA to require that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where food is manufactured, packed, or held for human or animal consumption to complete food facility registration with the FDA before beginning these activities. In addition to registration, the Bioterrorism Act requires that certain food businesses maintain and make records available to the FDA that indicate the source of the food or ingredients and the destination for the products. These recordkeeping requirements vary depending on the specific type of business.

Additional food facility registration requirements, found in Section 415 of the FDCA, were enacted by the Food Safety and Modernization Act (FSMA). The FSMA also establishes certain preventive controls to ensure food safety. For example, unless exempted, the owner, operator, or agent in charge of a facility will be required to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility as well as identify and implement controls to significantly minimize or prevent the occurrence of any hazards. Food facilities will also need to provide assurances that food is not adulterated under section 402 or misbranded under section 403(w) of the FDCA.

Additionally, the article describes the Current Good Manufacturing Practices (cGMP). The cGMP are published in 21 CFR 110. They primarily describe the methods, equipment, facilities, and controls for producing processed food under safe and sanitary conditions. Food manufacturers are also responsible for developing labels that are truthful and not misleading pursuant to the FDCA and other labeling regulations.

Another important regulation is the reporting requirement. Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. FDA allows conventional food companies to voluntarily forward reports of serious adverse events in connection with their products to FDA by submitting Form 3500. The agency requires reporting of serious adverse events involving dietary supplements.

In addition to the laws and regulations enforced by the FDA, food businesses are also subject to other federal, state, and local requirements. If you have any questions about complying with FDA regulations or how a FDA regulatory attorney may help you, please contact us at: contact@giannamore-law.com.

FDA Attorney

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