FDA Approved vs. Registered with FDA
FDA approval is different than registering with the FDA.
Establishing your brand as food safety focused can be an effective way to develop trust among consumers amidst the overwhelming waves of food borne illness outbreaks and recalls reported in the news. It may be tempting for some companies, especially foreign entities importing product into the United States, to use marketing language that demonstrates that the facility is compliant with FDA regulations. One such phrase that is sometimes used is “FDA Approved”, but is this even allowed? And how does this differ from “Registered with the FDA”?
Any food manufacturing facility that offers food products for sale in interstate commerce must be registered with the FDA (with the exception of meat, poultry and egg products that are overseen by the USDA). This registration gives the FDA the authority to enter and inspect the facility, and this inspection authority also includes access to food safety documentation needed to assess regulatory compliance and respond to food borne illness outbreaks and recalls.
The FDA does not approve dietary supplements.
However, the FDA is quite clear that registration is not equivalent to FDA approval of a facility, and “FDA Approved” is not a phrase that should typically be used. In fact, only a few specific segments of the food industry require official FDA approval, and the details can be found at this helpful FDA resource for consumers. This FDA article notes the following summary points regarding categories that do receive FDA approval, while also noting some categories that don’t receive FDA approval despite the commonly held perception that they do:
The FDA approves food additives in food for people.
The FDA approves color additives used in FDA-regulated products.
The FDA does not approve medical foods.
The FDA does not approve infant formula.
The FDA does not approve dietary supplements.
The FDA does not approve the food label, including the Nutrition Facts label.
The FDA does not approve structure-function claims on dietary supplements and other foods.
The FDA does not approve facilities.
The FDA does not approve infant formula.
Improper use of the FDA logo or trademark may violate federal law, so it is best to leave the FDA out of your marketing materials and to avoid the phrase “FDA Approved” for most facilities. Despite the lack of official “FDA Approval” it is still critical that you register your facility with the FDA (if required) and seek to comply with all applicable elements of food safety regulations. This includes the development of a preventive controls food safety plan and supply chain program by a PCQI, where applicable, and compliance with Good Manufacturing Practices, food safety training requirements, and record keeping requirements that apply to all facilities.
