FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

Working With Unusual or New Ingredients

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What You Need to Know

  • The FDA compiles a list of ingredients that are current approved for use in food. This is known as Generally Recognized As Safe (GRAS) and you can access the database here.

  • Not all ingredients have been classified as either allowable or prohibited. Sometimes, this is because the FDA hasn’t gathered enough information yet to make a determination

How to Assess Whether an Ingredient is Legal to Use in Your Product

Look it up and see if it is explicitly Banned as a Food INgredient

The FDA Substances Added to Food is a comprehensive list of ingredients which are both allowed and banned from foods. Illegal ingredients will be listed as “prohibited”

Search for FDA Guidance Documents on the Substance

Many new, trendy ingredients will not appear in the official FDA regulation or their databases. However, the FDA is quick to release guidance documents explaining their stance on a given topic — even if t hasn’t been coded into the regulation yet.

For example, while there is no mention of Cannabidiol (CBD) in the FDA Regulations, the commissioner released a report outlining the agency’s stance on the substance as a food ingredient (spoiler — it’s not allowed in food or cosmetics)

Generally Recognized As Safe (GRAS)

The GRAS list outlines ingredients which may be used in food.

Some general requirements when dealing with unusual ingredients are:

  • the substance must be food grade

  • If the FDA outlines specific limitations or conditions for use of that substance, it must be obeyed.

  • The substance must be included as an ingredient according to standard ingredient labeling requirements.

GRAS regulations are outlined in 21 CFR Part 182 and Part 184

If an Ingredient is not on the GRAS List

A company which wishes to introduce an ingredient not on the GRAS list may file a GRAS notice with the FDA. There are two ways to demonstrate a food is “generally recognized as safe”

1) By either proving that the ingredient has been in common use since 1958. If the ingredient is of biological origins and doesn’t have any known food safety issues, it will likely be accepted. or,

2) By providing scientifically valid information about that ingredient showing its safety. The FDA will respond by either stating that the GRAS notice is sufficient or insufficient. If deemed insufficient, then that food ingredient may not be used in food until a stronger case is built and the FDA approves a submitted GRAS notice.

To access more information about filing a GRAS petition, see 21 CFR 170.3 Subpart B