FDA GRAS Inventory Database Interactive Visualizations

The line graph shows the running total of GRAS notices by year per substance category (the colors match the colors from the box plots above). Hover over the bars and lines to see details. Use the filters to see how the trends change.

Note: The filters will change both figures.

Click and drag to scroll around the map. Zoom in and out to focus on different regions. Hover over a dot to see the Notifier, the number of GRAS notices submitted, and a table of the substance categories.

Note: The total number of GRAS notices may not match the sum on substance categories reflected in the table as some notices span multiple substance categories.

Notifying companies are shown with the total number of GRAS notices submitted parsed into the FDA’s decision, as shown in the legend. Scroll down to see all the notifiers listed. Use the filters to explore and see the top notifiers for each specification. Hover over the bars to see details.

All substances are listed individually. Use the filters to focus on each intended use, substance category, and notifier region. Hover over the bars to view details.

Note: Many substances have been grouped together for ease of use.

Each GRAS notice is shown as a dot and displays the number of days from filing to FDA’s decision letter. Decision trends are split into substance categories. Hover over each dot to see all information, including the original intended use in long form from the filing. Hover over the box plot to see the five-number summary. Use the filters to see how the decision timeline changes.

The table shows the pending substances by each notifying company. Use filters to explore the substance categories, population, and intended use categories.

Use the filter at the top to explore exempt and non-exempt infant formula types. Hover over the cells and bars to view details.

Note: The filter will change all figures.

Methods:

Data were downloaded as a .csv from the GRAS Notices Inventory website. Individual GRAS Notices were not reviewed, the data visualized here are only intended to represent the raw data on the FDA website and Excel database.

Notifier address and location

The supplied notifier addresses were converted to latitude and longitude. For notices with multiple addresses, the address of the first notifier listed was used. Notifier names were left as-is. Thus for companies that merged or were acquired, the notifier name was left as the original name listed with the notice.

Substances

For simplicity, similar spellings/phrasing of similar substances were grouped. For example, “fructooligosaccharide” and “oligofructose” were grouped with “fructooligosaccharide”. The original name used is listed in the pop-up tables for some visualizations.

Substance Categories

Substance categories were loosely grouped according to their structure or major nutrient composition. Substances could be classified into multiple categories. For example, GRN 134 lists a “soy protein hydrolysate with enzyme-modified lecithin”, which we grouped under both the “lipid” and “protein” categories.

The following categories were used: Carbohydrate, Protein, Lipid, Microorganism, Enzyme, Plant extract, Minerals and salts, Other.

Many substances do not perfectly fit a single category and were grouped with the most similar possible. For example, gamma-Amino butyric acid (GABA) is categorized within the “Protein” category given its amino group and synthesis from the amino acid glutamate.

Intended Use

We used the below categories as a guide, but not a strict rule, to classify the intended use of a substance. Notably, some substances could be listed with multiple intended uses. Furthermore, some notifiers may have described a specific use for the same substance that another notifier listed with a different intended use. Thus, the same substance may not have the same intended use(s) for each Notice.

The following categories were used: Technical agents, Preservatives, Food hygiene/processing/production,  Flavorant/Colorant/Aroma, Nutritional Additive, and Infant Formula. Substances intended for use in infant formula were categorized under “Infant Formula” if this was explicitly stated or the formula was intended to be consumed by infants ≤ 12 months of age. Formulas for those > 12 months of age (e.g., toddler milks, follow-on formulas) were not classified in the “infant formula” category. Definitions of physical and technical effects were adopted from 21 CFR § 170.3 paragraph (o) and are listed below.

Technical Agents

(1) Anticaking agents and free-flow agents (5) Curing and pickling agents, (6) Dough strengtheners, (7) Drying agents, (8) Emulsifiers and emulsifier salts, (10) Firming agents, (13) Flour treating agents, (14) Formulation aids, (15) Fumigants, (16) Humectants, (17) Leavening agents, (18) Lubricants and release agents, (22) Oxidizing and reducing agents, (23) pH control agents, (25) Propellants, aerating agents, and gases, (26) Sequestrants, (28) Stabilizers and thickeners, (29) Surface-active agents, (30) Surface-finishing agents, (31) Synergists, (32) Texturizers

Preservatives

(2) Antimicrobial agents (the primary use contributing to this category), (3) Antioxidants, (29) Surface-active agents, (30) Surface-finishing agents

Food hygiene/processing/production

(9) Enzymes (the primary use contributing to this category), (18) Lubricants and release agents, (22) Oxidizing and reducing agents, (23) pH control agents, (24) Processing aids, (25) Propellants, aerating agents, and gases, (27) Solvents and vehicles, (29) Surface-active agents, (30) Surface-finishing agents, (31) Synergists, (32) Texturizers

Flavorant/Colorant/Aroma

(4) Colors and coloring adjuncts, (11) Flavor enhancers, (12) Flavoring agents and adjuvants, (19) Non-nutritive sweeteners, (21) Nutritive sweeteners

Nutritional Additive

(3) Antioxidants, (20) Nutrient supplements, and substances listed for general, direct, secondary direct, or nutritional use in foods.

Infant formula type:

Formula were listed as exempt or non-exempt, according to the language used by the notifier listed on the FDA database. If a formula was not explicitly labeled with its exempt status, it was assumed to be non-exempt.

Intended Use Population:

According to the intended use, Notices were classified as being intended for infants (including infant formula or baby foods), children or toddlers (≥ 12 months of age), or the general population. Notices could include up to all three labels.

Infant population:

For infant formulas, Notices were labeled as being intended for term or pre-term formulas. Notices were only labeled with “preterm” if this was explicitly stated in the intended use. Otherwise, formulas were assumed to be intended for term infants.

Days of filing:

The difference between the date of filing and the date of closure were used to calculate the # days it took to receive an FDA decision.