FDA Gras List

The FDA GRAS list covers several categories of food additives. When classified as GRAS it means  “generally recognized as safe.” You will read about these topics on this web page.

FDA GRAS

Generally recognized as safe (GRAS) is an FDA designation that a food additive is considered safe by experts. As such, it is exempt from the usual FDA food additive tolerance requirements.

The FDA grants those exemptions for substances that experts qualify by scientific training and experience to be safe. In the case of a substance used in food prior to January 1, 1958, exemption comes from either scientific procedures or experience based on common use in food that proves safe under the conditions of their intended use.

The proponent asking for the exemption has the burden of proving that the use of the substance is “generally recognized as safe.” To establish this recognition of safety, the proponent must show that there is a consensus of expert opinions regarding the safety. If there is a severe conflict among the experts regarding the safety of the substance, this precludes a finding of a general recognition.

When a substance does not qualify for a GRAS exemption, the use of that substance is subject to the premarket approval mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA). In such a case, the FDA can take action to stop the distribution of the food substance and foods containing it on the grounds that the foods contain an unlawful food additive.

The FDA GRAS label typically exists in one of three forms:

1.    Self-affirmed. The manufacturer of this chemical or substance performed all the necessary research, including the formation of an expert panel to review safety concerns, and prepared to use these findings to defend its product’s GRAS status.

2.    FDA-pending. The manufacturer performed all of the research and review and submitted the results to the FDA fro GRAS approval.

3.    No comment. The FDA reviewed a product’s GRAS claim and responded with ‘no comment”. There are no further challenges to the product’s GRAS status.

According to the FDA, as described under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive.

Recently, in September 2009, the FDA granted GRAS designation for baobab, dried fruit pulp.

The FDA reviewed detailed analyses of the nutritional and phytochemical components in baobab with no animal safety data.

FDA GRAS List

The current GRAS list appears as Parts 182, 184, and 186 of Title 21 of the Code of Federal Regulations (CFR). It totals hundreds of substances including those that are added to cotton fabrics or paper and paperboard used as food packaging materials.

The FDA list of food additives, that are generally recognized as safe found in part 182, is generally divided into eight categorie .

They are listed here.

1.    Anti-caking agents.

2.    Chemical preservatives.

3.    Emulsifying agents.

4.    Nutrients.

5.    Sequestrants.

6.    Stabilizers.

7.    Miscellaneous.

8.    Synthetic flavoring Substances.

GRAS Notice Inventory

At the following web site, there is a chronological list (1998 – 2010) of 352 substances “pending approval”, or “FDA has no questions”.

http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing&displayAll=true

The following link provides the inventory of GRAS notices filed within each year since 1998. You will find:

• The name of the substance
• The file number (GRN No.) that FDA has assigned to the notice
• A hyperlink to the letter that FDA sent in response to the notice.  The text of this link also indicates the date of the letter.

The file number for each GRAS notice also serves as a hyperlink to additional information corresponding to the proposed "GRAS exemption claim" (proposed 21 CFR 170.36(c)(1)), including the following information, which FDA proposed to make readily accessible to the public:

• The name of the person who made the GRAS determination (notifier)
• The notifier’s address
• The intended conditions of use of the substance
• The statutory basis for the GRAS determination

Additional information includes:

• The date when FDA filed the notice
• The date when the evaluation process came to closure
• When applicable, a hyperlink to additional correspondence that FDA has issued regarding the GRAS notice
• The petition number if the substance was originally the subject of a GRAS petition
• In some cases, a hyperlink to the notice itself

http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/default.htm

The information is updated monthly.

The FDA GRAS list is comprehensive and includes food additives and dietary supplements. The FDA GRAS information is public and available for review.

Written by: Margaret Stenerson

10 3 2010