Agave Syrup and FDA GRAS status
IOAA Mexican agave syrup processor members have been and continue to evaluate the FDA GRAS.
At this time it is the view of IOAA processors that agave syrup should be exempt from premarket approval requirements of the FDA and considered GRAS.
Basis and references below:
All IOAA member processors are USA FDA certified / approved for making agave syrup for shipment into the United Sates for human consumption which, by definition, must be ‘generally recognized as safe’.
Agave syrup is obtained from 100% Agave by the thermal hydrolysis of inulin, a natural occurring polysaccharide (already with GRAS status), into simple natural sugars (Fructose 80 %, Glucose, 15 %, Sucrose 4 %). The Agave Syrup’s primary use is as a sweetener or for other food functionalities as part of formulation. There are no reports of adverse effect on human health when consumed in moderation.
Following is from the FDA website Industry Frequently Asked Questions About GRAS
1. What are the criteria for GRAS status?
Under sections 201(s) and 409 of the Act, and FDA’s implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
o 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of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
o Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common
use in foods requires a substantial history of consumption for food use by a significant number of consumers.
2. Can the use of a substance be GRAS even if it is not listed by FDA?
Yes. Because the use of a GRAS substance is not subject to premarket review and approval by FDA, it is impracticable to list all substances that are used in food on the basis of the GRAS provision (21 CFR 182.1). The use of a substance is GRAS because of widespread knowledge among the community of qualified experts, not because of a listing or other administrative activity.
Further evaluation of Agave Syrup and GRAS are included in IOAA White Paper, to be published Aug 2011.
Links:
FDA Food Guidance Compliance Regulatory Information
FDA Food Guidance Compliance Regulatory Food Ingredients and Packaging
FDA Food Guidance Compliance Regulatory Food: Gras Notice Inventory