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© Copyright 2008. Burdock Group. All rights reserved. Do not copy or reproduce without written permission from Burdock Group.
REGULATORY AND SCIENTIFICROADMAP FOR CLAIMS
By: George A. Burdock, Ph.D., Amy C. Mozingo, MS and John W. Rochowicz, BS
Consultants
 
REGULATORY AND SCIENTIFICROADMAP FOR CLAIMS
By: George A. Burdock, Ph.D., Amy C. Mozingo, MS and John W. Rochowicz, BS
ABSTRACT
Establishing a claim for foods, food ingredients or dietary supplements is the second step, following
the rst step of negotiating a maze of regulatory requirements, including a determination of which
regulatory agency has jurisdiction. Consideration must also be given as to whether the substance employs
nanotechnology and; if it is itself, or is a product of, a genetically modied or a cloned organism,
as well as other aspects. However, regardless of the regulatory agency, eventual claim or whether 
nanotechnology has been employed, safety must rst be demonstrated to the satisfaction of a generallyrecognized as safe (GRAS) Expert Panel or to FDA by means of a food additive petition or; in a NewDietary Ingredient Notication (NDIN). At this point, the substance becomes eligible for a claim,including a Health Claim, Qualied Health Claim, Nutrient Claim or Structure/Function Claim (SFC) for foods and/or dietary supplements. For the latter claim (SFC), FDA pre-market approval is not required.If the safety determination has been made by FDA as the result of a NDIN, the substance is only eligiblefor inclusion into a dietary supplement and not food and is restricted to a SFC only, but the claim does notrequire pre-market approval. The ow-chart type of graphic illustrating the decision-tree type nature of 
this process will make the decision process easier for the novice.
Consultants
2
•
INSIDER • Burdock Group eBook
naturalproductsinsider.com
 
Meat & Dairy (FSIS)Vegetable(APHIS)Fish or MinorSpecies(FDA)New PlantVarietiesGuidelinesGRAS orFood Additiveor Safety Review Health ClaimQualified HealthClaimStructure FunctionClaimYesYesYesNoYesNoCandidateSubstanceNoNoYesYes
DIETARYSUPPLEMENT
NDIN & Safety Required(Nanotechnology used?)
FOOD
Previous GRASorFAP?
New ornovel Food?
 
Whole food (Yes) or(No) food ingredient(e.g., oil, flour)Whole food: Meat, Dairy,Vegetable, Fish orMinor Species?GMO?To be addedto food?Marketed asa
DS Prior to10/15/94?
NanotechProduct?Yes
123456
No
7
NoYesNo
89
NutrientClaim
10111213
 Due to size and space limitations, this illustration (including graphic and accompanying explanation) includes generalizations and simplications and, may not be applicable
in some circumstances; further, much of the regulatory guidance in this area is unclear, untested and may change - therefore, no express or implied warranty is offered - this
 poster is for illustrative purposes only. Please contact Burdock Group consultants for a solution tailored to your specic needs.
© Copyright 2008. Burdock Group. All rights reserved. Do not copy or reproduce without written permission from Burdock Group.
REGULATORY AND SCIENTIFIC ROADMAP FOR CLAIMS
By: George A. Burdock, Ph.D., Amy C. Mozingo, MS and John W. Rochowicz, BS
Consultants
INSIDER • Burdock Group eBook•
 
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