REGULATORY AND SCIENTIFIC

ROADMAP FOR CLAIMS

By: George A. Burdock, Ph.D., Amy C. Mozingo, MS and John W. Rochowicz, BS

Consultants

© Copyright 2008. Burdock Group. All rights reserved. Do not copy or reproduce without written permission from Burdock Group.
 Consultants

REGULATORY AND SCIENTIFIC

ROADMAP 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 first 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 modified 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 first be demonstrated to the satisfaction of a generally
recognized as safe (GRAS) Expert Panel or to FDA by means of a food additive petition or; in a New
Dietary Ingredient Notification (NDIN). At this point, the substance becomes eligible for a claim,
including a Health Claim, Qualified 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 eligible
for inclusion into a dietary supplement and not food and is restricted to a SFC only, but the claim does not
require pre-market approval. The flow-chart type of graphic illustrating the decision-tree type nature of
this process will make the decision process easier for the novice.

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 REGULATORY AND SCIENTIFIC ROADMAP FOR CLAIMS
By: George A. Burdock, Ph.D., Amy C. Mozingo, MS and John W. Rochowicz, BS
Consultants
Candidate Previous GRAS Yes
Substance or FAP?
1
Meat & Dairy
No Yes Whole
Yesfood (Yes) or Yes Whole food: Meat, Dairy, (FSIS)
New or
(No) food ingredient Vegetable, Fish or
novel Food?
(e.g., oil, flour) Minor Species?
3 4 5 Vegetable
(APHIS)
No 7 6
No
Fish or Minor
Species
Marketed as No To be added (FDA)
a DS Prior to GMO?
to food? Yes
10/15/94?

Yes 8 No Yes No New Plant 2

Varieties
Guidelines Yes Nanotech
Product?
GRAS or
NDIN & Safety Required
Food Additive
(Nanotechnology used?) 9 No
or Safety Review

Structure Function Nutrient Qualified Health

10 11 12 13 Health Claim
Claim Claim Claim

DIETARY
FOOD
SUPPLEMENT

Due to size and space limitations, this illustration (including graphic and accompanying explanation) includes generalizations and simplifications 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 specific needs.

© Copyright 2008. Burdock Group. All rights reserved. Do not copy or reproduce without written permission from Burdock Group.

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 EXPLANATION
Decision Point Description on Substance Safety (Proof of claim is required and not resolved by
this flow chart.)

Step 1: If the substance is the product of a previous generally recognized as safe

determination (GRAS) or food additive petition (FAP) and for the specific food at
the required food levels, nearly all the work is done. What remains is to ensure there
have been no new developments in the safety of the substance and that this new use
will not substantively impact the aggregate consumption by the potentially exposed
population. If new information impacting safety has been developed, new food
categories are required, or new use levels required to produce the effect, a new GRAS
determination or FAP may be required. (Remember, that even if a food additive
petition represents the first approval, in most cases, additional approvals can be
accomplished through the GRAS process.)

Step 2: Regardless if the product has been previously GRASed or a regulation promulgated
(as an approved FAP), it was likely not to have been as a nanosized particle (NSP).
Because nano-sized particles have a high probability of not behaving in the same
manner as a “macro” particle, additional safety testing may be required and a
subsequent GRAS determination conducted or a new FAP be submitted to FDA.

Step 3: If the substance is a food, whether new or novel, there may be a “presumption of
GRAS” and no further action may have to be taken (for example, a new kiwi fruit
or new vegetable that has had substantive use elsewhere in the world). If there is a
presumption of GRAS, then there may be nothing standing in the way of marketing
the substance as a food or dietary supplement, claims not withstanding.

Step 4: If the substance is be marketed as a whole food, then it may be possible to proceed to
the end stage as a whole food or dietary supplement. It is suggested, however, that the
appropriate regulatory agency be sought out for a consultation. If the substance is not
a whole food, but a product of that food (such as an extract), an approval will have to
be obtained, whether a GRAS determination or FAP (or if as a dietary supplement, a
New Dietary Ingredient Notification must be submitted).

Step 5: If the whole food is meat or dairy then the U.S. Dept of Agriculture Food Safety
Inspection Service (FSIS) should be contacted. If there is any question of safety,
FSIS will contact FDA for its review (for example, FSIS requested FDA opinion on
the safety of cloned animals for meat production). If the substance is a vegetable,
USDA Animal and Plant Health Inspection Service (APHIS) should be contacted to
determine if importation of the plant raises any issues. If fish or minor species are
involved, FDA should be consulted.

Step 6: Is the substance a genetically modified organism or a product of a genetically

modified organism (GMO)? If yes, then consult the proposed guideline
Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant Varieties Intended for Food Use (http://www.fda.
gov/OHRMS/DOCKETS/98fr/04d-0369-gdl0001.pdf). These guidelines may require
a consultation with FDA if approval of an FAP is sought, but consultation with the
agency may not be required for a GRAS determination. If the substance is not a
GMO, proceed directly to the GRAS or FAP or safety review (Step 9).

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 Step 7: If the substance is not to be added to food, but to be taken either as a supplement or
whole food, then proceed to step 8. If the substance is to be added to food, proceed to
step 9.

Step 8: If the substance is to be used as a dietary supplement and was marketed as a dietary
supplement prior to 15 October 1994, then proceed to market. (Persuasive evidence of
marketing prior to 15 October 1994 is required.) If the substance was not marketed as a
dietary supplement prior to the stipulated date and it otherwise meets the requirements
stated in the Federal Food Drug and Cosmetic Act §201(ff), it must undergo the
New Dietary Ingredient Notification process. Note that if the substance has not been
approved for use in food, it may only be used as a dietary supplement (ingredient)
and only structure function claims may be made. The safety standard for a dietary
supplement (ingredient) is a “reasonable expectation of no harm,” a lower threshold than
required for addition to food.

Step 9: If a substance has not been previously approved for use in food or is to be used in
quantities exceeding the original approval or used in food categories not previously
approved, there is an obligation to go through a safety review and approval process. If
the substance meets these qualifications, but additional data has been developed which
may potentially impact the safety-in-use of the substance, there is an obligation to
review the new information and possibly an addendum to the first approval or, at the
least, a safety review by competent scientists indicating safety-in-use. The standard for
addition to food is higher than that for a supplement ingredient. The standard for food
is “reasonable certainty of no harm.”

Step 10: Structure function claims may be made for an entire food, a food ingredient (whether
as an added ingredient or naturally occurring component) or for a dietary supplement
(ingredient). For addition to food or for a health claim or qualified health claim, the
substance must meet the standard of “reasonable certainty of no harm.” For use as
a dietary supplement (only), the supplement ingredient must meet the standard of
“reasonable expectation of no harm.”

Step 11: Nutrient claims cannot be made without FDA input and approval.

Steps 12 and 13: Health claims and qualified health claims are the domain of FDA and may
only be made upon agency approval. Both types of claims can be made for foods,
food components (as an added ingredient or naturally occurring component) or for a
dietary supplement.

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© Copyright 2008. Burdock Group. All rights reserved. Do not copy or reproduce without written permission from Burdock Group.