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
Consultants

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

Candidate Substance

Previous GRAS or FAP?

Yes Meat & Dairy (FSIS) Vegetable (APHIS) Fish or Minor Species (FDA)

1
No New or novel Food? No Marketed as a DS Prior to
10/15/94?

Yes

3

4

Whole food (Yes) or Yes Yes (No) food ingredient (e.g., oil, flour)

5

Whole food: Meat, Dairy, Vegetable, Fish or Minor Species?

7
To be added to food? Yes

No GMO?

6

No

Yes New Plant Varieties Guidelines

Yes

8

No

No

2
Yes Nanotech Product? No

NDIN & Safety Required (Nanotechnology used?)

9

GRAS or Food Additive or Safety Review

10

Structure Function Claim

11

Nutrient Claim

12

Qualified Health Claim

13

Health Claim

DIETARY SUPPLEMENT

FOOD

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.
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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.) 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. 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. 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). 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. 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).

Step 2:

Step 3:

Step 4:

Step 5:

Step 6:

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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. 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. 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 8:

Step 9:

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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