Regulatory Oversight of Petfood, Treats and Supplements: FDA, CVM & AAFCO

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Animal Feed Ingredient & Dietary
Supplement
Safety and Regulatory Compliance
George A. Burdock, Ph.D.
Diplomate, American Board of Toxicology
Fellow, American College of Nutrition
President, Burdock Group
www.burdockgroup.com

Thank you for the opportunity
to speak with you today.
2
This material was presented by Dr. George A. Burdock
at the SSW Nutrition Insights meeting November 13,
2013
If you would like to receive additional information
regarding Burdock Group’s capabilities in food and
feed ingredients, or dietary supplement safety or
regulations governing any of the preceding, please
contact us at www.burdockgroup.com.
Disclaimer: Concepts and examples discussed in this
lecture are for illustrative purposes only and do not
constitute regulatory advice. The examples
provided herein may not apply to your specific
situation. Please contact us for an analysis of your
particular circumstance to determine the best
pathway for your product and team.

The Issue – “No such thing as Pet
Supplements”
FDA’s Center for Veterinary Medicine
• Does not recognize DSHEA as pertaining
to animals
• CVM maintains pet dietary supplements
are either:
o Unapproved food additives or
o Drugs
How do we address this
issue?

The Players
Center for Veterinary Medicine
• Regulates products for animals
• Drugs
• Devices
• Food additives
• Regulatory domain
• Companion animals (cats, horses & dogs)
• Production (food) animals (cattle, hogs, sheep, poultry)
• Minor species (exotic birds, zoo animals, etc.)
• Not within the CVM regulatory domain
• Veterinarians
• Vaccines
• Pesticides used for animals (e.g., flea and tick spray)

Are Pet Foods Regulated?
Federal Food Drug & Cosmetic Act
• §201(f) The term ''food'' means (1) articles
used for food or drink for man or other
animals, (2) chewing gum, and (3) articles
used for components of any such article.
• §(g)(1) The term ''drug'' means (B) articles
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
disease in man or other animals; and (C)
articles (other than food) intended to affect
the structure or any function of the body of
man or other animals;…[a dietary supplement
is not a drug solely because a claim is
made]…

Are Pet Foods Regulated?
• §201(s) The term ''food additive'' means any
substance the intended use of which results
or may reasonably be expected to result,
directly or indirectly, in its becoming a
component or otherwise affecting the
characteristics of any food … if such
substance is not generally recognized,
among experts qualified by scientific training
and experience to evaluate its safety, as
having been adequately shown through
scientific procedures (or, in the case as a
substance used in food prior to January 1,
1958, through either scientific procedures or
experience based on common use in food) to
be safe under the conditions of its intended

What does the law say?
• “Food” means food or feed whether for man
or animals
• Dietary supplements are foods
• Two means by which an ingredient may be
added to food
o GRAS
o Food Additive Petition
• But – CVM says
o DSHEA does not pertain to animals
o GRAS is only for low priority ingredients

Routes for Feed Ingredient Approval
© 2013 Burdock Groupwww.burdockgroup.com
8
FDA
Candidate Ingredient
Food Additive Petition

9
FDA
Scientific Data Review
Fulfilled Criteria of Redbook
& FDA

10
FDA
& FDA
Proposed Rule & Comment
Period
Final Rule in Federal
Register
Approved Food Additive

11
FDA
& FDA
Period
Register
Compliant
with
Federal Law

12
FDA Generally Recognized As
Safe
Food Additive Petition GRAS by Scientific Procedures
& FDA
Period
Register

13
Safe
& FDA
Experts Agree to Safety-In-
Use
Period
Register
Generally Recognized As Safe

14
Safe
& FDA
Use
Period
Register
Compliant
with
Federal Law

15
Safe
& FDA
Use
Period
Register
Notification to FDA
FDA Response

16
Safe
& FDA
Use
Period
Register
Notification to FDA
FDA Response
Compliant
with
Federal Law
FDA does not have the
regulatory authority to
“approve” a GRAS, it
may only “not object” or
state that the “notice
does not provide a
basis for a GRAS
determination”

17
Safe
Entry into the
Official Publication
& FDA
Use
Period
Register
Notification to FDA
FDA Response
AAFCO
Association of
American
Feed Control
Officials

The Players
Association of American Feed Control
Officials• No statutory authority – a private organization
• Formed in 1909
• No Federal regulation of food until 1938
• Consists of state feed control officials
• Objective
• To “level the playing field” between states
• By standardizing definitions of feed ingredients & commodities (not drugs)
• Methodology
• Committee accepts request for a definition
• “Model Bill” produced
• Approved by general vote
• Incorporated into the Official Publication
• Enforcement mechanism
• Incorporation into state laws
• Official Publication has become the default authority
• Recognized by CVM
• Recognized by several foreign countries

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19
What is AAFCO?
OfficialsChair, Ingredient Committee
Initial Committee Review
Committee Approval
CVM Review
(Regulatory discretion letter)
Continual renewal of
a “Memorandum of
Understanding”

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What is AAFCO?
Committee Approval
CVM Review
Vote by General Membership
AAFCO Board for Approval
Temporary Approval (1 year)
To States for their Review

What is AAFCO?
Association of American of Feed Control
Committee Approval
CVM Review
Approval (Official Publication)
Next AAFCO
Meeting
(one year later)

What is AAFCO?
Committee Approval
CVM Review
Next AAFCO
Meeting
(one year later)
Model bill
adopted by states
Iowa
automatically
adopts newest OP

What is AAFCO?
Committee Approval
CVM Review
Next AAFCO
Meeting
(one year later)
Model bill
adopted by states
Iowa
automatically
adopts newest OP
Because a “Memorandum of
Understanding” has no force of law
behind it, a product can be immediately
declared an adulterant.

What is AAFCO?
Committee Approval
CVM Review
Next AAFCO
Meeting
(one year later)
Model bill
adopted by states
Iowa
automatically
adopts newest OP
An AAFCO
ingredient
definition is not
compliant with
Federal Law
Because a “Memorandum of
Understanding” has no force of law
behind it, a product can be immediately
declared an adulterant.

*Although food containing these unapproved food additives is adulterated
within the meaning of section 402(a)(2)(c)(i), FDA is unlikely to initiate
enforcement action solely on this basis if the food additive in question is
included in the 2012 edition of the Official Publication of the Association of
American Feed Control Officials. As part of its efforts to work with State
partners, FDA has reviewed safety information related to many of these listed
products, and those listed in the 2012 Official Publication generally do not fall
within our current enforcement priorities.
FDA does not generally intend to recommend or initiate regulatory actions
against feed products that contain unapproved food additives if those
unapproved food additives are included as a feed ingredient definition in the
2012 Official Publication of the Association of American Feed Control Officials
(AAFCO), unless there are data indicating that safety or suitability issues exist
with an AAFCO defined ingredient.*
What Does FDA Say About All of This?
Draft CPG “LABELING AND MARKETING OF NUTRITIONAL PRODUCTS
INTENDED FOR USE TO DIAGNOSE, CURE, MITIGATE, TREAT, OR
PREVENT DISEASES IN DOGS AND CATS” September 10, 2012

The Regulatory Conundrum – Part I - CVM
• Food Additive Petitions
o Notoriously slow – several years
o Prohibitively expensive
• GRAS – Institutional Resistance
o Demand for “same quantity and quality” of data as for
FAP
o FDA GRAS Affirmations (FDA GRAS) – 2 substances
o GRAS determinations (Self-GRAS) (Pre-2010) – No
action
o GRAS Notifications
 Low approval rate
– 5 of 14 – “no basis”
– 5 of 14 – forced withdrawals
– 4 of 14 – “no questions” (some were re-submissions of
withdrawals)

The Regulatory Conundrum – Part II CVM
• Animal Dietary Supplements
o Do not contribute to “…taste, aroma or nutritive
value..”
 Cannot be GRAS or
 Food Additive Petition
o CVM maintains that DSHEA pertains only to
humans
 But, cannot control trade in animal dietary supplements
– Glucosamine and chondroitin for dogs
– Fiber in animal feed
– For example: Dog shedding formula: Omega-3 FA, glycine,
aspartic acid, proline, serine, biotin
 Therefore, has designated animal dietary supplements
as “low priority for enforcement”

The Regulatory Conundrum – Part III CVM
A Head-in-the-Sand Approach has a Poor History of
Success
• Regulatory discretion is not a “suitable home”
according to FDA’s own Counsel’s office – all
substances added to food must be either food
additives or GRAS
• Former Director initiated GRAS Notification process,
but it is being ignored as an appropriate vehicle for
approval
• CVM sorting through the OP list (500-600
substances)
o Will it self-GRAS some?

The Regulatory Conundrum – Part IV AAFCO
• Federal Preemption & the Supremacy Clause*
o States must accept Federal law & regulation
o States recognize all food additives and directives
in the Code of Federal Regulation & are included
in AAFCO OP
• Therefore, states must (theoretically) accept
GRAS determinations
o Probably more willing to accept FDA “no
questions” to a notification.
o Some have noted they will accept a “self-GRAS”
• But, AAFCO unwilling to add GRAS
determinations to OP
*USC Article VI, clause 2: “…shall be the supreme law of
the land…”

The Regulatory Conundrum – Part V AAFCO
• However – AAFCO is initiating a program on
specifications à la USP
o Analysis of safety must be a part of the process

Dietary Supplements for Pets – The Reality
Dogs Cats Birds Horses
Percent households owning 36.5% 30.4% 3.1% 1.5%
Number of households owning 43,346,000 36,117,000 3,671,000 1,780,000
Average number/household 1.6 2.1 2.3 2.7
Total number in the US 69,925,000 74,059,000 8,300,000 4,856,000
Veterinary visits per household/yr 2.6 1.6 0.3 1.9
Veterinary expenditure/yr $378 $191 $33 $373
Veterinary expenditure/animal $227 $90 $14 $133
WHAT CAN BE CONCLUDED FROM THE ABOVE?
1. There are a lot of pets in the US.
2. People care dearly about their pets.
https://www.avma.org/KB/Resources/Statistics/Pages/Mark
et-research-statistics-US-pet-ownership.aspx

Dietary Supplements for Pets – The Reality
• Dietary supplements $32 billion dollar
industry*
• 53% of American adults take at least one
dietary supplement**
• America has an ageing demographic
o Use of supplements increases with age
o People are sharing their supplements with
pets
BOTTOM LINE:
Owners will be sharing supplements with pets.
*2011 Nutrition Business
Journal
**NCCAM 2013

Dietary Supplements for Pets – The Solution
• National Animal Supplement Council
• A self-policing body
• Other self-policing industry bodies
o Flavor and Extract Manufacturers’ Association
GRASed >3000 flavor ingredients
o Cosmetic Ingredient Review > 3000
ingredients
*2011 Nutrition Business
Journal
**NCCAM 2013
Self-regulation Works!

Regulatory Oversight of Petfood, Treats and Supplements: FDA, CVM & AAFCO

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