FDA REGULATION OF
DIETARY SUPPLEMENTS AND
FOODS
Presented by
W. Patrick Noonan
And Chris Noonan
For
NUTRITION INDUSTRY ASSOCIATION
W. Patrick Noonan, P.C.
21800 Oxnard Street, Suite 840
Woodland Hills, California 91367
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What is the legal definition of
Dietary Supplement?
(A)
(B)
(C)
(D)
(E)
A vitamin;
A mineral;
An herb or other botanical
An amino acid;
A dietary substance for use by man to supplement
the diet by increasing the total dietary intake; or
(F) A concentrate, metabolite, constituent, extract, or
combination of any ingredient described above.
21 U.S.C. 321(ff)(1)
2
MARKETING OF HOMOTAURINE AS AN AMINO ACID
FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that
asked the agency to issue a regulation under FDC Act §201(ff)(3)(B) or §301(ll)
acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements
is permissible. OVOS filed the citizen petition because OVOS had not marketed
homotaurine as a dietary supplement or food before OVOS obtained authorization for an
IND pursuant to which at least two substantial clinical investigations have been instituted
and made public; thus, FDC Act §201(ff)(3)(B) appeared to prohibit the marketing of
homotaurine as a dietary supplement, and FDC Act §301(ll) appeared to prohibit its addition
to food. However, both sections contain provisions that authorize FDA to issue a regulation
that essentially waives their applicability to a particular substance.
In its response, FDA concluded that the request to exercise its rulemaking authority under
FDC Act §201(ff)(3)(B) or §301(ll) was moot because homotaurine is not a dietary
ingredient within the meaning of FDC Act §201(ff)(1)(A)-(F). FDA determined that
homotaurine is not an “amino acid” under FDC Act §201(ff)(1)(D) because it is a gammaamino sulfonic acid, and not an alpha-amino carboxylic acid or a constituent of proteins.
FDA also determined that OVOS’s homotaurine does not qualify as a botanical (or extract
thereof) because it is made synthetically. Further, FDA determined that there was no
evidence that homotaurine “has ever been a dietary substance for use by man to increase the
total dietary intake.”
3
DEFINITION OF
DIETARY SUBSTANCE
FDA Informal Guidance
The term “dietary substance” is not defined in the Act. FDA
interprets it with its common or usual meaning. Therefore, a “dietary
substance” means a substance that is commonly used as human food
or drink. The statutory language “for use by man to supplement the
diet by increasing the total dietary intake” supports this
interpretation; and one cannot increase the total dietary intake of
something that is not commonly part of the diet in the first place.
Humans do not commonly use chemically manufactured or synthetic
CLA as food or drink.*
*(CFSAN’s Felicia Satchell NDI CLA letter to Jason Crush
August 29, 2002.)
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Race To The Market Provision
An ingredient does not qualify as a dietary supplement


If the ingredient is subject to a new drug application under
Section 505 of FDC Act that was approved prior to initial
marketing of the dietary supplement ingredient.
If the ingredient is subject to an approved investigational new
drug IND application by FDA, for which one clinical study has
been published that occurred prior to the initial marketing of the
dietary supplement ingredient.
See Section 201(ff)(3)(B) of the FDC Act
5
FDCA SECTION 301(ll)
 FDCA Section 301(ll) makes it a prohibited act to introduce
or deliver for introduction into interstate commerce any food
to which has been added a drug approved under section 505,
a biological product licensed under section 351 of the Public
Health Service Act, or "drug or biological product for
which substantial clinical investigations have been instituted
and for which the existence of such investigations has been
made public."
 Of the four limited exceptions outlined in Section 301(ll) the
most useful is the "first to market" exception that allows the
addition of a drug or biological product to food if that drug
or biological product was first "marketed in food. "
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Regulatory Issues
Concerning New
Dietary Ingredients
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Safety Standard for Dietary Ingredients
in Dietary Supplements
The Dietary Supplement Health and Education Act of 1994
(DSHEA) explicitly exempts “dietary ingredients” in “dietary
supplement” products from regulation as “food additives” (and therefore,
from any need to be GRAS). 21 U.S.C. § 321(s)(6).
Instead, a dietary ingredient in a dietary supplement is subject to
other, somewhat-more-tolerant safety requirements. Such an ingredient
must not present “a significant or unreasonable risk of illness or injury
under . . . conditions of use recommended or suggested in labeling, or . . .
. if no conditions of use are suggested or recommended in the labeling,
under ordinary conditions of use.” 21 U.S.C. 342(f)(1)(A).
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“Old” or “New”?
 Is it an “old” dietary ingredient, or a “new”
dietary ingredient?
 The Dietary Supplement Health and
Education Act (DSHEA) of 1994 makes a
distinction between the two.
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Old Dietary Ingredient
 A dietary ingredient that was “lawfully”
marketed in the U.S. before Oct. 15, 1994.

“Lawfully marketed” means written evidence
that the ingredient in question is chemically
identical to a dietary ingredient that was
marketed in the U.S. before Oct 15, 1994.
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FDA Informal Guidance
FDA informal guidance to prove an ingredient is not a new
dietary ingredient:
(1) Marketed as a DS before October 15, 1994.
You need to demonstrate that the listing of an “old ingredient” in a
given publication is founded on accurate and reliable evidence
sufficient to support a finding that the ingredient was marketed
dietary ingredient prior to October 15, 1994 in the United States.
(2) Alternatively, you could submit independent
documentation that the ingredient is not a new dietary
ingredient, such as an invoice, a bill of lading, or a product
label.*
*(See CFSAN NDI letter dated July 15, 2001 concerning Glucose Metabolism Modulator)
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Present in the Food Supply
 DSHEA provides an important exception from the NDI
notification requirement. According to Section 413 (a)(1) of the
FDC Act a dietary supplement that contains an NDI is not
adulterated if “the dietary supplement contains only dietary
ingredients which have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered.”

FDA informal guidance
suggests that the extract of the food source material is not the same as the
actual article used for food or as an ingredient of food. (Malt barley
extract is not the same as Malt Barley.) The mere presence of a
substance as an inherent component of articles used for food does not
establish that the substance itself is “an article used for food.”
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New Dietary Ingredient
 Not marketed in the U.S. before
October 15, 1994.
 Must notify FDA 75 days prior to the
introduction of the ingredient into the
market.
 Section 113 FSMA – FDA must
publish guidance by July 4, 2011
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Section 402(f)(1) of FDC Act
Safety of Dietary Supplements and
Burden of Proof on FDA
(f)(1) If it is a dietary supplement or contains a dietary ingredient that(A) Presents a significant or unreasonable risk of illness or injury under –
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under
ordinary conditions of use;
(B) Is a new dietary ingredient for which there is inadequate information to provide
reasonable assurance that such ingredient does not present a significant or unreasonable
risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that
the authority to make such declaration shall not be delegated and the Secretary shall
promptly after such a declaration initiate a proceeding in accordance with sections 554
and 556 of title 5, United States Code, to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1)
under the conditions of use recommended or suggested in the labeling of such dietary
supplement.
In any proceeding under this subparagraph, the United States shall bear the burden of proof
on each element to show that a dietary supplement is adulterated. The court shall
decide any issue under this paragraph on a de novo basis.
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The NDI Submission Process
21 CFR § 190.6
1. Name and address.
2. Name of NDI; if botanical, full proper Latin name
3. Description including full characterization of the
ingredient.
4. Level of NDI in dietary supplements in the
amount included in dosage form products and
expected daily consumption.
5. Conditions of use recommended in product
labeling.
6. History of use or reasonably expected to be safe
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under conditions of use.
Background
On September 27, 2007, the President signed into law the Food
and Drug Administration Amendments Act of 2007 (FDAAA).
This law amends the Federal Food, Drug, and Cosmetic Act
(FT&C Act) by creating a new section 417, Reportable Food
Registry. Section 417 requires the Secretary of Health and
Human Services (the Secretary) to establish within the Food and
Drug Administration (FDA) a Reportable Food Registry. The
congressionally-identified purpose of the Reportable Food
Registry is to Provide a “reliable mechanism to track patterns of
adulteration in food [which] would support efforts by the Food
and Drug Administration to target limited inspection resources to
protect the public health” (Pub. L. 110-085, section 1005(a)(4)).
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Responsible Party
The responsible party is the person who submits the
registration under section 415(a) of the FD&C act (21
U.S.C. 350(d)) for a food facility that is required to register
under section 415(a), at which such article of food is
manufactured, processed, packed, or held. Persons who are
required to submit a facility registration under section 415 of
the FD&C Act are the owner, operator, or agent in charge of
a domestic or foreign facility engaged in manufacturing,
processing, packing, or holding food for consumption in the
United States. “Person” is defined in section 201(d) of the
FD&C Act (21 U.S.C. 321(e)) as including individuals,
partnerships, corporations, and associations.
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Reportable Food
A “reportable food” is an article of food (other than dietary
supplement or infant formula) for which there is a reasonable
probability that the use of, or exposure to, such article of food
will cause serious adverse health consequences or death to
humans or animals.
[Added May 2010] Infant formula and dietary supplements are
excluded from the requirements of the Reportable Food Registry.
Are there other reporting requirements for these foods?
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Submitting a Reportable Food Report
A responsible party is required to submit a
report to FDA through the Reportable Food
electronic portal as soon as practicable, but in
no case later than 24 hours after determining
that an article of food is a reportable food.
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When does a “transfer to another
person” occur under section
417(d)(2)(B) of the FD&C Act?
 A transfer to another person occurs when the responsible person releases
the food to another person. “Person” is defined in section 201(e) of the
FD&C Act as including individuals, partnerships, corporations and
associations.
 FDA does not consider an intra-company transfer in a vertically
integrated company to be a “transfer to another person,” where the
company maintains continuous possession of the article of food. For
example, if Company A owns a processing plant, warehouse facility, and
distribution facility, the intra-company transfer from the processing plant
to the warehouse facility and/or the warehouse facility to the distribution
facility would not be considered a transfer to another person.
20
If a reportable food is shipped to a third-party warehouse,
but the responsible party maintains ownership and direct
control over distribution, must the responsible party
submit the reportable food report?
Yes. Transfer to another person occurs when the responsible
person releases the food to another person. “Person” is
defined in section 201(e) of the FD&C Act (21 U.S.C.
321(e)) as including individuals, partnerships, corporations
and associations. In this situation, the warehouse operator is
a distinct legal person.
21
Recordkeeping and
Documentation
 What are the recordkeeping requirements for responsible parties?

The responsible party shall maintain records related to each report received,
notification made, and report submitted to the FDA under section 417 of the
FD&C Act for 2 years.
 Is a report to FDA or notification of instances of reportable food an admission
that the food involved is adulterated or caused or contributed to a death, serious
injury, or serious illness?

No. A report or notification of a reportable food shall not be considered an
admission that the food involved is adulterated or caused or contributed to a
death, serious injury, or serious illness. Any report or notification of an
instance of reportable food is considered a safety report under section 756 of
the FD&C Act (21 U.S.C. 379(v)), Safety Report Disclaimers, and may be
accompanied by a statement, which shall be part of any report that is
released for public disclosure, that denies that the report or notification
constitutes an admission that the product involved caused or contributed to a
death, serious injury, or serious illness.
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THE FDA FOOD SAFETY
MODERNIZATION ACT (FSMA) OF
JANUARY 4, 2011 Pub. Law No. 111-353
A. Major provisions of FSMA that are effective immediately include:
(1) Mandatory Recall Authority (FSMA Sect 206)
(2) Stronger records access authority (FSMA Sect 101)
(3) Whistleblower Protection (FSMA Sect. 402)
(4) Foreign facilities and refusal of inspection (FSMA Sect. 306)
An imported food will be refused admission if it is from a foreign establishment to which a
US inspector is refused entry for an inspection.
B. Additional significant provisions of FSMA that expected to take effect in the first year
after enactment:
(1)Targeting of inspection resources( FSMA Sect 201) increased inspection of domestic
facilities with high risk foods and foreign facilities.
(2) Suspension of food facility registration (FSMA Sect.102) Problems involving a food that
may cause serious adverse health consequences, FDA can shut down facility that packed,
received or held food by suspending registration
(3) Administrative detention (FSMA Sect. 207) FDA will have stronger authority to
administratively detain food.
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MODERNIZATION ACT, cont.
(4) Authority to require import certification (FSMA Sect. 303) FDA can require high risk food to
be accompanied by a certification that the food complies with FDC Act.
(5) Prior notice of imported food (FSMA Sect. 304) FDA will require prior notice of an imported
food shipment to include information on any country where the food was refused entry.
C. Additional Significant Provision of FSMA that are expected to take effect in the second
year. (2012)
(1) Hazard Analysis and Risk-Based Preventive Controls (HARBPC) FAMA Sect. 103 Domestic
and foreign facilities (with some exceptions such as dietary supplements and infant formula,
must develop a HARBPC plan
(2) Foreign Supplier Verification Program (FSMA Sect. 301) Importers will have to verify that
imported food complies with HARBPC requirements.
(3) Protection against Intentional Adulteration (FSMA Sect. 106)
(4) Laboratory Accreditation for Analysis of Foods (FSMA Sect.307) All testing of foods for
regulatory compliance must be done at a FDA accredited laboratory.
(5) Accreditation of Third-Party Auditors (FSMA Sect. 302)
(6) Voluntary Qualified Importer Program (FSMA Sect. 302)
(7) Improving the Reportable Food Registry (FSMA Sect. 211)
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D. No Observable Effect levels (NOEL) for heavy metals causing cancer or as reproductive
toxins found in Dietary Supplement Products under Prop 65
(1) Arsenic 10 mcg/day
(2) Cadmium 4.1 mcg/day
(3) Lead 0.5 mcg/day
(4) Mercury no established levels.
E. Overview of Proposition 65 Settlements
(1) Total Proposition 65 settlements
Proposition 65 defendants have paid a total of $258,942,932 in various types of financial
settlements. Of this roughly $259 million total, the California Attorney General has
collected approximately 33% of all settlement dollars paid, while citizen enforcers and their
attorneys have collected 66 %
(1) Average Prop 65 settlement
(2) Median Prop 65 settlement
(3) Largest Prop 65 settlement
(4) Smallest Prop 65 settlement
$65356
$17000
$42,500,000
$160
F. Product Category and Settlement Averages
(1) Dietary supplement and herbal remedies $89,669
(2) Food products
$ 74614
G. 2010 Proposition 65Notices of potential Prop 65 violation
(1) Dietary Supplement and Herbal products 629.
(2) Food Products 1,018
(3) Personal Care products 449
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Complaint for False Marking Violation
of 35 USC Section 292




A. False marking includes whoever marks, or affixes to, or uses in advertising in
connection with any unpatented article the word "patent" or any word or number importing
the same is patented , for the purpose of deceiving the public: or whoever marks upon, or
affixes to, or uses in advertising in connection with any article the words "patent applied
for," "Patent pending," or any word importing that an application for patent has been
made, when no application for patent has been made, or if made, is not pending, for the
purpose of deceiving the public SHALL BE FINED NO MORE THAN $500 for every
such offense.
B. Any person may sue for the penalty, in which event one-half to the person suing and the
other to the use of the United States.
C. In other words, it is a violation of 35 USC Section 292 to intentionally mark an item in
commerce with a patent number that has expired or that does not protect the item.
D. Since December 2009, when the US Court of Appeals for the Federal Circuit, in
Washington rules that defendants in such lawsuits could be liable for up to $500 per
offense, nearly 700 lawsuits have been filed
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