July 8, 2008

**[COMMENTS ON DOCKET NUMBER FDA-2008-P-0049]{.underline}**

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Room 1061 (HFA-305)

Rockville, MD 20852

Attn: Dr. Andrew C. von Eschenbach, Commissioner; Gerald F. Masoudi,
Chief Counsel; Dr. Stephen F. Sundlof, Director, Center for Food Safety
and Applied Nutrition; Leslye M. Fraser, Director, Office of Regulations
Policy and Social Sciences, Center for Food Safety and Applied
Nutrition; and Dr. Barbara Schneeman, Director, Center for Food Safety
and Applied Nutrition/Office of Nutritional Products, Labeling, and
Dietary Supplements

**Re: As You Sow's Opposition to the Petition of Swanson Health
Products, Inc. seeking federal preemption of California's Proposition
65.**

Dear Comm. von Eschenbach, Mr. Masoudi, Dr. Sundlof, Ms. Fraser, Dr.
Schneeman, and staff,

As You Sow is a California-based non-profit organization dedicated to
utilizing capital markets, shareholder leverage, innovative legal
strategies, and grantmaking to transform corporate behavior and create a
more socially and environmentally just society.[^1] Part of the
organization's mission includes reducing consumer exposure to
carcinogens and reproductive toxins through the enforcement of
California's Safe Drinking Water and Toxic Enforcement Act, popularly
known as "Proposition 65." As You Sow hereby respectfully requests that
the Commissioner of Food and Drugs reject the proposals presented by
Swanson Health Products, Inc. ("Swanson") in their Citizen's Petition
Docket Number FDA-2008-P-0049-0001/CP ("Petition") and take no action on
the grounds that Proposition 65 does not conflict irreconcilably with
either the Federal Food, Drug and Cosmetic Act ("FFDCA") or FDA's
implementing regulations. Instead, these comments urge FDA to continue
to evaluate conflicts between FDA regulations and Proposition 65 on a
case by case basis.

Swanson's Petition dishonestly states that "Proposition 65 requires that
***all*** products that expose persons in California to ***any
detectable amount*** of a chemical 'known to the State' to cause cancer
or reproductive harm must be accompanied by a warning."[^2] Despite the
demonstrably false and misleading claims presented in Swanson's
Petition,[^3] Proposition 65 does not require warning labels on all
products that expose consumers in California to any "detectable amount"
of certain toxic chemicals. Instead, Proposition 65 merely requires
warning labels when a product's toxic exposure of specified listed
chemicals exceeds certain threshold levels as established by
California's Office of Environmental Health Hazard Assessment
("OEHHA").[^4]

In the Petition, Swanson urges the FDA to "use this opportunity ... as
\[an exemplar\] to provide guidance and assistance to the entire food
and dietary supplement industry" with regard to Proposition 65; yet, if
the specifics of Swanson's case are to be used as an indicator,
following the suggested "exemplars" presented by the petition would only
result in further exposure of the citizens of California--- and the
entire United States---to a variety of untested and dangerous
products.[^5] Following the proposals of Swanson's Petition would run
contrary to the principles of federalism, would violate federal and
state-court preemption precedent, would deteriorate the FDA's ability to
protect American consumers, and would inhibit the capacity of the People
of California to enforce their popularly-enacted laws. Proposition 65
warnings do not "misbrand" safe products, do not cause consumer
confusion, and do not hinder FDA's ability to carry out its statutory
mandates, and---as a result---FDA should take no action regarding
Swanson's Petition and should continue to evaluate warning conflicts on
a case by case basis.

I.  **FACTUAL BACKGROUND**

According to the factual background presented by Swanson's Petition,
rogue vigilantes police and enforce California's unjust Proposition 65,
choosing only to act against purveyors of "harmless" products and
foods.[^6] This portrayal, however, could not be further from the truth:
in reality, citizens, consumer and environmental advocacy groups, and
the Attorney General of California perform Proposition 65 enforcement in
a combined effort to protect the public from products that contain
substantial amounts of chemicals specifically known to cause cancer and
reproductive toxicity.

A.  **Proposition 65**

By approving Proposition 65 by a two-to-one margin statewide in 1986,
the people of the State of California declared their right "\[t\]o be
informed about exposures to chemicals that cause cancer, birth defects,
or other reproductive harm."[^7] To effectuate this right, Proposition
65 requires that Californians be provided with a "clear and reasonable
warning" before being exposed to chemicals causing cancer or
reproductive toxicity as listed by the State of California.[^8] And,
"\[b\]y providing this information, Proposition 65 enables Californians
to make informed decisions about protecting themselves from exposure to
these chemicals."[^9]

Proposition 65 provides Californians with a mechanism to reduce exposure
to toxic chemicals that may not be sufficiently addressed by state or
federal regulation.[^10] Despite best efforts by state and federal
agencies, testing all potentially-dangerous products would be a
Herculean---and, likely, impossible---task; to address this obstacle,
Californians provided for citizen-enforcement of Proposition 65 in order
to further the scope of enforcement and, subsequently, the protection
provided by the initiative. The results have been astounding:
Proposition 65 has generated reformulations of hundreds of consumer
products with toxic chemicals, frequently on a nationwide basis,
including:

> brass faucets, ceramic ware, calcium supplements, water meters, water
> filters, galvanized pipe, crystal decanters, foil caps on wine
> bottles, brass keys, hand tools, exercise weights, raincoats and other
> plastic clothing, electrical tape, electrical cords and wires, bicycle
> cable locks, compact disc wallets, baby rash powders and creams . . .
> hemorrhoidal medicines, nasal sprays, correction fluid, spot remover,
> paint strippers . . . nail polish remover, dandruff shampoos, bottled
> water, wooden playground structures, and portable classrooms, among
> other products.[^11]

Beyond product reformulations, Proposition 65 has also significantly
increased the public's awareness about the adverse effects of exposure
to toxic chemicals and has provided a necessary incentive for product
manufacturers to remove harmful chemicals from their products without
litigation.[^12]

Since its implementation in 1987, the list of chemicals---updated
annually by the State--- has grown to include approximately 700 known
carcinogens and reproductive toxins. OEHHA, a division of the California
Environmental Protection Agency, maintains and updates the list using
the latest scientific research to establish safe-harbor levels and to
add---and remove---chemicals from the list.[^13] OEHHA's list of known
carcinogens and reproductive toxicants---and their respective threshold
levels---is established by the Developmental and Reproductive Toxicant
("DART") Identification Committee and the Carcinogen Identification
Committee ("CIC"), two governor-appointed panels of eminent scientific
experts selected from academia, government, and industry.

Contrary to the claims made in Swanson's Petition,[^14] OEHHA has
created safe-harbor levels in order to guide businesses in determining
whether a warning is necessary on products sold in California.[^15] "A
business has 'safe harbor' from Proposition 65 warning requirements . .
. if exposure to a chemical occurs at or below these levels. These safe
harbor numbers consist of no significant risk levels ("NSRLs") for
chemicals listed as causing cancer and maximum allowable dose levels
("MADLs") for chemicals listed as causing birth defects or other
reproductive harm."[^16] OEHHA creates these levels through vigorous
scientific review of the toxicity of each individual chemical.[^17] If a
listed chemical does not occur in a quantity greater than the listed
NSRL or MADL, then no warning label is required.[^18] For lead, the
chemical which is the subject of As You Sow's enforcement action against
Swanson, the NSRL is 1.5 µg/day and the MADL is .5 µg/day. Furthermore,
exposures occurring naturally in food and other products are exempt from
the warning requirement under Proposition 65.[^19]

B.  **Parties**

Founded in 1992, As You Sow is a small, non-profit organization whose
mission is utilizing capital markets, shareholder leverage, innovative
legal strategies and grantmaking to transform corporate behavior and
create a more socially and environmentally just society.[^20] Through
its Proposition 65 enforcement program, As You Sow has reached
settlements with more than 300 companies, resulting---in most cases---in
nationwide product reformulation to remove or greatly reduce hazardous
ingredients. These settlements have resulted in product reformulation in
cases involving toluene exposure in household products, lead exposure in
children's jewelry, and formaldehyde exposure in portable classrooms,
among others.[^21] Using the bulk of the proceeds from successful
settlements, As You Sow disburses grants to support other
community-based 501(c)(3) non-profit organizations similarly dedicated
to combating toxics contamination and exposures and promoting toxics
reduction, remediation, prevention, and environmental education
throughout California. Since 1992, As You Sow has distributed more than
\$1.8 million to over 60 different organizations dedicated to furthering
the purposes of Proposition 65.[^22]

Swanson Health Products, Inc. is one of the nation's largest mail-order
retailers of vitamin and dietary supplements, employing nearly 500
people and operating out of a 120,000 square-foot facility in Fargo,
North Dakota. All Swanson products are contract-manufactured in bulk by
major product manufacturers, shipped to Swanson at their headquarters in
Fargo, bottled and labeled by Swanson, and then shipped directly to
consumers. Swanson is a sophisticated retailer whose product-reach
extends around the globe: through its catalog, 800-number, and
website---www.swansonvitamins.com---Swanson markets 1200 different
products to consumers in California, across the nation, and around the
world.[^23]

C.  **As You Sow's Herbal Supplement Campaign**

For almost ten years, As You Sow has been investigating the occurrence
of high levels of lead and other heavy metals in dietary and herbal
supplements. These herbal "health" products constitute a \$20 billion
industry in the United States annually, and their popularity has
increased dramatically as more consumers turn away from modern medicine
and towards alternative treatments and remedies.[^24] To date, As You
Sow has settled twenty-eight of these cases---primarily with herbal
product manufacturers but also with distributors, wholesalers,
retailers, and mail-order companies--- resulting in the imposition of
testing and reformulation commitments, warning labels on thousands of
products, and bans on many products with excessively-high lead
levels.[^25] As a result, As You Sow's herbal and dietary supplement
campaign has increased awareness regarding metals in herbs in both the
herbal supplement industry and with consumers across the nation, and the
campaign has played a significant role in pushing the industry to make
safer products.

One of the heavy metals commonly found as a contaminant in herbal
supplements is lead. On February 27, 1987, OEHHA officially listed lead
as a chemical known to the State of California to cause reproductive
toxicity. On October 1, 1992, OEHHA officially listed lead and lead
compounds as chemicals known to cause cancer.

In addition to causing cancer and birth defects, lead affects almost
every organ and system in the human body. The most sensitive is the
central nervous system, particularly in children. Lead also damages the
kidneys and the immune system. The health effects are the same whether
it is breathed or swallowed. Lead is known to cross the placental
barrier and cause damage to the developing fetus. Harmful effects
include premature births, smaller babies, decreased mental ability,
learning difficulties, tendencies toward violence, and reduced growth in
young children. In adults, exposure to lead decreases cognitive ability
and reaction time, causes weakness in fingers, wrists or ankles, and
decreases memory abilities. Exposure to lead also causes spontaneous
abortions and anemia. It also permanently damages the male reproductive
system, even at very low levels.

A number of state and federal agencies have made the reduction of lead
exposure a priority. For example, the Consumer Products Safety
Commission ("CPSC"), the U.S. Environmental Protection Agency ("EPA"),
and numerous state agencies have taken the lead in controlling the
levels of lead in drinking water coolers (water coolers that release
lead must be recalled or repaired; new coolers must be lead-free; and
drinking water in schools must be tested for lead). The U.S. Center for
Disease Control and Prevention ("CDC") recommends that all children be
screened for lead poisoning at least once a year and has determined that
there is no safe level of exposure to lead. The sale of leaded gasoline
in this country was made illegal as of December 31, 1995. The U.S.
Department of Housing and Urban Development ("HUD") requires that
federally funded housing and renovations, public housing, and Indian
housing be tested for lead-based paint hazards. Hazards must be fixed by
covering the paint or removing it. The Occupational Safety and Health
Administration ("OSHA") has also set specific limits on the
concentration of lead in workroom air. But, because lead is a ubiquitous
ingredient in consumer products, members of the public continue to be
exposed to it at levels of public health concern.

Despite overwhelming evidence to the contrary, some violators continue
to claim that all or most of the lead in their herbal products is
\"naturally occurring," seeking to take advantage of the specific
exception in the Proposition 65 statute.   While some small amount of
lead does occur naturally in most soils, research has revealed that the
vast preponderance of the lead found in herbal products such as those
sold by Swanson, especially those grown and processed in China, is the
direct result of human activity, primarily the burning of coal and other
fossil fuels, and other sources of industrial pollution. Courts have
started to agree with this conclusion. In the case of *People v.*
*Suarez Corporation Industries*, the trial court---after extensive
consideration of expert testimony---held that lead found in herbal
supplements was primarily the result of man-made pollution and was not
"naturally occurring."[^26]

Attached as Exhibit B is recent court-approved Consent Judgment in the
matter of *As You Sow v. Idea Sphere, Inc*., resolving a similar case
involving high levels of lead found in a manufacturer's herbal
supplements.[^27] The Consent Judgment in that case---which was
negotiated this past Spring, approved by the court, and filed on June 4,
2008--- reflects As You Sow's current practice in settling similar
herbal product cases. It allows a "naturally occurring" exemption of
2.25 µg/day, calls for warnings on all products containing lead levels
between 2.25 and 10 µg/day, and requires complete prohibition on the
sale of any product exceeding 10 µg/day. The settlement agreement also
requires the defendant to purchase an Inductively Coupled Plasma Mass
Spectrophotometer ("ICPMS"), a re-circulating chiller, an SPS3
Autosampler, and a Bio Spectrophotometer Series II Detector---expensive
pieces of laboratory equipment used for analyzing products for the
presence of heavy metals---and to test all its products for lead and
other heavy metals prior to marketing the product.[^28]

It is important to note that all settlements of Proposition 65
enforcement actions must be approved by the court of appropriate
jurisdiction, after notice and hearing, and after a determination that
all provisions of the Consent Judgment---including reformulation
commitments, warning language, penalties, and attorney's fees---are in
the public interest.[^29] In addition, before such a hearing may be
held, the parties to the settlement are required to give advance notice
and copies of the Consent Judgment and Settlement Agreement to the
California Attorney General's Office. That office engages in thorough
scrutiny of all Proposition 65 settlements and often appears in court to
object if it determines that any aspect of the settlement agreement is
not in the public interest.

D.  **Current Action**

As You Sow initiated its Proposition 65 enforcement action against
Swanson in May 2007 after testing **ten** of Swanson's products and
finding that **nine** exposed consumers to lead levels above the limits
set by OEHHA under Proposition 65.[^30] Subsequent testing revealed
twenty-four more Swanson products, out of thirty-six tested, with
exposure levels that violated California law.[^31] Some Swanson products
tested as high as fifty and 120-times above the .5 µg/day MADL
established by OEHHA.[^32] Attached as Exhibit C is a chart detailing
three rounds of testing, conducted by As You Sow at an EPA certified
lab, of forty-eight Swanson products.[^33]

The dietary supplements at issue, however, are not the first unsafe or
misbranded products marketed by Swanson: in late 2007, FDA determined
that Swanson was in violation of the FDCA for its marketing of Red Yeast
Rice and Red Yeast Rice/Policosanol Complex. FDA found that Swanson's
dietary supplement contained unusually-high amounts of lovastatin, the
active ingredient in Mevacor--- a prescription drug used to treat
hypercholesterolemia.[^34] While "\[t\]raditional Red Yeast Rice does
not contain more than trace amounts of lovastatin, if any," FDA found
Swanson's product to contain enhanced or added amounts of lovastatin and
ordered Swanson to cease marketing the product as a dietary
supplement.[^35] Furthermore, Swanson now has prominent Proposition 65
warnings on its website for those Red Yeast Rice products containing
lovastatin,[^36] likely a preventive measure by Swanson as a result of
Proposition 65 enforcement actions brought by the California Attorney
General against other dietary supplement retailers of Red Yeast
Rice.[^37]

Also, in December 2005, Swanson agreed to remove a number of its
products from the California market after the California Women's Law
Center brought a Proposition 65 enforcement action against the
company.[^38] Some of Swanson's creams, gels, and lotion products were
found to contain progesterone, medroxyprogesterone acetate, testosterone
and its esters, methyltestosterone, testosterone cypionate, and
testosterone enanthate--- all chemicals known to cause cancer or
reproductive toxicity.[^39] Swanson removed the products from the
California market, paid a \$15,000 settlement to the private enforcer,
and agreed that, if the company decided to re-enter the California
market with those products, Swanson would provide an appropriate
Proposition 65 warning on the product, in its mail-order catalogue, and
on the appropriate webpages.[^40]

II. **PROPOSITION 65 DOES NOT UNDERMINE FDA'S ABILITY TO PROTECT
    CONSUMERS**

The purposes of both FDA and Proposition 65 are to protect consumers
from exposure to dangerous products. FDA fulfills this purpose by
monitoring product safety standards and monitoring labeling requirements
so that consumers purchase the product that they expect. Proposition 65
similarly informs consumers by alerting a purchaser to the presence of
carcinogenic or reproductive toxins within a product. Proposition 65,
however, does not cause consumer confusion and does not result in the
misbranding of a product, and---therefore, does not conflict with the
statutory mandates and mission-objectives of FDA.

A.  **Purpose of the FDA and the FDAC is to protect consumers**

Originally codified in 1938, the FDCA gave FDA the authority to regulate
the safety of food, drugs, and cosmetics within the United States.[^41]
The broad purpose of the FDCA, and the FDA, is to maintain and ensure
the safety and protection of the consuming public from dangerous
foods,[^42] and, for the purposes of the FDCA, dietary supplements are
considered foods, except where special provisions apply.[^43] And, among
other responsibilities vested by the FDCA, the Act charges FDA with
establishing labeling requirements for some foods, determining if foods
are mislabeled or adulterated, and establishing food-quality
standards.[^44]

B.  **Proposition 65 warnings do not result in misbranding as defined by
    the FDAC**

In an effort to prohibit false and misleading branding of products, FDA
regulates the claims made on food and dietary supplement labeling. Under
the FDCA, a label refers to "all labels and other written, printed, or
graphic matters (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article," and the Act lists the
specific requirements for a variety of foods.[^45] A dietary
supplement's label is insufficient---and, thus, misbranded---if the
label does not list, among other requirements, a descriptive name of the
product stating that it is a "supplement," a complete list of
ingredients, and the net contents of the product.[^46]

In determining whether a product is misbranded, FDA must consider the
totality of the labeling and advertising, including if the labeling
"fails to reveal facts . . . material with respect to consequences which
may result from the use of the article."[^47] In Swanson's case, as
noted above, the presence of significant amounts of lead in many of its
dietary supplements and the subsequent deleterious health effects
associated with lead exposure could be significant enough to amount to a
"consequence which may result from the use of the article." Thus,
according to the statute, the presence of lead in Swanson's herbal
supplements could result in a finding that Swanson has mislabeled their
products *without* a warning for the high lead levels. In effect, a
Proposition 65 warning would likely *assist* Swanson in complying with
FDA's labeling requirements.

Furthermore, the Dietary Supplement Health and Education Act
specifically states that "*a dietary supplement shall not be deemed
misbranded solely because its label or labeling contains directions or
conditions of use **or warnings***."[^48] As clearly explicated by the
federal statute, California's Proposition 65 warning requirements do not
result in the misbranding of dietary supplements because "warnings"
cannot be the sole reason for a determination of misbranding.[^49]

C.  **Proposition 65 warnings do not cause consumer confusion**

The rationale behind establishing labeling requirements for products is
to provide consumers with a clear picture of the contents, uses, side
effects, and applications of a particular food or dietary supplement.
Proposition 65's warning requirements in no way inhibit the ability of
FDA to effectuate this goal. If anything, Proposition 65 warnings
*enhance* FDA's capacity to provide a more comprehensive picture of
individual products for consumers. The warnings allow consumers to make
a more transparent and coherent product selection based upon their
knowledge of the potentially-dangerous chemical composition of
individual products.

It is not at all surprising that Swanson now claims its customers are
confused by the Proposition 65 warnings they receive: after As You Sow's
Proposition 65 enforcement action was filed, Swanson has been placing
generic Proposition 65 warnings inside ***all shipments*** to
California, regardless of the actual chemical composition of the dietary
or herbal supplement purchased.[^50] Those generic Proposition 65
warnings are now printed at the bottom of their packing slips, entirely
detached from the specific products that require a warning, and the
packing slips are placed in the bottom of the box in which the product
is shipped.[^51] This creates the implication (for those customers who
actually read the fine print on packing slips) that *all* of Swanson's
products contain chemicals known to cause cancer and reproductive
toxicity and, understandably, has resulted in significant confusion for
some of Swanson's customers. Also, consumers may be understandably upset
by the fact that Swanson failed to provide any Proposition 65 warning
prior to the product's purchase. The rationale behind Proposition 65
warnings is to give consumers a more complete understanding of a
product's chemical composition in order to better inform an individual's
product selection at the time of that selection: adding the warning to
the packing slip--- received by the consumer *after* the product has
been ordered, paid for, and shipped--- demolishes this objective.

The warning scheme currently utilized by Swanson is overly-broad,
unnecessary, misleading, and is in no way mandated by Proposition 65. In
fact, the warning scheme now used by Swanson would likely fail the
"clear and reasonable" standard required by the California law.[^52]
Thus, the consumer confusion resulting from Swanson's current warning
scheme is entirely irrelevant and inapposite to the application of
future, appropriate Proposition 65 warnings.

D.  **Because Proposition 65 warnings do not cause misbranding and do
    not cause consumer confusion, there is no conflict between the
    warnings and FDA regulations and statutory mandates**

Prior to FDA issuing a directive preempting Proposition 65 warnings on
products regulated by FDA, some type of conflict between the warnings
mandated by California law and FDA's regulations--- and the goals of
those regulations---should be found to exist. As demonstrated
specifically by the circumstances surrounding Swanson's Petition, there
is no conflict between Proposition 65 warnings and the misbranding of
dietary supplements. Furthermore, Proposition 65 warnings---when
properly implemented---do not result in consumer confusion, but,
instead, expand the consumer's ability to make sound decisions based
upon a more-thorough understanding of the chemical composition of a
product.[^53] Because there is no conflict between FDA regulations and
Proposition 65 warnings and because Proposition 65 warnings actually
assist in FDA's mission of "protecting the public health," there is no
reason for FDA to issue a broad directive regarding preemption of
Proposition 65.[^54]

In order to achieve FDA's goal of protecting Americans' health, the
agency must regulate the entire dietary supplement industry---a
tremendous task given the size of the industry and the burden of the
regulatory system created by Congress. The herbal and dietary supplement
industry is a multi-billion dollar annual industry comprised of
thousands of companies and hundreds of thousands of different products
and product lines.[^55] Despite the immensity of the industry, the
burden of determining if a product is unsafe is solely the
responsibility of the FDA.[^56] FDA's website presents the overwhelming
task posed by dietary supplement regulation:

> In that FDA has limited resources to analyze the composition of food
> products, including dietary supplements, it focuses these resources
> first on public health emergencies and products that may have caused
> injury or illness . . . The agency does not analyze dietary
> supplements before they are sold to consumers. **The manufacturer is
> responsible for ensuring that . . . the dietary ingredients are safe.
> FDA does not have resources to analyze dietary supplements sent to the
> agency by consumers who want to know their content**. [^57]

The dietary supplement industry is largely responsible for
self-regulation as a result of the sheer immensity of the industry's
size and FDA's already over-burdened and under-funded regulatory
schedule.[^58] As a result, Proposition 65 implementation, enforcement,
and warnings serve a useful middle-ground in the regulatory scheme:
because citizen and consumer group enforcers are not constrained by
governmental budget allotments (or, if they are limited by budget, the
number of potential enforcers still expands the scope of enforcement),
the citizen enforcers are able to perform proactive testing on a wide
swath of dietary supplements, whether or not those supplements have
previously caused immediate illnesses. Also, FDA's budget limitations
dictate that dietary supplements which have caused "public health
emergencies and . . . injury or illness" are given first priority,
but--- under circumstances such as lead in dietary supplements---the
toxic effects of the supplement may not be noticeable and, subsequently,
actionable by FDA for many years.[^59] Again, the proactive testing of
products by Proposition 65 citizen enforcers and the California Attorney
General's office, coupled with private--- but judicially approved---
settlement agreements, often provide reformulations, bans and/or warning
schemes that help to mitigate this risk and, in turn, help FDA to
fulfill its mission of "protecting the public health."[^60]

Because Proposition 65 does not interfere with FDA's statutory mandates,
regulations, and actually enhances the agency's ability to fulfill its
mission, FDA should take no action with regards to Swanson's citizen
petition. As is clearly demonstrable by the dietary supplements produced
by Swanson, preemption of Proposition 65 by FDA would only result in
further inadequate self-regulation by the industry and the production
and distribution of more dangerous products to consumers; this, coupled
with FDA's limited resources for testing dietary supplements---and the
beneficial support provided by Proposition 65 enforcers---all strongly
suggest that FDA should take no action regarding Swanson's petition and
should continue to examine regulatory and labeling conflicts on a case
by case basis.

III. **AN FDA DIRECTIVE FOLLOWING THE SUGGESTIONS OF SWANSON'S PETITION
     WOULD VIOLATE THE PRINCIPLES OF FEDERALISM AND CONTRADICT BOTH
     FEDERAL AND STATE COURT PREEMPTION PRECEDENT**

Not only would a directive following Swanson's Petition be unnecessary
and ill-advised in light of the fact that Proposition 65 warnings do not
conflict with any FDA statutory mandate, regulation, or agency mission
regarding dietary supplements, but following the requests in Swanson's
Petition would run contrary to the basic principles of federalism and
preemption-precedent established by both federal and state courts. The
Petition effectively argues for FDA preemption of Proposition 65, yet,
as a health and safety statute enacted by the voters of California to
enhance consumer protection, Proposition 65 falls within the traditional
police powers of the state and enjoys a strong presumption against
preemption.[^61] This strong presumption, when coupled with federal and
state court precedent regarding FDA preemption of Proposition 65,
suggests that FDA should take no action on Swanson's broad requests and,
instead, should continue to evaluate conflicts between FDA labeling
requirements and Proposition 65 warnings on a case by case basis.

Under Article VI of the United States Constitution, Congress may act to
preempt state law in areas that lay within the authority of the federal
government,[^62] rendering the preempted state statute "without
effect."[^63] Preemption, however, is strongly disfavored as an
encroachment on a state's rights and can only be found where Congress
has intended---either expressly or impliedly---to preempt state law.
Congressional intent to preempt state law is evident when Congress
"explicitly states it intends to preempt state authority."[^64] The
implied intent of Congress to preempt state authority is evident when
(1) it is clear that Congress intended the federal regulation to "occupy
the entire field of regulation, leaving no room for the states to
supplement federal law" or (2) when compliance with both federal and
state regulation is an impossibility.[^65] A party urging preemption
must overcome the strong presumption against it, especially in areas
traditionally regulated by the states.[^66] As a statute which protects
"the lives, limbs, \[and\] health" of California citizens, Proposition
65 falls squarely within a state's traditional police powers and,
subsequently, enjoys a strong presumption against preemption.[^67]
Ultimately, a determination of preemption lies in an analysis of
Congressional intent.[^68]

A.  **Congress did not expressly preempt state labeling requirements for
    dietary supplements, demonstrating Congressional intent to allow
    supplementary state labeling requirements**

In the case of dietary supplements, it is impossible to say that
Congress expressly intended to preempt state law because the preemption
clause that applies to national, uniform labeling requirements
specifically omits dietary supplements from the foods governed by the
regulation.[^69] Despite the claims of Swanson's Petition, dietary
supplements are not governed by 23 U.S.C. 343-1 because dietary
supplements are neither "a food which is the subject of a standard of
identity," nor one of the explicitly-listed food types which require
uniform labeling.[^70] Therefore, if anything, Congress' intent was
expressly to *not* preempt state labeling requirements by excluding
dietary supplements from its list of foods subject to the uniform
labeling requirements.[^71]

"Various provisions of the FDCA clearly demonstrate that 'Congress knows
how to write a preemption clause' when it wants to and that 'the
\[FDCA\] evidences, far from implied preemption, an instance of implied
*non*premption.'"[^72] Congress enacted a number of express preemption
provisions to the FDCA,[^73] and "\[t\]he inference to be drawn from
these provisions is that Congress . . . did not intend to limit states'
options in a broad fashion. The fact that Congress had the opportunity
to expressly preempt state labeling requirements for dietary
supplements--- yet intentionally chose not to---obviously demonstrates
that Congress has not expressly preempted state labeling requirements,
but it also weighs strongly against a finding of implied Congressional
preemption as well.

Notwithstanding Congress' explicit exemption of dietary supplements from
the regulations governing uniform labeling requirements, if the
preemption clause did apply, courts have repeatedly given these clauses
narrow interpretations: "\[r\]eading \[the MDA's preemption clause\]
broadly requires recognizing that *any* state law is, by definition a
law 'in addition to' federal law . . . \[thus rendering\] the 'different
from' language meaningless and forc\[ing\] a strained reading of the
statute."[^74] While the preemption clause at issue here, 21 U.S.C.
§343-1, does not borrow the exact language of the MDA's preemption
clause, the effect is the same: the regulation attempts to bar any state
regulation that is not "identical to the requirement\[s\]" of 21 U.S.C.
§ 343-1.[^75] Thus, even if the labeling preemption clause did apply to
dietary supplements, a court would likely not grant it full preemptive
effect because *all* state laws could be seen as requirements not
"identical to" the requirements of the FDCA.[^76]

B.  **Congress has not impliedly preempted state law regarding dietary
    supplements, further demonstrating Congress' explicit intent to
    allow supplementary state labeling requirements**

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1.  **Federal regulation does not "occupy the entire field" of dietary
    supplement labeling regulation**

In determining whether Congress intended to "occupy the entire field" of
dietary supplement labeling requirements, it is necessary to look at the
scope of the regulations at issue. Federal regulation "occup\[ies\] the
field" when the regulatory scheme implemented by Congress is so
pervasive as "to make reasonable the inference that Congress left no
room for the States to supplement it."[^77] Preemption "should not be
inferred, however, simply because the agency's regulations are
comprehensive."[^78]

It is impossible to reasonably infer that Congress left no room for the
states to supplement FDA's regulation of food and dietary supplements
given that states retain regulatory powers beyond FDA's minimum
regulations. In fact, Swanson's petition concedes this point:
"California's Sherman Food and Drug Act is one of several state statutes
that establishes state authority over food safety. . .\[and, while\] FDA
has mandated national uniformity in product labels and safety standards,
. . . **states retain the power to enforce higher standards**."[^79]
Thus, as Swanson's Petition concedes, states retain regulatory power
over food and dietary supplement safety standards,
and---consequently---it cannot be said, nor is it disputed, that federal
regulation is so pervasive as to leave no room for state law to
supplement it.

With regard to dietary supplement labeling specifically, Congress made
an explicit allowance for state regulations: "A dietary supplement shall
not be deemed misbranded solely because its label or labeling contains
directions or conditions of use **or warnings**."[^80] If Congress had
not intended for state law to enhance dietary supplement labeling
regulations, the warning allowance provided in the statute would be
entirely superfluous. Congress would have no need to provide a broad
exemption from misbranding if Congress intended to fully regulate the
warning labels that could be applied to dietary supplement labels. This,
again, demonstrates that Congress did not intend the FDA to "occupy the
entire field" of food regulation, broadly, and dietary supplement
labeling requirements, specifically. Because these regulations do not
"occupy the entire field," there is no implied preemption on the part of
Congress.

2.  **Compliance with both Proposition 65 and FDCA is possible, again
    demonstrating a lack of implied preemption**

Implied preemption may also be found when state and federal law
irreconcilably conflict. Courts have found conflict preemption when it
is impossible for a private party to comply with both state and federal
requirements.[^81] As described above, there is no conflict between
federal requirements for dietary supplements and Proposition 65
warnings.[^82] Proposition 65 requires a warning label to be placed on
products which contain known carcinogens or cause reproductive toxicity
above certain threshold levels for those chemicals.[^83] FDCA allows for
warnings to be placed on dietary supplements in addition to any federal
labeling requirements without the warnings constituting misbranding of
the labeling.[^84] Therefore, in the case of dietary supplements, it is
clearly possible to comply with both federal regulations governing
dietary supplements and Proposition 65.

In *Dental Amalgam*, the Ninth Circuit evaluated the claim that the
Medical Device Amendment ("MDA") to the FDCA preempted Proposition 65
with regard to warnings for mercury in dental amalgam.[^85] The MDA
requires that no state impose additional requirements regulating medical
devices--- in this case, dental amalgam.[^86] The court held that the
MDA did not preempt Proposition 65, despite the conflicting federal and
state requirements, because the federal regulations governing medical
devices were entirely generic requirements and not the type that would
preempt a state "law of general applicability" like Proposition 65.[^87]

Furthermore, the California Supreme Court held that the FDCA's uniform
labeling requirements did not preempt state law claims against
mislabeling under California's Sherman Food, Drug, and Cosmetic Law
("Sherman Law").[^88] In that case, consumer advocacy groups brought
suit against multiple California grocery store chains, stemming from the
stores' sale of salmon given an artificial coloring additive in order to
give the salmon's flesh the appearance of wild salmon. The court held
that the FDCA labeling requirements did not preempt California's Sherman
Law because of the strong presumption against preemption, because
Congress explicitly allowed states to enforce similar requirements, and
because California's requirement utilized the same requirements as the
national standard.[^89]

*Dowhal*, the case that Swanson's Petition utilizes to buttress its
argument that Proposition 65 conflicts with FDA labeling requirements,
is clearly distinguishable from the situation presented by Swanson's
case.[^90] First, in *Dowhal*, the nicotine replacement therapy ("NRT")
products at issue were nonprescription drugs, subject to entirely
different FDA labeling and safety requirements than dietary supplements
and food.[^91] Furthermore, the FDA had recently comprehensively
evaluated the health risks associated with using NRTs when FDA changed
the status of the products from prescription to nonprescription
drugs.[^92] This stands in stark contrast to the paucity of
federally-mandated regulations that exist for dietary supplements and
greatly reduces the deference given to the federal interests at stake
under the current circumstances. Finally, FDA had, when developing its
label, thoroughly evaluated and carefully balanced the risks between not
informing pregnant women of the potential reproductive harm caused by
NRT products and pregnant women continuing to smoke due to the warnings
on those NRT products.[^93] Because of the subtle issues at stake, FDA
developed a nuanced, situation-specific approach to the warning scheme
for NRT products.[^94] In contrast, no federal warning scheme for heavy
metals in dietary supplements currently exists, and the
situation-specific, nuanced, and balanced approach implemented by FDA
has not been applied to heavy metal concentrations in dietary
supplements.[^95] This is simply not a case where "the Federal
Government has weighed the competing interests relevant to the
particular requirements in question, reached an unambiguous conclusion
about how those competing considerations should be resolved. . . and
implemented that conclusion via a specific mandate on manufacturers or
producers."[^96] Thus, because there must be a conflict between federal
and state regulations and courts have only found a conflict with
Proposition 65 when FDA has implemented *specific and contradictory*
guidelines, there is no evidence of an implied preemption on the part of
Congress here.

IV. **CONCLUSION: FDA SHOULD TAKE NO ACTION REGARDING SWANSON'S
    PETITION**

The Petition makes a number of demonstrably false statements regarding
Proposition 65 warning requirements, Proposition 65 enforcement, and the
implications of Proposition 65 on FDA's ability to carry out its mission
of protecting American consumers. Ultimately, however, Swanson's
Petition fails to address one glaring issue: Proposition 65 and FDA
share the same goals---protecting the general public from exposure to
harmful products. As clearly demonstrated in these comments, Proposition
65 warnings do not result in the misbranding of dietary supplements, do
not cause consumer confusion, and do not hinder FDA's ability to carry
out its statutory mandates. Furthermore, an FDA decision to preempt
Proposition 65 would directly contradict well-established principles of
federalism and would run contrary to federal and state-court preemption
precedent. For all these compelling reasons, FDA should take no action
regarding Swanson's Petition and should continue to evaluate conflicts
between FDA regulations and Proposition 65 on a case by case basis.

> Respectfully submitted,
>
> Larry Fahn
>
> Executive Director
>
> Mark Rumold
>
> Law Clerk
>
> As You Sow
>
> San Francisco, CA

CC: As You Sow Board of Directors

> Andrew Packard; Counsel for As You Sow
>
> Stephanie Sheridan and Carol Brophy; Sedgwick, Detert, Moran & Arnold,
> Counsel for Swanson Health Products, Inc.
>
> Lee Swanson; CEO, Swanson Health Products
>
> Edward Weil; Supervising Deputy Attorney General of California,
> Environmental Enforcement Division

[^1]: *See* As You Sow Website, www.asyousow.org, describing the
    organization's campaigns and grantmaking program.

[^2]: Petition at 2 (emphasis in original).

[^3]: *Id*.

[^4]: There are also several notable exceptions to Proposition 65,
    including exceptions for naturally occurring toxins and exemptions
    for companies employing ten or fewer persons. Cal. Health & Safety
    Code § 25249.5 et. seq. (2007); OEHHA Proposition 65 Page,
    http://www.oehha.ca.gov/prop65.html.

[^5]: Petition at 2.

[^6]: *See* Petition at 5.

[^7]: Proposition 65 Ballot Text §1(b), available at
    http://traynor.uchastings.edu/cgi-bin/starfinder/6595/calprop.txt.

[^8]: Proposition 65 specifically states: "No person in the course of
    doing business shall knowingly and intentionally expose any
    individual to a chemical known to the state to cause cancer or
    reproductive toxicity without first giving clear and reasonable
    warning to such individual." Cal. Health & Safety Code § 25249.6

[^9]: OEHHA "Proposition 65 in Plain Language!" *available at*
    http://www.oehha.ca.gov/prop65/background/p65plain.html

[^10]: *Id*.

[^11]: The chemicals eliminated from these products include lead,
    mercury, trichloroethylene, perchloroethylene, methylene chloride,
    toluene, formaldehyde, coal tar, and arsenic. Clifford Rechtschaffen
    & Patrick Williams, *The Continued Success of Proposition 65 in
    Reducing Toxic Exposures*, 35 Envtl. L. Rep. 10850, n. 5 (2005). A
    copy of this informative law review article is attached as Exhibit
    A.

[^12]: *Id*. at 10851.

[^13]: *Supra* n. 8.

[^14]: *Supra* n. 2.

[^15]: *See* Reproductive and Cancer Hazard Assessment Section - OEHHA,
    Proposition 65: Process for Developing Safe Harbor Numbers, (2001),
    *available at* http://www.oehha.org/prop65/getNSRLs.html (follow
    "Process for Developing Safe Harbor Numbers").

[^16]: *Supra* n. 11 (abbreviations added).

[^17]: *See supra* n. 13.

[^18]: *Supra* n. 11.

[^19]: C[al. Code Regs. 22, § 12501]{.smallcaps} (2008).

[^20]: *See* *supra* n. 1.

[^21]: *See* As You Sow's Environmental Enforcement Page,
    http://www.asyousow.org/env_enforcement/.

[^22]: http://www.asyousow.org/grantmaking/

[^23]: Swanson Vitamins Website, www.swansonvitamins.com (follow "About
    Swanson" tab).

[^24]: Judy Foreman, *For the Facts on 'Natural' Remedies, Go Online*,
    Boston Globe, May 29, 2006, *available at*
    http://www.boston.com/yourlife/health/diseases/articles/2006/05/29/for_the_facts_on_natural_remedies_go_online/;
    *see also*, Dietary Supplement Health and Education Act, Pub. L. No.
    103-407 § 2, 108 Stat. 4325 (1994) (codified as amended in scattered
    sections at 21 U.S.C.).

[^25]: *See* e.g. *As You Sow v. Idea Sphere, Inc.*, Case No:
    CGC-07-468381, San Francisco Superior Court (2008) (Exhibit B).

[^26]: *People v. Suarez Corporation Industries*, Case No: SCV 237654,
    Sonoma Superior Court (2006).

[^27]: *Id*.

[^28]: The lab equipment and employee training are expected to cost at
    least \$242,000. *See* *id*. at 16.

[^29]: *See* Exhibit B.

[^30]: *See* Exhibit C(1).

[^31]: *See* Exhibit C(2)-(3).

[^32]: Two Swanson products tested at 25.20 and 63 µg/day, based on
    recommended daily dosage. Exhibit C(2); OEHHA, Proposition 65 Safe
    Harbor Levels: No Significant Risk Levels for Carcinogens and
    Maximum Allowable Dose Levels for Chemicals Causing Reproductive
    Toxicity at 12 (May 2008), *available at
    http://www.oehha.ca.gov/prop65/pdf/2008MayStatusReport.pdf* .

[^33]: Exhibit C(1)-(3).

[^34]: Letter from W. Charles Becoat, Director, Minneapolis District,
    Public Health Service, Food and Drug Administration, to Lee Swanson,
    President, Swanson Health Products, Inc., August 8, 2007, warning to
    Swanson regarding violation of FDCA, *available at*
    http://www.fda.gov/foi/warning_letters/s6455c.htm.

[^35]: *Id*.

[^36]: Swanson Vitamins Homepage, www.swansonvitamins.com (search "Red
    Yeast Rice;" then click on the product).

[^37]: *People v. Nutraceutical Corp*. Case No: RG07329561, Alameda
    Superior Court (2007).

[^38]: *Buckland v. Threshold Enterprises*, Case No: BC344046, Los
    Angeles Superior Court (2005).

[^39]: *Id*. at 1.

[^40]: *Id*. at 4-6.

[^41]: Since its inception, the FDCA has been amended numerous times
    including, of particular significance for these comments, the
    Nutrition Labeling and Education Act of 1990 ("NLEA") and the
    Dietary Supplement Health and Education Act of 1994 ("DSHEA"). For
    clarity purposes, unless explicitly mentioned, any reference to the
    FDCA is meant to broadly include any amendments to the Act. Federal
    Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 *et seq.*; Nutrition
    Labeling and Education Act of 1990, Pub. L. No. 101-535 § 6(a), 104
    Stat. 2362, (1990) (codified as amended at 21 U.S.C. § 343-1);
    Dietary Supplement Health and Education Act, Pub. L. No. 103-407 §
    2, 108 Stat. 4325 (1994) (codified as amended in scattered sections
    at 21 U.S.C.).

[^42]: *See* McDermott v. Wisconsin, 228 U.S. 115, 130 (1913).

[^43]: 21 U.S.C. § 321(ff) (2007).

[^44]: *See* 21 U.S.C. § 301 *et seq.* (2007); 21 U.S.C. § 341 (2007);
    21 U.S.C. § 342 (2007); 21 U.S.C. § 343 (2007).

[^45]: 21 U.S.C. § 321(m) (2007).

[^46]: 21 U.S.C. § 343(s) (2007).

[^47]: 21 U.S.C. § 321(n) (2007).

[^48]: 21 U.S.C. § 343(s) (2007) (emphasis added).

[^49]: *See id*.

[^50]: Attached as Exhibit D(1)-(3) are three examples of packing slips
    used by Swanson. Exhibit D(1) is a Swanson packing slip with no
    Proposition 65 warning used prior to receiving As You Sow's initial
    60-day Proposition 65 notice in May 2007. Exhibit D(2) is a packing
    slip with a generic Proposition 65 warning printed on the upper,
    right-hand quarter used by Swanson, starting in October 2007, on all
    products shipped into California. This warning does not refer to any
    specific product and creates the implication that all Swanson
    products contain chemicals that cause cancer. The third packing
    slip, Exhibit D(3), contains the same generic Proposition 65 warning
    language printed at the bottom of the packing slip, partially
    obscured by other printing, which creates the impression that the
    company is attempting to hide the mandatory California warning from
    the consumer. As You Sow is informed and believes that it has been
    used by Swanson exclusively for all California shipments since
    January 2008.

[^51]: *Id*.

[^52]: *See* Cal. Health & Safety Code § 25249.6 (2007).

[^53]: *See supra* n. 8.

[^54]: FDA Mission Statement,
    www.fda.gov/opacom/morechoices/mission.html.

[^55]: *See* [Mary K. Muth, *et al*., Economic Characterization of the
    Dietary Supplement Industry]{.smallcaps}, Contract No. 223-96-2290:
    Task Order 3 (Research Triangle Institute 1999) (Prepared for Clark
    Nardinelli, DHHS/Food and Drug Administration), *available at*
    http://www.cfsan.fda.gov/\~acrobat/ds-econ.pdf.

[^56]: 21 U.S.C. § 342(f).

[^57]: www.cfsan.fda.gov/\~dms/ds-oview.html#regulate (emphasis added).

[^58]: FDA Science Board, Subcommittee on Science and Technology, *FDA
    Science and Mission at Risk* (2007).

[^59]: FDA Overview of Dietary Supplements,
    http://vm.cfsan.fda.gov/\~dms/ds-oview.html; *see* Edwin van
    Wijingaarden & Mustafa Dosemeci, *Brain Cancer Mortality and
    Potential Occupational Exposure to Lead: Findings from the National
    Longitudinal Mortality Study*, *1979-1989*, 119 Int'l J. of Cancer
    1136 (linking job-related lead exposure to fifty percent increase in
    likelihood of developing brain cancer), Dr. Kim Cecil et al.,
    *Decreased Brain Volume in Adults with Childhood Lead Exposure*,
    PLoS Med, 2008; 5(5): e112 DOI (linking childhood lead exposure to
    decreased brain volume in adults, resulting in adverse cognitive and
    behavioral functioning).

[^60]: *Supra* n. 47.

[^61]: *Bronco Wine Co. v. Jolly*, 33 Cal. 4th 943, 955 (Cal. 2005).

[^62]: *Id*.

[^63]: *Dowhal v. Smithkline Beecham Consumer Healthcare*, 32 Cal. 4th
    910, 923 (Cal. 2005).

[^64]: *Bronco Wine*, 33 Cal. 4th at 955.

[^65]: *Bronco Wine*, 33 Cal.4th at 955 (quoting *Hines v. Davidowitz*,
    312 U.S. 52, 61, 67 (1941)).

[^66]: *Id.* at 956-57.

[^67]: *Comm. of Dental Amalgam Mfr. and Distrib. v. Stratton*, 92 F.3d
    807, 811 (9th Cir. 1996); *Bronco Wine*, 33 Cal. 4th at 956-57; *see
    also Florida Lime & Avocado Growers, Inc. v. Paul* 373 U.S. 132, 146
    (1963) (holding that state police powers are properly employed to
    protect consumers' health and prevent deception of consumers).

[^68]: *Dowhal*, 32 Cal. 4th at 923.

[^69]: *See* 21 USC §343-1

[^70]: *See id*. FDA has issued standards of identities for a variety of
    foods including milk, frozen desserts, bakery products, cereal
    flours, and macaroni and noodle products, yet there is no explicit
    standard of identity for dietary supplements. The only description
    of dietary supplements' identities comes under 21 C.F.R. 101, "Food
    labeling," but there is no explicit standard of identity for dietary
    supplements. *See* 21 C.F.R. 101.1 ("Principal display panel of
    package form food"), 21 C.F.R. 101.3 ("Identity labeling of food in
    packaged form"), *but see* 21 C.F.R. 131 (standard of identity for
    milk and cream).

[^71]: *See* 21 U.S.C. §343-1.

[^72]: *Farm Raised Salmon Cases*, 42 Cal. 4^th^ 1077, 1092 (Cal. 2008)
    (quoting *Consumer Justice Center v. Olympian Labs, Inc*., 99 Cal.
    App. 4th 1056, 1059, 1063 (2002)) (emphasis in original).

[^73]: *See e.g.* 21 U.S.C. §§ 360(k) (medical devices), 360(ss)
    (radiation emissions), 379(r) (nonprescription drugs), 379(s)
    (cosmetics).

[^74]: *Kennedy v. Collagen*, 67 F.3d 1453, 1457 (9th Cir. 1995); *see
    also* *Medtronic v. Lohr*, 518 U.S. 470 (1996) (holding MDA did not
    deny a state the right to provide traditional remedies for
    violations of common law duties when those duties paralleled federal
    requirements); *Dental Amalgam*, 92 F.3d (holding MDA's explicit
    preemption clause did not preempt Proposition 65 warning
    requirements).

[^75]: The statute specifically reads "\[N\]o State or political
    subdivision of a State may directly or indirectly establish under
    any authority or continue in effect as to any food in interstate
    commerce . . . any requirement for a food . . . that is not
    identical to the requirement\[s\]" set forth by the FDCA and the
    FDA. 21 U.S.C. §343-1

[^76]: *Dental Amalgam*, 92 F.3d at 812.

[^77]: *Rice v. Santa Fe Elevator Corp.*, 331 U.S. 218, 230 (1947).

[^78]: *R.J. Reynolds Tobacco Co. v. Durham County*, 479 U.S. 130, 149
    (1986).

[^79]: Petition at 11 (emphasis added).

[^80]: 21 USC 343(s) (emphasis added).

[^81]: *Dowhal*, 32 Cal. 4th at 910.

[^82]: *Supra* pgs. 7-12.

[^83]: Cal. Health & Safety Code § 25249.6, § 25249.8.

[^84]: 21 USC 343(s).

[^85]: *Dental Amalgam*, 92 F.3d at 809-10.

[^86]: *Id*. at 810.

[^87]: *Id*. at 812-14.

[^88]: *Farm Raised Salmon Cases*, 42 Cal. 4^th^ 1077 (Cal. 2008).

[^89]: *Id*. at 1092-94.

[^90]: Swanson's Petition actually cites two cases *Dowhal* and
    *Tri-Union Seafoods* in support of their specious claim that FDAC
    and Proposition 65 conflict irreconcilably; but, because *Tri-Union*
    is currently on appeal, it cannot be relied upon as stable,
    established precedent and will not be addressed here. *Dowhal v.
    Smithkline Beecham Consumer Healthcare*, 32 Cal. 4th 910 (2004);
    *People v. Tri-Union Seafoods*, 2006 WL 1544384 (Cal. Superior
    2006).

[^91]: *Dowhal*, 32 Cal. 4th at 918; *see* 21 U.S.C. §355 (2007), *but
    see* 21 U.S.C. § 343(s) (2007).

[^92]: *Dowhal*, 32 Cal. 4th at 920.

[^93]: *Id*.

[^94]: *See* *id*.

[^95]: *See* 21 U.S.C. § 343(s) (2007).

[^96]: *Medtronic v. Lohr*, 518 U.S. 470, 501 (1996).