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July 26, 2010

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Comments

Jonathan E. Quist

I agree with Mr. M.

This action is particularly confusing given that the information is _still_ publicly available. For example, a certain regulatory agency, the name of which I will not utter here, has published a copy of their warning letter to POM Wonderful here:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm

Keller Rohrback L.L.P. has information on their private investigation of POM Wonderful here: http://www.krclassaction.com/Default.aspx?tabid=2250

So it appears that the stated purpose of the restraining order is moot; that the order remains is, at least to my non-legally-trained mind, a clear violation of the First Amendment.

huh

Dust up must be something different than this which shows up in Google search?


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm

FEB 23 2010

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Matt Tupper, President
POM Wonderful
11444 West Olympic Blvd.
Los Angeles, California 90064

Re: CFSAN-OC-10-20

Dear Mr. Tupper:

The Food and Drug Administration (FDA) reviewed your websites at the Internet
addresses http://www.pomwonderful.com and http://www.pompills.com in January 2010.
FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the
Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).
You can find copies of the Act and related regulations through links in FDA's home page
at http://www.fda.gov.

Unapproved New Drugs

The label of your POM Wonderful 100% Pomegranate Juice product includes the Internet
address of your website, www.pomwonderful.com. Based on claims made in the labeling
for this product on your website, we have determined that your POM Wonderful 100%
Pomegranate Juice product is promoted for conditions that cause the product to be a drug
under section 201 (g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims
on your website establish that the product is a drug because it is intended for use in the
cure, mitigation, treatment, or prevention of disease. The marketing of this product with
these claims violates the Act.

Examples of some of the claims observed on your website include:

From a webpage titled "Featured Scientific Studies":

• "Atherosclerosis: ... In a pilot study of 19 subjects with carotid artery stenosis
(plaque buildup), patients who consumed 8 ounces of POM Wonderful 100%
Pomegranate Juice daily for a one-year period experienced a 30% reduction in
intima-media thickness of the carotid artery vs, a 9% increase for the placebo
group."
• "Blood Flow/Pressure: ... In a pilot study of 10 subjects with hypertension ... a
slight decrease in systolic blood pressure was experienced after consuming POM
Wonderful 100% Pomegranate Juice daily for two weeks."
• "Prostate Cancer: In a clinical study involving 46 men with rising PSA after
prostate cancer treatment (surgery or radiation) who consumed 8 ounces of POM
Wonderful 100% Pomegranate Juice daily over two years, PSA doubling time
increased from 15 to 54 months .... PSA doubling time is an indicator of
prostate cancer progression."
• "Erectile Function: A randomized, placebo-controlled crossover pilot study of 55
men with mild to moderate erectile dysfunction evaluated the efficacy of
consuming POM Wonderful variety pomegranate juice .... After consuming
POM daily for 4 weeks, the men reported 50% greater likelihood of experiencing
improved erections as compared to placebo."

From a webpage titled "10 Ways to Help Your Heart in 2010":

• "6) Drink POM Juice: Reducing LDL cholesterol helps improve blood flow and
artery stress. One study with 13 healthy male volunteers who drank POM
Wonderful 100% Pomegranate Juice for 2 weeks, (found) the amount of LDL
cholesterol oxidation decreased by 20% and antioxidant activity in the blood
increased by 9%."

From a webpage titled "Final POM tour round up: Fun moments:)":

• "Wonderful pomegranates [the variety of pomegranate used in your product]
contain:

o Polyphenol Antioxidants - help the body against 'free radicals' molecules that cause damage to our bodies over time. Free-radical damage is a major factor in aging and chronic diseases such as heart disease and cancer. Scientific research has shown that a daily amount of polyphenol antioxidants may help promote a healthy heart and prostate by minimizing factors that lead to atherosclerosis, or plaque in the arteries, and prostate cancer....
o Vitamin C - ... may also reduce the length and severity of colds....
o Fiber - ... may reduce LDL cholesterol, which may help lower the risk of heart disease."

From a webpage titled "Nature's Rainbow":

• "[R]ed-purple foods - such as pomegranates ... are rich in anthocyanins .
Anthocyanins are strong antioxidants, and research suggests that they may .
reduce the risk of certain types of cancer."

From a webpage titled "Other Antioxidant Benefits":

• "Pomegranate juice has a superior ability to prevent LDL cholesterol from being
oxidized by free radicals. Emerging science suggests that LDL oxidation may be
a precursor to atherosclerosis or arterial plaque."
Page 3-POM Wonderful, Los Angeles, California 90064

From a webpage titled "What Can Antioxidants Do For You?":

• "Hey guys, want to protect your prostate? Start by sipping on some POM
Wonderful 100% Pomegranate Juice. . .. POM 100% Pomegranate Juice has
been shown to slow prostate tumor growth ...."

From a webpage titled "POM: Sweet - And Safe for Diabetics":

• "There have actually been several studies published about diabetic patients who
consume 8 ounces of POM juice every day over an extended period.... [T]he
patients' state of oxidative stress ... actually decreased. Diabetes is a very
complicated disease, with many potential side effects. Diabetics are at risk for
heart disease, kidney disease, and other complications, many of which are
fundamentally a result of oxidative stress. Since diabetics often experience higher
levels of oxidative stress, the uniquely strong natural antioxidants that make POM
so healthy are particularly beneficial."

Your website also contains disease claims in the form of personal testimonials, including:

• "I have been drinking POM for about a month, daily ... I can tell you that I feel
much better!! My cholesterol and blood pressure are slightly lower ...."
• "I have recently been having a lot of problems with unusual lumps on my body
and they are very sore and uncomfortable I have found the only thing that
gets rid of the lumps is POM Wonderful. Since drinking the POM every time
I feel a lump they have amazingly gone down! Basically I use POM as a kind of
medicine."
• "I am so thankful for POM! It saved my boyfriend's life. The man of my dreams
was diagnosed with Prostate Cancer .... Upon being diagnosed, he has been
drinking two glasses of POM Juice [daily] .... We both believe that POM Juice
has been the crucial factor in keeping his PSA levels at an undetectable level. The
powerful antioxidants contained in this fluid have also helped keep him healthy
enough to fight the side effects of his treatments and give him energy to improve
his health ...."
• "I'm writing to tell you what POM wonderful [sic] has done for my mother
suffering from a severe heart infection.... [A]n infection blossomed in a valve of
her heart and traveled to the bones in her face.... I started bringing her POM and
showed her all of the health benefits for her heart and blood function.... Soon
she was admitted into Reston Hospital in Northern VA and ... returned home
with a ... line that administers IV antibiotics twice a day. . .. Through her
recovery she ... loyally consumes her POM juice like clock work, almost as if it
is a part of her medical routine [S]he swears that the pomegranate juice has
helped her keep her immunity up and is also what has kept her infection from
getting worse due to keeping her heart functions strong and the blood flowing
more efficiently.... She has received peace of mind knowing she is taking part in
keeping her system healthy through the antibiotic process by drinking POM."

In addition, when scientific publications are used commercially by the seller of a product
to promote the product to consumers, such publications may become evidence of the
product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a
publication or reference in the labeling of a dietary supplement is considered to be a
claim about disease treatment or prevention if the citation refers to a disease use and if, in
the context of the labeling as a whole, the citation implies treatment or prevention of a
disease. The following are examples of publications that are used to market your product
for disease treatment and prevention on your website and are thus evidence of your
product's intended use as a drug:

• Aviram, M., et al., Pomegranate juice consumption reduces oxidative stress,
artherogenic modifications to LDL, and platelet aggregation: studies in humans
and in artherosclerotic apolipoprotein E-deficient mice. American Journal of
Clinical Nutrition 2000;71:1062-76.
• Pantuck, A.J., et al., Phase II Study of Pomegranate Juice for Men with Rising
Prostate-Specific Antigen following Surgery or Radiation for Prostate Cancer.
Clin Cancer Res 2006;12(13).
• Rosenblat, M., et al., Anti-oxidative effects of pomegranate juice (PJ)
consumption by diabetic patients on serum and on macrophages. Atherosclerosis
187 (2006) 363-371.
• Forest, C.P., et AL., Efficacy and safety of pomegranate juice on improvement of
erectile dysfunction in male patients with mild to moderate erectile dysfunction: a
randomized, placebo-controlled, double-blind, cross-over study. International
Journal of Impotence Research (2007), 1-4.

We also reviewed your website www.pompills.com. which offers for sale your POMx
Pills and POMx Liquid products. Based on claims made in the labeling for these
products on this website, we have determined that your POMx products are promoted for
conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Act. The
therapeutic claims on your website establish that these products are drugs because they
are intended for use in the cure, mitigation, treatment, or prevention of disease. The
marketing of these products with these claims violates the Act. For example:

From a webpage titled "Medical Research":

• "We have researched the effects of pomegranate juice on cardiovascular health
for almost 10 years, and findings suggest that pomegranate juice may help
counteract factors leading to arterial plaque build-up, as well as inhibit a number
of factors associated with heart disease. Initial preclinical tests have shown that
POMx has equivalent cardiovascular benefits to POM Wonderful Juice."
• "A preliminary UCLA medical study on POM Wonderful 100% Pomegranate
Juice showed hopeful results for men with prostate cancer who drank an 8oz glass
of pomegranate juice daily. And every POMx capsule provides the antioxidant
power of an 80z glass of POM Wonderful 100% Pomegranate Juice."

From a webpage titled "Pomegranates and Prostate Health":

• "A preliminary UCLA medical study involving POM Wonderful 100%
Pomegranate Juice revealed promising news. Men who had been treated
surgically or with radiation for prostate cancer were given 80z of POM Wonderful
100% Pomegranate Juice. A majority of the 46 men participating in the study
experienced a significantly extended PSA doubling time. PSA (prostate-specific
antigen) is a marker that is thought to be associated with the progression of
prostate cancer; a slower PSA doubling time may reflect slower progression of the
disease.... According to Dr. David Heber, Director of UCLA's Center for
Human Nutrition, 'The most abundant and most active ingredients in
Pomegranate Juice are also found in POMx. Basic studies in our laboratory so
far indicate that POMx and Pomegranate Juice have the same effect on
prostate health. '"
• "Findings from a small study suggest that pomegranate juice may one day prove
an effective weapon against prostate cancer." [quoting The New York Times]

From a webpage titled "The Heart of the Matter":

• "POMx is made from the only pomegranates supported by $32 million of initial
scientific research from leading universities [t]he very same pomegranates in
POM Wonderful 100% Pomegranate Juice One pilot study on 19 patients
with atherosclerosis (clogged arteries) at the Technion Institute in Israel
demonstrated a reduction in arterial plaque growth. After one year, arterial plaque
decreased 30% for those patients who consumed 80z of POM Wonderful 100%
Pomegranate Juice daily, compared to a 9% worsening for patients who drank a
placebo."
• "A recently published study at the University of California, San Francisco
(UCSF) included 45 patients with impaired blood flow to the heart. Patients who
consumed 80z of POM Wonderful 100% Pomegranate Juice daily for 3 months
experienced 17% improved blood flow; those who drank a placebo experienced
an 18% decline."

Your POM Wonderful 100% Pomegranate Juice and POMx products are not generally
recognized as safe and effective for the above referenced uses and, therefore, the products
are new drugs as defined in section 201(P) of the Act [21 U.S.C. 321(P)]. Under section
505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the
United States without an approved New Drug Application (NDA). FDA approves a new
drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the
drug is safe and effective.


Misbranded Drugs

Your POM Wonderful 100% Pomegranate Juice and POMx products are offered for
conditions that are not amenable to self-diagnosis and treatment by individuals who are not
medical practitioners; therefore, adequate directions for use cannot be written so that a
layperson can use these drugs safely for their intended purposes. Thus, your products are
misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear
adequate directions for use [21 U.S.C. 352(f)(1)].
Misbranded Food

Your POM Wonderful 100% Pomegranate Juice is also a misbranded food within the
meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product
label bears a nutrient content claim but does not meet the requirements to make the claim.
Characterizing the level of a nutrient in food labeling of a product without complying
with the requirements pertaining to nutrient content claims for that nutrient misbrands the
product under section 403(r)(1)(A) of the Act. The following violative nutrient content
claims for POM Wonderful 100% Pomegranate Juice were found at
http://www.pomwonderful.com:

• "[U]niquely high levels of powerful antioxidants ...."
• "POM Wonderful 100% Pomegranate Juice ... full of antioxidants called phytochemicals."

Under 21 CFR 101.54(g), a nutrient content claim that characterizes the level of
antioxidant nutrients present in a food may be used on a label or in the labeling of that
food when, among other requirements, a reference daily intake (RDI) has been
established for each of the nutrients (21 CFR 101.54(g)(1)), and the names of the
antioxidant nutrients that are the subject of the claim are included either (1) as part of the
claim or (2) elsewhere on the same panel of the product label, provided that the nutrient
names are linked by a symbol to the claim (21 CFR 101.54(g)(4)). The nutrient content
claim "[U]niquely high levels of powerful antioxidants ... " fails to declare the name of
the antioxidant nutrients that are the subject of the claim, as required by 21 CFR
101.54(g)(4). The nutrient content claim "[F]ull of antioxidants called phytochemicals"
characterizes the level of the antioxidant nutrient "phytochemicals"; however, no RDI has
been established for phytochemicals. Accordingly, this claim does not meet the
requirements of 21 CFR 101.54(g)(1).

The above violations are not meant to be an all-inclusive list of deficiencies in your
products or their labeling. It is your responsibility to ensure that all of your products and
labeling are in compliance with the laws and regulations enforced by FDA. You should
take prompt action to correct the violations. Failure to promptly correct these violations
may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of
this letter as to the specific steps you have taken to correct the violations noted above and
to assure that similar violations do not occur.

Your response should include any documentation necessary to show that correction has
been achieved. If you cannot complete all corrections before you respond, please explain
the reason for the delay and the date by which each such item will be corrected.

Please send your reply to the attention of Kathleen M. Lewis, Compliance Officer, Food
and Drug Administration, Center for Food Safety and Applied Nutrition, Office of
Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College
Park, Maryland 20740.

If you have any questions regarding any issue in this letter, please contact Ms. Lewis at
(301) 436-2148 begin_of_the_skype_highlighting              (301) 436-2148      end_of_the_skype_highlighting.


Sincerely,
/S/
Roberta C. Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition


cc: Food and Drug Administration
Los Angeles District Office

eli bortman

There was an article in the Wash. Post March 4 about the FDA ("an agency," if you are not allowed to post my comment as I've written it) challenging POM's claim that one of its juice drinks had healty effects. Is this what the legal fee dispute is related to?

The judge is wrong. Shame on her!!

Joseph Marchelewski

I don't get this. The records were legally obtained, so how can the judge block using them?

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