Pom Wonderful

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD 20740

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.

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

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