an equal and opposite reaction
Case Details for "POM Wonderful "
FDA alleges Pom Wonderful misbranded products
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 the 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 the website include:
From a web page 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 web page 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 web page titled "Final POM tour round up: Fun moments:)":
• "Wonderful pomegranates [the variety of pomegranate used in your product] contain:
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....
Vitamin C - ... may also reduce the length and severity of colds....
Fiber - ... may reduce LDL cholesterol, which may help lower the risk of heart disease."
From a web page 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 web page 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 web page 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 web page 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."
The 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.
The FDA 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 web page 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 web page 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 web page 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).
Posted on:03/09/2010
Company: POM Wonderful
Affected Class: Purchasers of Pom Wonderful products
Scope: Nationwide
Contact Us Regarding This Investigation:
