Action Line: POM product claims are under FDA scrutiny
BY PHIL MULKINS World Action Line Editor
Sunday, January 27, 2013
1/27/13 at 4:21 AM
Dear Action Line: My wife buys "POM Wonderful" at the store and also pomegranate fruit for "the antioxidants." Is this beneficial or just holistic hooey? - M.S., Tulsa.
FDA beef: POM Wonderful's promoters are under attack by the federal government for their "deceptively advertised pomegranate products" and for "making unsupported health claims." On Feb. 23, 2010, the Food and Drug Administration began a crackdown on 17 companies making "unauthorized health claims about 22 food products." The FDA issued the makers of POM Wonderful a warning letter (read it at tulsaworld.com/fdapomwarning) citing online and product label references to its health effects.
Therapeutic claims to which the letter refers include its antioxidant cure of atherosclerosis, improving blood flow and lowering pressure, reducing prostate cancer, enhancing erectile function, helping the body fight free radicals and that its anthocyanins fight cancer, lower LDL (low-density lipoproteins) and cholesterol reducing arterial plaque, slowing prostate cancer and decreasing "diabetic oxidative stress."
"The POM Wonderful 100 percent Pomegranate Juice label features claims, as does your website, we determined promote the product as a drug, as defined in the Federal Food, Drug and Cosmetic Act. Therapeutic claims on your website establish the product is a drug as it is intended for 'use in the cure, mitigation and treatment or prevention of disease.' The marketing of this product with these claims violates the Act.
"It is your responsibility to ensure your products and labeling are in compliance with the laws enforced by FDA. Take prompt action to correct the violations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction."
FTC charge: On Jan. 16, 2013, the Federal Trade Commission upheld Chief Administrative Law Judge D. Michael Chappell's decision that "the marketers of POM Wonderful 100 percent Pomegranate Juice and POMx supplements deceptively advertised their products (see tulsaworld.com/pomruling). He also ruled POM did not have adequate support for claims that the products could treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction and that they were clinically proven to work.
The Commission issued a "final order" that bars POM marketers from making claims that a food, drug or dietary supplement is "effective in the diagnosis, cure, mitigation, treatment or prevention of any disease," including heart disease, prostate cancer and erectile dysfunction, "unless the claim is supported by two randomized, well-controlled, human clinical trials."
It also "prohibits misrepresentations regarding any test, study or research and requires competent and reliable scientific evidence to support claims" about the "health benefits, performance or efficacy of any food, drug or dietary supplement."
Original Print Headline: POM product claims are under FDA scrutiny
Submit Action Line questions by calling 918-699-8888, emailing phil.mulkins@tulsaworld.com or by mailing them to Tulsa World Action Line, PO Box 1770, Tulsa OK 74102-1770.
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