FDA Finds POM Wonderful Less So

WASHINGTONThe makers of POM Wonderful, Los Angeles, have found themselves in FDAs sights, after the agency sent the company a warning letter alleging the health claims made on its Web sites position the companys pomegranate products as unapproved new drugs. Specifically, FDA reviewed the POMwonderful.com and POMpills.com Web sites and product labels and determined therapeutic labeling claims promote the product for conditions that cause it to be classified as a drug.

There were several specific concerns cited. For example, a Web page on Featured Scientific Studies discussed studies showing consumption of POM Wonderful reduced atherosclerotic plaque, decreased blood pressure, addressed erectile dysfunction and slowed PSA levels in prostate cancer patients. Other Web pages discussing antioxidants claim pomegranate juice can reduce oxidation of low-density lipoprotein (LDL) cholesterol, preventing development of atherosclerosis, and slow the growth of prostate tumors. Also, by using scientific publications to promote the POM Wonderful and POMx supplement products to consumers, the publications become evidence of intended use and imply treatment of diseases.

FDA was also concerned about disease claims made in the form of personal testimonials, including one about getting rid of unusual lumps where the consumer stated, Basically I use POM as a kind of medicine.

The agency concluded the POM Wonderful and POMx products are not GRAS (generally recognized as safe) for the referenced uses, and are therefore new drugs; as they have not been the subject of a New Drug Application (NDA), they are unapproved new drugs that may not be legally marketed, and the current marketing makes them misbranded. Further, FDA determined the POM Wonderful juice is a misbranded food because its nutrient content claims in product labeling do not comply with federal regulations.

POM Wonderful responded to INSIDERs inquiry on the situation with the following comment: All statements made in connection with POM products are true and supported by unprecedented scientific research. We are currently reviewing the FDAs concerns and, as strong advocates of honest labeling and fair advertising, we are looking forward to working with the agency to resolve this matter. Once the FDA reviews and better understands the substantial science, we are confident that the agency will agree with our position.