FDA Cites POM Products As Drugs

The FDA just came down on POM, among other company's products, citing them for misleading labels and that their products are being marketed as new drugs.  Considering how many vegan bloggers gleefully accepted free samples from POM and promoted their juice recently (I turned them down), it's kinda cool to feel somewhat validated.  Here's an excerpt from an article about the announcement:

"POM Wonderful: POM Wonderful 100% Pomegranate Juice and POMx products (promoted for conditions that cause the products to be drugs)"

"...The consumer group Center for Science in the Public Interest (CSPI), which has lobbied the FDA to toughen food-label standards, hailed the FDA action in a news conference.  "This is a once-in-a-generation event," said Bruce Silverglade, CSPI legal affairs director. "Not since the early 1990s have we seen FDA actions of this magnitude..."

The actual letter sent to POM is stunning in its length and detail.  Here's some excerpts from the full "warning" letter here:

"...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..."

"...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..."

It's about time the FDA cracks down on this pseudo-science gobbleygook that too many bloggers blithely believe, repeat what companies say on their websites, and blather about without doing any homework.  It's refreshing to see the FDA finally doing it's job and warning companies that such misleading claims that effectively market their products as drugs must stop.

Comments

[Lance Mateas]

Great response. Kudos to you for printing the original articles. I find it interesting that they actually responded, which shows that at some level they actually care. It reminds me of a scene in Food, Inc. where a farmer puts the responsibility on consumers: demand what you want and we (farmers) will provide it! Keep it up, Mark.

[Food, Inc was great.. I hope that it (or "The Cove") win an Oscar and draw more attention to the issues covered in each.

Thanks for the feedback1 Best, Mark]

[POM Wonderful]

POM supports its scientific research & advocates honest labeling. We look forward to working with the FDA to resolve this matter. http://bit.ly/pomfda

[Sorry, but you guys aren't honest and lack integrity. See the post I made after this one. Your owner has been privitizing water in California (that's nothing to do with sustainability). He produces pesticides. Your company initiated legal proceedings against activists who were speaking the truth on their websites about your use of animals in testing. You company has the audacity to sue companies claiming their juices aren't 100% juice. The amount of money you spend on lawyers must be extraordinary. Guess you can't let your product stand on its own.

Furthermore, the statement that your "products [are] "essential to the health of all mankind" is quite silly and an example of the ample hype and hyperbole rampant at your website. Do you consider this "honest labeling?"

Depriving baby mice of oxygen to cause them brain injuries to test your juices? How noble! How good you are!

IMHO, your company is an example of the worst in food-related businesses. Exaggerated health claims, attempt to hide the truth about your business (and your owner's onerous activities), harassing activists with legitimate concerns, attacking other beverage companies, and bothering to send me such a silly note. Although, admittedly, because of your company's past behavior, I expected to get your comment in one form or another.

Your company has crossed the line many times, imho, and the abundance of ridiculous claims on your website, as well documented by the FDA, shows a complete lack of reality or true concern for your customers. It's stunning at the number of mis-statements, according to the FDA.

Your statement, "you look forward to working with the FDA" is absurd. How about an apology? Or better yet, apologies. Your company has a clear track record of not engaging in the kind of "sustainability" and "communal" nature you attempt to portray on your website. You shouldn't have to "work with the FDA" if you'd done your homework.

POM "Wonderful?" How about, POM "Hypocrisy, Animal Cruelty, Mis-leading Nutritonal Information," and We've Got Lawyers that we're dying to use." That would be more accurate.

'nuff said.]