The Federal Trade Commission says POM Wonderful's research does not substantiate the firm's pomegranate health claims, featured in one of the more aggressive and visible ad campaigns in the nutritionals and health foods market.

An administrative complaint FTC filed Sept. 27 against the Los Angeles firm ended speculation of a pending commission action, fueled most recently by POM's preemptive lawsuit against the agency (¹ Also see "POM Wonderful Misses Mark In Suit On FTC Claims Standard, Attorneys Say" - Pink Sheet, 20 September, 2010.).

Having already poured more than $34 million into pomegranate research, POM refused to enter a consent agreement with FTC and withdraw or modify claims for its pomegranate juices and POMx supplements.

"FTC is violating POM's constitutional rights to share useful and important information with the public, and therefore we have initiated a separate lawsuit to preserve these rights," the company said in a same-day statement.

POM markets its products with claims implying benefit against cardiovascular disease, prostate cancer and erectile dysfunction. One advertisement depicts a bottle of 100 percent pomegranate juice as a superhero saying, "I'm off to save prostates!"

FTC also highlights public statements made by POM principals and spokespeople that included allegedly misleading claims. Director Lynda Rae Resnick said in a 2008 interview pomegranate "is the magic elixir of our age and of all ages, and we know that it helps circulation, it helps Alzheimer's, it helps all sorts of things in the body."

Drug Claims, Or Food Research News?

The commission's ² complaint notes certain POM claims are false and misleading in light of the referenced research.

"Any consumer who sees POM Wonderful products as a silver bullet against disease has been misled," said David Vladeck, director of FTC's Bureau of Consumer Protection, in a release.

"Contrary to POM Wonderful's advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses."

FTC's complaint, for example, says "respondents continue to tout POM Wonderful's cardiovascular research and benefits despite the negative results" of a study funded by POM sister company Roll International and published October 2009 in the American Journal of Cardiology.

That ³ study showed pomegranate juice had "no significant effect" on the overall progression of carotid intima-media thickness in subjects at moderate risk for coronary heart disease.

However, POM says it does not make drug claims for pomegranate and is only communicating to consumers the results of "promising research" on a nutritious food.

"It's a shame that the government is unable to understand this fundamental distinction, and instead is wasting taxpayer resources to persecute the pomegranate," the firm adds.

Seeking FDA/FTC Demarcation

POM Wonderful's complaint against FTC, filed Sept. 13 in federal district court in the District of Columbia, defends its investments in science and marketing that "reasonably relied upon a clear line of demarcation between the FDA and FTC."

However, the crux of FTC's complaint alleges POM's claims are prima facie false and misleading and is not an argument that the claims violate the Food, Drug & Cosmetic Act.

POM has separate FDA concerns on its plate. The firm received a warning letter Feb. 23 calling its pomegranate products misbranded foods as well as unapproved and misbranded drugs, based on claims found on its website (⁴ Also see "FDA's Flurry Of Food Claim Warnings Sends Bold Enforcement Message" - Pink Sheet, 8 March, 2010.).

FDA's Center for Food Safety and Applied Nutrition still awaits resolution of its warning to POM, a spokesman said.

POM's "Uphill Battle"

Attorney Marc Ullman said it seems that "POM has a hard row to hoe" in convincing FTC its health claims are derived from gold-standard clinical trials.

Still, the partner in Ullman, Shapiro & Ullman added it may be a calculated risk, given what other firms have had to surrender to FTC in recent settlements.

Iovate Health Sciences agreed to pay $5.5 million as part of a settlement with the commission announced in July regarding unsubstantiated supplement claims (⁵ Also see "Supplement Firms Must Calculate Risk From Claims To Survive - Attorneys" - Pink Sheet, 16 August, 2010.).

Jonathan Emord, of Emord & Associates in Clifton, Va., said "POM is mounting an uphill battle," but its lawsuit could give a court the chance to decide on whether FTC goes too far in presuming a company's claim false in the absence of scientific proof.

Ullman has said a ruling against POM on the merits of its suit could ultimately prove damaging to industry as a whole.

FTC Complaint Names Individuals, Too

FTC's complaint includes POM and Roll, as well as POM President Matthew Tupper and directors Lynda and Stewart Resnick, the couple that founded POM in 2002.

FTC gives the respondents notice that they are to appear before an administrative law judge on May 24, 2011. Should FTC consequently decide to seek consumer redress, a sizeable monetary penalty against POM could be at stake.

A separate consent ⁶ agreement reached with Mark Dreher, POM's former head of scientific and regulatory affairs and frequent spokesman, restricts Dreher from making unsubstantiated claims about food, drug or supplement products, pomegranate-based or otherwise.

Dreher left POM in May 2009 and now is president and chief scientific officer of Nutrition Science Solutions consultancy in Wimberley, Texas. He could not be reached for comment.

- Dan Schiff ( ⁷ d.schiff@elsevier.com )

POM Wonderful Defends Its Claims, Says FTC Action Is Persecution

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