January 4, 2010
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The pomegranate juice and supplement products maker alleges that, by requiring health claims pass muster under the Food, Drug & Cosmetic Act, FTC impinges on Food and Drug Administration (FDA) authority. The Los Angeles company also takes exception with FTC’s requirement that firms conduct at least two “well-controlled” clinical studies to support health claims, calling it “a dramatic turn in the level of substantiation” and a further violation of a marketer’s First Amendment rights, reported The Tan Sheet.
According to plaintiff’s counsel Barry Coburn of Washington-based Coburn & Coffman, at stake is POM’s freedom of speech and its “investments in its science program and marketing strategy that reasonably relied upon a clear line of demarcation between the FDA and FTC.”
Though the FTC’s stance on claims may be troubling to supplement manufacturers and industry supporters, Anne Maher, partner at Kleinfeld, Kaplan & Becker and formerly of FTC’s Advertising Practices Division, said in a statement that POM essentially is disputing a non-existent standard, since the commission is considering claims on a case by case basis through consent orders and not via a rulemaking. “There’s other ways they can exert pressure on the Commission, but I don’t see it as a legal matter [challengeable] as an industry-wide rule; that’s not what it is,” she said.
For the dietary supplement industry, which relies heavily on its ability to make claims when appropriate, heavy repercussions could result from the ruling of this case—whether the outcome is in favor or against POM Wonderful.
According to Marc Ullman of New York law firm Ullman, Shapiro & Ullman, if FTC were to put such a policy into place through an Advertising Guide or Notice and comment rulemaking, it could potentially suppress the vast majority of claims being made for supplements. In addition, he said in an article for Natural Products Insider, “Should POM lose this litigation on the merits, the next time the proponents of expanded FTC powers seek to grant the Commission unfettered rulemaking powers, it will be able to counter industry objections by pointing to a federal court decision upholding the very practices the industry is objecting to. The long-term implications of such an outcome may be very serious indeed.”
The FTC complaint, on the other hand, charges that POM Wonderful LLC violated federal law by making deceptive disease prevention and treatment claims. The ads in question appeared in national publications; on internet sites such as pomtruth.com, pomwonderful.com and pompills.com; on bus stops and billboards; in newsletters to customers; and on tags attached to the product.
“Any consumer who sees POM Wonderful products as a silver bullet against disease has been misled,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “When a company touts scientific research in its advertising, the research must squarely support the claims made. Contrary to POM Wonderful’s advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses.”POM’s owners, Lynda and Stewart Resnick of Los Angeles, plan to contest the charges. “We stand behind the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranate,” the company said in a statement. “Our research is unprecedented among food and beverage companies, and we take pride in having initiated a program of modern scientific research to investigate the health benefits of this ancient and revered fruit.”
John Gay, president of the Natural Products Foundation, led the meeting, which focused on 12 companies that did not respond to the Natural Products Foundation’s notice of advertising non-compliance.
“Through the Foundation’s Truth in Advertising Program, we identify cases of non-compliant dietary supplement advertising and attempt to assist the companies involved in correcting their ads,” said Gay. “However, when companies refuse to bring their advertising into compliance, direct regulatory action needs to be taken.”
The Foundation’s Truth in Advertising program has issued 55 warning letters since January. Most companies receiving the letters have responded in a positive fashion, correcting problems identified by the Foundation, it reported. During the meeting with FTC representatives, Gay discussed the Foundation’s willingness to lead the self-regulatory program. Gay also discussed the need for support from the FTC to address problems that could not be resolved in a collegial manner. “The Natural Product Foundation’s primary goal throughout this effort is to work with industry members and raise the overall standard of dietary supplement advertising,” said Derek Hall, board chair of the Foundation. “The Truth in Advertising Program provides a much needed self-regulatory and educational presence in the world of dietary supplement advertising.”
Information is available on the Foundation’s website to assist companies in need of guidance, available here. Companies that want to proactively become members of the Truth in Advertising program can take the foundation’s pledge here.