“With no dietingeat as you always have, knowing W8-B-Gone is at work, ‘around the clock’ attacking the fat in your body."
“Take just one capsule and lose up to 5 pounds in 4 days."
“With the convenient W8-B-Gone 4-capsule pack, you can lose up to 20 pounds in only 16 days."
FTC quoted the above statements in a lawsuit that symbolizes the agency’s years-long crackdown on unsubstantiated weight-loss claims. FTC has long viewed with skepticism claims that a dietary supplement can produce substantial weight loss without diet and exercise.
In November, FTC announced resolution of a case against marketers of W8-B-Gone and other weight-loss pills as part of a broader sweep against false and misleading advertising in the dietary supplement industry. The lawsuit was resolved under a stipulated order that bans the defendants from selling weight-loss programs, products and services, according to the agency.
Andrew Lustigman, a lawyer for the defense, declined to comment on the lawsuit; he said not all the defendants have settled the case.
FTC also announced a lawsuit against Sunrise Nutraceuticals LLC, which has marketed a product (Elimidrol) targeting consumers who are seeking to withdraw from opiates. One of the Elimidrol advertisements quoted in the lawsuit proclaimed, “America’s #1 scientifically formulated detox support supplement that will provide you with the strength and comfort to successfully overcome withdrawal by alleviating the intense mental and physical discomfort during the process."
Such statements, FTC alleged, are not substantiated, and therefore are false and misleading. “The FTC takes the position that such claims [noted in the lawsuit] must be backed by pharmaceutical-level clinical trials," the Boca Raton, Florida-based company said in an email to Natural Products INSIDER. “Sunrise Nutraceuticals admits no wrongdoing, but at this time is cooperating with FTC and has chosen to discontinue its claims regarding symptoms of opiate withdrawal."
The advertisements, legal experts said, would possibly attract the attention of FDA as well.
“It kind of begs the question, where has the FDA been on this one?" observed Justin Prochnow, a shareholder in Denver with Greenberg Traurig LLP, in a phone interview. “You can’t sell a dietary supplement to treat addiction. Addition is deemed by FDA to be a sign or symptom of a disease condition. This FTC action could generate some more attention and raise some issues from the FDA standpoint as well."
Steven Shapiro, Of Counsel to Rivkin Radler LLP, characterized the opiate withdrawal ads as drug claims. “If you want to make drug claims, as far as the FDA is concerned, the product is an unapproved new drug," the New York-based lawyer said in a phone interview. And FTC takes the position that such claims must be substantiated by two randomized clinical trials, Shapiro added.
Green Coffee Bean
A separate lawsuit highlighted by FTC may never have been brought had it not been for a celebrity television personality. Dr. Mehmet Oz created a buzz during an April 26, 2012, episode of his show. Green coffee extract, Oz proclaimed, was a “magic weight loss cure for every body type."
Within weeks of the episode airing, defendants named in the 2014 FTC lawsuit began selling a dietary supplement that purportedly contained a green coffee bean extract. Advertising campaigns touting “Pure Green Coffee" were a success, with sales of 536,000 bottles at US$48 per bottle since May 2012, according to the government’s complaint.
FTC, however, cited a litany of false and misleading statements in the advertisements, including a failure to make certain disclosures.
“Hi guys, I’m Amy. I was looking for something that would help me lose a bit of weight, and I came across Pure Green Coffee," one testimonial quoted in the lawsuit said. “It’s a weight loss supplement. And I’ve had it for three weeks now and, honestly, I can say, it has shown me amazing results. I used to struggle to lose weight, but, honestly, this works miracles."
The testimonial and others like it, FTC noted, failed to reveal the people in them didn’t buy the product; instead, they were paid $200 and given a 30-day supply in exchange for their video testimony, none of which was disclosed.
The lawsuit also referenced various “news" websites promoting Pure Green Coffee. For instance, Helen Hasman, a supposed health and diet writer with Women’s Health Journal, claimed she “lost 27 pounds in nine weeks, with No special Diet, and No Exercise." The journalistand her storyare made up, according to the government.
“Reporters or commentators pictured on the sites are fictional," the FTC lawsuit asserted, “and they never conducted the tests or experienced the results described in the reports."
In support of their claims, the defendants referenced a green-coffee antioxidant study that involved 16 overweight subjects who were randomly assigned to three different treatment sequences. According to the study conducted in Bangalore, India, at the end of 22 weeks, the 16 subjects shed, on average, 17.7 pounds, 10.5 percent of their body weight and 16 percent of their body fat.
But FTC identified a number of deficiencies in the study, chiefly among them that most of the weight loss (10.5 pounds, on average) occurred outside treatment. FTC also said the study didn’t disclose whether the subjects exercised during the study.
On Nov. 17, 2015, the government announced a stipulated court order settled the charges against several of the individuals and companies named in the purported scheme.
“People looking for a dietary supplement to improve their health have to wade through a swamp of misleading ads," said Jessica Rich, director of FTC’s Bureau of Consumer Protection, in a statement commenting on the three cases above. “Be skeptical of ads for supplements that claim to cure diseases, reverse the signs of aging, or cause weight loss without diet or exercise."
Shyamie Dixit, who electronic court records list as counsel for a number of the defendants, didn’t respond to a request for comment.