You may have read recently that yogurt-manufacturer Dannon just lost a hefty lawsuit against the FDA and FTC. The federal agencies took the yogurt maker to court for making unsupported health claims.
That legal battle ended in a $21 million fine against Dannon. As well as a ruling to remove specific health claims on packaging and cease marketing its products in this way.
The first reaction – and the story carried in the popular press – is that this is a major win against big business. Two federal agencies joining together to take on a mega corporation and forcing it to be more honest in its advertising.
But if you look further than the headlines you will find a different story.
It’s a story about government agencies targeting small farms that are trying to sell simple, organic foods. It’s a story that keeps risky drugs on the market long after overwhelming evidence proves these drugs are dangerous. It’s a story that may end in your options being slashed. With you being forced to buy risky man-made drugs because you no longer have the choice of an all-natural and safe alternative.
How Dannon Fits into the Picture
Probiotics are big business. They’ve been credited with improving immunity and digestion.
Research shows they can fight off infectious diseases in the sick, the elderly, and children.
The World Health Organization says probiotic foods contain “live microorganisms which confer a health benefit.”
With so much to offer, probiotics provide a healthy alternative to antacids. This is where Dannon comes into the picture.
Dannon has produced a series of highly profitable yogurts under the banner of probiotics. These products offer natural health benefits. Namely… they improve digestion and immunity.
Probiotics Are a Booming Industry
The American College of Gastroenterology estimates that up to 100 million people in the U.S. suffer from digestive problems.
Evidence shows that probiotic foods can improve digestion.
This is why probiotics are such big business.
According to market research, world sales of probiotic and prebiotic foods reached $15.4 billion in 2008. The global market for probiotics is expected to grow to $19.6 billion by 2013.
Of these, probiotic foods are expected to reach $17 billion. And that market is mostly made up of dairy products such as yogurts and cultured drinks.
Dannon’s Dispute with Federal Agencies
Late last year, the FDA and FTC targeted Dannon. They demanded that it prove its health claims. So Dannon set up a clinical study to test the benefits of one of its yogurt drinks.
Dr. Daniel Merenstein headed up the study. He oversees research at Georgetown University School of Medicine. His results were published in the European Journal of Clinical Nutrition.
He found that the drink showed “promise in reducing overall incidences of illness.”
Further, common infections were 19 percent lower in children between three and six. And 24 percent lower for GI infections such as diarrhea, nausea, and vomiting.
“Children in school or daycare are especially susceptible to these illnesses,” says Dr. Merenstein. “We found differences in infection rates but not fewer missed school days.”
Both federal agencies reviewed his findings. And they declared that while the drink “may protect children slightly from GI illness, it has little effect on the quality of their daily life.”
New Rules Established
Fast forward to December 2010. Dannon is fined $21 million.
Dannon can no longer say that its yogurts reduce cold or flu. And the yogurt maker must remove the word “immunity” from all packaging.
It can advertise that its products relieve temporary irregularity – when it also states that three helpings a day are necessary to see this benefit.
And only when it can show two new, well-controlled human clinical studies that support these claims.
The most important ruling is the final one…
Any future claims made by Dannon must now get prior approval from the FDA.Agencies Broaden Role, Power
The decision is a major win for the FDA and FTC. It cements their role in which natural foods and products get approved.
James Prochnow is an attorney with New York law firm Greenberg Traurig. He specializes in food and dietary supplements.
And he says this decision is the first real sign that the FDA and FTC are upping their control over food and dietary supplements.
He says that health food companies will have to rethink their research and claims.
Which sounds like a good thing, right? Again, it’s two federal agencies looking out for the public good.
About Dr. Hadler
Dr. Nortin M. Hadler is a member of the American Society of Clinical Investigation. He studied at Yale and got his M.D. from Harvard Medical School. For the last 25 years he’s served as a faculty professor at the School of Medicine of the University of North Carolina. He continues to practice daily in the university’s hospitals.
But experts are convinced that it’s not as simple as that.
Dr. Nortin M. Hadler says it’s an agency attempt to keep natural health alternatives out of the drugs market.
“The Dietary Supplement and Health Education Act of 1994 permitted the unregulated sale of herbal products,” says Dr. Hadler. “Such substances are foodstuffs, not pharmaceuticals.”
He says this lawsuit is just another sign that the agencies are targeting alternative health remedies. And protecting the drug makers’ profits.
New Products Targeted
The Dannon lawsuit is not a one-off event. Experts say it’s an ongoing strategy to tackle the health-food industry.
And now there’s another lawsuit on the horizon.
The FTC has charged the makers of POM Wonderful 100% Pomegranate Juice with making unsubstantiated health claims. Specifically, that their products prevent heart disease.
“Any consumer who sees these products as a silver bullet against disease has been misled,” says David Vladeck. He’s the director of the FTC’s Bureau of Consumer Protection.
But the drinks maker says this isn’t true. And it’s filed a preemptive lawsuit against the FTC. It accuses the agency of setting new standards that subject natural foods and drinks to agency approval.
And the story doesn’t end there. The agencies have tackled whole-food groups. Why? Because they’ve promoted the health benefits of simple foods like walnuts and cherries.
The FDA sent a warning letter to a walnut maker. Simply for noting peer-reviewed studies on its website about the health benefits of walnuts.
These studies show that walnuts are a rich source of omega-3 fatty acids. Those acids may:
Help lower cholesterol.
Protect against heart disease and stroke.
Protect against some cancers.
- Ease arthritis.
The FDA didn’t challenge the truth behind those studies. Or question the benefits of walnuts or omega-3s.
It simply warned that these claims re-classify walnuts as “drugs.” As such, the company was in violation of the Federal Food, Drug, and Cosmetic Act.
But there was plenty of proof to support the company’s claims.
A reference page by the University of Maryland that documents over 65 scientific studies. All noting the benefits of omega-3 fatty acids.
A 2006 study by the Spanish Ministry of Health. The study shows walnuts improve heart health.
A 2009 article that compiled the results from a further 13 studies showing that walnuts build healthy hearts.
And beyond all the proof of their benefits… there is no evidence that walnuts pose any health risk.
But the FDA simply noted:
“Walnuts may not be legally marketed with the above claims without an approved new drug application.”
In other words, there may well be proof that walnuts offer health benefits. But if you want the public to know about them, you’ll have to submit a new application. Fund studies and tests… which costs money and time. Most small businesses just don’t have the resources.
Even if they do, there’s one final catch. The FDA can still veto your claims.
Instead, the walnut-grower dropped its claims from its website and advertising.
Job well done. The FDA took no further action.
The two important points to remember here are:
1) This all-natural food posed no threat to public health whatsoever.
2) The FDA had no doubts as to the credibility of the claims.
They simply chose to muscle in on a company promoting the benefits of a simple, organic food.
And this isn’t an isolated incident. Since 2006, the FDA has banned 29 other companies from making similar “claims.” This time about the health benefits of cherries.
Protecting the Drug Makers
Why are the agencies tightening up on natural health claims? Is it a genuine attempt to protect the public?
Dr. Hadler doesn’t think so. He says the FDA continues to approve pharmaceutical drugs for mass marketing. Despite weak evidence to support their safety claims.
“Lax definitions of effectiveness are the soft underbelly of the drug-evaluation process today,” says Dr. Hadler. “The application process is underwritten by the pharmaceutical firms. That places the FDA into a client role. Advisory panels are riddled with ‘experts’ with industry ties.”
And there is plenty of evidence of drugs being approved by the FDA. Drugs that later turn out to be risky or dangerous.
In fact, over a 25-year period, one in every 10 FDA approved drugs later turned out to be dangerous.
“Ten percent of all drugs approved by the FDA between 1975 and 1999 were withdrawn from the market because of [bad] reactions,” says Dr. Hadler.
Those drugs pose a real risk to the people taking them. But their effects can take years to develop. It often takes even longer for the FDA to investigate and get off the market. That whole time, the drug makers are earning millions.
There have been at least two big examples in the last three months:
The FDA recently banned a popular pain killer. Why? Because of overwhelming evidence of its dangers. But it took them 30 years and 5,000 lives to take action. (See the Undercover story here.)
- It has allowed drug companies like GlaxoSmithKlein to knowingly make useless and dangerous drugs. (Read our story here.)
So What’s Really Going On?
Why are these agencies clamping down on the natural health industry? Yet allowing dangerous drugs to stay on the market?
Karen B. Menzies is an attorney with California-based firm Robinson, Calcagnie, & Robinson.
She’s been at the forefront of drug product safety litigation for over a decade. She has an AV rating – the highest achievable rating for legal ability and ethical standards. That rating is peer-reviewed under the national legal directory. She’s also received a long list of accolades and awards including Lawyer of the Year by Lawyer’s Weekly USA, California Lawyer of the Year by California Lawyer magazine… and has made the Southern California Super Lawyers list for six years straight.
She has strong views about what’s really going on.
“This is an attempted power grab by the FDA,” says Menzies. “It’s a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have.”
Dr. Hadler agrees, saying it all comes down to money.
“There is so much at stake and so much money in play,” he says. “FDA-approved drugs are marketing exercises rather than attempts to test risk/benefit ratios.”
And he says that’s because the FDA is influenced by the drug makers.
“Many senior staff members are recruited from [the drugs] industry,” says Dr. Hadler.
And a further third of all FDA experts and consultants have industry ties.
“FDA regulations do not take exception to industry ties as long as they’re declared,” says Dr. Hadler. “Most are consulting arrangements, often for sizable sums.”
Dr. Hadler and his team have analyzed how these “arrangements” affect FDA approvals.
“Voting patterns suggest that advisors with conflicts vote against competitor products,” he says.
In other words, many of the FDA’s own experts are financially motivated to vote down alternative solutions. That’s because half of them are on drug companies’ pay rolls.
That means they have a financial interest in supporting prescription drugs. And limiting your access to alternative options.
There are plenty of ways for them to do this. They can keep the public ignorant of the health benefits of simple organic foods like cherries and walnuts.
They can also make it financially difficult for manufacturers to produce and market alternative health solutions and supplements.
One thing’s for sure. There will be further changes ahead. But we’ll be sure to keep you updated on this issue as it develops.
To your health,
NHD “Health Watch”