“The notion that people are making cancer treatment claims and preying on very vulnerable people and all they get is a warning letter?” Marc Ullman, an attorney in the firm Ullman, Shapiro & Ullman remarked to NutraIngredients-USA. “It’s inexplicable to me that FDA would not go directly to a seizure and/or an injunction.”
Claims before science
Puna Noni sells the juice of the Noni fruit, Morinda citrofolia, and supplements based on the juice, which has had a traditional use as a famine food in the tropical locations in which it grows. The company makes a wide variety of health claims for the juice, and has an extensive section on its website on cancer research connected to the botanical.
“We used to use Noni when I ran a health food store in the Virgin Islands,” said Roy Upton, founder of the American Herbal Pharmacopoeia. “We used to call it starvation food, because you’d have to be starving to eat it. We only used the leaves. The fruit falls off the tree and decays within hours to a gelatinous goo.”
Upton said he was not willing to dismiss any and all health claims associated with Noni, because he said he had not kept up on recent science into the botanical. But he did say that the claims seem to have gotten way out in front of the research.
“I would say that the product was based on marketing, it was not based on traditional use. At the time it first came out (more than 10 years ago, first pushed by a multilevel marketing company) there was not any science supporting its use as far as I knew, and I looked. At the same time, I would think it would have the same benefits you would get from any other fermented fruit drink,” he said.
In its warning letter, FDA cited numerous implied cancer claims made by company on its website. These claims were still on the website today depsite the warning letter. Among them was a testimonial by someone who identified himself as an MD who had this to say about the product’s effect on a patient who had metastized prostate cancer: “There is simply nothing else I am aware of that could possibly reduce Prostatic Specific Antigen from 55 (indicating uncontrolled cancer) to a normal 1.1, and DO IT IN JUST 2 WEEKS.”
Other subsections of the cancer research page are titled “Phytochemicals Reverse Cancer,” “Noni is a Treasure Chest of Phytochemicals,” and “How Noni Helps Fight off Cancer.”
FDA also cited the company for putting its products forward for a variety of other illegal health claims such as pain reduction, high blood pressure reduction, alleviation of depression and prevention of kidney and liver inflammation. Puna Noni did not respond to a request for comment in time for deadline.
FDA also cited the company for a number of GMP violations, chief among them that the company performed no identity tests on the Noni juice powder it used to manufacture its capsules. In addition, the company did not perform any finished product testing to make sure the capsules met specification and did not reserve any samples of each production lot as required by law.
A speed limit without enforcement
Taken together, the list of violations in the warning letter would seem to add up to a case for injunction, Ullman said.
“If they are not doing any identity testing, how do you know what you are making?” he asked.
“This is a clear example of FDA failing to protect public health by just sending a warning letter. The bottom line is where there is no enforcement, there is a category of people who will look at ways that they can take advantage of the rules. In order for any enforcement scheme to be effective there has to be a deterrent effect, and a warning letter doesn’t cut it,” Ullman said.